Journal of Physiotherapy 62 (2016) 124–129 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research Additional weekend therapy may reduce length of rehabilitation stay after stroke: a meta-analysis of individual patient data Coralie English a,b,c, Nora Shields d,e, Natasha K Brusco d,f, Nicholas F Taylor d,g, Jennifer J Watts h, Casey Peiris d, Julie Bernhardt i, Maria Crotty j, Adrian Esterman k,l, Leonie Segal m, Susan Hillier c a School of Health Sciences, University of Newcastle; b University of Newcastle Priority Research Centre for Stroke and Brain Injury, Hunter Medical Research Institute, Newcastle; c International Centre for Allied Health Evidence, Sansom Institute of Health Research, University of South Australia, Adelaide; d School of Allied Health, La Trobe University; _]4[TD$eFI Northern Health; [D6_f]FTI$ Physiotherapy Services, Cabrini Health; $DITF]g8[_ Allied Health Clinical Research Office, Eastern Health, Box Hill; h DFC$]I_9[T entre for Population Health Research, Deakin Health Economics, D]1F0_TD$I[ eakin University; i Stroke Division, Florey Institute of Neuroscience and Mental Health, Austin Campus, IT[2D$M]F_3 elbourne; j Department of Rehabilitation and Aged Care, Flinders UniversityF3_I]D,[$T Bedford Park$]TD4IF[_3 Campus; k Division of Health Sciences, University of South Australia, Adelaide; l Australian Institute of Health and Tropical Medicine, James Cook University, Cairns; m Health Economics and Social Policy, Health Economics and Social Policy Group, Division of Health Sciences, University of South Australia, Adelaide, Australia KEY WORDS ABSTRACT Physical therapy Questions: Among people receiving inpatient rehabilitation after stroke, does additional weekend Occupational therapy physiotherapy and/or occupational therapy reduce the length of rehabilitation hospital stay compared to Rehabilitation those who receive a weekday-only service, and does this change after controlling for individual factors? Stroke Does additional weekend therapy improve the ability to walk and perform activities of daily living, Weekend therapy measured at discharge? Does additional weekend therapy improve health-related quality of life, measured 6 months after discharge from rehabilitation? Which individual, clinical and hospital characteristics are associated with shorter length of rehabilitation hospital stay? Design: This study pooled individual data from two randomised, controlled trials (n = 350) using an individual patient data meta-analysis and multivariate regression. Participants: People with stroke admitted to inpatient rehabilitation facilities. Intervention: Additional weekend therapy (physiotherapy and/or occupational therapy) compared to usual care (5 days/week therapy). Outcome measures: Length of rehabilitation hospital stay, independence in activities of daily living measured with the Functional Independence Measure, walking speed and health-related quality of life. Results: Participants who received weekend therapy had a shorter length of rehabilitation hospital stay. In the un-adjusted analysis, this was not statistically significant (MD –5.7 days, 95% CI –13.0 to 1.5). Controlling for hospital site, age, walking speed and Functional Independence Measure score on admission, receiving weekend therapy was significantly associated with a shorter length of rehabilitation hospital stay (b = 7.5, 95% CI 1.7 to 13.4, p = 0.001). There were no significant between-group differences in Functional Independence Measure scores (MD 1.9 points, 95% CI –2.8 to 6.6), walking speed (MD 0.06 m/second, 95% CI –0.15 to 0.04) or health-related quality of life (SMD –0.04, 95% CI –0.26 to 0.19) at discharge. Discussion: Modest evidence indicates that additional weekend therapy might reduce rehabilitation hospital length of stay. Clinical Trial Registration: ACTRN12610000096055, ACTRN12609000973213. [English C, Shields N, Brusco NK, Taylor NF, Watts JJ, Peiris C, et al. (2016) Additional weekend therapy may reduce length of rehabilitation stay after stroke: a meta-analysis of individual patient data. Journal of Physiotherapy 62: 124–129] ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction rehabilitation after stroke. One trial,4 referred to here as the Saturday trial, investigated the effectiveness of additional physio- Rehabilitation for people who have had a stroke is expensive, therapy and occupational therapy services provided on Saturdays, costing an estimated AUD150 million per year in Australia.1F[I]92_D$T One of compared to usual care for people with a range of diagnoses, the most powerful ways of reducing cost is reducing the number of including stroke. The other trial,5 referred to here as the CIRCIT days spent in hospital.2 Providing therapy services on weekends trial, included only participants with stroke, and included three has become a more common part of usual care for rehabilitation arms: weekend physiotherapy services provided on Saturdays and facilities in Australia,3 although until recently there was little Sundays; group circuit class therapy provided 5 days per week; and published evidence to support its clinical effectiveness or impact usual care physiotherapy. In both trials, participants receiving on length of rehabilitation hospital stay. weekend therapy had a shorter mean length of rehabilitation hospital stay (by 2 days4 and 3 days5), compared to usual care Two recent, large, randomised, controlled trials investigated the consisting of therapy 5 days per week. However, in both trials, the effectiveness of weekend therapy services for people during http://dx.doi.org/10.1016/j.jphys.2016.05.015 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Research 125 between-group difference in length of rehabilitation hospital stay activities of daily living (FIM scores) and health-related quality of did not reach statistical significance. life were made 4 weeks after randomisation (CIRCIT trial), at discharge from rehabilitation (Saturday trial), and at approximately Individual patient data meta-analyses provide the opportunity 6 months after discharge (in both trials). Health-related quality of to pool data from trials at a participant level, resulting in greater life was measured with the Australian Quality of Life tool in statistical power to test secondary hypotheses more conclusively the CIRCIT trial and the EQ5D-3L tool in the Saturday trial. The and to conduct further exploratory analyses.6]3[_TD$6IF The aim of the average time post-randomisation for the discharge assessment present study was to conduct an individual patientT6D$3I][_F data meta- point in the Saturday trial for people with stroke was 34 days (SD analysis, combining data from the CIRCIT and Saturday trials, to 23)[D1IT$F];2_ therefore, these data were pooled with the 4-week data from investigate the effectiveness of providing additional weekend the CIRCIT trial. therapy services to people with stroke, compared to usual care in the Australian context. Data analyses Therefore, the primary research question for this study was: Data were pooled from the CIRCIT trial (all participants from the usual care group and the group that received therapy 7 days per 1]FID$T_73[ . Among people receiving inpatient rehabilitation after stroke, week) and the Saturday trial (participants with a diagnosis of does additional weekend physiotherapy and/or occupational stroke from the usual care group and from the group that received therapy reduce length of rehabilitation hospital stay compared additional therapy on Saturdays). Univariate analyses (Chi- to those who receive a weekday-only service, and does this squared or Fisher’s exact test for categorical variables, t-tests or change after controlling for individual factors? Mann-Whitney U for continuous variables) were used to compare participant characteristics at baseline between the two trials, and The secondary research questions were: outcomes between intervention and control groups in the pooled dataset. Descriptive statistics were used to summarise the average 1FID$T_83[] . Does additional weekend therapy improve the ability to walk weekly (Monday to Friday) therapy time provided to the usual care and to perform activities of daily living, measured at discharge? groups in the two trials, and the amount of additional weekend therapy provided. As length-of-stay data were not normally 2]FID$T_93[ . Does additional weekend therapy improve health-related distributed, the between-group difference was first examined quality of life, measured 6 months after discharge from using a Mann-Whitney U test. Independent t-tests were also rehabilitation? conducted to determine the mean differences and 95% confidence intervals (CI) to allow interpretation of the size of effect. ID$T_04[F]3. Which individual, clinical and hospital characteristics are Multivariate regression was used to explore the independent associated with shorter length of rehabilitation hospital stay? effect of providing weekend therapy services on rehabilitation length of hospital stay. A theoretically based model, which Method included factors known to influence length of hospital stay, was developed. As it was a secondary analysis of existing data, the Design choice of variables was constrained by the data available. Therefore, these participant factors were included: age, gender, Both trials were Phase-III multicentre, randomised, controlled co-morbidities, and baseline walking speed and FIM score. As trials with concealed allocation and blinded assessment of length of rehabilitation hospital stay differed both between trials outcomes. The full trial protocols have been published else- (CIRCIT versus Saturday trial), and across hospital site within the where.7,8 Randomisation in both trials, across seven hospital sites, trials, both of these factors were also included in the model, and occurred within 1 week of admission to rehabilitation. collinearity between variables within the model was assessed. Between-group differences in self-selected walking speed and Participants independence in activities of daily living (FIM scores) were examined using Mann-Whitney U tests (as data were not normally Briefly, the inclusion criteria for people with stroke in the CIRCIT distributed), and independent t-tests (to allow for interpretation of trial were: diagnosed stroke of moderate severity, defined as a the size of the effect). Analyses were conducted using commercial Functional Independence Measure (FIM) total score between 40 and 80 points or a motor subscale score between 38 and 62 points; and softwarea$I[F1]D4_T with significance set at a = 0.05. As health-related ability to mobilise independently prior to their stroke. There were no stroke-specific inclusion criteria for the Saturday trial. quality of life data were collected using two different tools, group data (means and standard deviations) were pooled in meta- Interventions analysis softwareb using[F1DI4_T]$ a fixed-effect modelDF4]I$2[T_ and reported as a standardised mean difference. A fixed-effect model was chosen In the CIRCIT trial, participants allocated to the 7-day arm because heterogeneity between the trials was assumed to be low. received additional physiotherapy services on Saturday and Sunday. This assumption was verified by checking heterogeneity using the In the Saturday trial, participants in the intervention arm received I2DT_31[$IF] statistic. additional physiotherapy and occupational therapy on Saturdays only. In both trials, usual care participants received physiotherapy Results and occupational therapy Monday to Friday only. The treating therapists recorded the amount of therapy time received by Flow of participants through the study participants in both trials. In the CIRCIT trial, therapists recorded the time that participants spent in physiotherapy sessions on trial- All participants that were randomised to therapy 7 days a week specific data sheets, up to the first 4 weeks of their rehabilitation stay. (n = 96) or usual care (n = 94) in the CIRCIT trial, and all In the Saturday trial, therapy time was recorded as part of routine participants in the Saturday trial with a diagnosis of stroke (usual hospital data collection procedures for the entire length of stay. care n = 79, weekend therapy n = 81) were included in the pooled analysis. Figure 1 presents the flow of participants through the Outcome measures trials. Table 1 compares baseline characteristics of all included participants. Table 2 compares baseline differences between usual Length of rehabilitation hospital stay was defined as the number care and weekend therapy participants for the pooled dataset. of days between admission to, and discharge from, the rehabilita- tion facility. Measures of walking speed and independence in
]GIF$DT)1_erugi([126 English et al: Weekend therapy for stroke rehabilitation CIRCIT trial Saturday trial (n = 190) (n = 160) Pooled data (n = 350) Baseline Weekend therapy Usual care (n = 177) (n = 173) Week 4/discharge Weekend therapy Usual care (n = 169) (n = 167) Month 6 Weekend therapy Usual care (n = 140) (n = 143) Figure 1. Flow of participants through the included studies. Reasons for loss to follow-up are reported in the main results papers of the included trials.4,5 Table 1 Baseline characteristics of participants, amount of therapy received and length of stay, by trial. Characteristic CIRCIT (n = 190) Saturday trial (n = 160) MD (95% CI)a2_]F[D$T1I or p-value for Chi2 test Age (y), mean (SD) range 70 (13) 23 to 91 75 (12) 36 to 92 5 (2 to 7) Gender, n male (%) 111 (58) 86 (54) 0.22 First stroke, n (%) 153 (81) 0.11 Living prior to admission, n (%) 129 (81)bDIF]$T_2[ 1.0 183 (96) home 6 (3) 150 (94) 0.001 residential aged care/other 1 (1) 5 (3) missing 5 (3) 5 (1 to 10) Charlson co-morbidity index score, ]ID8F[n_T$1 (_T$D9IF%[1] ) 89 (47) 6 (2 to 9) 0 53 (28) 51 (32) 1 48 (25) 38 (24) 0.11 >1 66 (16) 40 to 112 71 (44) 0.20 (0.11 to 0.29) FIM total (18 to 126), mean (SD) range 41 (3) 15 to 78 72 (25) 19 to 123 133 (113 to 154) FIM motor (13 to 91), mean (SD) range 96 (51) 46 (21) 13 to 88 Participants unable to walk, n (%) 0.43 (0.24) 0.05 to 1.20 76 (48) 41 (33 to 49) Gait speed of those able to walk (m/s), mean (SD) range 134 (75) 19 to 483 0.63 (0.34) 0.09 to 1.92 –24.4 (–17.6 to –31.2) Weekday therapy time (min/wk), mean (SD) range 36 (23) 0 to 140 267 (115) 28 to 595 Extra weekend therapy time (min/wk), mean (SD) rangecDT$_2[]FI 58.6 (37.6) 14 to 240 76 (32) 0 to 168 Length of stay (d)dT2]F_ID$[ 34.1 (23.2) 4 to 119 a MD is calculated as Saturday trial minus CIRCIT.]FID$T02[_ b Participants with previous hemiplegia as recorded by the Charlson co-morbidity index2.][DI$1_TF c For the CIRCIT trial this is physiotherapy time provided Saturday and Sunday. For the Saturday trial this refers to physiotherapy and occupational therapy time provided on SaturdaysD_2F.]TI[$ d 12 participants had missing data for length of stay in the CIRCIT trial$D[2T_I.3F] FIM = Functional Independence Measure_TD4[IF$2]. CIRCIT versus Saturday trial was 76FID$T_84[] minutes/week (SD 32)15_D$IT[F]. The mean difference was 41D$_TIF]4[9 minutes[T_D/]F$I05 week (95% CI 33 to 50). Participants in the Saturday trial had higher FIM scores on admission to rehabilitation, suggesting that they were less Additional weekend therapy compared to usual care disabled than those in the CIRCIT trial. A similar proportion of participants in both trials were able to walk at admission to Pooling the individual data, participants receiving weekend rehabilitation, and of those able to walk, the average walking speed therapy had, on average, 5.7 days shorter length of rehabilitation was faster in the Saturday trial participants. Significantly more hospital stay, although in the unadjusted model this difference did people in the Saturday trial had at least one co-morbidity. not reach statistical significance (T$1[IF5_]MD D –5.7 days2_,F5ITD[]$ FI9[16_D$T] 5% CI –13.0 to 1.5, 90% CI –11.8 to 0.335TD_]FI)$[ , as shown in Table 3. The multivariate Participants in the CIRCIT trial received an average of 134F$DI[T]_34 regression model showed that age, baseline FIM score, baseline minutes/week (SD 75)[15_TD$FI] of physiotherapy during weekdays. This was walking speed, hospital site and treatment group (weekend significantly less than the 267T4[D$IF]_ minutes/week (SD 115)5_[TD$]FI1 of therapy versus usual care) all contributed significantly to length physiotherapy provided during weekdays in the Saturday trial of rehabilitation hospital stay (Table 4). As there was co-linearity (mean difference 133$D]FT_54I[ minutes]4[/6_TD$IF week, 95% CI 113 to 154). The between trial and hospital site, the model was first tested with trial CIRCIT trial participants in the intervention arm received an only, then with hospital sites only. Including hospital sites average of 36F_TI[$]74D minutes/week (SD 23)T[]$_FDI15 of additional weekend explained more of the variance (adjusted r2 0.386 versus 0.356); physiotherapy. Again, this was significantly less than the average therefore, the final model included dummy variables for hospital additional therapy (physiotherapy and occupational therapy) sites. Controlling for all these variables, randomisation to the provided to intervention participants in the Saturday trial, which
Research 127 Table 2 Exp (n = 177) Baseline characteristics of participants by group. 73 (12) 36 to 91 Characteristic Con (n = 173) 104 (59) 169 (97) Age (y), mean (SD) range 72 (13) 23 to 92 68 (38) Gender, n male (%) 93 (54) 67 (21) 19 to 118 Living at home prior to admission, n (%) 164 (95) 42 (17) 13 to 88 No important co-morbidities, n (%)a[2FDT]I$_ 72 (42) 0.51 (0.31) 0.05 to 1.61 FIM total (18 to 126), mean (SD) range FIM motor (13 to 91), mean (SD) range 70 (21) 21 to 123 Gait speed of those able to walk (m/s), mean (SD) range 45 (18) 13 to 88 0.55 (0.31) 0.10 to 1.90 a Charlson co-morbidity index = D052T]FI[$_ . Con = control group (usual care only), Exp = experimental group (extra weekend therapy), FIM = Functional Independence Measure2.4]D[FTI$_ Table 3 Mean (SD) range of continuous outcomes by group, and mean difference (95% CI) between groups. Outcome Con (n = 173) Exp (n = 177) MD (95% CI)a[2]D$FIT_ Exp minus con Length of stay (d) 49.9 (36.7) 6 to 240 44.1 (30.7) 4 to 199 –5.7 (–13.0 to 1.5) Gait speed of those able to walk at 4 wk/dischargebI[T]_DF$2 (m/s) 0.71 (0.45) 0.07 to 2.27 0.65 (0.40) 0.07 to 2.08 –0.06 (–0.16 to 0.04) FIM total at 4 wk/dischargebF]2D[$I_T (18 to 126) 95 (22) 18 to 125 97 (22) 26 to 126 2 (–3 to 7) FIM total at 6 months (13 to 91) 102 (22) 33 to 126 102 (23) 22 to 126 0 (–5 to 5) a All comparisons were non-significant on Mann-Whitney U tests.IDFT$_[]26 b At discharge in the Saturday trial and at 4 weeks in CIRCIT[F27_$].TID Con = control group (usual care only), Exp = experimental group (extra weekend therapy), FIM = Functional Independence MeasureIDF$T_]42[. Table 4 Multivariate regression analysis of factors associated with length of hospital stay. Independent variable Unstandardised ß (SE) 95% CI for ß Standardised ß p-value Group 7.5 (3.0) 1.7 to 13.3 0.111 0.011 FIM total at baseline –0.4 (0.1) –0.6 to –0.2 –0.263 < 0.001 Walking speed at baseline (m/s) –23.1 (5.7) –34.3 to –11.9 –0.226 < 0.001 Age (y) –0.3 (0.1) –0.6 to –0.1 –0.125 Female –4.9 (3.1) –10.9 to 1.1 –0.710 0.006 CCI = 1 –3.5 (3.7) –10.8 to 3.9 –0.045 0.112 CCI > 1 –2.9 (3.6) –10.0 to 4.1 –0.041 0.354 Hospital site 1 3.1 (4.5) –5.8 to 11.9 0.035 0.412 Hospital site 3 18.8 (4.0) 11.0 to 26.6 0.252 0.490 Hospital site 4 66.2 (11.6) 43.4 to 89.1 0.259 < 0.001 Hospital site 5 20.0 (5.5) 9.2 to 30.8 0.176 < 0.001 Hospital site 6 11.5 (6.4) –1.3 to 24.2 0.082 < 0.001 Hospital site 7 11.9 (8.0) –3.8 to 27.6 0.068 0.077 0.136 CCI = Charlson co-morbidity index, where the referent is Charlson co-morbidity index = 0, a CCI of 1 means one co-morbidity, and CCI > 1 means 2 or more co-morbidities; FIM = Functional Independence Measure]T_.8FID$2[ Hospital sites were entered as dummy variables; the referent is Hospital 2. The variables of trial (CIRCIT vs Saturday trial) and hospital site had high collinearity, therefore the variable of trial was removed from the model. reug_4)D$FIG][(iT weekend therapy group was found to be an independent predictor Study SMD (95% CI) of shorter rehabilitation hospital length of stay (MD 7.5 days, 95% English5 Fixed CI 1.7 to 13.4), accounting for 39% of the variance in length of Peiris4 rehabilitation hospital stay. Pooled The FIM scores at discharge/4 weeks were not different between usual care and weekend therapy participants (MD –2 –1 0 1 2 1.9 points, 95% CI –2.8 to 6.6). At the same time point, walking speed was also not significantly different between the groups (MD Favours con Favours exp –0.06 m/second, 95% CI –0.15 to 0.04); see Table 3. Similarly, there Figure 4. Standardised mean difference (95% CI) of the pooled effect of adding extra w]FID$T_5[[(Figure_2)TD$IG] as no significant between-group ]dFI[56D_T$ ifference in FIM scores at weekend therapy on health-related quality of life at 6 months. Con = control group = usual care; Exp = experimental group = extra weekend Study SMD (95% CI) therapy. English5 Fixed Peiris4 6 months (MD 0 points, 95% CI –5 to 5). There was no significant Pooled difference between usual care and weekend therapy participants in health-related quality of life at discharge/4 weeks (SMD –0.04, –2 –1 0 1 2 95% CI –0.26 to 0.19, I24_T5D[]FI$ = 0%), as shown in Figure 2. For a more detailed forest plot, see Figure 3 on the eAddenda. At 6 months, Favours con Favours exp there was a trend toward participants who received usual care therapy to report a higher quality of life compared to participants Figure 2. Standardised mean difference (95% CI) of the pooled effect of adding extra who received weekend therapy (standardised mean difference – weekend therapy on health-related quality of life at discharge/4 weeks. 0.17, 95% CI –0.41 to 0.06, I2 = 0%), as shown in Figure 4. For a more Con = control group = usual care; Exp = experimental group = extra weekend detailed forest plot, see Figure 5 on the eAddenda. therapy.
128 English et al: Weekend therapy for stroke rehabilitation Discussion used in the two trials, however, data could not be pooled at an individual level. When data were pooled in a traditional meta- Pooling data from two Australian rehabilitation trials in an analysis utilising standardised mean differences to account for individual patient data meta-analysis identified that partici- differences between the outcome measures used, there was no pants who received additional therapy services on the weekend significant between-group difference in health-related quality of had an average shorter length of rehabilitation hospital stay of life at discharge from hospital, and a trend toward better quality of 5.7 days. Despite the increased sample size, this difference was life for participants who received usual care therapy at 6 months. still not statistically significant in an unadjusted analysis. When Given the large amount of missing data at 6 months, this result analysis was adjusted to control for person-related factors should be interpreted with caution. known to influence recovery trajectories (severity of disability, age, co-morbidities) and health service-related factors (hospital The present study has shown the value of using individual site), a significant and independent association was found patient meta-analyses, and the complexities and challenges with between weekend therapy provision and shorter length of such an approach. Despite having very similar a priori hypotheses, rehabilitation hospital stay. The difference in the outcome for there were only three common outcome measures across the two the adjusted and unadjusted analysis highlights that there is not trials (length of rehabilitation hospital stay, FIM and walking a simple causal pathway between increased weekend therapy speed). Lack of commonality in outcome measures is a real issue service provision and rehabilitation hospital length of stay. This for rehabilitation trials. An exploration of the Virtual International is not surprising. It is known that there are many complex, Stroke Trial Archives (VISTA) database in 2012 found that there interrelated factors that influence when someone is discharged were 69 different outcome measures used across 38 rehabilitation from a rehabilitation hospital. The present model was not trials.13 Twenty-five (36%) of these measures were used in only one perfect, in that it explained only 38% of the variance in length of trial. Reaching consensus in outcome measures is a fraught issue, stay. This is because it was limited by the data collected in the but one that must be tackled to enable future pooling of trial data. original two randomised, controlled trials. There were other The first Stroke Recovery and Rehabilitation Roundtable is factors that were likely to have influenced rehabilitation currently working on consensus statements regarding measure- hospital length of stay, including: additional person-related ment in clinical trials.14 factors (cognition, depression, fatigue), social factors (availabil- ity of a carer, home environment, financial issues) and hospital Controlling for person-related and hospital system-related system-related factors (accessibility of outpatient services, factors, some evidence of benefit for providing weekend therapy discharge planning practices). services on length of rehabilitation hospital stay was found, with a resultant possibility of cost savings to the healthcare system. This The present results confirm that there is considerable work highlighted what could be achieved with collaboration variability in length of rehabilitation hospital stay for people between trialists. with stroke. It was found that participants with slower walking speeds and those requiring more assistance with activities of What is already known on this topic: Provision of weekend daily living on admission to rehabilitation had a longer length of therapy for people in inpatient rehabilitation after stroke varies rehabilitation hospital stay. This was not surprising and was nationally and internationally. Trials of additional weekend consistent with other research findings.9,10 In the present physiotherapy are promising but inconclusive about the effect analysis, it was found that the hospital in which people with on length of stay. stroke received their rehabilitation care contributed significantly What this study adds: Unadjusted pooling of individual to the variance in length of rehabilitation hospital stay. The key patient data from existing trials does not identify a significant factors that drive variation in length of stay are unknown, but improvement in length of stay. When the analyses were may include: hospital and health service policies and practices; adjusted for important patient-related factors and hospital site, the level of demand for access to rehabilitation centres; the time there was significantly shorter average length of stay in the taken for approval and completion of essential home modifica- rehabilitation hospital for people receiving additional weekend tions; access to funding for carer and domiciliary support; and therapy. access to ongoing therapy services. Identifying the key factors driving variation in length of stay is likely to be a complex task, Footnotes: a SPSS Statistics Version 21, IBM Corp, Armonk, USA. but is one that is vital to understanding how to improve the cost b Review Manager Version 5.3, The Cochrane Collaboration, effectiveness of care for people with stroke. Without a thorough Copenhagen, Denmark. understanding of what the key service-related factors are, and how to control them, the impact of changes in clinical care eAddenda: Figures 3 and 5 can found at doi:10.1016/j.jphys. provision on length of rehabilitation hospital stay will not be 2016.05.015. accurately determined. Ethics approval: Ethical approval for the CIRCIT trial was This was an exploratory secondary analysis of clinical trial granted by the University of South Australia Human Research data and should be considered hypothesis-generating rather Ethics Committee, Southern Adelaide Health Service/Flinders than definitive evidence of cause and effect. While a full cost- University Clinical Research Ethics Committee, Sir Charles effectiveness analysis was not conducted, the results lend Gardiner Group Human Research Ethics Committee, Royal weight to the economic argument for implementing weekend Adelaide Hospital Research Ethics Committee, Central Northern therapy. Average rehabilitation bed-day costs vary between and Adelaide Health Service Ethics of Human Research Committee and within countries. Based on 2013 estimates of bed-day costs in the St Vincent’s Hospital Human Research Ethics Committee. the two main states of Australia in which the CIRCIT and Ethics approval for the Saturday trial was granted from the Eastern Saturday trials were conducted,11 a reduction of between 5 and Health Research and Ethics Committee and La Trobe University 7 days represents a cost-saving of between AUD4855 and Human Research Ethics Committee. All participants (or their AUD6797 in South Australia and between AUD3770 and proxy) in both trials provided informed written consent prior to AUD5278 in Victoria. These savings would need to be offset data collection. against the cost of providing weekend therapy. These findings are in line with the published cost-effectiveness evaluation of Competing interest: Nil. the Saturday trial.12 Source of support: The CIRCIT trial was funded by National Health and Medical Research Council Grant 631905. The Saturday Health-related quality of life is an important outcome to be trial was supported by National Health and Medical Research included in rehabilitation trials, and both the CIRCIT and Saturday Council Partnership Grant 541958. trials measured this construct. Because different instruments were Acknowledgement: Nil. Provenance: Not invited. Peer reviewed.
Research 129 Correspondence: Coralie English, School of Health Sciences, 7. Hillier S, English C, Crotty M, Segal L, Bernhardt J, Esterman A. Circuit class or seven- University of NewcastleT[$DI_F1,]7 _NDT5$]F7[I ewcastle, Australia. Email: Coralie. day therapy for increasing intensity of rehabilitation after stroke: protocol of the [email protected] CIRCIT trial. Int J Stroke. 2011;6:560–565. References 8. Taylor NF, Brusco NK, Watts JJ, Shields N, Peiris C, Sullivan N, et al. A study protocol of a randomised controlled trial incorporating a health economic anal- 1. Dewey HM, Thrift AG, Mihalopoulos C, Carter R, Macdonell RA, McNeil JJ, et al. Cost ysis to investigate if additional allied health services for rehabilitation reduce of stroke in Australia from a societal perspective: results from the North East length of stay without compromising patient outcomes. BMC Health Serv Res. Melbourne Stroke Incidence Study (NEMESIS). Stroke. 2001;32:2409–2416. 2010;10:308. 2. Saxena SK, Ng TP, Yong D, Fong NP, Gerald K. Total direct cost, length of hospital 9. Camicia M, Wang H, DiVita M, Mix J, Niewczyk P. Length of stay at inpatient stay, institutional discharges and their determinants from rehabilitation settings in rehabilitation facility and stroke patient outcomes. Rehabil Nurs. 2016;41:78–90. stroke patients. Acta Neurol Scand. 2006;114:307–314. 10. Grant C, Goldsmith CH, Anton HA. Inpatient stroke rehabilitation lengths of stay in 3. Shaw KD, Taylor NF, Brusco NK. Physiotherapy services provided outside of Canada derived from the National Rehabilitation Reporting System, 2008 and business hours in Australian hospitals: a national survey. Physiother Res Int. 2009. Arch Phys Med Rehabil. 2014;95:74–78. 2013;18:115–123. 11. IHPA National Hospital Data Collection Australian Public Hospitals Cost Report 4. Peiris CL, Taylor NF, Shields N. Additional Saturday allied health services increase 2012-2013, Round 17. 2015; https://http://www.ihpa.gov.au/publications/nation- habitual physical activity among patients receiving inpatient rehabilitation for al-hospital-cost-data-collection-australian-public-hospitals-cost-report-2012. lower limb orthopedic conditions: a randomized controlled trial. Arch Phys Med Accessed 13th November, 2015 Rehabil. 2012;93:1365–1370. 12. Brusco NK, Taylor NF, Watts JJ, Shields N. Economic evaluation of adult rehabilita- 5. English C, Bernhardt J, Crotty M, Esterman A, Segal L, Hillier S. Circuit class therapy tion: a systematic review and meta-analysis of randomized controlled trials in a or seven-day week therapy for increasing rehabilitation intensity of therapy after variety of settings. Arch Phys Med Rehabil. 2014;95:94–116. stroke (CIRCIT): a randomized controlled trial. Int J Stroke. 2015;10:594–602. 13. Ali M, English C, Bernhardt J, Sunnerhagen KS, Brady M. VISTA-Rehab Collabora- 6. van Walraven C. Individual patient meta-analysis – rewards and challenges. J Clin tion. More outcomes than trials: a call for consistent data collection across stroke Epidemiol. 2010;63:235–237. rehabilitation trials. Int J Stroke. 2013;8:18–24. 14. Bernhardt J, Borschmann K, Boyd L, Carmichael T, Corbett D, Cramer S, et al. Moving rehabilitation research forward: Developing consensus statements for rehabilita- tion and recovery research. Int J Stroke. 2016;11(4):454–458.
Journal of Physiotherapy 62 (2016) 145–152 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research A progressive exercise and structured advice program does not improve activity more than structured advice alone following a distal radial fracture: a multi-centre, randomised trial Andrea M Bruder a, Nora Shields a,b, Karen J Dodd c, Raphael Hau d, Nicholas F Taylor a,e a School of Allied Health, La Trobe University; b Department of Allied Health, Northern Health; c College of Science, Health and Engineering, La Trobe University; d Department of Orthopaedic Surgery, Northern Health; e Allied Health Clinical Research Office, Eastern Health, Melbourne, Australia KEY WORDS ABSTRACT Distal radial fracture Question: Does a program of exercise and structured advice implemented during the rehabilitation Exercise phase following a distal radial fracture achieve better recovery of upper limb activity than structured Advice advice alone? Design: A phase I/II, multi-centre, randomised, controlled trial with concealed allocation, Rehabilitation assessor blinding and intention-to-treat analysis. Participants: Thirty-three adults (25 female, mean age Physical therapy 54 years) following distal radial fracture managed in a cast. Intervention: The experimental intervention was a 6-week program of progressive exercise and structured advice implemented over three consultations by a physiotherapist. The control intervention was a program of structured advice only, delivered by a physiotherapist over three consultations. Outcome measures: The primary outcome was upper limb activity limitations, assessed by the Patient-Rated Wrist Evaluation and the shortened version of the Disabilities of the Arm, Shoulder and Hand outcome measure (QuickDASH). The secondary outcomes were wrist range of movement, grip strength and pain. All measures were completed at baseline (week 0), after the intervention (week 7) and at 6 months (week 24). Results: There were no significant between-group differences in upper limb activity as measured by the Patient-Rated Wrist Evaluation at week 7 and week 24 assessments (mean difference –4 units, 95% CI –10 to 2; mean difference 0 units, 95% CI –3 to 3, respectively), or QuickDASH at week 7 and week 24 assessments (mean difference –5 units, 95% CI –16 to 6; mean difference 0.3 units, 95% CI –6 to 7, respectively). The secondary outcomes did not demonstrate any significant between-group effects. Conclusion: The prescription of exercise in addition to a structured advice program over three physiotherapy consultations may convey no extra benefit following distal radial fracture managed in a cast. Trial registration: ACTRN12612000118808. [Bruder AM, Shields N, Dodd KJ, Hau R, Taylor NF (2016) A progressive exercise and structured advice program does not improve activity more than structured advice alone following a distal radial fracture: a multi-centre, randomised trial. Journal of Physiotherapy 62: 145-152] ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction been found to be moderately-to-strongly associated with short- Distal radial fractures are a common upper limb fracture,1,2 term improvements of impairment and activity following this type with a greater incidence in older women who have been diagnosed of fracture.10 Exercise prescription and advice to encourage with osteoporosis and have a history of falling.1–3 Ongoing problems after distal radial fracture can include pain, stiffness movement in usual tasks of daily living are interventions that and weakness, which can lead to difficulty completing everyday functional tasks4,5 such as preparing meals, housework and promote patient independence through the use of a self-manage- shopping.6 People who have had a distal radial facture are ment approach.11 Self-management programs typically focus on regularly referred to physiotherapy for rehabilitation to restore full joint range of movement and regain functional ability.7 equipping patients with chronic illnesses with the knowledge and Exercise and advice are the most commonly used interventions by skills needed to manage their conditions,12 including decision- physiotherapists during rehabilitation after distal radial fracture.8 making, symptom management, expected trajectory of recovery, Prescription of exercise by a physiotherapist after distal radial and self efficacy.13 The application of these self-management fracture focuses on promoting movement, which is a key principle of fracture management.9 Adherence to prescribed exercise has principles may also be appropriate in distal radial fracture rehabilitation. Despite their widespread use,8 the interventions of exercise and advice have never been independently evaluated as programs of treatment for this patient group in a randomised, controlled trial.14 A high-quality trial has compared a single session of http://dx.doi.org/10.1016/j.jphys.2016.05.011 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
146 Bruder et al: Exercise and advice after distal radius fracture physiotherapist-led advice and exercise compared with no interventions. These same physiotherapists were involved in the physiotherapy intervention, and identified short-term benefits in design of the program of structured advice that was administered pain and activity.15 That trial suggested that exercise and advice to both groups, and assisted with the selection of exercises could be useful in people after distal radial fracture; however, it prescribed to the experimental group. None of the treating was unclear how much benefit was contributed by each interven- physiotherapists were involved in randomisation or participant tion. Given this, there was a need for a randomised, controlled assessment. Given that the treating physiotherapists were clinical trial to find out if a progressive exercise program prescribed responsible for providing the intervention (advice only or advice by a physiotherapist could improve activity and decrease im- and exercise), they could not be blinded to group allocation. pairment after distal radial fracture. Such a trial would provide evidence for clinicians about the effectiveness of prescribing a Intervention progressive exercise program, with a possible medium-term impact on older adults following a distal radial fracture. The experimental group received a program of exercise and structured advice over three physiotherapy consultations (approxi- Therefore, the research question for this randomised trial was: mately 20 to 30 minutes each) in weeks 1, 3 and 5 (from removal of cast) as shown in Table 1. This was in addition to their usual activities. Does a program of exercise and structured advice implemented In week 1, the patient received structured advice15 and seven during the rehabilitation phase following a distal radial fracture exercises15,17 that were outlined in a home exercise diary and an achieve better recovery of upper limb activity than structured exercise program instruction booklet (see appendix 1 on eAddenda). advice alone? Participants were asked to record the number of sets and repetitions they completed for each exercise in their home diary. At the end of Method each week the participants were asked to return their exercise diary to the researchers using a reply paid envelope. In week 3, the Design participant received further advice on sleep, relaxation and work strategies, as necessary. The seven exercises were reviewed and A multi-centre, two-group, randomised, controlled trial was progressed by the physiotherapist, by either adding an exercise with conducted, incorporating concealed allocation, blinding of outcome an increased challenge or increasing the resistance of an existing assessors where possible, and intention-to-treat analysis of repeated exercise. In week 5, the participant received advice on medium-term measures. The trial was conducted across two hospital-based goal setting and discharge planning, and had their exercises physiotherapy departments between June 2012 and July 2013. The progressed to heavier loads and/or increased weight-bearing. trial is reported here according to the CONSORT guidelines.16 The control group received three physiotherapy consultations Participants were randomly allocated to either the experimental of similar duration to the experimental group in weeks 1, 3 and 5, or control group after baseline assessment. A researcher, who was but received only the program of advice. All participants were not involved in patient recruitment, assessment or treatment, used a provided with an elastic threaded compression sleeve for the wrist web-based system (randomization.com) to generate the random and forearm, and educated on its application to help control allocation sequence in permuted blocks of six. The permuted blocks swelling. were stratified for location and hand dominance. Allocations were sealed in sequentially numbered, opaque envelopes, which were Outcome measures kept off site. After the assessor had completed the baseline assessment, the next envelope in the sequence that matched the Primary outcome participant’s department location and hand dominance was selected The primary outcome was upper limb activity, as measured by and assigned by the treating physiotherapist. the Patient-Rated Wrist Evaluation18 and the shortened version of The treating physiotherapists were provided with an informa- the Disabilities of the Arm, Shoulder and Hand outcome measure tion sheet for each consultation, which outlined the advice that (QuickDASH) questionnaires.19 Participants completed the 10-item should be given to both groups, and an information sheet with activity-specific section of the Patient-Rated Wrist Evaluation diagrams and explanations for each of the exercises that should be (sections 2A and 2B), in which they rated wrist-related activity prescribed to the experimental group. At the end of each limitations from 0 (no difficulty with the activity) to 10 (unable to consultation, the treating physiotherapist recorded the following perform the activity). An overall score was calculated out of 50 by details: whether the participant attended, the duration of the adding the scores for the 10 items and dividing by two. This session in minutes, whether the participant reported any adverse questionnaire was developed to assess people with wrist pathology effects, any changes made to the prescribed program, and and has been used in previous trials involving participants with comments about the participant’s adherence to the intervention. distal radial fractures. It has been shown to be a sensitive, valid and reliable assessment tool.20 The 19-item QuickDASH questionnaire19 All participants completed assessments at baseline (week 0), (including one compulsory 11-item disability module, and two four- immediately following the intervention phase of the study (week item optional work and sports modules) asked participants to rate 7) and at 6 months (week 24). These assessments were conducted their ability to perform upper limb tasks from 1 (no difficulty) to 5 by an assessor who was unaware of group allocation and was not (unable to perform). The score was calculated by adding the total involved in administering treatment. number of all the responses, dividing it by the number of answered responses and subtracting 1 from the result. This score was then Participants, therapists and centres multiplied by 25 to give a QuickDASH disability score out of 100 for the 11-item module, and for the optional work and sports modules. Adults with a distal radial fracture and who were referred to The QuickDASH measures disability in people with upper extremity physiotherapy for rehabilitation after removal of their cast were musculoskeletal disorders and has been shown to have good invited to participate if they were: aged 21 years; able to follow psychometric properties.21 The minimum clinically important simple written and verbal instructions in English; and willing and difference on the Patient-Rated Wrist Evaluation and QuickDASH able to provide informed consent to participate. Volunteers were have been determined as 14 points out of 10022 and 15 points out of excluded if they had: a history of a pre-existing inflammatory 100,23 respectively. joint condition; signs and symptoms of complex regional pain syndrome; a previous wrist fracture on the affected side; or Secondary outcomes bilateral wrist fractures. The secondary outcomes measured impairments: wrist range of Three senior musculoskeletal physiotherapists with experience movement, grip strength and pain. Range of movement of wrist in outpatient services ranging from 5 to 17 years delivered all
Research 147 Dosage Table 1 Session when the intervention was provided Intervention. to the participants Intervention provided by the physiotherapist Session 1 Session 2 Session 3 (Week 1) (Week 3) (Week 5) Program of advice - E, C E, C E, C advice to manage movement - E, C E, C E, C advice to prevent and manage swelling and pain and skin care - E, C E, C explanation of fracture healing principles - advice to promote sleep and relaxation (as necessary) - E, C E, C advice regarding work strategies (as necessary) - E, C E, C advice for return to work - E, C E, C goal setting – short-term - E, C E, C goal setting – long-term - E, C E, C explanation of anatomy and function of the wrist - E, C advice for return to leisure activities discharge planning 2 sets x 20 reps, 3/day E, C 3 sets x 10 reps, 3/day E, C Program of exercises 2 sets x 20 reps, each direction, 3/day active finger ROM 2 sets x 20 reps, each direction, 3/day EE ball squeeze 2 sets x 20 reps, each direction, 3/day EEE active wrist flexion and extension ROM 1 set x 5 reps with 15 sec hold, 3/day EE active pronation and supination ROM 2 sets x 10 reps, 1/day EEE active radial and ulnar deviation ROM 1 set x 3 reps with 10 sec hold, 3/day EEE active-assisted wrist extension ROM 1 set x 3 reps with 15 sec hold, 3/day EE wrist and forearm flexor and extensor strength exercises 2 sets x 10 reps, 1/day E partial weight-bearing wrist extension ROM forearm flexor and extensor passive stretch 1 set x 5 reps with 15 sec hold, 3/day EE wrist and forearm flexor and extensor strength 2 sets x 10 reps, 1/day E exercises using light weights E wrist weight-bearing stretch wrist and forearm flexor, extensor and supinator E strength exercises using heavier weights E C = control group, E = experimental group, reps = repetitions, ROM = range of movement. flexion, wrist extension and supination were measured using a In addition, a per-protocol analysis was completed to goniometer, as recommended by the American Society of Hand investigate whether there was an association between inter- Therapists.24 Isometric grip strength was measured in kg using a vention protocol adherence and outcomes. An adherence calibrated Jamar dynamometera on setting two to ensure maximal threshold for the experimental group was set at a participant grip strength25 and with the elbow flexed to 90 deg. Pain was performing 70% of the prescribed exercise program. This was measured using the five-item pain-specific module of the Patient- determined by calculating a ratio, where the number of exercise Rated Wrist Evaluation; participants rated their wrist-related pain repetitions performed per week (as recorded in the home from 0 (no pain) to 10 (severe pain). The overall total score on a exercise diary) was divided by the number of exercise repeti- scale out of 100 was also calculated for the Patient-Rated Wrist tions prescribed per week and multiplied by 100. The relation- Evaluation, where pain and function problems were weighted ship between exercise program adherence in the experimental equally.26 group and change in treatment effect as measured on the QuickDASH questionnaire, Patient-Rated Wrist Evaluation and Adherence to the home-based exercise program was measured grip strength was explored using the Pearson product-moment using an exercise diary. Participants were asked to make daily (r) correlation coefficient. entries about the number of exercise sessions they performed and the number of exercises they completed per session. To calculate The number of participants who demonstrated the minimum adherence, the amount of performed exercise was compared to the clinically important difference in upper limb activity was amount of prescribed exercise.10 Adherence to the intervention calculated on the Patient-Rated Wrist Evaluation and QuickDASH protocol in the control and experimental groups was recorded by questionnaires. Relative risk calculations were completed using a the physiotherapist at each consultation. web-based calculatorc to determine the chance that a participant would demonstrate the minimum clinically important difference Data analysis on either the Patient-Rated Wrist Evaluation or QuickDASH questionnaires. A sample size of 15 in each group was calculated as sufficient to identify a between-group difference of 14 points on the Patient- Results Rated Wrist Evaluation as statistically significant,22 based on a standard deviation of 13 on a transformed 0 to 50 scale.15 This was Flow of participants, therapists and centres through the study based on a Type 1 error rate of 0.05, which was consistent with recommendations,27 and power of 0.80. Data analysis was Seventy adults with a distal radial fracture were referred performed using standard softwareb. Descriptive statistics were (Figure 1). Thirty-three adults met the inclusion criteria, consented calculated for the characteristics of the participants and treating to participate in the trial and were randomised to either the physiotherapists, and for all available data on each outcome experimental (n = 19) or control (n = 14) group. Two participants measure at each time point. from the experimental group dropped out during the intervention phase; one due to medical reasons and one did not attend after the Treatment outcome for all primary and secondary measures first physiotherapy session. Two adults from the control group between the experimental and control groups was analysed with failed to attend the week 24 follow-up assessment session. ANCOVA using the baseline measures as covariates, from baseline to 7 weeks and from baseline to 24 weeks. The primary analysis The two groups were similar in terms of age, gender was carried out as intention-to-treat using all available data, but distribution, type of distal radial fracture, and management of without using imputation methods.16
rugiF([]eG_I1)$TD148 Bruder et al: Exercise and advice after distal radius fracture Figure 1. Design and flow of participants through the trial. distal radial fracture (Table 2). Almost equal recruitment was weeks 5 and 6. A second participant allocated to the control group achieved across the two trial sites. Two of the three senior reported wrist pain and stiffness to the treating therapist at the physiotherapists provided 88% of the interventions, due to the week 5 session and to the assessor at week 7. third therapist resigning from the health service during the trial. Effect of the intervention Compliance with trial method Primary outcome On average, the control group attended 2.9 (SD 0.3) out of the There were no significant between-group differences for upper three physiotherapy consultations and the experimental group attended 2.7 (SD 0.6) consultations. Of the 14 participants limb activity, as measured by the Patient-Rated Wrist Evaluation, allocated to the control group, one was reported by the treating at either the week 7 assessment (MD –4 points, 95% CI –10 to 2) or physiotherapist as having not adhered to the program of advice, week 24 assessment (MD 0 points, 95% CI –3 to 3), as shown in due to commencing self-prescribed exercises. Of the 19 partici- Table 3. Similar results were found for the per protocol analysis, pants allocated to the experimental group, 10 adhered to the which is presented in Table 4. Individual participant data are intervention protocol threshold, completing 70% of the pre- presented in Table 5 (see eAddenda for Table 5). scribed exercises. There were no significant between-group differences for upper No serious adverse effects were reported. There were two minor limb activity, as measured on the QuickDASH disability module, at adverse effects. One participant allocated to the experimental group either the week 7 assessment (MD –5 points, 95% CI –16 to 6) or reported wrist pain after commencing the exercises in week 1. The week 24 assessment (MD 0 points, 95% CI –6 to 7), as shown in physiotherapist reduced the training intensity and the participant Table 3. Similar results were found for the per protocol analysis, was able to resume and complete the training program in which is presented in Table 4. Individual participant data are presented in Table 5 (see eAddenda for Table 5).
Research 149 Table 2 Randomised (n = 33) Lost to follow-up (n = 4) Baseline characteristics of participants, therapists and centres. Exp (n = 19) Con (n = 14) Exp (n = 3) Con (n = 1) Characteristic 51 (17) 58 (18) 57 (23) 55 (-) Participants 4 (21) 4 (29) 1 (33) 0 (0) Age (yr), mean (SD) Gender, n males (%) 17 (90) 13 (93) 2 (67) 1 (100) Hand dominance, n (%) 1 (5) 1 (7) 1 (33) 0 (0) right 1 (5) 0 (0) 0 (0) 0 (0) left ambidextrous 13 (68) 11 (79) 2 (67) 1 (100) Mechanism of fracture, n (%) 4 (21) 3 (21) 1 (33) 0 (0) fall from level 2 (11) 0 (0) 0 (0) 0 (0) fall from height or medium speed injury 12 (63) 9 (64) 2 (67) 0 (0) other Side of fracture, n dominant (%) 11 (58) 8 (57) 1 (33) 0 (0) Type of fracture, n (%) 8 (42) 6 (43) 2 (67) 1 (100) extra-articular intra-articular 19 (100) 14 (100) 3 (100) 1 (100) Type of fixation, n (%) 6.5 (0.8) 6.1 (0.5) 7.2 (1.3) 6.5 (-) cast 7.5 (0.9) 7.2 (1.1) 8.1 (1.2) 8.1 (-) Period of immobilisation (wk), mean (SD) 7.5 (3.1) 7.8 (6.5) 6.3 (1.2) 9.0 (-) Time from initial injury to initial assessment (wk), mean (SD) 2.7 (0.6) 2.9 (0.3) 2.0 (1) 3.0 (-) Time from cast removal to baseline assessment (d), mean (SD) Physiotherapy session attendance, mean (SD) 2 (11) 2 (14) 0 (0) 0 (0) 8 (42) 5 (36) 2 (67) 1 (100) Therapists 9 (47) 7 (50) 1 (33) Treated one participant, n (%) 0 (0) Treated two participants, n (%) Treated three participants, n (%) 10 (53) 7 (50) 2 (67) 1 (100) 9 (47) 7 (50) 1 (33) 0 (0) Centres Participants treated, n (%) health service 1 health service 2 Con = control group, Exp = experimental group. The chance that a participant would demonstrate the that physiotherapist-led rehabilitation programs are beneficial for minimum clinically important difference on the Patient-Rated people following a distal radial fracture.15,28 Wrist Evaluation at week 7 was similar for both groups, with a relative risk of 1.12 (95% CI 0.81 to 1.55). There was an identical One explanation for the present results could be that a result for the QuickDASH at week 7, with a relative risk of 1.12 (95% structured advice program may be more important than a set of CI 0.81 to 1.55). prescribed exercises following a distal radial fracture; that is, the provision of prescribed exercises to a structured advice program There was no correlation between adherence with the home provided no added benefit. Movement is a key principle of fracture exercise program and change in Patient-Rated Wrist Evaluation management9 and was incorporated into every physiotherapy from baseline to week 7 (r = 0.12, n = 17). There was a small advice consultation. Participants were encouraged to continue negative correlation between adherence with the home exercise with their usual tasks of daily living, such as washing the dishes, program and change in QuickDASH from baseline to week 7 (r = – hanging wet clothes up on a line and getting dressed – all activities 0.31, n = 17), indicating that those who adhered to the exercise that require wrist strength and range of movement. Although not program did not improve as much as those who did not complete the aim of this trial, one interpretation of the results could be that the prescribed exercises. a program of structured advice is beneficial for people following a distal radial fracture. A previous trial that examined one session of Secondary outcomes advice and exercise provided by a physiotherapist demonstrated There were no significant between-group differences for wrist improved outcomes of patients after a wrist fracture compared with no physiotherapy intervention.15 Currently, there are no flexion, wrist extension and supination range of movement, pain or trials that have examined advice as the manipulated variable in a grip strength at either week 7 or week 24 for either intention-to- randomised, controlled trial for this patient population. There has treat or per protocol analyses. There was no relationship between been an attempt to examine the effect of advice for other adherence with the home exercise program and change in grip musculoskeletal conditions. A systematic review of randomised, strength from baseline to week 7 (r = 0.04, n = 17). controlled trials that examined the effect of advice for the management of low back pain found that simple advice to stay Discussion active and continue normal daily activities was as effective as advice and specific exercise for improving pain, back-specific This trial found no difference in outcomes between a function and work disability in people with acute low back pain.29 physiotherapist-led program of exercise and structured advice Frost et al found that people with sub-acute low back pain were no compared with a program of structured advice only in people better off on the Oswestry disability index or the Roland Morris following a distal radial fracture. There were no significant disability questionnaire when they received routine physiother- between-group differences immediately after the program (week apy compared with one assessment and advice session by a 7) or at follow-up (week 24) for any outcome, irrespective of physiotherapist.30 These results suggest the hypothesis that a whether data were analysed by intention to treat or per protocol. structured advice program to move during the acute stage of This is not consistent with previous research, which found people musculoskeletal conditions could be effective. Future research following a wrist fracture who adhered to an exercise program should investigate whether a structured advice program as achieved better short-term improvements in wrist extension and the manipulated variable in a randomised, controlled trial arm use.10 However, since both treatment groups in the present improves activity for people following a distal radial fracture, trial received extensive structured advice from a physiotherapist, and how physiotherapists can best encourage and motivate the results may be consistent with previous research suggesting people to move.
Table 3 Mean (SD) of groups, mean (SD) difference within groups, and mean (95% CI) difference between groups as per intent Outcome Groups Week 0 Week 7 Week Exp (n = 19) Con (n = 14) Exp (n = 17) Con (n = 14) Exp (n = 16) PRWE activity section (0 to 50) 24 (11) 25 (11) 3 (2) 7 (11) 2 (5) QuickDASH 11-item (0 to 100) 43 (13) 44 (23) 10 (7) 16 (21) 5 (8) QuickDASH (work) 4-item (0 to 100) 50 (29) 40a (27) 10 (10) 15a (20) 5 (13) QuickDASH (sport) 4-item (0 to 100) 70b (26) 54c (43) 8d (11) 50c (48) 2e (5) Wrist extension range (deg) 48 (14) 46 (12) 57 (12) 64 (8) Wrist flexion range (deg) 34 (12) 31 (13) 49 (11) 59 (7) 54 (13) Wrist supination range (deg) 50 (13) 42 (11) 63 (15) 49 (11) 68 (15) Grip strength (kg) 12 (6) 61 (12) 14 (5) PRWE pain section (0 to 50) 5 (4) 6 (9) 10 (5) 13 (12) 7 (7) PRWE total (0 to 100) 23 (7) 19 (9) 13 (7) 10 (11) 9 (11) 47 (15) 44 (17) 17 (22) Con = control group, Exp = experimental group, PRWE = Patient-Rated Wrist Evaluation. a n = 13, b n = 9, c n = 5, d n = 8, e n = 7, f n = 4. Table 4 Mean (SD) of groups, mean (SD) difference within groups, and mean (95% CI) difference between groups as per protoc Outcome Goups Week 7 Week 0 Week Exp (n = 10) Con (n = 13) Exp (n = 10) Con (n = 13) Exp (n = 10) PRWE activity section (0 to 50) 23 (9) 25 (11) 3 (2) 7 (11) 3 (6) QuickDASH 11-item (0 to 100) 39 (14) 44 (24) 11 (9) 16 (22) 7 (10) QuickDASH (work) 4-item (0 to 100) 41 (29) 37 (26) 10 (12) 15 (21) 7 (16) QuickDASH (sport) 4-item (0 to 100) 70a (33) 42a (40) 5a (6) 53a (54) 3a (6) Wrist extension range (deg) 48 (10) 44 (11) 58 (10) 63 (8) Wrist flexion range (deg) 30 (12) 47 (9) 58 (7) 53 (15) Wrist supination range (deg) 31 (6) 41 (11) 61 (20) 47 (10) 6 (17) Grip strength (kg) 46 (12) 13 (7) 62 (12) 15 (6) PRWE pain section (0 to 50) 4 (5) 11 (6) PRWE total (0 to 100) 5 (5) 19 (10) 14 (8) 11 (9) 8 (8) 23 (6) 44 (18) 10 (12) 11 (13) 46 (13) 17 (23) Con = control group, Exp = experimental group, PRWE = Patient-Rated Wrist Evaluation. a n = 4, b n = 3.
tion to treat. Difference within groups Difference between groups 150 Bruder et al: Exercise and advice after distal radius fracture k 24 Week 7 minus week Week 24 minus week Week 7 minus week 0 Week 24 minus week 0 0 0 Con (n = 13) Exp Con Exp Con Exp minus Con Exp minus Con 2 (4) 5 (11) –20 (9) –18 (15) –21 (11) –23 (11) –4 (–10 to 2) 0 (–3 to 3) 6 (13) –31 (14) –28 (24) –35 (14) –38 (19) –5 (–16 to 6) 0 (–6 to 7) 23f (39) –35 (22) –25 (28) –41 (31) –38 (21) –7 (–17 to 4) –1 (–12 to 9) 61 (8) –59 (29) –63 (30) –34 (36) –45 (–84 to –6) –24 (–55 to 7) 56 (11) –5 (47) 0 (–5 to 6) 65 (11) 10 (9) 13 (10) 14 (9) 17 (9) –2 (–8 to 3) –4 (–12 to 3) 16 (13) 15 (7) 17 (10) 18 (11) 24 (9) –2 (–8 to 4) –1 (–11 to 9) 13 (13) 19 (14) 17 (12) 23 (16) –2 (–12 to 7) –0 (–4 to 4) 5 (6) 10 (5) –0 (–5 to 4) 8 (10) 7 (4) 7 (5) 9 (5) –13 (6) 0 (–3 to 4) 1 (–7 to 9) –12 (8) –9 (10) –15 (9) –36 (15) –1 (–7 to 5) –31 (15) –27 (22) –36 (19) –4 (–15 to 7) col. Difference within groups Difference between groups k 24 Week 7 minus week Week 24 minus week Week 7 minus week 0 Week 24 minus week 0 0 0 Con (n = 12) Exp Con Exp Con Exp minus Con Exp minus Con 2 (4) 6 (11) –20 (9) –18 (15) –20 (12) –23 (12) –4 (–12 to 4) 1 (–4 to 5) 6 (14) –28 (16) –28 (25) –33 (16) –38 (20) –3 (–18 to 12) 2 (–7 to 11) 27b(47) –31 (20) –22 (27) –34 (32) –35 (18) 1 (–13 to 4) 60 (7) –66 (37) –67 (39) –6 (–20 to 9) –37 (–94 to 20) 54 (10) 11 (36) –17 (4) –64 (–136 to 7) 65 (11) 10 (10) 14 (10) 15 (11) 17 (9) 1 (–5 to 8) 13 (9) 16 (8) 18 (11) 19 (13) 25 (9) –1 (–8 to 6) –5 (–15 to 4) 21 (13) 19 (13) –1 (–9 to 6) –3 (–15 to 10) 6 (7) 15 (16) 25 (15) –4 (–17 to 9) 8 (11) 8 (6) 7 (5) 10 (6) 9 (5) 0 (–5 to 5) –9 (10) –14 (9) 1 (–4 to 5) 1 (–5 to 7) –11 (8) –27 (23) –34 (19) –12 (6) –1 (–9 to 7) 3 (–8 to 13) –32 (14) –36 (16) –4 (–19 to 11)
Research 151 Another possible explanation is that exercise can be effective, but cast removal is a reasonable time frame, when the fracture would the particular exercise regimen used in the present study was not an be expected to be at the stage of consolidation.9 There is also the effective one. It has been proposed that variation in the quality of possibility of contamination bias given that two physiotherapists administration of complex interventions, including education provided treatment to 88% of the participants. However, con- programs, could influence their effectiveness.31 The selection of sultations were monitored and so contamination bias is not the exercises was based on previous research,15,17 which demon- thought to have influenced the findings. strated between-group improvements in activity and impairment measures in favour of people after a distal radial fracture. In For clinical practice, the results suggest that the additional addition, three experienced musculoskeletal physiotherapists prescription of exercise to a structured program of advice over three contributed to the exercise program design and implementation physiotherapy consultations may convey no benefit following a in the present study. At the end of each physiotherapy consultation, wrist fracture managed in a cast. Exercise is an intervention the treating therapist was asked to record information about frequently used by physiotherapists in distal radial fracture whether they had made changes to the prescribed program rehabilitation, but no high-quality trials had investigated its effect and make comments about the participant’s adherence to the as the manipulated variable in a randomised, controlled trial.8 The intervention. This enabled checking to see if the physiotherapists present trial was the first to do so, with the results supporting had implemented the exercise intervention as designed. Based on previous research, which found inconclusive evidence for the benefit this, the authors are confident in the design of the exercise program of exercise following an upper limb fracture,14 and insufficient and the implementation of the exercise intervention. evidence of how best to manage distal radial fractures during rehabilitation.4 The present trial did not aim to investigate the role of Other considerations when interpreting the lack of statistically physiotherapy, as both groups received physiotherapy. Also, it did significant results are the participants’ adherence to the prescribed not aim to investigate whether advice to move was beneficial program and the submitted exercise diaries. Only 10 of the following a distal radial fracture. However, one interpretation could 19 participants allocated to the experimental group completed at be that advice is a useful intervention. Given this, future research is least 70% of the prescribed exercises. Even though the per protocol needed to determine whether a program of structured advice, as the analysis found similar results to the intention-to-treat analysis, manipulated variable in a randomised, controlled trial, improves poor adherence may be one explanation for the results, rather than activity for people following a distal radial fracture. a lack of treatment efficacy.32 Strategies such as providing the participants with written and illustrated exercises,33 maintaining What is already known on this topic: Fracture of the distal an exercise diary34,35 and regular monitoring35 were implemented, radius can result in pain, stiffness, weakness and impaired as research suggests that combining these types of strategies may function. Physiotherapist-led advice and exercise improve pain help to optimise adherence.36 Future research might consider and activity in this population. However, it is unclear how much implementing a similar exercise program but include other benefit is contributed by each intervention. strategies to optimise adherence such as a telephone or SMS What this study adds: The prescription of exercise in addition reminder and/or improving patient motivation through techniques to a structured advice program over three physiotherapy such as motivational interviewing.37 It would also be useful to consultations may convey no extra benefit following distal examine participant outcome expectations at commencement of radial fracture managed in a cast. the program to analyse how expectations may influence exercise program adherence in people following a distal radial fracture. Footnotes: aJamar hand dynamometer, Lafayette Instrument Company, Lafayette, USA. bPredictive Analysis Software V.21, SPSS, Some strengths of this multi-centre trial were that participants Chicago, USA. cRelative Risk Calculator V.14.12.0, MedCalc, Ostend, were randomly allocated to groups, allocation was concealed and Belgium. the two groups were similar at baseline. The assessor remained blind to participant allocation at all assessment time points, and eAddenda: Table 5 and Appendix 1 can be found online at measures of at least one outcome were obtained from > 85% of the doi:10.1016/j.jphys.2016.05.011 participants initially allocated to each group. Data analyses were completed as intention-to-treat and per protocol for all outcome Ethics approval: The Northern Health Ethics Committee, measures. Given this, the authors are reasonably confident that Eastern Health Ethics Committee and La Trobe University Ethics there was a low risk of bias. A systematic review examining the Committees have approved this study. All participants gave effect of exercise on reducing impairment and increasing activity written informed consent before data collection began. in the rehabilitation of people with upper limb fractures14 identified a need to investigate exercise as the manipulated Competing interests: Nil variable in a randomised, controlled trial. Another strength of this Source of support: This study was funded by a grant awarded trial was that it attempted to investigate the effect of exercise by from the Physiotherapy Research Foundation, PRF Grant ID S12- controlling the type and amount of advice provided to each group, 019. which has not been previously attempted with people following a Acknowledgements: Adele Taylor, Paula O’Neil (Northern distal radial fracture. Health), and Judy Bottrell (Eastern Health) are acknowledged for their role in treating the participants recruited to this study. The A limitation of the present trial was a protocol variation. It was authors would also like to thank all the participants who gave their intended to use accelerometers as a third primary outcome to time to participate in this study. quantify the extent of arm usage (the amount and intensity of arm Provenance: Not invited. Peer reviewed. activity) of participants using the mean total activity over seven Correspondence: Andrea Bruder, School of Allied Health, La consecutive days. However, accelerometry data were obtained on Trobe University, Australia. Email: [email protected] only 51% of the sample. These data are available from the authors, who intend to report elsewhere on the feasibility of measuring arm References use in this population. Another possible limitation of the present trial was that the outcomes focused on impairment and activity 1. Bradley C, Harrison J. Descriptive epidemiology of traumatic fractures in Australia. and did not include information about employment or rate of In: Australian Insitute of Health and Welfare. ed. Vol 17. Canberra: Australian return to work. Rate of return to work may have impacted on pain Institute of Health and Welfare; 2004. levels at the week 7 assessments and could be one explanation for no significant between-group differences. We did not measure the 2. Larsen CF, Lauritsen J. Epidemiology of acute wrist trauma. Int J Epidemiol. rate of improvement by assessing participants during the 1993;22:911–916. intervention implementation phase and may have failed to detect one group improving faster than another. However, 6 weeks after 3. Sanders KM, Seeman E, Ugoni AM, Pasco JA, Martin TJ, Skoric B, et al. Age- and gender-specific rate of fractures in Australia: A population based study. Osteopo- rosis Int. 1999;10:240–247. 4. Handoll HH, Madhok R, Howe TE. Rehabilitation for distal radial fractures in adults. 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Journal of Physiotherapy 62 (2016) 166 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Critically Appraised Papers A randomised trial of an intensive physiotherapy program for patients in intensive care Synopsis Summary of: Moss M, Nordon-Craft A, Malone D, Van Pelt D, Frankel outcome measure was the short form of the Continuous Scale Physical SK, Warner ML, et al. A randomized trial of an Intensive Physical Functional Performance Test score, measured 4 weeks following Therapy Program for Acute Respiratory Failure Patients. Am J Respir Crit enrolment. Secondary outcomes included ICU and hospital-free days Care Med. 2016;in press. 4 weeks following enrolment, discharge to home, hospital mortality and institution-free days 90 and 180 days following enrolment. Question: In adults admitted to an intensive care unit, does a Functional tests, including the Timed Up and Go Test, Berg Balance Test program of intensive physiotherapy improve long-term physical and Short Form-36 Health Survey, were performed on those who functional performance compared with a program of standard care returned for outpatient assessment. Results: Compared with standard physiotherapy? Design: Randomised, controlled trial with 1]FD[IT1_$ :1 alloca- care, those receiving intensive intervention received a higher total tion. Assessors were blinded, but clinicians and participants were not. duration of physiotherapy (DIFM][T_$2 D 322 minutes, 95% CI 254 to 390) and Setting: Five medical centres located in Denver, Colorado, United States more sessions (MID[3F_T]$ D TI_F6$]D[4 .3 D[sIF5]T_$ essions, 95% CI 4.4 to 8.2). Physical of America. Participants: Inclusion criteria were: aged 18 years and functioning assessments were available for 89/104 (86%) participants requiring mechanical ventilation for 5 days (changed to 4 days 4 weeks following enrolment. There were noF[6_T]DI$ significant differences after 78 participants were enrolled). Exclusion criteria included: recent in the Continuous Scale Physical Functional Performance Test myocardial infarction, significant language barrier, severe physical or (mean difference –1.9, 95% CI –13.0 to 9.2) or any of the secondary cognitive impairment limiting physiotherapy participation and un- outcomes. There were no differences in the primary outcome when likely to survive 6 months. Randomisation of 120 participants allocated participants were grouped according to pre-existing comorbidities or 59 to intensive physiotherapy and 61 to standard care. Interventions: age tertiles. Conclusion: Intensive physiotherapy did not improve On the first day of awakening, the participants were randomised to long-term physical functional performance compared with standard either intensive physiotherapy (breathing techniques, range of motion, physiotherapy. strengthening and core mobility/strength exercises, functional mobili- ty retraining) or standard physiotherapy (range of motion, positioning, [95% CIs calculated by the CAP Editor] functional mobility retraining), delivered by distinct study teams for up to 28 days. Following this, physiotherapy intervention was at the Provenance: Invited. Not peer-reviewed. treating team’s discretion. Intensive physiotherapy comprised 30- minute sessions (ICU) or up to 60-minute sessions (wards) 7 days Elizabeth H Skinner weekly, with up to 60-minute home/outpatient sessions three times Physiotherapy, Monash University, Melbourne, Australia weekly. The standard program comprised 20-minute sessions, three times weekly until discharge home. Outcome measures: The primary http://dx.doi.org/10.1016/j.jphys.2016.02.005 Commentary have been present at randomisation. Thirdly, although described as an early intervention, intensive treatment was not initiated until a Survivors of acute respiratory failure requiring intensive care unit median_DF[]1I$T of 84[$_D]FTI days (FIID$]T[5_ QR 6F_][DT6I$ to 11)D.[2]FTI_$ Despite the results of this and other (ICU) admission and mechanical ventilation frequently suffer enduring rehabilitation trials for critical illness survivors, these studies consis- impairments of physical function.1 To date, no trial, including that of tently report a perilous state of physical function beyond hospital Moss and colleagues, which commenced an intervention during discharge.1,2 It is important that we continue to seek interventions to hospitalisation, has impacted performance-based measures of physical improve these outcomes. However, the results of the AVERT trial3 are a function after hospital discharge. The authors are to be applauded for salient reminder that we don’t yet understand the who, when and how conducting a trial with high treatment fidelity, and that achieved of rehabilitation for survivors of critical illness. separation and sample size, as these elements have not always been achieved in rehabilitation trials.2,3]FT_3D[$I However, the results must be Provenance: Invited. Not peer-reviewed. viewed with caution. Firstly, the primary outcome (Physical Functional Performance Test score) is not validated in critical illness survivors. The Susan C Berney test exhibited a substantial floor effect at the primary time point, with Department of Physiotherapy, Austin Health, Melbourne, Australia a completion rate of 33% of participants. This increased to 48% at 3 months and 43% at 6 months. Furthermore, as measured by the short E-mail address: [email protected] (S.C. Berney). form of the Continuous Scale Physical Functional Performance Test score, two participants achieved functional independence on comple- References tion of physiotherapy treatment (both in the control group), despite 50% of participants being discharged home. Secondly, a significant 1. Needham DM, et al. Am J Resp Crit Care Med. 2013;188:567–576. between-group difference in age was observed and, although not 2. Denehy L, et al. Crit Care. 2013;17:R156. significant, the intervention group were weaker, had lower bed 3. Bernhardt J, et al. Lancet. 2015;386:46–55. mobility scores and completed less available rehabilitation days in ICU than the standard care arm, suggesting important differences may http://dx.doi.org/10.1016/j.jphys.2016.02.004 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 62 (2016) 166 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Critically Appraised Papers A randomised trial of an intensive physiotherapy program for patients in intensive care Synopsis Summary of: Moss M, Nordon-Craft A, Malone D, Van Pelt D, Frankel outcome measure was the short form of the Continuous Scale Physical SK, Warner ML, et al. A randomized trial of an Intensive Physical Functional Performance Test score, measured 4 weeks following Therapy Program for Acute Respiratory Failure Patients. Am J Respir Crit enrolment. Secondary outcomes included ICU and hospital-free days Care Med. 2016;in press. 4 weeks following enrolment, discharge to home, hospital mortality and institution-free days 90 and 180 days following enrolment. Question: In adults admitted to an intensive care unit, does a Functional tests, including the Timed Up and Go Test, Berg Balance Test program of intensive physiotherapy improve long-term physical and Short Form-36 Health Survey, were performed on those who functional performance compared with a program of standard care returned for outpatient assessment. Results: Compared with standard physiotherapy? Design: Randomised, controlled trial with 1]FD[IT1_$ :1 alloca- care, those receiving intensive intervention received a higher total tion. Assessors were blinded, but clinicians and participants were not. duration of physiotherapy (DIFM][T_$2 D 322 minutes, 95% CI 254 to 390) and Setting: Five medical centres located in Denver, Colorado, United States more sessions (MID[3F_T]$ D TI_F6$]D[4 .3 D[sIF5]T_$ essions, 95% CI 4.4 to 8.2). Physical of America. Participants: Inclusion criteria were: aged 18 years and functioning assessments were available for 89/104 (86%) participants requiring mechanical ventilation for 5 days (changed to 4 days 4 weeks following enrolment. There were noF[6_T]DI$ significant differences after 78 participants were enrolled). Exclusion criteria included: recent in the Continuous Scale Physical Functional Performance Test myocardial infarction, significant language barrier, severe physical or (mean difference –1.9, 95% CI –13.0 to 9.2) or any of the secondary cognitive impairment limiting physiotherapy participation and un- outcomes. There were no differences in the primary outcome when likely to survive 6 months. Randomisation of 120 participants allocated participants were grouped according to pre-existing comorbidities or 59 to intensive physiotherapy and 61 to standard care. Interventions: age tertiles. Conclusion: Intensive physiotherapy did not improve On the first day of awakening, the participants were randomised to long-term physical functional performance compared with standard either intensive physiotherapy (breathing techniques, range of motion, physiotherapy. strengthening and core mobility/strength exercises, functional mobili- ty retraining) or standard physiotherapy (range of motion, positioning, [95% CIs calculated by the CAP Editor] functional mobility retraining), delivered by distinct study teams for up to 28 days. Following this, physiotherapy intervention was at the Provenance: Invited. Not peer-reviewed. treating team’s discretion. Intensive physiotherapy comprised 30- minute sessions (ICU) or up to 60-minute sessions (wards) 7 days Elizabeth H Skinner weekly, with up to 60-minute home/outpatient sessions three times Physiotherapy, Monash University, Melbourne, Australia weekly. The standard program comprised 20-minute sessions, three times weekly until discharge home. Outcome measures: The primary http://dx.doi.org/10.1016/j.jphys.2016.02.005 Commentary have been present at randomisation. Thirdly, although described as an early intervention, intensive treatment was not initiated until a Survivors of acute respiratory failure requiring intensive care unit median_DF[]1I$T of 84[$_D]FTI days (FIID$]T[5_ QR 6F_][DT6I$ to 11)D.[2]FTI_$ Despite the results of this and other (ICU) admission and mechanical ventilation frequently suffer enduring rehabilitation trials for critical illness survivors, these studies consis- impairments of physical function.1 To date, no trial, including that of tently report a perilous state of physical function beyond hospital Moss and colleagues, which commenced an intervention during discharge.1,2 It is important that we continue to seek interventions to hospitalisation, has impacted performance-based measures of physical improve these outcomes. However, the results of the AVERT trial3 are a function after hospital discharge. The authors are to be applauded for salient reminder that we don’t yet understand the who, when and how conducting a trial with high treatment fidelity, and that achieved of rehabilitation for survivors of critical illness. separation and sample size, as these elements have not always been achieved in rehabilitation trials.2,3]FT_3D[$I However, the results must be Provenance: Invited. Not peer-reviewed. viewed with caution. Firstly, the primary outcome (Physical Functional Performance Test score) is not validated in critical illness survivors. The Susan C Berney test exhibited a substantial floor effect at the primary time point, with Department of Physiotherapy, Austin Health, Melbourne, Australia a completion rate of 33% of participants. This increased to 48% at 3 months and 43% at 6 months. Furthermore, as measured by the short E-mail address: [email protected] (S.C. Berney). form of the Continuous Scale Physical Functional Performance Test score, two participants achieved functional independence on comple- References tion of physiotherapy treatment (both in the control group), despite 50% of participants being discharged home. Secondly, a significant 1. Needham DM, et al. Am J Resp Crit Care Med. 2013;188:567–576. between-group difference in age was observed and, although not 2. Denehy L, et al. Crit Care. 2013;17:R156. significant, the intervention group were weaker, had lower bed 3. Bernhardt J, et al. Lancet. 2015;386:46–55. mobility scores and completed less available rehabilitation days in ICU than the standard care arm, suggesting important differences may http://dx.doi.org/10.1016/j.jphys.2016.02.004 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 62 (2016) 165 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Trial Protocol Back school or brain school for patients undergoing surgery for lumbar radiculopathy? Protocol for a randomised, controlled trial Kelly Ickmans a,b,1, Maarten Moens c,d, Koen Putman e,f, Ronald Buyl e,f, Lisa Goudman c,d,1, Eva Huysmans a,e,1, Ina Diener g, Tine Logghe h, Adriaan Louw i, Jo Nijs a,b,1 a Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy (KIMA), Vrije Universiteit Brussel; b Department of Physical Medicine and Physiotherapy, University Hospital Brussels; c Department of Neurosurgery, University Hospital Brussels; d Department of Manual Therapy (MANU), Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel; e Department of Public Health (GEWE), Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel; f Inter University Centre for Health Economics Research (I-CHER), Vrije Universiteit Brussels, Brussels, Belgium; g Division of Physiotherapy, Faculty of Medicine and Health Sciences, University of Stellenbosch, Stellenbosch, South Africa; h Department of Physical Medicine and Rehabilitation, Sint-Dimpna Ziekenhuis, Geel, Belgium; i International Spine and Pain Institute, Story City, USA Abstract session plus an educational booklet. Measurements: Self-reported pain and endogenous pain modulation (including measurements Introduction: Despite scientific progress with regard to pain of simultaneous cortical activation via electroencephalography) neuroscience, perioperative education tends to stick to the will be the primary outcome measures. Secondary outcome biomedical model. This may involve, for example, explaining the measures will include daily functioning, return to work, postoper- surgical procedure or ‘back school’ (education that focuses on ative healthcare utilisation and surgical experience/satisfaction. biomechanics of the lumbar spine and ergonomics). Current Psychological factors will be measured as possible treatment perioperative education strategies that are based on the biomedi- mediators. Procedure: All assessments will take place in the week cal model are not only ineffective, they can even increase anxiety preceding surgery (baseline), andT[F1I_D$] at 3 days and 6 weeks DI$[_9a]FT fter and fear in patients undergoing spinal surgery. Therefore, surgery. Intermediate and long-term follow-up assessments will perioperative pain neuroscience education is proposed as a take place at 6, 12 and 24 months after surgery. Analysis: All data dramatic shift in educating patients prior to and following surgery analyses will be based on the intention-to-treat principle. for lumbar radiculopathy. Rather than focusing on the surgical Repeated measures AN(C)OVA analyses will be used to evaluate procedure, ergonomics or lumbar biomechanics, perioperative and compare treatment effects. Baseline data, treatment centre, pain neuroscience education teaches people about the underlying age and gender will be included as covariates. Statistical, as well as mechanisms of pain, including the pain they will feel following clinicallyD1,]T_0F$[I significant differences will be evaluated and effect sizes surgery. Research objectives: The primary objective of the study is will be determined. In addition, the numbers needed to treat will to examine whether perioperative pain neuroscience education be calculated. Discussion: This study will _1Td]DIF$[ etermine whether pain (‘brain school’) is more effective than DcF$T_5[I] lassic back school in neuroscience education is worthwhile for patients undergoing reducing pain and improving pain inhibition in patients undergo- surgery for lumbar radiculopathy. It is expected that participants ing surgery for spinal radiculopathy. A secondary objective is to who receive perioperative pain neuroscience education will report examine whether perioperative pain neuroscience education is less pain2DT[]FI1_$ and have improved endogenous pain modulation, lower more effective than ]cFI_DT$5[ lassic back school in: reducing postoperative postoperative healthcare costs and improved surgical experience. healthcare expenditure, improving functioning in daily life, Lower pain and improved endogenous pain modulation after [6_TD$IF]increasing return to work, and7$[]DIFT_ improving surgical experience surgery may Dr$]_3FT1[I educe I4F1]Dt_T[$ he risk of developing postoperative chronic (ie, being better prepared for surgery, reducing incongruence pain. between the expected and actual experience) in patients undergoing surgery for spinal radiculopathy. Design: A multi- Trial registration: ClinicalTrials.gov. Registration number: centre, two-arm (1:1) randomised, controlled trial with 2-year NCT02630732. Was this trial prospectively registered? Yes. Date follow-up. Participants and setting: People undergoing surgery of trial registration: 25 November 2015. Funded by:T_$D]F4I[ Applied for lumbar radiculopathy (n = 86) in two Flemish hospitals (one Biomedical Research Program, Institute for the Agency for tertiary care, universityD$8F]-[_TI based hospital and one regional, second- Innovation by Science and Technology (IWT), Belgium. Funder ary care hospital) will be recruited for the study. Intervention: All approval number: IWT-TBM project no. 150180. Anticipated participants will receive usual preoperative and postoperative care completion date: 30 April 2019. Provenance: Not invitedD]I.F$_15T[ PF[ID$T16]_ eer related to the surgery for lumbar radiculopathy. The experimental reviewed. Corresponding author: Vrije Universiteit Brussel, BE- group will also receive perioperative pain neuroscience education 1090 Brussels, Belgium. comprising one preoperative and one postoperative individual educational session plus an educational booklet. Control: Parti- Full protocol: Available on the eAddenda at doi:10.1016/j.jphys. cipants in the control group will receive perioperative back school 2016.05.009 on top of usual preoperative and postoperative care, comprising one preoperative and one postoperative individual educational 1Member of the Pain in Motion International Research Group, www.paininmotion.be http://dx.doi.org/10.1016/j.jphys.2016.05.009 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 62 (2016) 164 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Trial Protocol Ballistic strength training compared with usual care for improving mobility following traumatic brain injury: protocol for a randomised, controlled trial $[DIT8_G]F avin Williams a,b, Louise Ada c$_FTI,9[D] FIL$D_9][T eanne Hassett c,d, Meg E Morris e1$FDTI0]_,[ DF_1I]RT$[ oss Clark f, Adam L Bryant b[2_TD1,]FI$ TI_F]$[3J1D ohn Olver g a Physiotherapy Department, Epworth Healthcare; b School of Physiotherapy, Faulty of Medicine, Dentistry and Health Sciences, The University of$DF]T_[I1 Melbourne; c Faculty of Health Sciences, The University of Sydney; d The George Institute for Global Health, Sydney Medical School, The University ofFTDI_]$[3 Sydney; e Healthscope and School of Allied Health, La Trobe University, Melbourne; f School of Health and Sport Sciences, University of the Sunshine Coast, Sippy Downs; g FR$DT_]I5[ ehabilitation Medicine, Epworth Healthcare, Melbourne, Australia Abstract test. Strength will be measured by a 6FT_61[I$]D repetition maximum, seated7F],[T_1ID$ single leg press test. Balance will be measured as the single limb Introduction: Traumatic brain injury is the leading cause of support time. Health-related quality of life will be measured using disability in young adults aged 15 to 45 years. Mobility limitations the Assessment of Quality of Life. Outcomes will be measured at are prevalent, and range in severity from interfering with basic baseline (0 months), Da$IF18]_[T t completion of theD7[IF]_T$ intervention phase day-to-day tasks to restricting participation in higher level social, (3 months), and 3 months after cessation of intervention leisure, employment and sporting activities. Despite the preva- (6 months). Baseline measures will be completed prior to lence and severity of physical impairments, such as poor balance randomisation. Assessors blinded to group allocation will perform and spasticity, the main contributor to mobility limitations all measures. Analysis: Baseline characteristics of participants will following traumatic brain injury is low muscle power generation. be determined according to group, using descriptive statistics. The Strengthening exercises that are performed quickly are termed proportion of patients compliant with the intervention will be ‘ballistic’ as they are aimed at improving the rate of force calculated according to group and compared using Fisher’s exact production and, hence, muscle power. This is compared with test. Compliance with the intervention will be defined as those conventional strength training, which is performed slowly and who have satisfactorily completed at least 80% of the allocated aims to improve maximum force production, yet has limited sessions (29 of 36 sessions). The between-group difference for all impact on mobility. Research question: In people recovering from outcomes will be estimated using analysis of covariance, adjusting traumatic brain injury6[:T_D$]FI (1)[14_TDIF]$ is a 12-week ballistic strength-training for baseline High Level Mobility Assessment Tool score, age, gender program targeting the three muscle groups critical for walking and length of post-traumatic amnesia. Analyses will be conducted more effective than usual care at improving mobility, strength and on an intention-to-treat basis. Discussion: Strength training in balance; and (2) does improved mobility translate to better health- neurological rehabilitation is highly topical because muscle related quality of lifeD$IT[1F_5]? Design: A prospective, multi-centre, weakness has been identified as the primary impairment leading randomised, single-blind trial with concealed allocation will be to mobility limitations in many neurological populations. This conducted. Participants and setting: Participants will be patients project represents the first international study of ballistic strength with a neurologically based movement disorder affecting mobility training after traumatic brain injury. The novelty of ballistic as a result of traumatic brain injury. Patients will be recruited strength training is that the exercises attempt to replicate how during the acute phase of rehabilitation (n = 166), from brain lower limb muscles work, by targeting the high angular velocities injury units in large metropolitan hospitals in Melbourne and attained during walking and higher level activities. Sydney, Australia. Intervention: For 12 weeks, participants in the experimental group will have three 60-minute sessions of usual Trial registration: Australian New Zealand Clinical Trials Registry. physiotherapy intervention replaced by three 60-minute sessions Registration number: ACTRN12611001098921. Was this trial of strength training (ballistic strength, gait). The three key muscle prospectively registered? Yes. Date of trial registration: groups responsible for forward propulsion will be targeted: ankle 21 October 2011. Funded by: Epworth Research Institute, Royal plantarflexors, hip flexors and the hip extensors. Initial loads will Automobile Club Victoria (RACV), National Health and Medical be low, to facilitate high contraction velocities. Progression to Research Council (NHMRC). Funder approval number: NHMRC higher loads will occur only if participants can perform the Grant ID APP1104237. Anticipated completion date: December exercises ballistically. The control group will have their three 60- 2019. Provenance: Invited. Peer reviewed. Corresponding minute sessions of usual physiotherapy intervention (balance, author: Gavin Williams, Physiotherapy Department, Epworth strength, stretch, cardiovascular fitness, gait) standardised so that Hospital, Richmond, 3121, Victoria, Australia. Email: gavin. all participants have equivalent therapy time. Both groups will [email protected] continue to receive usual rehabilitation. Outcome measures: The primary outcome will be mobility, measured using the High Level Full protocol: Available on the eAddenda at ]hT[1$FI9_D ttp://doi:10.1016/j. Mobility Assessment Tool. The secondary outcomes will be jphys.2016.04.003 walking speed, muscle strength, balance and health-related quality of life. Walking speed will be measured using the 10-m walking http://dx.doi.org/10.1016/j.jphys.2016.04.003 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 62 (2016) 171 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Clinimetrics Charlson Comorbidities Index Summary Description: The Charlson Comorbidity Index (CCI) was Classification of Diseases 10 codes and validated in six nations, including Australia.4 The updated CCI and original CCI demonstrated developed and validated as a measure of 1-year mortality risk and burden of disease.1–4 To account for age being an independent similar levels of discrimination for in-hospital mortality with C statistics of 0.727 to 0.878 and 0.723 to 0.882, respectively.4 predictor of mortality, a Combined Age-CCI (CA-CCI) score can be generated.1–3 The CCI has been extensively used in clinical research The CCI has moderate to good inter-rater reliability of 0.74 to 0.945 in older cohorts with cancer.3,9 The CCI and SR-CCI have high to address the confounding influence of comorbidities, predict test re-test reliability with intraclass correlation coefficients of outcomes, standardise comorbidities abstracted from medical 0.92 (p < 0.0001) and 0.91 (p < 0.0001), respectively.7 A moderate records or administrative databases and for self report of level of agreement was identified between the SR-CCI and CCI, with comorbidities.1,3,5–9 In clinical practice, the CCI reduces comorbid- most items having Kappa statistics (K) ranging from 0.433 to 0.541 ities into a single numeric score that may assist health professionals (p < 0.0001), while diabetes had a high level of agreement with stratifying patients into subgroups based on disease severity, (K = 0.764; p < 0.0001).6 Spearman correlations up to 0.63 have developing targeted models of care and resource allocation.3,8 been reported between the SR-CCI and CCI.6,7 The CCI consists of 17 comorbidities, with two subcategories for The CCI has content validity, as the diseases and severity diabetes and liver disease.1–3 Comorbidities are weighted from 1 to weights were statistically derived from relative risks of a 6 for mortality risk and disease severity, and then summed to form the proportional regression model to predict mortality.1,9–11 One total CCI score.1–3 The CA-CCI is generated by adding 1 point to the CCI score for each decade of age over 40 years.1–3 The CCI and CA-CCI weakness that has been reported for the CCI is omission of diseases require minimal training and are freely available for researchers and (eg, anaemia, mental illness), which are present in other health professionals, with guidelines reported in Charlson et al.1 To indices.3,11,12 However, the updated CCI retained 12 comorbidities, enable rapid electronic calculation of the CCI and CA-CCI, a Microsoft and prediction of mortality remained high. Increased number of excel spreadsheet has been developed.3 The CCI has been modified, with adaptations to comorbidities, administration and scoring.3–7,9 The comorbidities in indices (ie, 30 in the Elixhauser Comorbidity Measure versus 17 in the CCI) also potentially reduces utility.4,11 Self Reported-CCI (SR-CCI) can be self-administered or performed as a 10-minute interview.6,7 The SR-CCI uses the same scoring algorithm Traditional construct validity using the known groups method is as the CCI, except presence of liver disease is scored as 2 points.6,7 rarely tested in comorbidity indices.10,11 Poorer utilisation of cancer Psychometric properties: The CCI is reliable and valid for diverse screening in patients with high CCI scores is an example of construct validity for the CCI.10,11 There is no gold standard measure for clinical cohorts (eg, cancer, amputation and arthritis) in a variety of healthcare settings.3,4,8,9 Charlson Comorbidity Index scores comorbidity, so criterion validity (which encompasses concurrent 5 have been associated with a 1-year mortality of 85%, while 10-year and predictive validity) has been demonstrated for the CCI through survival for a CA-CCI of 5 was 34%.1 Charlson Comorbidity Index scores > 8 have not been well studied.1,3,10 Due to advances in comparison to other comorbidity indices and prediction of out- comes.1,5,8–11 The CCI has moderate to good correlation (> 0.4) with disease management, the CCI was updated using International other comorbidity indices and predictive validity for criterion such as mortality, readmission, disability and length of stay.3,7,9,11 Commentary Comorbidity, which impacts on contemporary clinical practice and Provenance: Invited. Not peer reviewed. research, is a major consideration in health systems reform and Caroline E Roffmana,b, John Buchanana,b and Garry T Allisona,b funding models.8 However, there is a lack of consensus on the most aSchool of Physiotherapy & Exercise Science, Faculty of Health effective method for measuring comorbidity.3,8–12 To ensure imple- Sciences, Curtin University bRoyal Perth Hospital, Perth, Australia mentation of a comorbidity index that is sensitive, it is important to determine if the outcome of interest is mortality or function.9,12 The CCI References has utility due to low cost, ease of administration and interpretation in 1. Charlson ME, et al. J Chron Dis. 1D$2]FI_T[ 987;40:373–383. efficient timeframes.3,7–9 The CCI is feasible in various healthcare 2. Charlson ME, et al. J Clin Epidemiol. 1T$_DFI]4[ 994;47:1245–1251. 3. Hall WH, et al. BMC Cancer. ID2]F[5$T_ 004;4:1471–2407. settings, including those with limited access to medical records (eg, 4. Quan H, et al. Am J Epidemiol. ]FI6D[$_T2011;173:676–682. primary care, outreach).9 The CCI can be incorporated into electronic 5. Amusat N, et al. J Physiother. _7FTD$I[]2014;60:217–223. medical record and data collection systems.3 The SR-CCI has the 6. Ng X, et al. Rheumatol Int. $_DTI[8F2] 015;35:2005–2011. 7. Katz JN, et al. Med Care. T9[_1D$]IF 996;34:73–84. potential to be biased by the client’s medical knowledge, recall or 8. Roffman CE, et al. J Physiother. ]FID$2T[7_ 014;60:224–231. literacy.6,7,9 Depending on primary diagnosis and comorbidities 9. de Groot V, et al. J Clin Epidemiol. DT0IF]21$[_ 003;56:221–229. 10. Hall SF. J Clin Epidemiol. 1FIT]$2D_[ 006;59:849–855. being investigated, the CCI score may differ between studies (eg, in 11. Molto´ A, et al. Clin Exp Rheumatol. FI[2]_TD$2014;32:S131–S134. 12. Groll DL, et al. J Clin Epidemiol. ]2FI6D[$T_ 005;58:595–602. a client with leukaemia, COPD and myocardial infarction, the CCI score can be 2 or 3).3 To enable standardised comparison of healthcare outcomes between different cohorts and centres, further research on measurement of comorbidity is warranted. http://dx.doi.org/10.1016/j.jphys.2016.05.008 1836-9553/Crown Copyright ß 2016 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 62 (2016) 130–137 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research Constraint-induced movement therapy improves upper limb activity and participation in hemiplegic cerebral palsy: a systematic review Hsiu-Ching Chiu a, Louise Ada b a Department of Physical Therapy, I-Shou University, Kaohsiung, Taiwan (ROC); b Discipline of Physiotherapy,The University of Sydney, Sydney, Australia KEY WORDS ABSTRACT Cerebral palsy Questions: Does constraint-induced movement therapy improve activity and participation in children Systematic review with hemiplegic cerebral palsy? Does it improve activity and participation more than the same dose of Meta-analysis upper limb therapy without restraint? Is the effect of constraint-induced movement therapy related to Randomised controlled trials the duration of intervention or the age of the children? Design: Systematic review of randomised trials Constraint-induced movement therapy with meta-analysis. Participants: Children with hemiplegic cerebral palsy with any level of motor disability. Intervention: The experimental group received constraint-induced movement therapy (defined as restraint of the less affected upper limb during supervised activity practice of the more affected upper limb). The control group received no intervention, sham intervention, or the same dose of upper limb therapy. Outcome measures: Measures of upper limb activity and participation were used in the analysis. Results: Constraint-induced movement therapy was more effective than no/sham intervention in terms of upper limb activity (SMD 0.63, 95% CI 0.20 to 1.06) and participation (SMD 1.21, 95% CI 0.41 to 2.02). However, constraint-induced movement therapy was no better than the same dose of upper limb therapy without restraint either in terms of upper limb activity (SMD 0.05, 95% CI –0.21 to 0.32) or participation (SMD –0.02, 95% CI –0.34 to 0.31). The effect of constraint-induced movement therapy was not related to the duration of intervention or the age of the children. Conclusions: This review suggests that constraint-induced movement therapy is more effective than no intervention, but no more effective than the same dose of upper limb practice without restraint. Registration: PROSPERO CRD42015024665. [Chiu H-C, Ada L (2016) Constraint-induced movement therapy improves upper limb activity and participation in hemiplegic cerebral palsy: a systematic review. Journal of Physiotherapy 62: 130–137] ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction intensive, targeted practice with the more affected limb during restraint of the less affected limb.5 While restrained, only the Cerebral palsy is a non-progressive neurological condition affected upper limb can be used to carry out activities, forcing resulting in motor impairments that can change over time.1 The children to find solutions to their movement problems.4,5 impairments may originate directly from damage to an immature brain, or indirectly from compensatory movements or disuse during There are four systematic reviews specifically examining the development.1 Such impairments may result in activity limitations effect of CIMT in children with cerebral palsy or hemiplegia from that require rehabilitation throughout life.1 Among children with other causes.5–8 Two of the reviews included all published studies, cerebral palsy, 29% have hemiplegia, that is, one side of the body is regardless of design, and included low levels of evidence such as affected much more than the other, and the upper limb is typically case studies.5,8 The Cochrane review on this topic has not been more involved than the lower limb.2 They may develop ‘learned updated since 2007 and includes only three randomised trials. non-use’ in their affected upper limb, because they tend to learn These three trials were not pooled into a meta-analysis but the alternative strategies to manage daily tasks using the less affected authors concluded that there was a trend towards a beneficial limb.3–5 Performance of tasks is often more efficient using the less effect of CIMT.7 The most recent review6 to focus on CIMT reported affected upper limb, even if there is only mild impairment in the a standardised effect size of 0.55 from the pooled estimate of more affected limb.3 Children with hemiplegic cerebral palsy 27 randomised trials of CIMT versus conventional therapy. One of usually have the intellectual capacity to attend regular schools, yet the post-hoc analyses carried out was to divide the trials on the impaired upper limb function tends to restrict their participation in basis of the equivalence of dose of intervention. When CIMT was education and leisure, and impact their social image. compared with a dose-equivalent intervention, the effect was much smaller (SMD 0.37) than the effect among trials without a Therapists working with children with hemiplegic cerebral dose-equivalent comparison group (SMD 0.84). These results give palsy encourage movement of the affected limb by repetitive insight into the mechanism of CIMT. The effect of CIMT may be due practice of unilateral and bimanual activities. Constraint-induced to nothing more than the large amounts of practice that restraint of movement therapy (CIMT) aims to overcome ‘learned non-use’ by the less affected upper limb produces. http://dx.doi.org/10.1016/j.jphys.2016.05.013 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Research 131 In order to fully investigate the effect of CIMT on children with Assessment of characteristics of studies hemiplegic cerebral palsy, trials where CIMT is compared with no intervention need to be pooled separately from trials where CIMT Quality is compared with the same dose of practice without restraint of the The quality of included studies was assessed by extracting unaffected limb. The present systematic review therefore took this approach. In addition, this review examined outcomes at the level PEDro scores from the PEDro website. Each score on the PEDro of activity and participation, because not only is the effect of CIMT website is generated by two accredited raters scoring the trial, with on upper limb activity of interest, but also how improved activity any discrepancies in rating resolved by a third accredited rater. might translate into the broader context of using the upper limb to participate at home, at school and in the community. This review Participants also sought to determine whether the amount of benefit obtained Studies involving participants of either gender, regardless of the from CIMT is associated with certain characteristics of the children or the CIMT. level of initial disability, were included. The Manual Ability Classification System was used to quantify the severity of upper Therefore, the research questions for this systematic review limb disability. The Manual Ability Classification System classifies were: how children with cerebral palsy use their hands to handle objects in daily activities, with I = minor limitations and V = severe 1. Does CIMT improve activity and participation in children with limitations.9 Age and Manual Ability Classification System level hemiplegic cerebral palsy? were recorded so that the similarity of participants between studies could be examined. If the Manual Ability Classification 2. Does CIMT improve activity and participation more than the System level was not reported, reviewers classified the partici- same dose of upper limb therapy without restraint? pants based on the available information. 3. Is the effect of CIMT related to the duration of intervention or the Intervention age of the child? The experimental group had to have received CIMT (defined as Method restraint of the less affected upper limb during task practice of the more affected upper limb). To be eligible to answer the first study Identification and selection of studies question, the control group had to receive no/sham intervention, defined as usual therapy 20% of the time that the experimental Searches were conducted of Medline (1966 to June 2015), group spent restrained. To be eligible to answer the second study CINAHL (1982 to June 2015), PubMed (1966 to June 2015), Embase question, the control group received the same dose of upper limb (1974 to June 2015), the Cochrane Library (1966 to June 2015), therapy (unilateral or bilateral or both), defined as equal to or Web of Science (1945 to June 2015) and the Physiotherapy greater than the time that the experimental group spent Evidence Database (PEDro) (to June 2015), without language restrained. Participants could be receiving other therapy as long restrictions using words related to cerebral palsy and randomised as both groups received it. The frequency and duration of the controlled trials and words related to constraint-induced movement intervention was recorded so that the similarity of intervention therapy (such as constraint-induced movement therapy, forced between studies could be examined. and massed practice) (see Appendix 1 for full search strategy). Titles and abstracts were displayed and screened by one reviewer Outcome measures to identify relevant studies. Full-text copies of relevant studies Measures that reflected upper limb activity and participation were retrieved and their reference lists were screened. The methods of the retrieved papers were screened independently were used in the analysis. Upper limb activity was measured as by two reviewers against the inclusion criteria: randomised or what the child could do with their more affected limb. Therefore, quasi-randomised trials; children or adolescents (< 18 years of measures using direct observation of unimanual performance of age) with hemiplegic cerebral palsy; experimental intervention of standardised upper limb tasks, such as Jebsen-Taylor Test of Hand CIMT; control intervention of no/sham intervention or same dose Function, Nine-Hole Peg Test or Bruininks-Oseretsky Test of Motor of upper limb therapy; and outcome measure(s) of activity or Proficiency, Quality of Upper Extremity Skills Test or Melbourne participation (Box 1). Assessment of Unilateral Upper Limb Function, were used and reported as either level of difficulty or time taken. Upper limb Box 1. Inclusion criteria. participation was measured as what the child did in real life. Therefore, measures using direct observation or parent perception Design of bimanual real-life play, such as the Assisting Hand Assessment randomised or quasi-randomised trial or Pediatric Motor Activity Log, were used and reported as level of Participants difficulty. children (ie, < 18 years old) hemiplegic cerebral palsy Data analysis any level of disability Intervention Data were extracted from the included studies by one reviewer constraint-induced movement therapy (ie, restraint of the and cross-checked by a second reviewer. Information about the method (ie, design, participants, intervention and measures) and less affected limb) applied during supervised activity outcome data (ie, number of participants, mean (SD) activity and practice of the more affected upper limb participation) were extracted. Authors of papers with missing data Outcome measures were contacted. measures of activity or participation Comparisons Most studies reported post-intervention scores immediately constraint-induced movement therapy vs no/sham after intervention; therefore, these scores were used to obtain the intervention (sham defined as usual therapy 20% of pooled estimate of the effect of intervention. Since different time restrained) measurement tools were used, the effect size was reported as constraint-induced movement therapy vs same dose of Cohen’s standardised mean difference (SMD, 95% CI). A random- upper limb therapy (defined as time restrained) effects model was used. The analyses were performed using MIX 2.0, which is a statistical add-in for performing meta-analysis in Excel.10,11 Simple linear regression was used to determine the association between the duration of CIMT and the effect of CIMT (on activity
]GIFDT)1_erugi([$132 Chiu and Ada: Constraint-induced movement in cerebral palsy Titles and abstracts screened investigated children classified as Manual Ability Classification (n = 597) System level I/II/III in the more affected limb (ie, able to handle objects without or with adaptive behaviour). Papers excluded (n = 551) Intervention The experimental group received CIMT with supervised Potentially relevant papers retrieved for evaluation of full text (n = 46) upper limb practice (22 comparisons). The types of restraint included slings (seven studies), splints (four studies), gloves Papers excluded after evaluation of full text (n = 15) (eight studies), casts (two studies), and bandage (one study). • research design not RCT (n = 5) Restraint was worn for 35 hours/week (range 2 to 84) for a • intervention not only CIMT or mCIMT (n = 1) duration of 5 weeks (range 2 to 10) in the comparisons with no/ • participants not only hemiplegia (n = 1) sham intervention and 23 hours/week (range 12 to 30) for a • no supervised practice during restraint (n = 1) duration of 5 weeks (range 2 to 10) in the comparisons with the • both groups received CIMT (n = 4) same dose of upper limb therapy. Supervised practice was • control unsuitable (n = 3) undertaken for 50% of the time that the restraint was worn in the comparisons with no/sham intervention and 100% of the Papers included in systematic time that restraint was worn in the comparisons with the same review (n = 31) dose of upper limb therapy. The control group received no/sham • studies (n = 21) intervention (15 comparisons) or the same dose of upper limb • comparisons (n = 22) therapy (seven comparisons). Sham intervention was a small amount (range 0.3 to 2.2 hours/week) of usual therapy, which Figure 1. Flow of studies through the review. was not necessarily specific to the upper limb and often not RCT = randomised controlled trial, CIMT = constraint-induced movement therapy, specified. The same dose of upper limb therapy usually involved mCIMT = modified constraint-induced movement therapy. bilateral training. Both groups received usual therapy in six comparisons. and participation) and as well as between age and the effect of CIMT (on activity and participation). Only the no/sham treatment- Outcome measures controlled studies were used in this analysis. Measures of upper limb activity were reported in 19 studies. Results The measures chosen for the analysis of upper limb activity were: Jebsen-Taylor Test of Hand Function (four studies), Bruininks- Flow of studies through the review Oseretsky Test of Motor Proficiency (one study), Quality of Upper Extremity Skills Test (six studies), Nine-Hole Peg Test (one study), The search strategy identified 597 studies. After screening Melbourne Assessment of Unilateral Upper Limb Function (three titles and abstracts, 46 full papers were retrieved. After being studies), Box and Block Test (two studies) and Pediatric Arm assessed against the inclusion criteria, 31 papers12–42 of 21 Function Test (two studies). studies12,14–18,21–24,27,28,30,31,36–42 were included in the review (Figure 1; see Appendix 2 for excluded papers). Measures of upper limb participation were reported in 12 studies. The measures chosen for the analysis of upper limb Characteristics of included studies participation were: Assisting Hand Assessment (eight studies), Pediatric Motor Activity Log (three studies) and Caregiver The 21 studies provided 22 comparisons that were relevant to Functional Use Survey (one study). this review because one study had three arms (reported in Fedrizzi et al 201324 and Facchin et al 201125). Among Effect of constraint-induced movement therapy versus no/sham the 22 comparisons, 15 investigated CIMT versus no/sham intervention intervention12,15–18,22–24,30,36–40,42 and seven investigated CIMT versus the same dose of upper limb therapy.14,21,24,27,28,31,41 Activity A summary of the studies is presented in Table 1. The immediate effect of CIMT compared with no/sham Quality intervention on activity was examined by pooling post-interven- The mean PEDro score of the papers was 5.8 (range 3 to 8) tion data from 11 comparisons with a PEDro score of 5.5 and 302 participants, using a random-effects model. Four studies were (Table 2). The majority of the papers: were randomised (100%), unable to be included in the analysis because they had no analysed the between-group difference (97%), reported point appropriate measure of activity13,22,40 or because of missing estimates and variability (87%), had similar groups at baseline data.38 CIMT increased activity (SMD 0.63, 95% CI 0.20 to 1.06) (84%), reported < 15% loss to follow-up (74%) and had blinded compared with no/sham intervention (Figure 2). See Figure 3 on assessors (65%). The majority of studies did not conceal the the eAddenda for the detailed forest plot. There was substantial allocation list (58%), carry out an intention-to-treat analysis (65%), statistical heterogeneity (I2 = 65%), indicating that the variation nor blind participants or therapists (100%). between the results of the trials was above the variation expected by chance. Sensitivity analyses revealed that the heterogeneity Participants was not explained by the quality of the trials, assessor blinding, Participants were children and adolescents who were classified number or severity of participants. as having hemiplegic cerebral palsy, with the mean age across Participation studies ranging from 2.4 to 10.2 years. Fourteen studies (63%) The immediate effect of CIMT compared with no/sham involved participants aged < 4 years. Most of the studies intervention on participation was examined by pooling post- intervention data from eight comparisons with a PEDro score of 5.5 and 215 participants, using a random-effects model. Seven studies were unable to be included in the analysis because they had no appropriate measure of participation.17,18,23,24,36,37,42 CIMT increased participation (SMD 1.21, 95% CI 0.41 to 2.02) compared with no/sham intervention (Figure 4). See Figure 5 on the eAddenda for the detailed forest plot. There was
Research 133 Table 1 Outcome measures Characteristics of included studies (n = 21 studies across 31 papers, with 22 comparisons). Activity: MAUULF Study Design Participants Intervention (0 to 100) Control Experimental Both Participation: AHA (0 to 100) CIMT versus no/sham intervention Timing = 0, 9, 26, 52 wk Aarts et al 201012 RCT n = 50 Restraint = sling Usual therapy Aarts et al 201113 Mean age (range) = 2.9 yr 3 h/d x 3/wk x 6 wk 1.5 h/wk x 8 wk Participation: AHA (2.5 to 8) (Total: 54 h) (Total: 12 h) (0 to 100) Geerdink Classification = hemiplegia, Super = 3 h/d x 3/wk et al 201326 MACS I to III x 6 wk+ Bimanual Timing = 0, 8 wk practice 3 h/d x 3/wk x 2 wk Activity: JTTHFb (s) (Total: 72 h) Participation: CFUS-freq Al-Oraibi RCT n = 14 Restraint = glove Usual therapy (0 to 5) et al 201115 Timing = 0, 3 wk Mean age (range) = 4.8 yr 2 h/d x 6 or 7/wk x 2 h/wk x 8 wk Activity: QUEST-grasp (1.8 to 9) 8 wk (Total: 92 h) (Total: 16 h) (0 to 100) Classification = hemiplegia, Super = 2 h/d x 6/wk Timing = 0, 4, 12 wk MACSa I to V x 8 wk (Total: 92 h) Activity: JTTHFb (s) Timing = –1, 3, 7 wk Charles RCT n = 22 Restraint = sling No intervention et al 200616 Participation: AHA Mean age (range) = 6.7 yr 6 h/d x 5/wk x 2 wk (0 to 100) (4 to 8) (Total: 60 h) Timing = 0, 8 wk Classification = spastic Super = 7 h/d x 5/wk Activity: MAUULF (0 to 100) hemiplegia, MACSa I to III x 2 wk (Total: 70 h) Timing = 0, 2, 12, 52 wk Choudhary RCT n = 31 Restraint = sling No intervention Usual therapy et al 201317 Activity: QUEST-grasp (%) Mean age (range) = 5.1 yr 3 h/d x 2-3/wk x 0.3 h/d x 7/ Timing = 0, 10, 12, 26 wk (3 to 8) 4 wk + 2 h/d x 4-5/ wk x 4 wk Activity: BOTMP-subtest 8 (0 to 9) Classification = hemiplegia, wk x 4 wk (Total: (Total: 8.5 h) Participation: PMAL-quality MACSa I to III 66 h) (0 to 5) Super = 2 h/d x 2-3/ Timing = 0, 4, 12 wk Activity: PAFT (0 to 120) wk x 4 wk (Total: Timing = 0, 5 wk 20 h) Activity: BBT (blocks) Timing = 0, 6 wk De Brito Branda˜o RCT n = 16 Restraint = sling Usual therapy et al 201018 Activity: QUEST (%) Mean age (range) = 6 yr 10 h/d x 5/wk x 2 wk 0.75 h/wk x 3 wk Participation: PMAL-quality Eliasson et al 201122 (4 to 8) (Total = 100 h) (Total = 2 h) (0 to 5) Timing = 0, 3 wk Classification = spastic Super = 3 h/d x 5/wk hemiplegia, MACS I to III x 2 wk+ bimanual practice 0.75 h/d x 3/wk x 1 wk (Total: 32 h) Cross-over n = 25 Restraint = glove No intervention Usual therapy RCT Mean age (range) = 2.4 yr 2 h/d x 7/wk x 8 wk (1.5 to 5) (Total: 102 h) Classification = hemiplegia, Super = 2 h/d x 7/wk MACSa I to V x 8 wk (Total: 102 h) Eugster-Buesch RCT n = 23 Restraint = splint No intervention Usual therapy et al 201223 Mean age (range) = 10.7 yr 6 h/d x 7/wk x 2 wk (6 to 16) (Total: 84 h) Classification = hemiplegia, Super = 2 h/d x 7/wk MACSa I to III x 2 wk (Total: 28 h) Fedrizzi RCT n = 48 Restraint = glove Usual therapy et al 201324 Mean age (range) = 4.3 yr 3 h/d x 7/wk x 10 wk 1-2/wk x 10 wk Facchin et al 201125 (2 to 8) (Total: 210 h) (Total: 15 h) Classification = hemiplegia, Super = 3 h/d x 7/wk MACSa I to V x 10 wk (Total: 210 h) Rostami RCT n = 16 Restraint = splint No intervention Usual therapy et al 201230 Mean age (range) = 8.2 yr 5 h/d x 7/wk x 4wk 0.5 h/d x 2/ (6 to 12) (Total: 140 h) wk x 4 wk Classification = spastic Super = 1.5 h/d x 3/wk (Total: 4 h) hemiplegia, MACSa I to III x 4 wk (Total: 18 h) Smania Cross-over n = 10 Restraint = glove Usual therapy et al 200936 RCT Mean age (range) = 3.3 yr 8 h/d x 7/wk x 5 wk 1 h/d x 2/wk x 5 wk (1 to 9) (Total: 280 h) (Total: 10 h) Sung et al 200537 Classification = hemiplegia, Super = 1 h/d x 2/wk MACSa I to III x 5 wk (Total: 10 h) RCT n = 31 Restraint = cast Usual therapy Mean age (range) = 3.1 yr 12 h/d x 7/wk x 6 wk 0.5 h/d x 2/wk x 6 wk ( 8) (Total: 500 h) (Total: 6 h) Classification = hemiplegia, Super = 0.5 h/d x 2/ MACSa I to III wk x 6 wk (Total: 6 h) Taub RCT n = 18 Restraint = cast Usual therapy et al 200438 Mean age (range) = 3.5 yr 12 h/d x 7/wk x 3 wk 2.2 h/wk x 3 wk DeLuca et al 200620 (0.5 to 8) (Total: 250 h) (Total = 7 h) Classification = hemiplegia, Super = 6 h/d x 7/wk MACSa I to V x 3 wk (Total: 125 h)
134 Chiu and Ada: Constraint-induced movement in cerebral palsy Table 1 (Continued ) Study Design Participants Intervention Outcome measures Experimental Control Both Taub et al 201139 RCT n = 20 Restraint = splint No intervention Usual therapy Activity: PAFT (0 to 64) Mean age (range) = 3.7 yr 12 h/d x 5/wk x 3 wk 1.5 hr/wk x 3 wk Participation: PMAL-quality (2 to 6) (Total: 90 h) (Total: 4.5 h) Classification = hemiplegia, Super = 6 h/d x 5/wk (0 to 5) MACSa I to V x 3 wk (Total: 90 h) Timing = 0, 3 wk Wallen RCT n = 50 Restraint = glove Usual therapy Participation: AHA et al 201140 (0 to 100) Mean age (range) = 3.1 yr 2 h/d x 7/wk x 8 wk 0.3 h x 7/wk x 8 wk Timing = 0, 10, 26 wk (1.5 to 8) (Total: 112 h) (Total: 17 h) Classification = spastic Super = 2 h/d x 7/wk hemiplegia, MACS I to IV x 8 wk (Total: 112 h) Yu et al 201242 RCT n = 20 Restraint = sling No intervention Usual therapy Activity: BBT (blocks) Mean age 1 h/d x 2/wk x 10 wk 0.5 h/d x 2/wk Timing = 0, 10 wk (range) = 9.4 yr (Total: 20 h) x 10 wk (9 to 10) Super = 1 h/d x 2/wk (Total: 10 h) Classification = hemiplegia, x 10 wk (Total: 20 h) MACSa I to III CIMT versus same dose of upper limb therapy Abd el-Kafy RCT n = 27 Restraint = sling Bimanual practice Activity: QUEST (%) et al 201414 Timing = 0, 4, 12 wk Mean age (range) = 6.1 yr 6 h/d x 5/wk x 4 wk 6 h/d x 5/wk x 4 wk (4 to 8) (Total: 120 h) (Total: 120 h) Classification = spastic Super = 6 h/d x 5/wk hemiplegia, MACS II to IV x 4 wk (Total: 120 h) Deppe RCT n = 29 Restraint = bandage Bimanual practice Activity: MAUULF (0 to 122) et al 201321 Participation: AHA (22 to 88) Mean age (range) = 6.3 yr 4 h/d x 5/wk x 3 wk 4 h/d x 5/wk x 4 wk Timing = 0, 4 wk (3.3 to 12) (Total: 60 h) (Total: 80 h) Classification = hemiplegia, Super = 4 h/d x 5/wk MACS I to III x 3 wk + bimanual practice 4 h/d x 5/wk x 1 wk (Total: 80 h) Fedrizzi RCT n = 48 Restraint = glove Bimanual practice Activity: QUEST-grasp (%) et al 201324 Timing = 0, 10, 26 wk Mean age (range) = 4 yr 3 h/d x 7/wk x 10 wk 3 h/d x 7/wk x 10 wk Facchin et al 201125 (2 to 8) (Total: 210 h) (Total: 210 h) Classification = hemiplegia, Super = 3 h/d x 3/wk MACSa I to V x 10 wk (Total: 210 h) Gelkop et al 201527 Cross-over n = 12 Restraint = glove Bimanual practice Activity: QUEST-grasp (%) RCT Mean age (range) = 4.3 yr 2 h/d x 6/wk x 8 wk 2 hx 6/wk x 8 wk Participation: AHA (1.5 to 7) (Total: 96 h) (Total: 96 h) Classification = spastic Super = 2 h/d x 6/wk (0 to 100) hemiplegia, MACS I to III x 8 wk (Total: 96 h) Timing = 0, 8 wk Gordon RCT n = 42 Restraint = sling Bimanual practice Activity: JTTHFb (s) et al 201128 Mean age (range) = 6.3 yr 6 h/d x 5/wk x 3 wk 6 h/d x 5/wk x 3 wk Participation: AHA (logits) (3.5 to 10) (Total: 90 h) (Total: 90 h) Timing = 0, 3 wk De Brito Brandao Classification = hemiplegia, Super = 6 h/d x 5/wk et al 201219 MACS I to III x 3 wk (Total: 90 h) Hung et al 201129 Sakzewski RCT n = 63 Restraint = glove Bimanual practice Activity: JTTHFb (s) et al 2011a31 Participation: AHA Mean age (range) = 10.2 yr 6 h/d x 5/wk x 2 wk 6 h/d x 10 days Sakzewski (0 to 100) et al 2011b32 (5 to 16) (Total: 60 h) (Total: 60 h) Timing = 0, 3 wk Sakzewski Classification = spastic Super = 6 h/d 5/wk x et al 2011c33 hemiplegia, MACS I to III 2 wk (Total: 60 h) Sakzewski et al 2011d34 Sakzewski et al 201235 Xu et al 201241 RCT n = 45 Restraint = splint Bimanual practice Activity: 9-HPTb (s) Timing = 0, 2 wk Mean age (range) = 4.6 yr 3 h/d x 5/wk x 2 wk 3 h/d x 5/wk x 2 wk (2 to 14) (Total: 30 h) (Total: 30 h) Classification = hemiplegia, Super = 4 h/d x 5/wk MACSa I to III x 2 wk (Total: 40 h) a MACS level estimated by reviewers. b Experimental and control scores reversed for analysis because a smaller score denotes better performance. AHA = Assisting Hand Assessment, BBT = Box and Block Test, BOTMP = Bruininks-Oseretsky Test of Motor Proficiency, CFUS freq = Caregiver Functional Use Survey, JTFHT = Jebsen-Taylor Test of Hand Function, MACS = Manual Ability Classification System, MAUULF = Melbourne Assessment of Unilateral Upper Limb Function, PAFT = Pediatric Arm Function Test, PMAL = Pediatric Motor Activity Log, QUEST = Quality of Upper Extremity Skills Test, RCT = randomised controlled trial, Super = supervised practice, 9-HPT = Nine Hole Peg Test. substantial statistical heterogeneity (I2 = 84%), indicating that Effect of constraint-induced movement therapy versus same dose the variation between the results of the trials was above the of upper limb therapy variation expected by chance. Sensitivity analyses revealed that the heterogeneity was not explained by the quality of Activity the trials, assessor blinding or the number or severity The immediate effect of CIMT compared with the same dose of of participants. upper limb therapy on activity was examined by pooling data after
Research 135 Table 2 PEDro scores for included papers (n = 31). Study Random Concealed Groups Participant Therapist Assessor < 15% Intention- Between-group Point Total allocation allocation similar at blinding blinding blinding dropouts to-treat difference estimate and (0 to 10) baseline analysis reported variability reported Aarts et al 201012 Y NY N NYY N Y Y6 Y Y6 Aarts et al 201113 Y NY N NYY N Y N5 Y Y4 Abd el-Kafy et al 201414 Y NY N NYY N Y Y5 Y Y8 Al-Oraibi et al 201115 Y NN N N YN N Y Y8 Y Y6 Charles et al 200616 Y NY N N YN N Y N4 Y Y7 Choudhary et al 201317 Y Y Y N NYY Y Y Y4 Y Y7 De Brito Branda˜o et al 201018 Y Y Y N NYY Y Y N4 Y N4 De Brito Branda˜o et al 201219 Y Y Y N NNY N Y Y6 Y Y8 De Luca et al 200620 Y NN N NYY N Y Y7 Y Y5 Deppe et al 201321 Y Y Y N NYY N Y Y7 Y Y7 Eliasson et al 201122 Y NN N N YN N Y Y8 Y Y7 Eugster-Buesch et al 201223 Y Y Y N NYY N Y Y7 Y Y7 Fedrizzi et al 201324 Y NY N NNY N Y Y4 Y Y4 Facchin et al 201125 Y NY N NNY N Y Y5 Y Y5 Geerdink et al 201326 Y NY N NNY Y Y Y8 Y Y5 Gelkop et al 201527 Y Y Y N NYY Y N Y3 Gordon et al 201128 Y Y Y N NYY N Hung et al 201129 Y NN N NYY N Rostami et al 201230 Y NY N NYY Y Sakzewski et al 2011a31 Y Y Y N NNY Y Sakzewski et al 2011b32 Y Y Y N NYY Y Sakzewski et al 2011c33 Y Y Y N NNY Y Sakzewski et al 2011d34 Y Y Y N NNY Y Sakzewski et al 201235 Y Y Y N NNY Y Smania et al 200936 Y NN N N YN N Sung et al 200537 Y NY N N NN N Taub et al 200438 Y NY N N YN N Taub et al 201139 Y NY N NNY N Wallen et al 201140 Y Y Y N NYY Y Xu et al 201241 Y NY N N YN N Yu et al 201242 Y NY N N NN N Y = yes, N = no, PEDro = Physiotherapy Evidence Database. PEDro scores extracted from website www.pedro.org.au intervention from five comparisons with a PEDro score of 6.8 and Participation The immediate effect of CIMT compared with the same dose of 218 participants, using a random-effects model. Two studies were upper limb therapy on participation was examined by pooling data unable to be included in the analysis because they had no post- after intervention from four comparisons with a PEDro score of intervention data41 or missing data.14 CIMT did not increase 7.5 and 146 participants, using a random-effect model. Three activity (SMD 0.05, 95% CI –0.21 to 0.32, I2 = 0%) compared with the studies were unable to be included in the analysis because they had no appropriate participation measure.14,24,41 CIMT did not same dose of upper limb therapy (Figure 6). See Figure 7 on the increase participation (SMD –0.02, 95% CI –0.34 to 0.31, I2 = 0%) compared with the same dose of upper limb therapy (Figure 8). See e[(Figu]GI$DT)2_er Addenda for the detailed forest plot. Fer]4GuIgiF$([)DT_ igure 9 on the eAddenda for the detailed forest plot. Study SMD (95% CI) Random Aarts 2010 SMD (95% CI) Random Charles 2006 Study Choudhary 2013 Aarts 2010 De Brito 2010 Al-Oraibi 2011 Eugster 2012 Charles 2006 Fedrizzi 2013 Eliasson 2011 Rostami 2012 Rostami 2012 Smania 2009 Taub 2004 Sung 2005 Taub 2011 Taub 2011 Wallen 2011 Yu 2012 Pooled Pooled –2 –1 0 1 2 3 4 5 6 –2 –1 0 1 2 3 4 5 6 Favours con Favours exp Favours con Favours exp Figure 2. SMD (95% CI) of effect of constraint-induced movement therapy compared Figure 4. SMD (95% CI) of effect of constraint-induced movement therapy with no with no/sham intervention on upper limb activity immediately after intervention intervention on upper limb participation immediately after intervention by pooling by pooling data from 11 trials (n = 302) using a random-effects model (I2 = 65%). data from eight trials (n = 215) using a random-effects model (I2 = 84%).
]GIF$DT)6_erugi([136 Chiu and Ada: Constraint-induced movement in cerebral palsy Study SMD (95% CI) effective, it was no more effective than the same dose of upper limb Random therapy without restraint. This suggests that the mechanism of the effect is the dose of practice undertaken, rather than the type of Deppe 2013 practice (ie, CIMT). In the studies where CIMT was compared with no/sham intervention, children in the CIMT group were restrained Fedrizzi 2013 for an average of 5 hours/day and they spent just over 50% of this period engaged in supervised practice. In the studies where CIMT Gelkop 2015 was compared with the same dose of upper limb practice without restraint, children in the CIMT group were restrained for an average Gordon 2011 of 4 hours/day and they spent 100% of this period engaged in supervised practice, sometimes carrying out extra unrestrained Sakzewski 2011a practice. Pooled The findings from this review are supported by the findings of the only other systematic review to specifically examine CIMT –2 –1 0 1 2 3 where a meta-analysis was performed.5 In this previous review, Favours con Favours exp when all studies were pooled, CIMT provided a moderate beneficial effect of 0.55. When only the studies of CIMT against a non- Figure 6. SMD (95% CI) of effect of constraint-induced movement therapy with equivalent dose intervention were analysed, the estimated effect same dose of upper limb therapy on upper limb activity immediately after size was 0.84, which was similar to our estimated effect size of intervention by pooling data from five trials (n = 218) using a random-effect model 0.63 for activity and 1.21 for participation. On the other hand, when only the studies of CIMT against an equivalent dose of (]GIF$DT)8_erugi([ I2 = 0%). practice were analysed, the estimated effect size was 0.37, which is larger than our estimated effect size of 0.05 for activity and –0.02 Study SMD (95% CI) for participation. This may be because Chen et al5 included seven Random studies in their analysis that were not considered dose equivalent by our definition.12,13,26,36,40,43,44 Since the control groups in these Deppe 2013 studies received less practice than the CIMT groups, this may explain why the effect that Chen et al found was larger than in our Gelkop 2015 review. In a general review, Sazewski et al45 also came to the conclusion that the mechanism of the effect was the dose of Gordon 2011 practice undertaken, rather than the type of practice. Sakzewski 2011a There were some limitations to this review. First, there were some missing data, so not all the included studies are represented Pooled in the final pooled estimate, although this only amounts to 15% of the total data. Second, although a large number of studies were –2 –1 0 1 2 3 represented, most were of a small sample size. On average, there Favours con Favours exp were 33 participants per study included in the meta-analyses, leaving the review vulnerable to small trial bias. Third, there were Figure 8. SMD (95% CI) of effect of constraint-induced movement therapy with high levels of statistical heterogeneity (I2 > 60%) in the analyses of CIMT against no/sham intervention, and the source of this same dose of upper limb therapy on upper limb participation immediately after heterogeneity was not obvious. intervention by pooling data from four trials (n = 146) using a random-effects This review generates several implications for clinical practice model (I2 = 0%). with children with hemiplegic cerebral palsy. CIMT is an effective way to improve upper limb function at the activity level and this can Relation between the effect and duration of constraint-induced be expected to carry over into participation in real life. Given that movement therapy and age for activity and participation the same dose of practice without restraint is likely to result in the same outcome, it seems that as long as large amounts of practice are There was no significant relation between duration of CIMT carried out, regardless of whether that is with restraint (unimanual) (total duration of CIMT) and effect of CIMT on activity (r = –0.25, or without restraint (bimanual and unimanual), improvement will p = 0.46) or participation (r = –0.10, p = 0.81). Neither was there a occur. In the studies of CIMT against no/sham intervention, children significant relation between age and effect of CIMT on activity were supervised to practise using their upper limb for an average of (r = 0.37, p = 0.26) or participation (r = 0.58, p = 0.13). 2.5 hours a day, with a further 2.5 hours of restraint forcing more practice. Ultimately, the way in which practice is achieved may be Discussion best chosen by a combination of the child and the parents, as well as the therapists. For example, it may be easier to ‘force’ practice over This systematic review found that CIMT had a beneficial effect long periods of time at home using CIMT than practising without compared with no/sham intervention for children with hemiplegic restraint under the supervision of parents. cerebral palsy. Furthermore, the effect was beneficial in terms of both activity and participation, suggesting that the improved What is already known on this topic: Children with hemi- upper limb activity carried over into what the children actually did plegia due to cerebral palsy may have impairments due to in real life with their upper limb. On the other hand, when CIMT damage to an immature brain, indirectly from compensatory was compared with the same dose of upper limb therapy, there movements or from learned disuse. Such impairments may was little effect on activity or participation. Neither duration of result in limitations in activity requiring rehabilitation through- CIMT nor age influenced the size of the effect of CIMT. out life. What this study adds: Constraint-induced movement thera- This review was based on randomised trials of reasonable to py is an effective way to improve upper limb function, but as good quality. Given that 8 was the likely maximum PEDro score long as large amounts of practice are carried out, regardless of achievable, because it is not possible to blind the therapists or whether that is achieved with or without restraint, this benefit participants during complex interventions such as CIMT, the mean can be expected. PEDro score of 5.8 for the papers included in this review suggested that the findings were reasonably credible. Although CIMT was
Research 137 eAddenda: Figures 3, 5, 7 and 9; Appendices 1 and 2, can found 22. Eliasson AC, Shaw K, Berg E, Krumlinde-Sundholm L. An ecological approach of Constraint Induced Movement Therapy for 2-3-year-old children: a randomized at: doi:10.1016/j.jphys.2016.05.013 control trial. Res Dev Disabil. 2011;32:2820–2828. Ethics approval: Not applicable 23. Eugster-Buesch F, de Bruin ED, Boltshauser E, Steinlin M, Kuenzle C, Muller E, et al. Forced-use therapy for children with cerebral palsy in the community setting: Competing interests: Nil a single-blinded randomized controlled pilot trial. J Pediatr Rehabil Med. 2012;5:65–74. Source of support: This research was, in part, supported by I- 24. Fedrizzi E, Rosa-Rizzotto M, Turconi AC, Pagliano E, Fazzi E, Pozza LV, et al. Shou University, under Grant no. ISU 103-04-06A. Unimanual and bimanual intensive training in children with hemiplegic cerebral palsy and persistence in time of hand function improvement: 6-month follow-up Acknowledgement: Nil results of a multisite clinical trial. J Child Neurol. 2013;28:161–175. Provenance: Not invited. Peer reviewed. 25. Facchin P, Rosa-Rizzotto M, Visona Dalla Pozza L, Turconi AC, Pagliano E, Signorini S, et al. Multisite trial comparing the efficacy of constraint-induced movement Correspondence: Hsiu-Ching Chiu, Department of Physical therapy with that of bimanual intensive training in children with hemiplegic cerebral palsy: postintervention results. Am J Phys Med Rehabil. 2011;90:539–553. Therapy, I-Shou University, Taiwan (ROC). Email: hsiuchingchiu@ 26. Geerdink Y, Aarts P, Geurts AC. Motor learning curve and long-term effectiveness of isu.edu.tw modified constraint-induced movement therapy in children with unilateral cere- bral palsy: a randomized controlled trial. Res Dev Disabil. 2013;34:923–931. 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Bax L, Yu LM, Ikeda N, Tsuruta H, Moons KG. Development and validation of MIX: upper limb rehabilitation on quality of life: a randomized trial in children with comprehensive free software for meta-analysis of causal research data. BMC Med unilateral cerebral palsy. Dev Med Child Neurol. 2012;54:415–423. Res Methodol. 2006;6:50. 36. Smania N, Aglioti SM, Cosentino A, Camin M, Gandolfi M, Tinazzi M, et al. A 11. Bax L, Yu LM, Ikeda N, Tsuruta H, Moons KG. MIX: comprehensive free software for modified constraint-induced movement therapy (CIT) program improves paretic meta-analysis of causal research data. Version 2.0. 2014. arm use and function in children with cerebral palsy. Eur J Phys Rehabil Med. 2009;45:493–500. 12. Aarts PB, Jongerius PH, Geerdink YA, van Limbeek J, Geurts AC. Effectiveness of modified constraint-induced movement therapy in children with unilateral spastic 37. Sung I, Ryu J, Pyun S, Yoo S, Song W, Park M. Efficacy of forced-use therapy in cerebral palsy: a randomized controlled trial. Neurorehabil Neural Repair. hemiplegic cerebral palsy. Arch Phys Med Rehabil. 2005;86:2195–2198. 2010;24:509–518. 38. Taub E, Ramey SL, DeLuca S, Echols K. Efficacy of constraint-induced movement 13. Aarts PB, Jongerius PH, Geerdink YA, van Limbeek J, Geurts AC. Modified Con- therapy for children with cerebral palsy with asymmetric motor impairment. straint-Induced Movement Therapy combined with Bimanual Training (mCIMT- Pediatr. 2004;113:305–312. BiT) in children with unilateral spastic cerebral palsy: how are improvements in arm-hand use established? Res Dev Disabil. 2011;32:271–279. 39. Taub E, Griffin A, Uswatte G, Gammons K, Nick J, Law CR. Treatment of congenital hemiparesis with pediatric constraint-induced movement therapy. J Child Neurol. 14. Abd El-Kafy EM, Elshemy SA, Alghamdi MS. Effect of constraint-induced therapy on 2011;26:1163–1173. upper limb functions: a randomized control trial. Scand J Occup Ther. 2014;21: 11–23. 40. Wallen M, Ziviani J, Naylor O, Evans R, Novak I, Herbert RD. Modified constraint- induced therapy for children with hemiplegic cerebral palsy: a randomized trial. 15. Al-Oraibi S, Eliasson AC. Implementation of constraint-induced movement therapy Dev Med Child Neurol. 2011;53:1091–1099. for young children with unilateral cerebral palsy in Jordan: a home-based model. Disabil Rehabil. 2011;33:2006–2012. 41. Xu K, Wang L, Mai J, He L. Efficacy of constraint-induced movement therapy and electrical stimulation on hand function of children with hemiplegic cerebral palsy: 16. Charles JR, Wolf SL, Schneider JA, Gordon AM, Charles JR, Wolf SL, et al. Efficacy of a a controlled clinical trial. Disabil Rehabil. 2012;34:337–346. child-friendly form of constraint-induced movement therapy in hemiplegic cere- bral palsy: a randomized control trial. Dev Med Child Neurol. 2006;48:635–642. 42. Yu J, Kang H, Jung J. Effects of modified constraint induced movement therapy on hand dexterity, grip strength and activities of daily living of children with cerebral 17. Choudhary A, Gulati S, Kabra M, Singh UP, Sankhyan N, Pandey RM, et al. Efficacy of palsy: a randomized control trial. J Phys Ther Sci. 2012;24:1029–1031. modified constraint induced movement therapy in improving upper limb function in children with hemiplegic cerebral palsy: a randomized controlled trial. Brain 43. Chen CL, Kang LJ, Hong WH, Chen FC, Chen HC, Wu CY. Effect of therapist-based Dev. 2013;35:870–876. constraint-induced therapy at home on motor control, motor performance and daily function in children with cerebral palsy: a randomized controlled study. Clin 18. De Brito Brandao M, Mancini MC, Vaz DV, Pereira de Melo AP, Fonseca ST. Adapted Rehabil. 2013;27:236–245. version of constraint-induced movement therapy promotes functioning in children with cerebral palsy: a randomized controlled trial. Clin Rehabil. 44. Hsin YJ, Chen FC, Lin KC, Kang LJ, Chen CL, Chen CY. Efficacy of constraint-induced 2010;24:639–647. therapy on functional performance and health-related quality of life for children with cerebral palsy: a randomized controlled trial. J Child Neurol. 2012;27:992–999. 19. De Brito Brandao M, Gordon AM, Mancini MC. Functional impact of constraint therapy and bimanual training in children with cerebral palsy: a randomized 45. Sakzewski L, Ziviani J, Boyd RN. Efficacy of upper limb therapies for unilateral controlled trial. Am J Occup Ther. 2012;66:672–681. cerebral palsy: a meta-analysis. Pediatr. 2014;133:e175–e204. 20. Deluca SC, Echols K, Law CR, Ramey SL. Intensive pediatric constraint-induced Websites therapy for children with cerebral palsy: randomized, controlled, crossover trial. J Child Neurol. 2006;21:931–938. PEDro www.pedro.org.au 21. Deppe W, Thuemmler K, Fleischer J, Berger C, Meyer S, Wiedemann B. Modified constraint-induced movement therapy versus intensive bimanual training for children with hemiplegia - a randomized controlled trial. Clin Rehabil. 2013;27:909–920.
Journal of Physiotherapy 62 (2016) 176–177 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Media Creating early opportunities to learn and move for infants with cerebral palsy Shepherd R, Ed. Cerebral Palsy in Infancy. Elsevier, Churchill injury. The potential for plasticity and re-organisation is complex Livingstone; 1st Edition, 2014. ISBN 978-0-7020-5099-2. and dependent on stages of brain development, as well as experience. Evidence $T_[FiD]I9 s presented from both animal and human Maturation and development of the central nervous and models of research about the importance of activity and the musculoskeletal systems in typically developing children occur environment in shaping the developing brain, whether impaired or rapidly during the first 18 months of life.]F[6_$ITD This occurs through not[I.F$T]D4_ The importance of experiential activity on the subsequent repetitive exploration and experience. For infants with cerebral development of neuromuscular junctions, motor neurons within palsy, the lack of opportunity to practise and experience the spinal cord and motor axons, is also examined. movement can place already vulnerable central nervous and musculoskeletal systems in double jeopardy. In this first edition of Part 3 Cerebral Palsy in Infancy, therapists and exercise professionals are In part 3, the key impairments associated with cerebral palsy at challenged to commence task-specific intensive training for infants with cerebral palsy as early as possible, using the principles physiological and impairment-based levels are discussed. While of effective neurorehabilitation for older children and adults. the aim of this book was to shift the traditional ideas of cerebral palsy management towards preventative, motor-learning and Shepherd, who is renowned worldwide for transforming task-specific principals, this section pays respect to existing rehabilitation practice using a motor learning approach, edits this understanding and methods for the management of secondary book, which comprises contributions from multi-disciplinary musculoskeletal sequalae of cerebral palsy. The authors build a international experts, includingF1TD$[_]I neuroscientists, physiotherapists, strong physiological understanding of the changes in muscle paediatricians and occupational therapists (including Cioni, structure and function in cerebral palsy. This in turn presents the Damiano, Einspieler, Fetters and Gordon). This seminal book is opportunity to shape further research in maintaining muscle relevant to clinicians and researchers who may need to update integrity utilising active, task-specific methods. their knowledge about recent breakthroughs in early assessment and intervention. There has been a shift in focus away from passive Part 4 techniques or only starting intervention once maladaptive features Part 4 extends from Part 1 by exploring the ideas of early (eg, muscle shortening) have occurred. Best available evidence now supports goal-orientated training early in development for diagnosis in order to harness the plastic musculoskeletal system infants at ‘high risk’ or with a diagnosis of cerebral palsy.1,2T_D5[$]IF This and target key stages of motor-cognitive development. Interna- book consists of five parts, including annotations that support the tional authorities on the early predictive diagnosis of cerebral palsy respective chapters with examples of emerging research, including open the section with a detailed insight into the General assessment and intervention strategies. Movements assessment. The importance of early detection is highlighted as a case for improving the ability to better investigate Part 1 and administer interventions for the infant at risk of cerebral palsy. In the first chapter, the importance of early-targeted activity for In this section, theories are presented about muscles being highly adaptive body structures and self-initiated movement as a key infants with cerebral palsy is introduced. Although timing is critical component of future early intervention strategies. Care must be for rehabilitation following brain injury, most infants with cerebral taken when interpreting the studies presented within this section palsy are not diagnosed until the first or second year of life.3 The that link motor and cognitive development, as there are many subsequent delay in appropriate intervention during critical periods contributing factors to an infant’s neurodevelopmental outcome. of development can result in structural, mechanical and functional maladaptations that lead to muscle weakness and poor motor Part 5 control. Intervention for_3]D[IFT$ cerebral palsyT7$]D_FI[ during infancy differs from The last and most extensive part of this book outlines the later childhood, DFT_b]I[8$ ecause the underlying impairments are weakness and motor control, with spasticity not developing until after the clinical application of early intervention for infants with cerebral first few years of life. Now that early detection is possible with palsy. The approach is based on the principles of neurorehabilita- neuroimaging and the General Movements assessment, a strong tion in adults, but using task-orientated play and activities to theoretical case is made for starting intervention earlier.4D$]TIF_2[ encourage muscle activation, contractibility, strength and devel- opment of motor control relevant to infants. The importance of Part 2 developing postural control through key developmental mile- Janet Eyre and Mary Galea discuss in depth the neuroscience of stones is presented not only as being important for typically developing children, but also as an important goal for young starting early intervention and the key role of the cortico-spinal infants with cerebral palsy. Strategies for parents and therapists to tract in the production of skilled movement. It was once thought create an environment in which to drive these fundamental actions that brain lesions earlier in life, compared with those at an older are described in detail. Annotations by leaders in the field describe age, would result in better functional outcomes, DT8[]_b$FI ecause the rapid novel interventions that are currently being tested in research and unique neural organisational process in the perinatal period settings to encourage early active motor control of the upper and results in an altered physical presentation after perinatal brain lower limbs. These includeIF$DT_1[] mobiles, constraint-induced movement http://dx.doi.org/10.1016/j.jphys.2016.05.002 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Appraisal Media 177 therapy, bimanual upper limb training, treadmills, early action Provenance: Invited. Not peer1_FI][T$D0 reviewed. observation and interactive technologies. These emerging modali- ties aim to encourage intensive repetitive training, which is Alicia Spittlea,b,c and Amanda Kwonga,b,c essential to drive musculoskeletal and neural development. aDepartment of Physiotherapy, University of Melbourne bVictorian Infant Brain Studies, Murdoch Children’s Research Institute This book emphasises recent research on early detection of cNewborn Research, The Royal Women’s Hospital, Melbourne, infants with cerebral palsy, and its translation into clinical practice with the aim of timely and targeted early intervention. Whilst Australia there is a strong theoretical basis involving biomechanics and neuroscience for early interventions, some of the supporting References evidence is still preliminary. Most research, to date, has focused on older children, and studies on younger children are sparse in 1. McIntyre S, et al. Dev Disabil Res Rev. 2011;17:114–129. comparison.5 Nonetheless, now that early detection of infants with 2. Novak I, et al. Dev Med Child Neurol. 2013;55:885–910. cerebral palsy is possible, there is a unique opportunity in this field 3. Hubermann L, et al. J Child Neurol. 2016;31:364–369. for early intervention. Physiotherapists play a critical role in 4. Spittle AJ, et al. Pediatrics. 2009;123:512–517. working with infants and families to create an enriched 5. Morgan C, et al. Dev Med Child Neurol. 2016. http://dx.doi.org/10.1111/dmcn.13105. environment in which to learn and move. Article first published online: 29 Mar 2016.
Journal of Physiotherapy 62 (2016) 121–123 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Editorial $[FDC1]I_T ulturally informed practice and physiotherapy Bernadette Brady a, Irena Veljanova b, Lucinda Chipchase c a Departments of Pain Medicine and Physiotherapy, Liverpool Hospital; b School of Social Science and Psychology, Western Sydney University; c School of Science and Health, Western Sydney University, Sydney, Australia Australia is culturally diverse, with more than half (52.2%) of the explore the concepts of culture, illness and health. Culture population born overseas or having at least one parent born describes the learned values, behaviours and beliefs that are overseas.1]$FDI[T_6 Since 2005, migration has been the main driver of shared by members of a particular social group.7_T[D]FI7$ At any point in Australia’s population growth, contributing approximately 60% of time, an individual Dc]F[I$T_01 an concurrently identify as belonging to more overall growth.1 While historically the bulk of Australia’s overseas- than one social group, including, but not limited to: ethnicity, born population comprised migrants from Anglo-Celtic descent, the gender, social class, role category or sexual orientation.7 This dismantling of the White Australia Policy four decades ago heralded intersectionality of belonging makes the culture of an individual a new era of more inclusive migration policies. This saw a sustained dynamic and constantly evolving. Ethnoculture – the culture rise in the proportion of migrants to Australia from non-English related to ethnic group belonging – is the cultural dimension of speaking countries.2 The combination of Indigenous populations particular interest when discussing culturally and linguistically and the long history of immigration has created a culturally rich and diverse communities. This term encompasses groups united by diverse Australia.2 The growth in migrants and refugees, many of commonality in language, nationality, race, historical origin and/or whom have been displaced due to conflict and persecution, has religion.7 An individual’s ethnoculture frames how they perceive, fuelled debate about the preparedness of plural societies like experience and engage in health and illness. However, while Australia for the challenges associated with such cultural diversity. beliefs and practices are shared by ethnocultural communities, One challenge is health system responsiveness; specifically, health there is considerable intra-cultural variation that is influenced by systems must be responsive to the social, economic and cultural the social, economic and political circumstances within which an factors underpinning disparities in health for patients from individual exists.7 When considering the multiple dimensions that culturally and linguistically diverse backgrounds. With interna- underpin an illness experience, it is not surprising that differences tional migration continuing to rise, it is timely to consider whether have been observed across ethnocultural groups. Australian health professionals, including physiotherapists, are equipped to deliver culturally responsive healthcare. Cross-cultural comparisons emphasise that the way illness is reported, portrayed and managed is different between ethnocul- Culturally responsive healthcare, an extension of patient-centred tural groups. In pain medicine, this manifests in contrasting self- care, ensures that attention is given to social and cultural factors reported symptoms and behaviours, whether in response to during therapeutic encounters by exploring the beliefs and values comparable medical and physical examination findings, or to that underpin the illness experience.3F[]2DI$_T A number of terms have been identical experimental pain stimuli.8 An example is the ethno- used, often interchangeably, to describe culturally responsive cultural variance observed during childbirth. Some ethnocultures healthcare or practice, such as cultural competency and cultural do not frame labour pain as natural and seek to ablate it, while for safety.3,4 Broadly, these terms describe the attributes required by others, pharmacological interventions are rejected.9[1FI_$D]T Further, some health professionals to engage effectively with health consumers ethnocultures are verbally expressive of symptoms such as pain, from culturally diverse communities.3,4 Our national physiotherapy while for others it shameful to express pain, with silence being competency standards cite cultural competence, cultural respon- considered a sign of strength.9 Using this example, we see that for siveness and cultural safety in four of seven requirements for the same physical experience (childbirth), there are varied ways in physiotherapists.5 Further, accreditation standards for physiothera- which the experience is interpreted and expressed. This highlights py entry-level programs require teaching of skills necessary for that a person’s cognitions, emotions and behavioural responses to culturally responsive physiotherapy practice.6 Thus, DtF[I$8_]T he profession health and illness are framed by cultural experiences. Therefore, if clearly recognises the importance of culturally responsive practice. physiotherapy assessments and treatments do not account for However, given that cultural responsiveness is not a static these different cultural constructions, how can they be culturally competence to be achieved once, but a continually evolving process, responsive? it is reasonable to question whether we are delivering culturally responsive care. If not, where do physiotherapists receive guidance Is the physiotherapy profession accounting for cultural regarding how to implement practices responsive to the changing diversity? demographics of the Australian population? Culture, illness and health To evaluate whether the physiotherapy profession recognises the influence of ethnoculture on health and disease, we must To understand what is required to F$aIDT_9[] chieve culturally responsive consider three aspects of the profession: entry-level education, practice in contemporary multicultural Australia, we must first research evidence and experiences in clinical practice. 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
122 Editorial Entry-level education DI$F][T_14for _1[FD$5]dTI elivery DIF$[T6]1o_ f culturally responsive care by recognising that health is influenced by psychological and social factors.211FTD3[I_$] When applied, Entry-level physiotherapy programs are required to include this model positions the patient as the focus of the encounter, with learning outcomes that focus on culturally responsive and patient- their own unique narrative and interpretation of their presenting centred physiotherapy practice. From a review of Australian illness. Considered enquiry into the patient’s narrative will unravel university websites, entry-level programs address this require- the ethnocultural, social and environmental experiences that ment via units of study focused on Indigenous health and/or the shape and frame a patient’s understanding of their health concern. social determinants of disease. While such content is invaluable, We therefore commend the research being done to address some compartmentalising information into dedicated units means that physiotherapists’ reluctance to adopt the biopsychosocial model.22 these skills are often viewed as abstract and may not be integrated However, additional steps could be undertaken to optimise into physiotherapy practice.10]F2ID1$_T[ In fact, physiotherapy students culturally responsive practice, as outlined below. perceive that their learning about ethnoculture comes from interactions with culturally diverse people, rather than from The use of professional health interpreters over informal dedicated units of study, questioning the value of such units.11 interpreters enhances accuracy of communication and discussion Therefore, it is necessary that physiotherapy programs embed of sensitive topics.23[1ITFD$7]_ However, interpreters alone do not bridge cultural responsiveness skills within all aspects of the curriculum. cross-cultural communication gaps. Cross-cultural differences in For example, it would be valuable to have students exposed early verbal and non-verbal communication should be elucidated to in their training to cross-cultural communication and culturally reduce the likelihood of misunderstandings.24 For example, informed assessments, as well as provided with opportunities for physiotherapists should be aware of nuances that exist in their experiential learning. This could include learning activities language and that colloquialisms, such as ‘no pain, no gain’, may be integrated with students and community members from a variety misinterpreted by patients from other ethnocultural and language of ethnocultural backgrounds. backgrounds. Further, providing physiotherapists the opportunity to view diverse communication styles, perhaps through vignettes Research evidence or simulation models, may facilitate appreciation of cross-cultural differences with respect to pauses/silences, eye contact, body There is a lack of published research in physiotherapy that is language and spatial distancing. Such modules could be incorpo- inclusive of culturally and linguistically diverse communities.12 A rated into professional development activities conducted by the literature search of key physiotherapy journals between 1994 and Australian Physiotherapy Association to ensure that physiothera- 2014 found that < 3% of publications raised an issue related to pists have access to ongoing development during their careers. culturally and linguistically diverse health and physiotherapy practice.12 Therefore, while some individual physiotherapists and In order to enhance the therapeutic relationship, cultural practices may be operating in culturally responsive ways, these mismatches between physiotherapists’ and patients’ understand- approaches are not widely disseminated. Clinicians require support ing of health and disease need to be identified and addressed. by researchers and academics to evaluate and replicate their Physiotherapists should familiarise themselves with common culturally responsive services. Further, publication of such practices beliefs and practices held by the communities they service, will ensure that all physiotherapists have access to an evidence base recognising that there is intra-cultural and inter-cultural variation. that is relevant to Australia’s culturally diverse population. In addition, reflection on their own personal and professional cultures and associated biases is important.24 A variety of Experiences in clinical practice strategies could be applied, including education by, and involve- ment with_91F[,TID$] ethnocultural community leaders, particularly those In the absence of evidence, many physiotherapists will be guided from the communities in which their practice is embedded. by their personal experience with ethnoculturally diverse commu- Further, utilisation of previously developed self-assessment tools, nities or the experience of more senior colleagues.13 However, these such as the Implicit Association Tests developed by Greenwald experiences may not always facilitate culturally responsive et alFITD_],$[20 25_FIT$18[]D to evaluate unconscious thoughts or feelings about a practice. For example, there is evidence that physiotherapists particular ethnocultural group may also be useful. The results of operate with perceived ethnocultural stereotypes, display limited such tests reflect biases in intergroup social interactions and can cultural sensitivity and hold assimilation beliefs.14,15 This may encourage therapist reflection regarding how their perceptions influence the quality of care provided to consumers from culturally may influence decision-making. and linguistically diverse backgrounds. In addition, physiothera- pists are among many health professionals who underutilise health There are differences in the explanatory models of health and interpreters for consultations and may display negative attitudes illness held by members of different communities. In many towards health interpreting services.16,17 While these behaviours Western societies, such as Australia, the biopsychosocial model is may be limited to a few practitioners, they highlight the need for the current focus. For other ethnocultures, however, there are professional development. different models of health and illness, such as the notion of balance and imbalance[F_12ITD$], and the Chinese ‘yin and yang’ theory.24 Therefore, Towards culturally responsive practice to understand the illness perspective of a particular patient, the therapist must enquire about and attempt to understand the There is a clear need for health professions, including cultural explanatory model of health that the patient brings to physiotherapists, to be culturally responsive. Arguments for the encounter. This may be achieved during the physiotherapy cultural responsiveness lie in the disparities in health outcomes assessment by incorporating elements of ethnocultural interview- for patients from culturally and linguistically diverse communi- ing, such as questions surrounding: ethnicity, migration history ties.18–20 Evidence suggests that these disparities are exacerbated and experience, religious and dietary practices, and the patient’s by culturally insensitive practices, such as inadequate communi- understanding of the meaning and cause of their condition. Such cation, limited ethnocultural knowledge, prejudice and practition- approaches need to be undertaken with sensitivity and respect, so er ethnocentrism.19,20 Therefore, as a start to what we hope is an as not to increase marginalisation of patients from culturally and ongoing dialogue within the profession, we provide suggestions to linguistically diverse backgrounds, provoke underlying stresses or guide culturally responsive practice for physiotherapists. Impor- fracture the therapeutic relationship. tantly, fundamental steps towards enhancing culturally responsive practice have already been taken, including the profession’s Physiotherapy interventions should also account for a patient’s acceptance of the biopsychosocial model. This model is optimal ethnoculture. Consideration of cultural barriers such as the inappropriateness of manual therapy in some ethnocultures,24 and strategies to enhance therapy effectiveness when differences in explanatory models of health and disease exist.26 This may include delivery of interventions in group settings or engagement with
Editorial 123 family members with communities that are collectivist in nature. $]DTF[_RI5 eferences Similarly, physiotherapists promoting patient self-management may wish to consider how this is framed for patients who may be 1. Australian Bureau of Statistics. Perspectives on $DTFI]_M[2 igrants. March 2013. www.abs. more fatalistic in their beliefs.24 Finally, discussing the therapeutic gov.au/ausstats/abs@nsf/Latestproducts/3416. options and their implications should be performed with consid- 0Main+Features2Mar+2013. Accessed 20 February 2016. eration of the patient’s role within their ethnocultural community. Importantly, modifications to therapy should be performed on an 2. Department of Immigration and Border Protection. Australia’s Migration Trends 2013- individual basis and only after establishing the relationship 2014. 2014. https://www.border.gov.au/ReportsandPublications/Documents/ between a patient’s ethnocultural group membership and their statistics/migration-trends13-14.pdf. Accessed 20 Feburary 2016. illness presentation. Approaching culturally adapted treatments in this manner will ensure that physiotherapists avoid stereotyping 3. Institute for Community Ethnicity and Policy Alternatives (ICEPA) VictoriaD$FT_2I][ Univer- patients based on assumed ethnocultural identity. sity. Cultural responsivenessTDI$2[_F] framework]2DFT_3I[$ - Guidelines for Victorian healthD$T_2]IF[ services. Melbourne, Australia: Department of Health, Victoria; 2009. In conclusion, the capacity of physiotherapy to meet the needs of multicultural Australia is dependent on the profession’s capacity 4. National Health Medical Research Council. Cultural competency in health:A guide for to implement culturally responsive practices. Recognition of this policy, partnerships and participation. Canberra: NHMRC; 2005. emerging need should extend beyond competency statements and professional standards, and include all levels of physiotherapy 5. Physiotherapy Board of Australia, Physiotherapy Board of New2_TD$]F[I Zealand. Physio- practice. Entry-level programs may require redesign to ensure that therapy practice thresholds in Australia and Aotearoa New Zealand, 2015. Melbourne: students develop the necessary skills for practice in multicultural Physiotherapy Board of Australia; 2015. societies. Professional development activities should address the delivery of physiotherapy assessments and treatments within a 6. Australian Physiotherapy Council. Australian Standards forD]IT_2[$F Physiotherapy. Canberra, multicultural society, thereby equipping therapists with the skills Australia: Australian Physiotherapy Council; 2006. to deliver culturally responsive healthcare. Such approaches require support and engagement from all levels of the profession, 7. Helman C. Culture Health and Illness: An Introduction for Health Professionals. 2nd ed. from the student physiotherapist to senior members. Finally, Burlington: Elsevier Science; 2014. greater recognition of culturally responsive practice should be reflected in research priorities of the profession that promote and 8. Campbell CM, et al. Pain Manag. 2012;2:219–230. support research inclusive of culturally and linguistically diverse 9. Callister L, et al. Pain Manag Nurs. 2003;4:145–154. communities. 10. Kraemer T. J Phys Ther Educ. 2001;15:36. 11. Chipchase L. Connect Physiotherapy Conference 2015; 2015; Gold Coast, Australia. Ethics approval: N/A Competing interests: Nil. http://www.physiotherapy.asn.au/DocumentsFolder/CONFERENCE2015/ Source(s) of support: Nil. Program/Educators%20Final%205.pdf Acknowledgements: Nil. 12. Brady B, et al. Physotherapy Buisness, Education and Leadership Symposium: New Correspondence: Bernadette Brady, 6_]D[T$DIF epartments of Pain Frontiers; 1/11/2014, 2014; Cairns, Australia. http://www.physiotherapy.asn.au/ Medicine and Physiotherapy, Liverpool Hospital4[_TD,]FI$ Australia. Email: DocumentsFolder/CONFERENCE%202014/Program%20PDFs/ [email protected] Symposium%202014%20Program%20-%20web%20version%2018.9.2014.pdf 13. Redpath AA, et al. J Physiother. 2015;61:210–216. 14. Lee TS, et al. Physiotherapy. 2006;92:166–170. 15. Jaggi A, et al. Physiotherapy. 1995;81:330–337. 16. Lee TS, et al. Aust J Physiother. 2005;51:161–165. 17. Kale E, et al. Patient Educ Couns. 2010;81:187–191. 18. Brady B, et al. Pain. 2016;157:321–328. 19. Khoo S-E. J Pop Research. 2012;29:119–140. 20. Johnstone M-J, et al. Diversity in Health & Social Care. 2008;5:19–30. 21. Engel GL. Am J Psychiatry. 1980;137:535–544. 22. Synnott A, et al. J Physiother. 2015;61:68–76. 23. Flores G. Med Care Res Rev. 2005;62:255–299. 24. Black JD, et al. J Phys Ther Educ. 2002;16:3–10. 25. Greenwald AG, et al. J Pers Soc Psychol. 1998;74:1464–1480. 26. Kleinman A. The illness narratives: suffering, healing, and the human condition. New York: Basic Books; 1988. http://dx.doi.org/10.1016/j.jphys.2016.05.010 Readers’ Choice Award for 2015 The Editorial Board is pleased to announce the annual Readers’ Choice Award, which recognises the paper published in Journal of Physiotherapy that generates the most interest by readers of the journal. The winning paper is chosen based on the number of times that each paper published in a given year is downloaded in the six months after its day of publication. The winning paper from among those published in 2015 is ‘Physiotherapy management of lateral epicondylalgia’ by Dr Leanne Bisset from Griffith University and Professor Bill Vicenzino from University of Queensland and the NHMRC Centre for Research Excellence Spinal Pain, Injury and Health.1 The winning paper is one of the journal’s new Invited Topical Reviews. It deftly summarises the results of an enormous amount of research into the prevalence, diagnosis, assessment, prognosis and management of tennis elbow. The physiotherapy interventions considered by the paper include: exercise; manual therapy and manipulation; orthotics and taping; acupuncture and dry needling; various forms of electrotherapy; and multimodal programs. A clear and concise section on evidence-informed clinical reasoning helps to guide clinicians in how to apply the summarised research to individual patients. The only other Invited Topical Review2 published in the same year was also ranked within the top five, indicating the popularity of this relatively new category of paper in the journal. The Editorial Board of Journal of Physiotherapy congratulates Dr Bisset and Professor Vicenzino on their success. References 1. Bisset LM, Vicenzino B. Physiotherapy management of lateral epicondylalgia. J Physiother. 2015;61:174–181. 2. Sherrington C, Tiedemann A. Physiotherapy in the prevention of falls in older people. J Physiother. 2015;61:54–60. http://dx.doi.org/10.1016/j.jphys.2016.06.001
Journal of Physiotherapy 62 (2016) 167 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Critically Appraised Papers Early physiotherapy for selected patients with acute low back pain leads to small improvements in disability compared with usual care based on advice Synopsis Summary of: Fritz JM, Magel JS, McFadden M, Asche C, Thackeray A, back pain severity, pain catastrophising scale, fear avoidance beliefs Meier W, Brennan G. Early physical therapy vs usual care in patients questionnaire, global rating of change, and the EuroQol tool. Results: with recent-onset low back pain. JAMA 2015;314(14)_]4$D:[FIT 1459-1467. A total of 214 participants completed the 3-month follow-up. At 3 months, the Oswestry Disability Index improved more in the early T_$D1[IF]Question: Does early physiotherapy I_$r]D5T[F educe disability in selected physiotherapy group than the usual care group, by –3.2 units (95% patients with acute low back pain? Design: Randomised, controlled confidence interval –5.9 to –]TD[F$08_I .5). At 1 year, the Oswestry Disability trial with concealed allocation and blinded outcome assessment. Index scores did not significantly differ between groups (mean Setting: A primary care centre in the United States. Participants: Key difference –2.0 units, 95% CI –5.0 to 1.0). At 3 months,F_]ID[$9T some inclusion criteria were: adults with low back pain of less than secondary outcomes, such as the pain catastrophising scale, fear 16 days duration, an Oswestry score > 20% and symptoms not avoidance beliefs for work, and patient self-rating of success and extending below the knee. ]6FK_[TD$I ey exclusion criteria were previous overall health, improved significantly more in the early physiother- lumbar surgery or signs of nerve root compression$DT.[2]F_I Randomisation of apy group when compared to usual TDF$I[_0]c1 are. At 12 months, there were 220 participants allocated 108 to the early physiotherapy group and no differences between the groups, except for patient rating of 112 to a usual care group. Interventions: Both groups received overall health and quality of life, which favoured the early education about the favourable prognosis of low back pain and were physiotherapy group. Conclusion: The addition of early physiother- advised to stay as active as possible, and to follow-up with the apy, which focused on spinal manipulation and exercise prescription primary care physician as needed. In addition, the early physiother- in selected patients, led to small improvements in disability and apy group received four treatment sessions over 3 weeks with a quality of life compared to usual care alone. physiotherapist. Physiotherapy comprised a high velocity spinal manipulation technique, and instruction on range of motion and Provenance: Invited. Not peerI1$_F[T]D reviewed. trunk strengthening exercises, which patients were advised to perform 10 times three to four times each day. Outcome measures: Nicholas Taylor The primary outcome was the change in the Oswestry Disability Section Editor, Journal of Physiotherapy Index (scored ]FfTD_I$[7 rom 0 to 100, with higher scores indicating greater disability) at 3 months. Secondary outcome measures, measured at http://dx.doi.org/10.1016/j.jphys.2016.05.001 4 weeks, 3 months and 1 year, included a numeric pain rating of low Commentary based on reassessment findings within or between sessions). There was also no consideration of patient preferences or goals. Physiothera- The aim of this study was ambitious, given the rapid recovery that pists are likely to use more comprehensive and flexible treatment most patients with acute low back pain achieve,1 making it approaches in clinical practice, such as those evaluated in another challenging to demonstrate large differences between treatment recent trial.2 groups. When evaluating the clinical implications of any study, it is worthwhile considering the participants, treatments and A range of clinically relevant outcome measures were evaluated. outcomes. There were some statistically significant but clinically small between-group effects providing limited support for the role of The trial focused on a subgroup of participants who satisfied the physiotherapy in the management of selected patients with acute criteria for a clinical prediction rule. The findings of the study are low back pain. Although even small effects may be promising in this therefore only applicable to this select group of participants, which population, readers will wonder whether larger effects might have represented approximately 18% of those screened for the trial. been achievable if a more flexible treatment approach had been utilised. Participants in both groups received education and advice, which the study authors acknowledged were likely to be beyond what is Provenance: Invited. Not peer reviewed. normally delivered in usual primary care. There were no details provided about the nature and extent of the additional primary Andrew Hahne physician care provided to either group (including how many Discipline of Physiotherapy, La Trobe University, Melbourne, Australia physician visits participants attended). It is therefore impossible to determine whether participants actually received primary physician References care that was truly reflective of ‘usual care’. 1. Menezes Costa LD, et al. CMAJ. 2012;184:E613–E624. The manipulation and exercise intervention was based on previous 2. Ford JJ, et al. Br J Sports Med. 2016;50:237–245. development work showing benefits in this population. However, the treatment was prescriptive, with all participants receiving the same http://dx.doi.org/10.1016/j.jphys.2016.05.003 manipulation technique at specified times, as well as the same exercises and dosages. This provided no opportunity for therapist clinical reasoning (including no opportunity to modify the treatment 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 62 (2016) 167 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Critically Appraised Papers Early physiotherapy for selected patients with acute low back pain leads to small improvements in disability compared with usual care based on advice Synopsis Summary of: Fritz JM, Magel JS, McFadden M, Asche C, Thackeray A, back pain severity, pain catastrophising scale, fear avoidance beliefs Meier W, Brennan G. Early physical therapy vs usual care in patients questionnaire, global rating of change, and the EuroQol tool. Results: with recent-onset low back pain. JAMA 2015;314(14)_]4$D:[FIT 1459-1467. A total of 214 participants completed the 3-month follow-up. At 3 months, the Oswestry Disability Index improved more in the early T_$D1[IF]Question: Does early physiotherapy I_$r]D5T[F educe disability in selected physiotherapy group than the usual care group, by –3.2 units (95% patients with acute low back pain? Design: Randomised, controlled confidence interval –5.9 to –]TD[F$08_I .5). At 1 year, the Oswestry Disability trial with concealed allocation and blinded outcome assessment. Index scores did not significantly differ between groups (mean Setting: A primary care centre in the United States. Participants: Key difference –2.0 units, 95% CI –5.0 to 1.0). At 3 months,F_]ID[$9T some inclusion criteria were: adults with low back pain of less than secondary outcomes, such as the pain catastrophising scale, fear 16 days duration, an Oswestry score > 20% and symptoms not avoidance beliefs for work, and patient self-rating of success and extending below the knee. ]6FK_[TD$I ey exclusion criteria were previous overall health, improved significantly more in the early physiother- lumbar surgery or signs of nerve root compression$DT.[2]F_I Randomisation of apy group when compared to usual TDF$I[_0]c1 are. At 12 months, there were 220 participants allocated 108 to the early physiotherapy group and no differences between the groups, except for patient rating of 112 to a usual care group. Interventions: Both groups received overall health and quality of life, which favoured the early education about the favourable prognosis of low back pain and were physiotherapy group. Conclusion: The addition of early physiother- advised to stay as active as possible, and to follow-up with the apy, which focused on spinal manipulation and exercise prescription primary care physician as needed. In addition, the early physiother- in selected patients, led to small improvements in disability and apy group received four treatment sessions over 3 weeks with a quality of life compared to usual care alone. physiotherapist. Physiotherapy comprised a high velocity spinal manipulation technique, and instruction on range of motion and Provenance: Invited. Not peerI1$_F[T]D reviewed. trunk strengthening exercises, which patients were advised to perform 10 times three to four times each day. Outcome measures: Nicholas Taylor The primary outcome was the change in the Oswestry Disability Section Editor, Journal of Physiotherapy Index (scored ]FfTD_I$[7 rom 0 to 100, with higher scores indicating greater disability) at 3 months. Secondary outcome measures, measured at http://dx.doi.org/10.1016/j.jphys.2016.05.001 4 weeks, 3 months and 1 year, included a numeric pain rating of low Commentary based on reassessment findings within or between sessions). There was also no consideration of patient preferences or goals. Physiothera- The aim of this study was ambitious, given the rapid recovery that pists are likely to use more comprehensive and flexible treatment most patients with acute low back pain achieve,1 making it approaches in clinical practice, such as those evaluated in another challenging to demonstrate large differences between treatment recent trial.2 groups. When evaluating the clinical implications of any study, it is worthwhile considering the participants, treatments and A range of clinically relevant outcome measures were evaluated. outcomes. There were some statistically significant but clinically small between-group effects providing limited support for the role of The trial focused on a subgroup of participants who satisfied the physiotherapy in the management of selected patients with acute criteria for a clinical prediction rule. The findings of the study are low back pain. Although even small effects may be promising in this therefore only applicable to this select group of participants, which population, readers will wonder whether larger effects might have represented approximately 18% of those screened for the trial. been achievable if a more flexible treatment approach had been utilised. Participants in both groups received education and advice, which the study authors acknowledged were likely to be beyond what is Provenance: Invited. Not peer reviewed. normally delivered in usual primary care. There were no details provided about the nature and extent of the additional primary Andrew Hahne physician care provided to either group (including how many Discipline of Physiotherapy, La Trobe University, Melbourne, Australia physician visits participants attended). It is therefore impossible to determine whether participants actually received primary physician References care that was truly reflective of ‘usual care’. 1. Menezes Costa LD, et al. CMAJ. 2012;184:E613–E624. The manipulation and exercise intervention was based on previous 2. Ford JJ, et al. Br J Sports Med. 2016;50:237–245. development work showing benefits in this population. However, the treatment was prescriptive, with all participants receiving the same http://dx.doi.org/10.1016/j.jphys.2016.05.003 manipulation technique at specified times, as well as the same exercises and dosages. This provided no opportunity for therapist clinical reasoning (including no opportunity to modify the treatment 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 62 (2016) 172–174 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Research Note Interpretation of dichotomous outcomes: risk, odds, risk ratios, odds ratios and number needed to treat Introduction having occurred during a specific period of observation, as in this example, this measure of risk is called an incidence (Strictly Clinical research often investigates whether a patient’s speaking, this is an incidence proportion, ie, the proportion of diagnosis, prognostic characteristics or treatment are related to people in whom the outcome occurs during a specified period of his or her clinical outcomes. The outcomes may be continuous time. An incidence rate measures the occurrence of the outcome measures, which can occupy any point on a scale, for example: pain per unit of person-time). Although the outcome may be positive intensity on a Visual Analogue Scale (0 to 100)1 or body (eg, recovery) or negative (eg, falling), we still talk about the ‘risk’ temperature in degrees.2 Other outcomes are measured on ordinal of that outcome. If the outcome of interest was recorded at a single scales, where the differences between adjacent categories may time point, such as the number of people in a community sample vary along the scale, for example: manual muscle testing grades of who have neck pain, this measure is called a prevalence. none, trace, poor, fair, good and normal.3 Some continuous outcomes may not be strictly linear (because each step on the Odds scale may not have exactly the same magnitude), but are often treated as such, for example: the Berg Balance Scale (0 to Odds are calculated differently from risk and are defined as the 56 points).4 In contrast, it is generally clear whether an outcome number of people in whom the outcome (eg, a fall) occurred is dichotomous because it only has two states (such as yes/no, divided by the number of people in whom the outcome did not better/not better, or dead/alive). Dichotomous outcomes can also occur. The odds of falling (using the same data from Maki et al6 be derived from continuous scales (eg, categorising temperatures above) would be 59/37 or 1.59. Note that the odds and the risk for as febrile/not febrile) or from ordinal scales (eg, categorising the same data are not the same (Box 1), because their muscle contraction as present/absent). Such dichotomisation is denominators are different. generally not recommended, primarily due to loss of information.5 However, if the threshold used is nominated a priori and based on a Comparing risk or odds between groups clinically relevant point on the scale, then dichotomisation of a continuous outcome may be appropriate.5 The example above from Maki et al6 describes the risk or odds of an event (a fall) in one population (independent ambulatory older The reporting and interpretation of studies with dichotomous people). However, many clinical studies investigate the difference outcomes can be challenging. There are several ways to report the in risk or odds for a dichotomous outcome based on certain patient findings about dichotomous outcomes, including: proportions, characteristics or exposures. For example, we may want to know if percentages, risk, odds, risk ratios, odds ratios, number needed to older people fall more often than younger people, or if trial treat, likelihood ratios, sensitivity, specificity, and pre-test and participants who were randomised to receive a Tai Chi interven- post-test probability – each of which has a different meaning. The tion fell less often than those who were randomised to no purpose of this two-part series is to describe the correct treatment. This is commonly performed by calculating the ratio of interpretation of commonly used methods of reporting dichoto- either the risk (risk ratio) or the odds (odds ratio) between the mous outcomes. This first paper focuses on risk, odds, risk ratio, groups of interest. odds ratio and number needed to treat. The second paper will focus on sensitivity, specificity and likelihood ratios. A risk ratio (also known as relative risk) is calculated by dividing the risk of the outcome (eg, a fall) in people with a characteristic or Risk and odds exposure (eg, received a Tai Chi intervention) by the risk of the same outcome in the people who do not have that characteristic or The chance of a dichotomous outcome occurring can be exposure (eg, control group). In a similar way, odds ratios are described in terms of risk or odds. While these terms may sound calculated by dividing the odds of the outcome in people who have similar, they have different meanings and methods of calculation. a particular characteristic by the odds of the same outcome in people who do not have that characteristic. A worked example for Risk calculating both risk ratios and odds ratios can be seen in Box 1. It is critical to note that the value of the relative risk and the odds ratio Risk is defined as the probability of an event during a specified are different, despite being based on the same data, and therefore period of time. In clinical studies, risk is often calculated as the the interpretation is also different. number of people in whom an outcome occurs divided by the total number of people assessed. There are various ways to express risk. It is useful to recognise that risk ratios and odds ratios can be The raw count of a dichotomous outcome can be summarised as a greater than or less than 1. When greater than 1, this indicates that proportion or a percentage. For example, in an observational people with the clinical characteristic (positive test result, study6 of 96 independent ambulatory older people, 59 had a fall prognostic characteristic or treatment exposure) are more likely during a 1-year period. This could be reported as a proportion (59/ to have the outcome of interest (diagnosis, prognostic outcome or 96 = 0.61) or as a percentage (61%). If the outcome was recorded as treatment outcome) than people without that clinical characteris- tic. When risk ratios or odds ratios are less than 1, this indicates http://dx.doi.org/10.1016/j.jphys.2016.02.016 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Appraisal Research Note 173 Box 1. Calculation of risk, odds, risk ratios, risk reduction and odds ratios using hypothetical data. In a randomised controlled trial involving 500 female athletes followed for 1 year, 125 report an injury by 1 year. Risk 125/500 = 0.25 or 25% Odds 125/375 = 0.33 or 33% In the trial, 250 received preventative treatment and 250 did not; 75 of the untreated athletes were injured and 50 of the treated athletes were injured. Untreated Injured Uninjured Row total Treated 75 175 250 Column total 50 200 250 125 375 500 Risk ratio (also known as (75/250) / (50/250) = 1.5 relative risk) or 30% / 20% = 1.5 The risk of injury among the untreated athletes is 1.5 times the risk among the treated athletes. Absolute risk reduction Alternatively, the inverse calculation can be made. Relative risk reduction (50/250) / (75/250) = 2/3 Number needed to treat or 20% / 30% = 2/3 Odds ratio The risk of injury among the treated athletes is two-thirds of the risk among the untreated athletes. Risk in untreated athletes is 75 /250 = 30% Risk in treated athletes is 50/250 = 20% Absolute risk reduction is 30% – 20% = 10% The absolute difference between the risk of an injury in a treated athlete and an untreated athlete over a 1 -year period is 10%. Relative risk is (risk in treated) / (risk in untreated) = 20% / 30% = 67% Relative risk reduction = 100% – relative risk = 100% – 67% = 33% The relative reduction in risk associated with being treated is 33%. 100% / absolute risk reduction = 100% / 10% = 10 For every 10 athletes that undergo the preventative treatment, one is likely to remain uninjured when she would otherwise have had an injury. (75/175) / (50/200) = 1.71 or 0.43 / 0.25 = 1.71 The odds of injury among the untreated athletes is 1.71 times higher than the odds among the treated athletes. Alternatively, the inverse calculation can be made. (50/200) / (75/175) = 0.58 or 0.25 / 0.43 = 0.58 The odds of injury among the treated athletes is 0.58 times the odds among the untreated athletes. Italic text presents the interpretation of the statistic in sentence format. that these people with the clinical characteristic are less likely to that the people with generalised joint laxity had 2.8 times the risk have the outcome of interest. of having an anterior cruciate injury compared with those without generalised joint laxity. As mentioned previously, risk ratios of less The possible range of odds ratios is from 0 to infinity. In than 1 mean the risk of the outcome is less in those with the contrast, the range of risk ratios starts at 0 but has an upper limit characteristic than in those without. For example, Kiely et al8 that depends on the risk in the reference group (the people who do investigated the risk of stroke among people with moderate-to- not have the clinical characteristic). For example, if the risk in the high physical activity and compared it with the risk among people reference group is 50%, the maximum value that a relative risk can with low physical activity. They reported an risk ratio of 0.8. This have is 2.0, because this would indicate that 100% of people with was correctly interpreted as: moderate-to-high physical activity the clinical characteristic have the outcome of interest. was associated with a relative reduction in the risk of stroke by 20% compared with low physical activity. Interpretation of risk ratios Absolute risk reduction and relative risk reduction Risk ratios are relatively easy and intuitive to interpret. For example, a study investigating risk factors for non-contact anterior To correctly interpret the clinical importance of risk ratios, it is cruciate injury reported a risk ratio of 2.8 for the presence of critical to understand that the absolute risk reduction (also called generalised joint laxity.7 A correct interpretation would be to say
174 Appraisal Research Note absolute risk difference, because the change in risk is not always a lower than risk ratios. They only become similar when the reduction) and relative risk reduction mean different things. In the incidence or prevalence is very low.9 Holcomb et al9 found that in stroke example above, the relative risk was 0.8, indicating a 20% nearly half of the studies they reviewed, the odds ratio was more relative reduction in risk associated with moderate-to-high than 20% larger than the risk ratio when using the same data. They physical activity. How much this reduces the absolute risk of also found that 26% of the studies they reviewed incorrectly stroke is dependent on the baseline risk. If the risk of stroke in the interpreted odds ratios as risk ratios. It could be asked why odds low physical activity participants were 10%, an relative risk of ratios are used if they are often misinterpreted. One explanation is 0.8 would mean that the risk of a stroke in those who performed that odds ratios have mathematical properties that make them moderate-to-high physical activity would be 8% (0.10 x 0.8). This more easily managed within some statistical procedures. More means the absolute risk reduction was 2% (ie, from 10% down to 8%). thorough explanations are available for interested readers.10 If, however, the risk of stroke in the low physical activity participants were 1%, then the same relative risk would only Confidence intervals result in an absolute risk reduction of 0.2%. This demonstrates the importance of distinguishing the relative risk reduction and the All of the statistics mentioned above, from basic risk and odds absolute risk reduction. The baseline risk is very important to the through to NNT, can be calculated with 95% CIs. Briefly, with each absolute risk reduction but not considered in relative risk statistic, the 95% CI indicates the range of uncertainty around the reduction. The same risk ratio (eg, 0.8) will have a greater impact estimate. An excellent and more detailed explanation of the on absolute risk reduction, the more common the outcome is. interpretation of 95% CI for dichotomous measures has previously been presented in this journal.11 With risk ratios or odds ratios, a Number needed to treat 95% CI that crosses 1 indicates that the result is not statistically significant, whereas a 95% CI that does not include 1 indicates that Another statistic that is used to help in the interpretation of risk the difference between groups can be attributed to the distin- ratios is the number needed to treat (NNT), which is a simple way of guishing treatment, exposure or characteristic between groups. understanding how many patients need to be treated for one The 95% CI around the NNT is easy to interpret when the result is patient, on average, to benefit. For example, let us imagine that we statistically significant, but it is particularly unintuitive when the conducted a clinical trial to determine if participants who were result is not statistically significant, so readers are referred to randomised to receive a Tai Chi intervention fell less often than further explanation elsewhere.12 those who were randomised to no treatment. If the incidence of falling was 30% in the Tai Chi group and 60% in the no-treatment Summary group, the absolute risk reduction would be 30% and the risk ratio would be 0.5. The formula for the NNT is 100%/absolute risk Statistics that summarise dichotomous outcome measures, reduction. So, in our example, this would be 100%/30% = 3.3. This including risk ratios, odds ratios, absolute risk reduction and means that 3.3 patients would need to be treated with the Tai Chi relative risk reduction, are commonly used, but have different intervention to prevent one fall. Because it is not possible to treat a meanings. A good understanding of these terms will enable readers fraction of a patient, the NNT may be reported with the decimal of clinical studies to ensure that they correctly interpret the clinical places rounded off (in this example, to 3) or conservatively importance of the findings reported. rounded up to the next highest whole number of participants (in this example, to 4). Acknowledgements: Nil. Competing interests:Nil. It is worth noting that, while the treatment was very effective (it Provenance: Not commissioned. Peer reviewed. halved the rate of falls), the NNT was affected by both the effectiveness of the treatment and the risk in the reference group Mark Hancocka and Peter Kentb,c (the no-treatment group). So, if the risk in the no-treatment group aFaculty of Medicine and Health Sciences, Macquarie University, had been only 10%, a treatment with the same relative risk would have an NNT of 20 (100%/absolute risk reduction = 100/5 = 20). The Sydney, Australia reason for this is that most people (nine out of 10) had no fall bSchool of Physiotherapy and Exercise Science, Curtin University, during the follow-up period, so even a very effective treatment would need to be given to many people in that population before it Perth, Australia prevented a fall. cDepartment of Sports Science and Clinical Biomechanics, University of Interpretation of odds ratios Southern Denmark, Denmark Odds ratios are somewhat more difficult and less intuitive to References interpret than risk ratios. An odds ratio of 2 from a randomised, controlled trial means that the intervention doubled the odds of the 1. Price DD, et al. Pain. 1983;17:45–56. outcome occurring compared with the control group. However, 2. Brearley AL, et al. J Physiother. 2015;61:19:9–203. because we tend not to think in terms of odds, this is not easy to 3. Hislop HJ, Montgomery J. Daniels and Worthingham’s Muscle testing: techniques of interpret. Importantly, an odds ratio of 2 is not the same as an risk ratio of 2. For the same study data, the odds ratio will usually be manual examination. Philadelphia, Pennsylvania: WB Saunders Company; 1995. further from 1 than the risk ratio. Therefore, when greater than 1, 4. Berg K, et al. Scand J Rehabil Med. 1995;27:27–36. odds ratios are almost always substantially higher than risk ratios 5. Altman DG, Royston P. BMJ. 2006;332(7549):1080. and when less than 1, odds ratios are almost always substantially 6. Maki BE, et al. J Gerontol. 1994;49:M72–M84. 7. Uhorchak JM, et al. Am J Sports Med. 2003;31:831–842. 8. Kiely DK, et al. Am J Epidemiol. 1994;140:608–620. 9. Holcomb WL, et al. Obstet Gynecol. 2001;98:685–688. 10. Sackett DL, et al. Evidence-Based Med. 1996;1:164–166. 11. Herbert RD. Aust J Physiother. 2000;46:309–313. 12. Herbert RD, et al. Practical Evidence-Based Physiotherapy. 2nd[FD$37]_IT edition Edinburgh: Butterworth Heinemann; 2011.
Journal of Physiotherapy 62 (2016) 175 Appraisal Journal of Correspondence PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Is ‘high-intensity’ a bad word? Despite the long-recognised health benefits of exercise and especially among cancer populations. One of the most challenging physical activity, purposeful integration of exercise training into barriers to optimising exercise prescription is knowing how and standard cancer treatment, extending through survivorship, has when to adjust frequency, intensity and duration to favourably been relatively restrained. However, significant advances have influence healthy adaptation without exceeding recovery capacity. been made in the field of exercise oncology in the last two decades. Given the prevalence of fatigue and low cardiorespiratory fitness Numerous clinical trials have demonstrated therapeutic benefits of among cancer survivors, matching progressive overload with structured exercise to enhance health and physiological function.1$DTF_I[]2 sufficient recovery is paramount; however, this balance can coexist Moreover, habitual exercise has emerged as a central component with the addition of brief, high-intensity efforts. Although for primary and secondary disease prevention in cancer survivors. peripheral to the work of Dennett et al,3 previous research in While the latest exercise guidelines2 state that individuals should non-cancer older adults has shown that high-intensity resistance ‘avoid inactivity’ and engage in ‘150 minutes of moderate-intensity exercise increases resting energy expenditure, ease of movement exercise or 75 minutes of vigorous-intensity exercise per week’, and promotes participation in spontaneous physical activity known given the notable heterogeneity among cancer survivors, optimal to be critical for long-term weight maintenance.5 Provided that the exercise prescription/progression varies. exercise prescription has been individually tailored and not contraindicated, future work should consider a hybrid of moder- Accordingly, our group read with interest the work of Dennett ate-intensity aerobic exercise combined with at least one session of and colleagues3 that sought to clarify a dose-response effect high-intensity resistance exercise per week. An integrated approach concerning exercise on inflammation, fatigue and functional such as this may enhance fatigue reduction while also advancing mobility among adult cancer survivors. Indeed, their research cardio-metabolic function in cancer survivors. Thus, active inclu- further underscores the safety and systemic health benefits of sion of high-intensity resistance exercise could prove exceptionally exercise training, as well as providing a clearer indication of what valuable as it uniquely enhances strength and physiologic reserve, exercise intensity may be most appropriate to reduce fatigue and both of which promote greater free-living physical activity. support mobility in cancer survivors. Consistent with their results, Certainly we can all agree[FD$T_]6I: these are good words. our group recently found that a modest volume of supervised, moderate-intensity exercise (progressed to home-based work- Stephen J Cartera, Robert L Herronb, Laura Q Rogersa outs) translated to improvements in rate-pressure product (an and Gary R Huntera,c index of myocardial strain) during submaximal walking.4 Impor- tantly, these changes were associated with lower reported fatigue aDepartment of Nutrition Sciences, University of Alabama at among breast cancer survivors who had completed their primary Birmingham, Birmingham treatment. Thus, it seems that positive exercise-induced changes in heart rate (ie, less cardio-metabolic strain) during activities of daily bDepartment of Kinesiology, The University of Alabama, Tuscaloosa living translate to a lower perception of fatigue among cancer cDepartment of Human Studies,FDT_3I[]$ University of Alabama at Birmingham, survivors. Within this context, perhaps the benefits of moderate- intensity exercise to alleviate fatigue are intimately linked to Birmingham,D$T_F[4I] USA enhanced physiologic function, as evidenced by increased ease of walking and ability to perform everyday tasks. References However, our group contends that high-intensity resistance 1. Sasso JP, et al. J Cachexia Sarcopenia Muscle. 2015;6:115–124. exercise (> 75% of one repetition maximum) in combination with 2. Schmitz KH, et al. Med Sci Sports Exerc. 2010;42:1409–1426. moderate-intensity aerobic exercise should not be discounted, 3. Dennett AM, et al. J Physiother. 2016;62:68–82. 4. Carter SJ, et al. J Cancer Surviv. 2016. 2016 Apr 9. [Epub ahead of print]. 5. Hunter GR, et al. Sports Med. 2004;34:329–348. http://dx.doi.org/10.1016/j.jphys.2016.05.017 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 62 (2016) 153–158 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research Kinesio Taping does not improve the symptoms or function of older people with knee osteoarthritis: a randomised trial Bruna Wageck a,bDT_I$5[F], Guilherme S Nunes a, Nicolas Bernardon Bohlen a, Gilmar Moraes Santos a, Marcos de Noronha a,cFD]$[I6_T a Department of Physiotherapy, Center of Health and Sport Sciences, Santa Catarina State University, Floriano´polis, Brazil; b D$T_I[D]7F epartment of Rehabilitation, Nutrition and Sport, La Trobe University, Melbourne, Australia; c Department of Community and Allied Health, La Trobe University, Bendigo, Australia KEY WORDS ABSTRACT Bandages Question: Does Kinesio Taping reduce pain and swelling, and increase muscle strength, function and Knee injuries knee-related health status in older people with knee osteoarthritis]$_I?FTD[8 Design: Randomised, controlled trial Muscle strength with concealed allocation, intention-to-treat analysis and blinded assessment. Participants: Seventy-six Pain older people with knee osteoarthritis. Intervention: The experimental group received three Oedema simultaneous Kinesio Taping techniques to treat pain, strength and swelling. The control group received sham taping. All participants kept the taping on for 4 days. Outcome measures: The outcomes were: concentric muscle strength of knee extensors and flexors, measured by isokinetic dynamometry with an angular velocity of 60 deg/second normalised for body mass [(Nm/kg) x 100 (%)]; pressure pain threshold via digital pressure algometry (kgf/cm2); lower-limb swelling via volumetry (l) and perimetry (cm); physical function via the Lysholm Knee Scoring Scale (0 = worst to 100 = best); and knee-related health status via the Western Ontario and McMaster (WOMAC) osteoarthritis index (0 = best to 96 = worst). Outcomes were measured at Day 4 (end of the taping period) and Day 19 (follow-up) after the start of the treatment. Results: At Day 4, there were no significant between-group differences for knee extensor muscle strength (MD –1%, 95% CI –7 to 5), knee flexor muscle strength (MD 2%, 95% CI –3 to 7), the pressure pain threshold at any measured point, volumetry (MD 0.05 L, 95% CI –0.01 to 0.11), perimetry at any measured point, Lysholm score (MD –4 points, 95% CI –9 to 2), or WOMAC score (MD –2 points, 95% CI –8 to 4). The lack of significant between-group difference was also seen at the follow-up assessment on Day 19. Conclusion: The Kinesio Taping techniques investigated in this study provided no beneficial effects for older people with knee osteoarthritis on any of the assessed outcomes. Trial registration: Brazilian Registry of Clinical Trials, RBR-36r3t5. [Wageck B, Nunes GS, Bohlen NB, Santos GM, de Noronha M (2016) Kinesio Taping does not improve the symptoms or function of older people with knee osteoarthritis: a randomised trial. Journal of Physiotherapy 62: 153–158] ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction could lead to a further decrease in muscle strength, resulting in Some musculoskeletal diseases that are commonly seen as part more pain, with the process becoming a vicious cycle of pain- of the ageing process may lead to important functional limitations weakness-pain.8 This process is usually accompanied by a decrease in the older population; osteoarthritis is one of the main examples.1$DT_[]F4I Knee osteoarthritis is associated with joint and muscle in joint function, which in turn leads to difficulties with activities of dysfunction, with consequent impairment in balance and gait.2,3 daily living and a decrease in quality of life.4 Therefore, pain relief These impairments are often seen along with pain, swelling, crepitation, decreased range of movement, joint laxity, presence and functional improvement must be one of the main objectives of osteophytes and changes in the congruence of the joint when treating knee osteoarthritis.4 According to Jevsevar,5 surfaces.1,3–5 pharmacological and invasive interventions for osteoarthritis are The clinical progression of knee osteoarthritis is associated with several factors, one of which is a decrease in quadriceps strength.6,7 typically incompletely effective, have some potential adverse side Therefore, strengthening of these muscles is usually one of the main aims in the treatment of knee osteoarthritis. However, the effects, and/or have effectiveness that is not comprehensively pain associated with knee osteoarthritis can be a limiting factor for established.5 Thus, non-pharmacological treatments for the strengthening. If pain reduces adherence to strength training, this symptoms (mainly pain) should be further investigated. Among the different modalities used in physiotherapy to treat knee osteoarthritis, the application of taping has gained populari- ty,5,9 with several possible techniques. The Kinesio Taping technique has been seen in clinical practice, despite a lack of high-quality studies supporting its efficacy.10 Nevertheless, some http://dx.doi.org/10.1016/j.jphys.2016.05.012 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
154 Wageck et al: Kinesio Taping for knee osteoarthritis isolated studies have presented results that give clinicians and the fourth day, after removal of the Kinesio Taping, all participants researchers some encouragement in the use of Kinesio Taping. were again assessed by an assessor who was blinded to group Vithoulkaa et al reported that Kinesio Taping could increase the allocation. A third assessment was performed 15 days after the torque generated by the quadriceps in women without knee second assessment (Figure 1). pain.11 Campolo et al showed a reduction in pain due to Kinesio Taping during functional activities in people with patellofemoral Participants, therapists and centres pain.12 The Kinesio Taping application, with its varied application techniques, could therefore be beneficial in treating people with Older people with a clinical diagnosis of tibiofemoral osteoar- knee osteoarthritis. thritis were recruited via outpatient clinics in a state capital of Brazil to take part in this study. Inclusion criteria were: minimum Therefore, the research question for this randomised, controlled age of 60 years, minimum pain of 4/10 on a visual analogue scale, trial was: knee joint stiffness during standing activities, stiffness that had been present for at least 6 months at screening, pain during passive Does Kinesio Taping reduce pain and swelling, and increase mobilisation of the knee, intermittent swelling, and radiographic muscle strength, function and knee-related health status in signs of joint degeneration. Any grade of the Kellgren-Lawrence older people with knee osteoarthritis? scale was permissible. Exclusion criteria were: systemic rheumatic diseases, history of surgery in the affected limb, presence of any Method other injuries in the affected limb (bone, muscle or skin), history of skin allergy, and any other condition that could affect assessments. Design For participants with bilateral knee osteoarthritis, the most affected side was used, according to the visual analogue scale of This was a randomised clinical trial in which participants were pain. allocated to either the experimental group, which received three simultaneous Kinesio Taping applications, or the control group, Intervention which received a single sham Kinesio Taping application. Potential participants were screened to determine eligibility before baseline The experimental group received three Kinesio Taping elements assessment and randomisation to an intervention. Randomisation (Figure 2A–C) applied simultaneously (Figure 2D). This advanced was performed using individual allocation codes placed within application with multiple layers of Kinesio Taping is indicated opaque, sealed envelopes by a person having no contact with the when more than one effect of taping is desired.13 Kase et al13 participants and assessors. Participants of both groups were suggested the use of advanced applications for diverse injuries irugeF([_1)TD$IG]i nstructed to keep the Kinesio Taping on the skin for 4 days and on Assessed for eligibility (n = 80) Excluded (n = 4) • history of surgery in the affected knee Measured strength, pressure pain threshold, swelling, Lysholm and WOMAC Day 0 Randomised (n = 76) (n = 38) (n = 38) Lost to follow-up Experimental Group Control Group Lost to follow-up • hypertensive • Kinesio Taping for knee • sham Kinesio • hypertensive Taping application event (n = 2) pain, strength and • Taping in situ for 4 d event (n = 1) swelling • cardiovascular • Taping in situ for 4 d problem (n = 1) Day 4 Measured strength, pressure pain threshold, swelling, Lysholm and WOMAC (n = 36) (n = 36) Lost to follow-up Lost to follow-up • refused to • refused to return (n = 15) return (n = 16) • adverse health event (n = 2) Measured strength, pressure pain threshold, swelling, Lysholm and WOMAC Day 19 (n = 19) (n = 20) Figure 1. Flow diagram.
ure_2)TD$FIG]gi([ Research 155 Figure 2. Kinesio Taping applications used in the study. A. Drainage element of the experimental application. B. Muscle strength element of the experimental application. C. Pain-relief element of the experimental application. D. Combined experimental application. E. Sham application. such as epicondylalgia, quadriceps contusion, sciatica, knee The control group received a sham application. The participants ligament injuries and ankle sprain. The multi-layer application lay supine on a plinth with the leg to be taped in maximum passive was selected due to the multifactorial characteristics of osteoar- knee flexion. Two ‘I’-shaped strips of Kinesio Taping were applied, thritis. The elements were chosen to address each main symptom: without any tension, across the quadriceps muscle group. These muscle weakness, pain and swelling. Participants received the two strips were applied 20 cm and 10 cm above the superior pole intervention or sham in a single session, which took place in a room of the patella (Figure 2E). The tape size applied was one-third of the at the university physiotherapy clinic. Elastic tapes were applied thigh circumference at the region of application. by a physiotherapistD,F_$T1I0][ who was experienced in Kinesio Taping D_1[$IF]tT echniques, in the order described below. Outcome measures Drainage technique All participants were assessed before treatment, after treatment The first element applied was a technique recommended to and at follow-up by a blinded assessor. At each assessment point, outcomes were measured in the following order: functional stimulate drainage of knee swelling.13$DF]9TI_[ Participants lay supine on a assessment, knee-related health status, perimetry, pressure pain plinth with the leg to be taped in maximum passive knee flexion. threshold, volumetry and muscle strength. Two pieces of tape were applied according to Kase et al,13 as shown in Figure 2A, with the body of each piece divided longitudinally Isokinetic muscle strength into four narrower strips. The first piece was applied laterally at the Knee extensor and flexor isokinetic concentric strength were knee, with the base of the tape 15 cm above the articular line of the knee and the body of the tape crossing the front of the knee with assessed with an isokinetic dynamometera. Participants were 2 cm between each divided strip. The second piece was applied seated with the hip in 85 deg and the knee in 90 deg of flexion. The starting on the medial side of the knee, crossing the front of the rotational dynamometer axis was aligned with the lateral condyle knee, following the same procedure as the first piece. The two of the femur and the resistance was applied to the shank, 5 cm drainage strips crossed each other on the anterior aspect of the above the lateral malleolus. The test range of movement was from knee and they were applied with the pre-tension that was 90 deg of flexion to 0 deg (full extension). To be familiarised with originally found in the tape.13 the equipment, participants performed five submaximal knee flexions and extensions followed by a 3-minute rest interval before Muscular relaxation technique performing two sets of three maximal knee extensions and flexions The next element was applied with the aim of obtaining with angular velocity of 60 deg/second; there was a 5-minute interval between the sets.14 Data were recorded as peak torque and quadriceps relaxation to minimise pressure between the femur divided by body mass, and expressed as a percentage, that is, (Nm/ and patella and, thus, reduce pain.13 The participants lay supine on kg) x 100 (%), with gravity correction also performed.14 The mean a plinth with the leg to be taped in maximum passive knee flexion. of the peaks of each set was used for analysis. A ‘Y-strip’ of tape was applied on the rectus femoris muscle in a Y shape. The tape was applied to the tibial tuberosity and the arms of Pressure pain threshold the ‘Y’ were adhered around either side of the patella. The body of The pressure pain threshold was assessed with a pressure the strip was applied in a cephalad direction, ending 15 cm below the anterior superior iliac spine (Figure 2B). The Kinesio Taping was algometerb. The participant was seated with knees flexed to 90 deg applied with the pre-tension that was originally found in the and progressive pressure was applied perpendicular to the skin. tape.13 Participants were instructed to report immediately when the sensation of pressure was accompanied by pain. The amount of Pain relief technique (star application) pressure at that moment was recorded and considered as the The final element has been recommended for decompressing pressure pain threshold.15DF_I]T2[$ The pressure was applied and recorded at six points around the knee in a random order: the base and apex nerve endings in order to reduce pain at the knee joint.13 The of the patella, the lateral and medial extremities of the patella, and participants lay supine on a plinth with the leg to be taped in the lateral and medial aspects of the knee joint line. Data were also maximum passive knee flexion. Four 10-cm long ‘I-strips’ of tape collected from an unaffected region of the body, the forearm, as a were applied to the medial side of the knee in a star shape reference value for the pressure pain threshold.15 Each point was (Figure 2C). The application started from the middle of each strip assessed once, after one familiarisation trial at each point.15 Data (ie, the point where there was no tension in the tape) and from that were recorded as kgf/cm2. point, full tension was applied to the length of the Kinesio Tape.13
156 Wageck et al: Kinesio Taping for knee osteoarthritis Volumetry Table 1 An acrylic box (67 x 30 x 21 cm) was used to assess lower limb Baseline characteristics of participants (n = 76). volume. The box was filled with water to the level of an escape spout Characteristic Exp (n = 38) Con (n = 38) (59 cm from the base) and the water temperature was maintained between 28 and 32 8C.16 Initially, the participants were seated on a Age (yr), mean (SD) 69.6 (6.9) 68.6 (6.3) platform higher than the box. The limb to be measured was then Gender, n female (%) 35 (92) 31 (82) slowly lowered into the box until the sole of the foot was in total Height (cm), mean (SD) contact with the bottom of the box. At the same time, the opposite Weight (kg), mean (SD) 1.61 (0.09) 1.60 (0.08) limb was lowered to the ground outside the box. Participants were Body mass index (kg/m2), mean (SD) 77.8 (15.0) 79.9 (10.2) instructed to stand and remain relaxed with body weight Pain (0 to 10 VAS), mean (SD) 30.0 (4.9) 31.3 (4.1) distributed equally to both limbs. The assessed limb was kept from Symptom onset (yr), mean (SD) touching the box or moving until the water ceased dripping from the 7.6 (1.7) 7.5 (2.2) escape spout.16 The water that flowed from the escape spout was 10.5 (9.8) 10.3 (11.3) collected and measured on a scale with 1-g precisionc. The results in kg were converted into litres [density (g/cm3) = mass (g)/volume Con = control group, Exp = experimental group, VAS = visual analogue scale. (cm3)], considering the water density = 1 g/cm3.17 This procedure was performed twice and the mean was used for analysis. characteristics of the participants are presented in Table 1 and the first two columns of data in Table 2. Perimetry A measuring tape was used to measure the perimeter of the Effect of intervention limb. The participant was positioned in supine on a plinth, with the The ANOVA analyses showed no difference between the hips in neutral position and the knees in full extension. The experimental group and control group for any of the outcomes participant was instructed to lie still without muscle contraction in investigated at the end of the 4-day intervention period, or 15 days the assessed limb. From that position, the assessor measured the later (Table 2). Individual participant data are presented in Table 3 knee at three points: the fold at the popliteal fossa, 5 cm above that (see eAddenda for Table 3). fold, and 5 cm below.16 Each level was assessed three times and the mean of each level was used for analysis. Discussion Physical function The main objective of the Kinesio Taping application used here Physical function was assessed using the Lysholm Knee Scoring was to treat pain, directly or indirectly. However, the compilation of different Kinesio Taping techniques did not present any Scale questionnaire.18 Designed for use in people with a knee injury, advantage compared with a sham application. The reason for that the questionnaire includes eight questions related to daily activities, could possibly be explained by the short time that participants had pain, instability and swelling. It generates a final score that can vary the Kinesio Taping on (4 days), which may not have been long from 0 to 100; high scores mean good physical function.18,19 enough to induce any real benefits in a chronic condition like knee osteoarthritis. Alternatively, Kinesio Taping may not have the Knee-related health status benefits advocated by its users. Knee-related health status was assessed via the Western The present results differed from those of Anandkumar et al,23 Ontario and McMaster (WOMAC) osteoarthritis index.20 The who also investigated the effects of Kinesio Taping on people with questionnaire is divided in three main domains: pain, joint knee osteoarthritis. They compared an experimental group who stiffness and physical activities. The total score is given by the received Kinesio Taping to a control group and reported a reduction in sum of the three domain scores and varies from 0 to 96; high scores pain in the Kinesio Taping group while climbing stairs. Their study mean poor health status.19,20 used the visual analogue scale to measure pain, which may be considered a more subjective method compared to algometry, which Data analysis was the method used in the present study. Anandkumar et al23 found a decrease in pain in the treatment group; however, it is unclear All the analyses followed the intention-to-treat principle. whether the measurements were performed with or without the Missing data were processed with a multiple imputation Kinesio Taping on, making it hard to understand how blinding of method.21 Twenty imputed data sets were created using the assessors was performed. In the present study, beside the direct baseline and post-intervention data to predict the missing data.21 method of measuring pain, two questionnaires that include questions Analysis of variance (ANOVA) with a linear mixed model was used related to pain (Lysholm and WOMAC) were also used, and the to verify the effect of the Kinesio Taping. The mean difference and score was isolated and analysed from the pain domain from the 95% CI were also calculated for each between-group comparison. WOMAC questionnaire. There were still no between-group differ- The confidence level adopted was 5% and the statistical analyses ences in pain (analysis available from the authors upon request). were processed using the software SPSSd. Considering the lack of significant difference in pain between The sample size was calculated to give the study sufficient groups, it was not a surprise to see no significant between-group statistical power to identify an isokinetic concentric quadriceps difference for muscle strength. It is known that muscle contraction strength mean difference of 15 Nm/kg (standard deviation of can be negatively affected in the presence of pain,24 thus, it could be 21 Nm/kg) between the groups22 as statistically significant. The expected that muscle strength would also remain comparable minimum sample size that was needed was 37 participants per between groups. A Kinesio Taping technique was chosen that, in group, based on power of 80%, an alpha of 5%, and a possible loss to theory, would promote quadriceps relaxation, thus decrease patellar follow-up of 15%. pressure, improve joint biomechanics and increase muscle contrac- tion strength. However, this increase in strength was not observed. Results Some previous studies have investigated the possible effects of Kinesio Taping on muscle strength in different populations, and the Flow of participants, therapists and centres through the study results are controversial;11,23,25,26 however, only one study investi- gated the effect of Kinesio Taping on quadriceps muscle strength in From the 80 participants that were screened, 76 met the older people with knee osteoarthritis.23 In that study, isokinetic inclusion criteria and were included in the study. Two participants testing took place 30 minutes after the Kinesio Taping application in each group could not be assessed after the intervention because and the results showed an increase in strength for the Kinesio Taping they had an adverse health event (Figure 1). The baseline group. Unfortunately it was unclear whether the assessments were performed with the Kinesio Taping on the skin, or after the removal of the tape.23 If the testing was performed with the Kinesio Taping still applied, it might be argued that the effects of Kinesio Taping
Research 157 Table 2 Mean (SD) of groups, mean (SD) difference within groups, and mean (95% CI) difference between groups. Outcome Groups Difference within groups Difference between groups Day 0 Day 4 Day 19 Day 4 minus Day 19 minus Day 4 minus Day 19 minus Day 0 Day 0 Day 0 Day 0 Exp Con Exp Con Exp Con Exp Con Exp Con Exp Exp (n = 38) (n = 38) (n = 36) (n = 36) (n = 19) (n = 20) minus Con minus Con Knee extensor muscle strength (%) 81 74 86 79 97 88 45 16 14 –1 2 Knee flexor muscle strength (%) (41) (33) (37) (29) (30) (26) (13) (15) (30) (–11 to 14) Pressure Pain Threshold (kgf/cm2[)_T]DF3I$ 38 34 44 37 46 42 (23) (–7 to 5) (20) (20) (22) (21) (16) (15) 63 8 0 superior patellar extremity (11) (11) (16) 92 (–8 to 7) inferior patellar extremity 4.3 4.3 4.4 4.2 4.6 4.7 lateral patellar extremity (1.5) (1.4) (1.6) (1.6) (1.3) (0.9) (16) (–3 to 7) medial patellar extremity 4.8 4.6 4.9 4.7 5.1 4.7 lateral knee region (2.1) (1.6) (1.6) (1.6) (1.7) (1.0) 0.2 –0.1 0.4 0.3 0.3 0.0 medial knee region 3.7 3.8 4.0 3.9 4.5 4.4 (1.3) (1.0) (1.5) (1.5) (–0.3 to 0.8) (–0.7 to 0.7) Volumetry (DFI]L[4$_T ) (1.3) (1.2) (1.3) (1.2) (1.5) (0.9) 0.1 0.1 0.4 0.1 Perimetry (cm) 3.8 3.6 3.6 3.7 4.2 4.0 (1.5) (1.6) (1.7) (1.4) 0.1 0.2 fold at the popliteal fossa (1.3) (1.4) (1.3) (1.0) (1.2) (0.8) 0.3 0.1 0.8 0.6 (–0.6 to 0.8) (–0.5 to 0.9) superior point 2.9 2.9 3.0 3.0 3.0 2.8 (1.0) (1.0) (1.2) (1.1) inferior point (1.2) (1.1) (1.2) (1.3) (0.8) (0.9) –0.2 0.1 0.4 0.5 0.2 0.1 Lysholm (0 to 100) 2.3 2.1 2.4 2.2 2.6 2.5 (1.0) (1.0) (1.3) (1.4) (–0.3 to 0.6) (–0.4 to 0.6) WOMAC (0 to 96) (1.0) (0.8) (1.1) (0.8) (0.9) (0.5) 0.1 0.1 0.2 –0.1 5.9 6.0 5.9 6.0 5.9 6.0 (0.9) (1.2) (1.0) (1.2) –0.3 –0.1 (1.0) (1.0) (1.0) (1.0) (1.0) (1.0) 0.1 0.1 0.3 0.4 (–0.7 to 0.2) (–0.7 to 0.5) (0.8) (0.9) (0.8) (0.9) 40.6 41.2 40.2 41.3 40.4 41.4 0.0 0.0 0.0 0.0 0.0 0.3 (3.5) (3.6) (3.5) (3.8) (3.6) (3.7) (0.1) (0.1) (0.1) (0.1) (–0.5 to 0.5) (–0.2 to 0.8) 44.0 44.9 43.9 44.8 44.0 44.8 (5.0) (4.8) (4.9) (4.7) (4.9) (4.6) 0.0 0.0 37.1 37.9 37.1 38.2 37.1 38.2 (–0.4 to 0.3) (–0.4 to 0.4) (3.0) (3.4) (3.1) (4.1) (3.1) (3.7) 0.1 0.0 49 50 53 58 54 55 (–0.01 to 0.1) (–0.02 to 0.1) (16) (19) (17) (19) (18) (17) 48 49 37 39 40 43 –0.3 0.1 –0.1 0.2 –0.4 –0.4 (15) (19) (16) (19) (16) (17) (1.4) (1.2) (1.2) (1.4) (–1.0 to 0.2) (–1.0 to 0.2) –0.1 –0.1 –0.1 –0.1 (0.9) (1.5) (0.8) (1.1) –0.1 0.0 0.0 0.3 0.0 0.3 (–0.6 to 0.5) (–0.4 to 0.4) (0.6) (1.3) (0.6) (0.7) –0.3 –0.3 4 8 5 5 (–0.8 to 0.2) (–0.6 to 0.0) (11) (13) (12) (12) –12 –9 –8 –6 –3 1 (13) (13) (10) (8) (–9 to 2) (–5 to 6) –2 –3 (–8 to 4) (–7 to 2) Con = control group, Exp = experimental group, Lysholm = Lysholm Knee Scoring Scale (0 = worst to 100 = best), WOMAC = Western Ontario and McMaster osteoarthritis index (0 = best to 96 = worst). were only expected while the tape application was in place. the present study, suggest that the possible changes in swelling However, it is unclear from the Kinesio Taping creators whether the promoted by Kinesio Taping could occur only at a cellular level, possible benefits of Kinesio Taping should only be expected while the having little, if any, clinical relevance. tape is on.13 In the present study, all assessments were performed after the removal of the Kinesio Taping, ensuring that the assessor Therefore, it seems that the lack of positive results in knee- was blinded to group allocation. Also, it is believed that any effects of related health status is only a consequence of the lack of positive Kinesio Taping should endure longer than the time of application results in pain, strength and swelling. As ageing is a natural itself, otherwise the use of Kinesio Taping becomes financially non- process, older people usually face difficulties with mobility and viable, especially for more disadvantaged populations such as the other activities that have an impact on their daily life,29[12D]F_IT$ and knee one in the present study. Another important distinction between the osteoarthritis sufferers seem to experience those difficulties. study by Anandkumar et al23 and the present study relates to the duration of Kinesio Taping application. Anandkumar et al23 had The number of dropouts at follow-up on Day 19 may be Kinesio Taping applied for 30 minutes, and they reported improve- considered as a limitation of the study. As improvements were not ments in pain and strength. When analysing the results from both seen at the post-treatment assessment on Day 4, it is possible that studies, there could be a suggestion that shorter duration of the large dropout rate for the follow-up assessment was a reflection applications (30 minutes) might have better effects than a longer of the lack of satisfaction experienced by participants in both application (4 days). However, this suggestion seems flawed and the groups. Thus, the follow-up results should be considered with physiological foundation and rationale around it are unclear. caution due to multiple imputation of the missing data.21 However, the impact of the loss to follow-up at Day 19 on the study results was In the present study, it was expected that the Kinesio Taping likely to be small due to the fact that even with full follow-up, a drainage technique could have an indirect influence on pain. If positive result would be unlikely and poorly credible if it were to there was a reduction in swelling, it could improve joint mobility, occur. In addition to this, the high proportion of participation among decrease intra-articular pressure and offer pain relief. The Kinesio those screened improves the external validity of the present study. Taping creator states that micro-waves are formed immediately under the skin when applying Kinesio Taping, and the micro- The present study showed that a 4-day application of Kinesio waves, along with muscle activation, could facilitate the move- Taping techniques had no significant effect on pain, muscle ment of the swelling in the joint towards the lymphatic vessels and strength, swelling, knee-related health status, or physical function consequently improve drainage.13 A study from Aguilar-Ferra´ ndiz in older people with knee osteoarthritis. et al27 using bioelectrical impedance reported that after 4 weeks of using Kinesio Taping, post-menopausal females with mild-to- What is already known on this topic: People with knee moderate chronic venous insufficiency had a decrease in extracel- osteoarthritis may experience pain and exhibit swelling, re- lular liquid in the lower limb that was tested; however, the same duced range of movement and reduced quadriceps strength. authors, in a different study with the same population character- These signs and symptoms may impair balance and gait. istics, found no difference in lower limb volume measured by limb What this study adds: People with knee osteoarthritis did not circumference after Kinesio Taping application.28 The conflicting experience any significant benefits in pain, swelling, quadri- results from Aguilar-Ferrandiz et al,27,28 along with the results of ceps strength, knee function or knee-related health status from Kinesio Taping applied for four days.
158 Wageck et al: Kinesio Taping for knee osteoarthritis Footnotes: aBiodex Medical System, model Multi Joint System 10. Parreira PCS, Costa LCM, Hespanhol Junior LC, Lopes AD, Costa LOP. Current 4, Shirley, NY, USA. bEMG System do Brasil, model EMG230C, Sa˜o evidence does not support the use of Kinesio Taping in clinical practice: a Paulo, Brazil. cProdigital, model NE7304, Sa˜o Paulo, Brazil. dSPSS systematic review. J Physiother. 2014;60:31–39. Inc. Version 17.0, Chicago, IL, USA. 11. Vithoulkaa I, Benekab A, Mallioub P, Aggelousisb N, Karatsolisa K, Diamantopou- eAddenda: Table 3 can be found online at doi:10.1016/j.jphys. losa K. The effects of Kinesio-Taping on quadriceps strength during isokinetic 2016.05.012 exercise in healthy non-athlete women. Isokinet Exerc Sci. 2010;18:1–6. Ethics approval: The Human Research Ethics Committee of 12. Campolo M, Babu J, Dmochowska K, Scariah S, Varughese J. A comparison of two Universidade do Estado de Santa Catarina approved this study taping techniques (Kinesio and McConnell) and their effect on anterior knee pain (approval number CAAE: 08132212.2.0000.0118). All participants during functional activities. Int J Sports Phys Ther. 2013;8:105–110. gave written informed consent before data collection began. 13. Kase K, Wallis J, Kase T. Clinical Therapeutic Applications of the Kinesio Taping Competing interest: Nil. Method. Tokyo, Japan: Kenı´-kai information; 2003. Source of support: This research was funded by the National Council of Technological and Scientific Development (CNPq) 14. Almosnino S, Brandon S, Sled E. Does choice of angular velocity affect pain level through the process 481895/2011-6. during isokinetic strength testing of knee osteoarthritis patients? Eur J Phys Rehabil Acknowledgement: Nil. Med. 2012;48:569–575. Provenance: Not invited. Peer reviewed. Correspondence: Guilherme S Nunes, Department of Physio- 15. Wylde V, Palmer S, Learmonth I, Dieppe P. Test-retest reliability of Quantitative therapy, Center of Health and Sport Sciences, Santa Catarina State Sensory Testing in knee osteoarthritis and healthy participants. Osteoarthritis University, Floriano´ polis, Brazil. Email: [email protected] Cartilage. 2011;19:655–658. References 16. Nunes GS, Yamashitafuji I, Wageck B, Teixeira GG, Karloh M, de Noronha M. Reliability of volumetry and perimetry to assess knee volume. J Sport Rehabil. 1. Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, et al. 2015.(in press). American College of Rheumatology 2012 recommendations for the use of non- pharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and 17. Man IOW, Markland KL, Morrissey MC. The validity and reliability of the Perometer knee. Arthritis Care Res. 2012;64:465–474. in evaluating human knee volume. Clin Physiol Funct Imaging. 2004;24:352–358. 2. Nu´ n˜ ez M, Nu´ n˜ ez E, Segur JM, Macule´ F, Sanchez A, Herna´ ndez MV, et al. Health- 18. Peccin MS, Ciconelli R, Cohen M. Questiona´ rio especı´fico para sintomas do joelho. related quality of life and costs in patients with osteoarthritis on waiting list for Acta Ortop Bras. 2006;14:268–272. total knee replacement. Osteoarthritis Cartilage. 2007;15:258–265. 19. Nunes G, de Castro LV, Wageck B, Kume V, Chiesa GS, de Noronha M. Translation 3. Thomas A, Eichenberger G, Kempton C, Pape D, York S, Decker AM, et al. Recom- into Portuguese of questionnaires to assess knee injuries. Acta Ortop Bras. mendations for the treatment of knee osteoarthritis, using various therapy tech- 2013;21:288–294. niques, based on categorizations of a literature review. J Geriatr Phys Ther. 2009;32:33–38. 20. Fernandes M. Traduc¸a˜o e validac¸a˜o do questiona´ rio de qualidade de vida especı´fico para osteoartrose WOMAC (Western Ontario McMaster Universities) para a lı´ngua 4. Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, et al. OARSI portuguesa [thesis]. Universidade Federal de Sa˜o Paulo: Sa˜o Paulo; 2003. recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 21. Sterne JAC, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, et al. Multiple 2008;16:137–162. imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009;338:b2393. 5. Jevsevar DS. Treatment of osteoarthritis of the knee: evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013;21:571–576. 22. Jan M-H, Lin J-J, Liau J-J, Lin Y-F, Lin D-H. Investigation of clinical effects of high- and low-resistance training for patients with knee osteoarthritis: a randomized 6. Slemenda C, Heilman DK, Brandt KD, Katz BP, Mazzuca SA, Braunstein EM, et al. controlled trial. Phys Ther. 2008;88:427–436. Reduced quadriceps strength relative to body weight: a risk factor for knee osteoarthritis in women? Arthritis Rheum. 1998;41:1951–1959. 23. Anandkumar S, Sudarshan S, Nagpal P. Efficacy of kinesio taping on isokinetic quadriceps torque in knee osteoarthritis: a double blinded randomized controlled 7. Conroy MB, Kwoh CK, Krishnan E, Nevitt MC, Boudreau R, Carbone LD, et al. Muscle study. Physiother Theory Pract. 2014;30:375–383. strength, mass, and quality in older men and women with knee osteoarthritis. Arthritis Care Res. 2012;64:15–21. 24. Henriksen M, Rosager S, Aaboe J, Graven-Nielsen T, Bliddal H. Experimental knee pain reduces muscle strength. Journal Pain. 2011;12:460–467. 8. Melo MO, Araga˜o FA, Vaz MA. Neuromuscular electrical stimulation for muscle strengthening in elderly with knee osteoarthritis - a systematic review. Comple- 25. Lins CAA, Neto FL, Amorim ABC, Macedo LB, Brasileiro JS. Kinesio Taping1 does not ment Ther Clin Pract. 2013;19:27–31. alter neuromuscular performance of femoral quadriceps or lower limb function in healthy subjects: randomized, blind, controlled, clinical trial. Man Ther. 2013;18: 9. Hinman RS, Crossley KM, McConnell J, Bennell KL. Efficacy of knee tape in the 41–45. management of osteoarthritis of the knee: blinded randomised controlled trial. BMJ. 2003;327(7407):135. 26. Fu T-C, Wong AMK, Pei Y-C, Wu KP, Chou S-W, Lin Y-CC.. Effect of Kinesio taping on muscle strength in athletes-a pilot study. J Sci Med Sport. 2008;11:198–201. 27. Aguilar-Ferra´ ndiz ME, Castro-Sa´ nchez AM, Matara´ n-Pen˜ arrocha GA, Guisado-Bar- rilao R, Garcı´a-Rı´os MC, Moreno-Lorenzo C. A randomized controlled trial of a mixed Kinesio taping-compression technique on venous symptoms, pain, periph- eral venous flow, clinical severity and overall health status in postmenopausal women with chronic venous insufficiency. Clin Rehabil. 2014;28:69–81. 28. Aguilar-Ferra´ ndiz ME, Castro-Sa´ nchez AM, Matara´ n-Pen˜ arrocha GA, Garcı´a-Muro F, Serge T, Moreno-Lorenzo C. Effects of kinesio taping on venous symptoms, bioelectrical activity of the gastrocnemius muscle, range of ankle motion, and quality of life in postmenopausal women with chronic venous insufficiency: a randomized controlled trial. Arch Phys Med Rehabil. 2013;94:2315–2328. 29. Creamer P, Hochberg MC. The relationship between psychosocial variables and pain reporting in osteoarthritis of the knee. Arthritis Care Res. 1998;11:60–65.
Journal of Physiotherapy 62 (2016) 159–163 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research New exercise-integrated technology can monitor the dosage and quality of exercise performed against an elastic resistance band by adolescents with patellofemoral pain: an observational study Michael S Rathleff a,b,c, Thomas Bandholm d, Kate A McGirr a, Stine I Harring a, Anders S Sørensen e, Kristian Thorborg d,f,g a Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University; b Department of Occupational and Physiotherapy, Aalborg University Hospital; c Research Unit for General Practice and Department of Clinical Medicine, Aalborg University, Aalborg; d Physical Medicine & Rehabilitation Research – Copenhagen (PMR-C), Department of Occupational and Physical Therapy, Department of Orthopedic Surgery, and Clinical Research Center, Hvidovre Hospital, University of Copenhagen, Copenhagen; e The Mærsk Mc-Kinney Møller institute, University of Southern Denmark; f Sports Orthopedic Research Center Copenhagen (SORC-C), Arthroscopic Centre Hvidovre, Amager-Hvidovre Hospital, Copenhagen University; g Department of Occupational and Physical Therapy, Department of Orthopedic Surgery, and Clinical Research Center, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark KEY WORDS ABSTRACT Patellofemoral pain Question: Is the exercise-integrated BandcizerTM system feasible for recording exercise dosage (time Exercise therapy under tension (TUT) and repetitions) and pain scores among adolescents with patellofemoral pain? Do Compliance adolescents practise the exercises as prescribed (TUT and repetitions)? Do adolescents accurately report Adolescents the exercises they do in an exercise diary? Design: Observational feasibility study. Participants: Twenty Physical therapy adolescents between 15 and 19 years of age with patellofemoral pain. Intervention: Participants were prescribed three exercise sessions per week (one with and two without supervision) for 6 weeks. The exercises included three hip and one knee exercise with an elastic resistance band. Participants were instructed to perform three sets with a predefined TUT (3 seconds concentric; 2 seconds isometric; 3 seconds eccentric; 2 seconds pause), equating to 80 seconds for 10 repetitions (one set). Outcome measures: The exercise-integrated system consisted of a sensor attached to the elastic resistance band that was connected to the Bandtrainer app on an electronic tablet device. Pain intensity was reported on a visual analogue scale on the app. Participants also completed a self-report exercise diary. Results: No major problems were reported with the system. Participants performed 2541 exercise sets during the 6 weeks; 5% were performed with the predefined TUT (ie, within 10 seconds of the 80-second target) and 90% were performed below the target TUT. On average, the participants received 15% of the instructed exercise dosage based on TUT. The exercise dosage reported in the exercise diaries was 2.3 times higher than the TUT data from the electronic system. Pain intensity was successfully collected in 100% of the exercise sets. Conclusion: The system was feasible for adolescents with patellofemoral pain. The system made it possible to capture detailed data about the TUT, repetitions and sets during home-based exercises together with pain intensity before and after each exercise. [Rathleff MS, Bandholm T, McGirr KA, Harring SI, Sørensen AS, Thorborg K (2016) New exercise-integrated technology can monitor the dosage and quality of exercise performed against an elastic resistance band by adolescents with patellofemoral pain: an observational study. Journal of Physiotherapy 62: 159–163] ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction patients with patellofemoral pain.6 Exercise dosage may be an Knee pain is common during adolescence, with a reported important aspect of the intervention because a higher self- prevalence of up to 25%.1,2 Patellofemoral pain has a prevalence of 6 to 7%, making it the most common knee condition amongst reported exercise dosage is associated with improved odds of adolescents.3 Pain is typically long-standing and results in severe recovery.3,7 Adherence to prescribed exercises is likely to be reductions in function and health-related quality of life.4 Symptoms of patellofemoral pain include diffuse anterior knee important because low adherence would be expected to reduce the pain provoked by squatting, sitting for extended periods of time, magnitude of their effect.3,7 This is a challenge because adherence and descending and ascending stairs.5 to exercise protocols is approximately 50% for clinic-based The latest Cochrane systematic review concluded that lower- programs, and reportedly lower for home-based exercise.8 extremity exercise therapy is effective in reducing knee pain in Adherence involves a number of factors, including how often the patient performs the exercises, whether the quantity of the exercise performed is sufficient to provide a therapeutic benefit, and how long the patient continues to perform the exercises.9 Pain http://dx.doi.org/10.1016/j.jphys.2016.05.016 1836-9553/ß 2016 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
160 Rathleff et al: Patellofemoral pain and adherence to exercises during exercises may help to explain non-adherence to exercise males and 18 were females. Their average age was 17 years (range programs, which is why continuous pain monitoring may be an 15 to 19), height was 167 cm (SD 6), weight was 60 kg (SD 8) and important factor in explaining adherence.10 pain duration was 3.5 years (SD 1.4). The latest systematic review on self-reported adherence to Inclusion criteria were: the insidious onset of anterior knee or home-based intervention rehabilitation programs concluded: ‘The retropatellar pain lasting > 6 weeks and provoked by at least two of results expose a gap in the literature for well-developed measures the following activities – prolonged sitting, prolonged kneeling, that capture self-reported adherence to prescribed but unsuper- squatting, running, hopping or stair climbing; tenderness on vised home-based rehabilitation exercises’.9 A lack of objective palpation of the patella; pain when stepping down or double-leg measurements limits the ability of clinicians and researchers to squatting; and worst pain intensity during the previous week of > evaluate the outcome of exercise interventions. This makes it 30 mm on a 100-mm visual analogue scale. Exclusion criteria virtually impossible to ascertain if a lack of improvement is due to were: injury to other areas of the body; pain in the hip, lumbar the incorrect exercise, dosage, or due to poor adherence. In a recent spine or other areas of the knee (eg, participants with Osgood- series of studies,11–13 technology that measures these factors has Schlatter disease or other knee conditions not related to been developed and validated; the BandcizerTM is an in-built patellofemoral pain would be excluded); previous knee surgery; sensor attached to an elastic resistance band and connected to an self-reported patellofemoral instability; knee joint effusion; iPad, hereafter referred to as the exercise monitoring system. In physiotherapy treatment for knee pain within the previous year; lab-based studies, the exercise monitoring system has shown that and weekly or more frequent usage of anti-inflammatory drugs.3 it can validly quantify exercise data, such as the number of repetitions and sets, as well as the time under tension.11 The Intervention feasibility of using the exercise monitoring system connected to an iPad (hereafter referred to as the tablet device) during week-long Exercises home-based interventions in clinical populations is currently The description of the exercise intervention follows the unknown and, thus, it is too premature to use the system in clinical trials or clinical practice. It is therefore pertinent to test the Template for Intervention Description and Replication (TIDieR) feasibility of the system and record any issues associated with checklist.15 The exercise intervention lasted 6 weeks and covered using it during home-based unsupervised interventions. three weekly exercise sessions (one group-based session at the local hospital and two sessions at home without supervision). The The general research question for this study related to whether exercises were prescribed by two physiotherapy students under it is feasible to use the exercise monitoring system connected to a the supervision of a senior physiotherapist with 7 years of clinical tablet device to measure exercise adherence and dosage among experience in musculoskeletal physiotherapy. Before they pre- adolescents with patellofemoral pain. scribed the exercises to the participants, the physiotherapy students attended 2 hours of training on prescribing the exercises. Therefore, the research questions for this feasibility study were: The exercise program included three hip and one knee exercise with an elastic band. Participants were instructed to perform the 1. Is the exercise monitoring system feasible for recording exercise exercises with a predefined time under tension (3 seconds dosage (time under tension and repetitions) and pain scores concentric; 2 seconds isometric; 3 seconds eccentric; 2 seconds among adolescents with patellofemoral pain? pause), equating to 80 seconds for 10 repetitions in a set, with a total of three sets prescribed. They were instructed to perform the 2. Do patients perform exercises as prescribed, with respect to exercises at 10 repetition-maximum and used exercises previously time under tension and repetitions? used for treating patellofemoral pain.16 The exercises were: knee extension (loading from 90 deg flexion to full extension), hip 3. Do patients accurately report the exercises that they perform in external rotation (loading starting from 0 deg external rotation to an exercise diary? full external rotation), hip abduction (loading starting from 0 deg hip abduction progressing to full hip abduction) and hip extension Methods (loading starting from 20 deg hip flexion to full hip extension) (see Figure 1). During the supervised exercise sessions, the participants Design were repeatedly told that adherence was important and would improve their likelihood of recovery. During the supervised group The study was designed as a feasibility study. The term sessions, the participants received instructions to ensure proper feasibility study refers to studies that are carried out in preparation exercise form. for future large-scale definitive studies such as randomised trials or observational studies, and to address key issues of uncertainty14 Equipment – in this case, uncertainty related to the home-based use of the The exercise monitoring system consisted of a BandcizerTM BandcizerTM system. The study investigated whether the exercise monitoring system could be used to record exercise dosage and attached to the elastic exercise band used to resist the exercises, pain, to test whether adolescents with patellofemoral pain perform connected via Bluetooth to the Bandtrainer app installed on an iPad their exercises as prescribed, and to test whether they report their tablet device (Figure 1). The University of Southern Denmark and adherence accurately in their exercise diary. This was tested the National Danish Partnership UNIK developed the BandcizerTM among 20 adolescents with patellofemoral pain that were and the Bandtrainer app. The BandcizerTM consists of two prescribed 6 weeks of exercises. connected parts that are mounted on either side of an elastic band, held together by internal magnets. The two parts form a Participants, therapists, centres sensor that measures deformation and, thereby, stretch of the elastic band. The measured data are transmitted via Bluetooth-4 Participants were recruited from upper secondary schools using low energy, directly to the tablet device.11 The Bandtrainer app has a similar process to that described by Rathleff et al.3 In short, an inbuilt visual analogue scale where users record their current adolescents in these schools answered an online questionnaire on knee pain intensity before and after each exercise set. The exercises musculoskeletal pain and if they reported knee pain, they were are shown on the tablet and the participant selects which exercise contacted by telephone and offered a clinical examination by a they wish to perform by tapping on a picture of the relevant physiotherapist to determine the specific knee condition. As the exercise (see screenshot in Figure 1). Both the BandcizerTM and the present study was a feasibility study, no formal sample-size tablet device need charging at least once every week. calculation was conducted. Twenty adolescents between 15 and 19 years of age with patellofemoral pain were included. Two were
]GIF$DT)1_rugi([e Research 161 Figure 1. BandcizerTM attached to an elastic band and connected through Bluetooth to an iPad. Outcomes between total time under tension and the average composite change in hip and knee strength. This was tested using a Pearson Strength testing correlation coefficient. Normality was checked with Q-Q plot. At baseline and after the intervention, isometric strength Results measurements were recorded for knee extension and hip abduction, external rotation and extension using strap-mounted, Is the system feasible for monitoring? hand-held dynamometry. The test protocol was based on previous studies by Rathleff et al13 for knee extension, hip abduction and No major problems were reported with the exercise monitoring external rotation, and the short-lever hip extension test described system. Two participants reported that the sensor fell off the elastic by Thorborg et al.17 The reliability of the strength measurements band twice and two participants reported they had to restart the was above ICC 0.88.17,18 tablet app ‘a couple of times’ during the 6 weeks. Feasibility and adherence Do adolescents adhere to the training prescription? For exploratory purposes, and to inform a future large-scale Based on data from the exercise monitoring system, the trial on exercise dosage, the participants were asked to continually 20 participants performed 2541 of the 8640 prescribed exercise fill out an exercise diary during the 6 weeks and had their strength sets during the 6-week intervention period. The average time measured before and after the 6-week intervention. This allowed under tension was 53 seconds (95% CI 51 to 55): 5% were for the association between self-reported adherence and objec- performed with the predefined time under tension (ie, within tively assessed adherence to exercise to be explored. All problems 10 seconds of the 80-second target), 5% were above the target time were recorded by asking the participants and the physiotherapists under tension and 90% were below the target time under tension. to document all issues with the exercise monitoring system. The median number of repetitions per set was 10 (IQR 9 to 10). Overall, 52% of the exercise sets contained the predefined number Data analysis of repetitions (10) and 24% had a lower number of repetitions. On average, the participants received 15% (range 0 to 52) of the Data from the exercise monitoring system, stored on the tablet instructed exercise dosage based on time under tension. device, were transferred to a computer and an automatic algorithm extracted the number of repetitions, sets and time under tension Do adolescents report their exercises accurately? from the data. The algorithm accurately measures time under tension in four steps: stretches are amplified using a Gaussian filter designed According to the self-report data, the participants performed for stretches with duration between 1 and 10 seconds; individual 3069 exercise sets and received 36% (range 0 to 78) of the stretches are identified and counted by peak-detection and thresh- prescribed exercise dosage based on time under tension. An olding of the filtered data; the relaxation level between stretches is exploratory analysis showed a significant association between identified as the minimal tension occurring between peaks; and the self-reported data and time under tension data from the exercise threshold for tension is chosen as 10% above the relaxed state with monitoring system (r = 0.77, p < 0.001); however, the exercise respect to the peak tension, and the time under tension of each dosage reported in the exercise diaries was 2.3 times higher than stretch is measured as the time where the tension is above this the time under tension data from the exercise monitoring system. threshold. For each exercise, a report is generated, which includes a graphic plot of measured tension versus time, annotated with the Isometric strength and exercise dosage calculated thresholds and time under tension of each individual stretch, as well as the total time under tension and time for the Six participants did not attend the follow-up strength exercise. The reports allow manual verification of data quality as well measurement session. The follow-up strength measurements as the quality of the automatic time under tension measurement. were performed on the remaining 14 participants the day after the intervention period ended. On average, the participants Issues with using the exercise monitoring system were increased their knee and hip strength by 11% (95% CI 4 to 13). described narratively while the association between self-reported Knee extension strength increased by an average 24 N, corre- adherence and data from the exercise monitoring system were sponding to 8% (95% CI –2 to 18). Hip abduction strength increased described using an unpaired t-test and the Pearson correlation by 17 N, corresponding to 12% (95% CI 2 to 22). Hip external coefficient. Changes in isometric strength and knee pain before and after each exercise set were tested using a paired-samples t-test. An exploratory analysis was performed to test the association
grF([e_2)TD$IG]ui162 Rathleff et al: Patellofemoral pain and adherence to exercises 10 Current knee pain (cm on a visual analogue scale) 9 8 7 6 5 * * * * 4 3 2 1 0 Before After Before After Before After Before After Hip abduction Hip extension Hip external rotation Knee extension Figure 2. Current knee pain before and after each of the four exercises. Error bars indicate one standard deviation. Asterisks denote a statistically significant change from before to after the exercise. rotation strength increased by 10 N, corresponding to 11% (95% CI exercise stimulus than prescribed. The reason for the low time 3 to 18). Hip extension strength increased by 18 N, corresponding under tension is unknown, but perhaps the participants did not to 14% (95% CI –2 to 29). An exploratory analysis showed a positive receive adequate feedback during their supervised exercise association between average increase in isometric knee and hip sessions. A possible solution could be to use the tablet to deliver strength and the total exercise dosage recorded by the exercise real-time feedback on the exercise execution, or to use a mobile monitoring system (r = 0.49, p = 0.07). phone with a metronome. Previous research among adolescents with patellofemoral pain has suggested that adherence is Pain intensity before and after exercises important and improves recovery. Specifically, Rathleff and colleagues showed a dose-response association between the Pain intensity was successfully collected before and after each average number of home-based training sessions per week and exercise set in 100% of the exercise sets. On average, their current the odds of being recovered after 12 months.3 This finding was knee pain increased significantly by 0.4 to 0.9 cm on the visual based on self-report data and may have been biased because of analogue scale during each of the four exercises, with the last strong overestimation of exercise adherence in the self-report exercise (hip external rotation) associated with the largest increase training diaries, given the findings of the present study. However, in knee pain (Figure 2). the association between objective and self-reported exercise dosage was preserved in the current study, which could suggest Discussion that the association between adherence and effect may still hold true despite large overestimation of self-reported exercise dosage. The present study reports novel objective measurement of adherence collected during a 6-week exercise program with two Similar to what has previously been reported,3 the average weekly unsupervised sessions and one weekly supervised session. adherence was low in the present study. To address low adherence The exercise monitoring system proved to be feasible for use in a issues, there is a need to investigate the minimum exercise dosage clinical population of adolescents with patellofemoral pain, with required to obtain a clinical effect and how much exercise is only minor issues with the system having been reported. The needed to obtain the largest possible effect. This is important sensor in the exercise monitoring system fell off the elastic exercise information in both the clinical setting and research. Until now, it band a few times. Subsequent use of stronger magnets that secured has not been possible to investigate the dose-response association. the sensor more firmly to the elastic band appears to solve this The present study suggests that the exercise monitoring system is issue. This is important because adherence is underestimated if the feasible for use in adolescents with patellofemoral pain and will sensor is not connected to the elastic band at all times. allow researchers to explore such questions in future randomised, controlled trials. Likewise, it will give clinicians and patients an The exercise monitoring system allowed calculation of the total opportunity to receive information on exercise dosage during exercise dosage and recording of pain intensity before and after unsupervised training, which may in some cases encourage better each exercise. The objective data from the exercise monitoring adherence and help clinicians to adjust exercise dosage. system revealed that the participants only received 15% of the prescribed exercise dosage and still improved isometric hip and The participants who received the largest dose of exercise knee strength. The participants reported much higher adherence in during the 6 weeks showed the largest increases in knee and hip their exercise diaries, with an average of 36% of the prescribed strength. The total exercise dose was expressed as total time under exercise dosage. The discrepancy between objective data and self- tension; total time under tension refers to the total time of all reported data suggests that training diaries from this population concentric, quasi-isometric and eccentric contraction phases in a should be interpreted with great care, as they may severely single training set.19 In combination with load and movement overestimate the actual exercise dosage. velocity, time under tension is an important descriptor of strengthening exercises because it reflects the time factor of the Most of the exercise sets were performed with a time under exercise stimulus.20,21 Increasing the amount of time under tension much lower than the target. This resulted in a lower tension has been shown to increase myofibrillar protein synthesis after a single, work-matched, strength-training session in healthy
Research 163 subjects.21,22 Likewise, a higher duration of tendon strain per second (TB), and last (KT) authors, who are not patent holders and contraction (3 seconds cycling loading versus 1 second cycling loading) led to a superior adaptation, which improved the have no possible financial conflicts of interest with respect to the mechanical and structural properties of the Achilles tendon.23 Hence, the total time under tension in combination with the elastic band sensor, had the final say. No disagreements occurred. relative intensity (repetition maximum) is a relevant combined measure of the total exercise dosage during an exercise program, Sources of support: The study was funded by the Association of as it relates to the tissue-specific response. Danish Physiotherapists Research Fund and the Danish Society of The self-reported pain intensity levels increased < 1 cm on average after each exercise. This suggest that exercises performed Sports Physiotherapy Research Fund. None of the funders have any unsupervised at 10 repetition maximum are tolerated by adolescents with patellofemoral pain. This is important because role in the study other than to provide funding. it suggests that low adherence may not be caused by large increases in pain after each exercise set. However, the error bars in Acknowledgements: Nil. Figure 2 are quite wide, which suggests a large variance in knee pain intensity before and after each exercise. Changes in pain Provenance: Not invited. Peer reviewed. during home exercises may be highly relevant to monitor for both clinical and research purposes as this may be a major barrier to Correspondence: Michael Rathleff, Center for Sensory-Motor exercise adherence. The exercise monitoring system would allow clinicians to monitor their patient’s knee pain during home Interaction (SMI), Department of Health Science and Technology, exercises. This may help to tailor the exercise dose to each individual and continuously adjust the exercise dose based on the Faculty of Medicine, Aalborg University, Aalborg, Denmark. Email: individual patient’s pain response. [email protected] This study was conducted among a highly selected age group, where previous research has documented low levels of adherence to References exercise programs.5 Therefore, the low levels of adherence and poor association between data from the exercise monitoring system and 1. Molgaard C, Rathleff MS, Simonsen O. Patellofemoral pain syndrome and its the exercise diaries may not be transferable to other clinical association with hip, ankle, and foot function in 16- to 18-year-old high school populations or other age groups. In addition, the price of a tablet students: a single-blind case-control study. J Am Podiatr Med Assoc. 2011;101:215– device makes it an expensive solution for measuring adherence. A 222. less costly solution would be to record the data directly on the sensor itself. However, this would remove the option of recording 2. Rathleff MS, Roos EM, Olesen JL, Rasmussen S. High prevalence of daily and multi- knee pain intensity before and after each exercise set. site pain–a cross-sectional population-based study among 3000 Danish adoles- cents. BMC Pediatr. 2013;13:191. In summary, the exercise monitoring system proved to be feasible for use in adolescents with patellofemoral pain, and only 3. Rathleff MS, Roos EM, Olesen JL, Rasmussen S. Exercise during school hours when minor issues were reported. This new system makes it possible for added to patient education improves outcome for 2 years in adolescent patello- clinicians and researchers to capture a detailed description of time femoral pain: a cluster randomised trial. Br J Sports Med. 2015;49:406–412. under tension, number of repetitions and sets during home-based exercises, together with pain intensity before and after each 4. Rathleff MS, Roos EM, Olesen JL, Rasmussen S, Arendt-Nielsen L. Lower mechanical exercise. Data from the exercise monitoring system revealed that pressure pain thresholds in female adolescents with patellofemoral pain syn- adolescents with patellofemoral pain only received 15% of the total drome. J Orthop Sports Phys Ther. 2013;43:414–421. exercise dosage that they were prescribed. Comparison of the methods of recording the exercises suggests that self-report diary 5. Witvrouw E, Callaghan MJ, Stefanik JJ, Noehren B, Bazett-Jones DM, Willson JD, et cards provide an overestimate of adherence. al. Patellofemoral pain: consensus statement from the 3rd International Patello- femoral Pain Research Retreat held in Vancouver, September 2013. Brit J Sport Med. What is already known on this topic: Exercise therapy 2014;48:411–414. reduces patellofemoral pain in adolescents. The dose of exer- cise performed may be important to achieve the reduction in 6. van der Heijden RA, Lankhorst NE, van Linschoten R, Bierma-Zeinstra SM, van pain, but adherence is typically low, especially for home-based Middelkoop M. Exercise for treating patellofemoral pain syndrome. Cochrane exercise. Database Syst Rev. 2015;1:CD010387. What this study adds: A new system of monitoring adher- ence can capture detailed information about adherence to 7. Osteras B, Osteras H, Torstensen TA, Vasseljen O. Dose-response effects of medical exercises performed against an elastic resistance band. These exercise therapy in patients with patellofemoral pain syndrome: a randomised data show that self-report diaries typically overestimate ad- controlled clinical trial. Physiotherapy. 2013;99:126–131. herence. 8. Holden MA, Haywood KL, Potia TA, Gee M, McLean S. Recommendations for Ethics approval: The Ethics Committee of the North Denmark exercise adherence measures in musculoskeletal settings: a systematic review Region approved this study (2011-0069). All participants gave and consensus meeting (protocol). Syst Rev. 2014;3:10. written informed consent before data collection began. 9. Bollen JC, Dean SG, Siegert RJ, Howe TE, Goodwin VA. A systematic review of Competing interests: One of the authors of this study is a patent measures of self-reported adherence to unsupervised home-based rehabilitation holder for the elastic band sensor (ASS). ASS contacted the exercise programmes, and their psychometric properties. BMJ Open. researchers (MSR, KT and TB) to collaborate on a scientific 2014;4:e005044. evaluation of BandcizerTM. ASS was involved in the design of the study, including the pre-specified plan for data reduction and 10. Campbell R, Evans M, Tucker M, Quilty B, Dieppe P, Donovan JL. Why don’t patients statistical analyses, but was not involved in the data collection, and do their exercises? Understanding non-compliance with physiotherapy in patients was not allowed to see the results until the final approval of the with osteoarthritis of the knee. J Epidemiol Community Health. 2001;55:132–138. manuscript was required. At this point, ASS was allowed to comment on the results and interpretation. In any case of 11. Rathleff MS, Thorborg K, Rode LA, McGirr KA, Sørensen AS, Bøgild A, et al. disagreement with that in the manuscript draft, the first (MSR), Adherence to commonly prescribed, home-based strength training exercises for the lower extremity can be objectively monitored using the bandcizer. J Strength Cond Res. 2015;29:627–636. 12. McGirr K, Harring SI, Kennedy TS, Pedersen MF, Hirata RP, Thorborg K, et al. An elastic exercise band mounted with a Bandcizer can differentiate between commonly prescribed home exercises for the shoulder. 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Muscle time under tension during resistance exercise stimulates differential muscle protein sub-fractional synthetic responses in men. J Physiol. 2012;590:351–362. 23. Arampatzis A, Karamanidis K, Albracht K. Adaptational responses of the human Achilles tendon by modulation of the applied cyclic strain magnitude. J Exp Biol. 2007;210:2743–2753.
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