Journal of Physiotherapy 65 (2019) 88–94 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Research Additional early active repetitive motor training did not prevent contracture in adults receiving task-specific upper limb training after stroke: a randomised trial Sally Horsley a, Natasha A Lannin b,c, Kathryn S Hayward d,e,f, Robert D Herbert g,h a Allied Health, Sunshine Coast University Hospital, Sunshine Coast Hospital and Health Service, Sunshine Coast; b School of Allied Health (Occupational Therapy), La Trobe University, Melbourne; c Occupational Therapy Department, Alfred Health, Melbourne; d Mount Isa Centre for Rural and Remote Health, James Cook University, Mount Isa; e Stroke Theme, Florey Institute of Neuroscience and Mental Health, Melbourne; f NHMRC CRE in Stroke Rehabilitation and Brain Recovery, Melbourne; g Neuroscience Research Australia (NeuRA), Sydney; h School of Medical Sciences, University of New South Wales, Sydney, Australia KEY WORDS ABSTRACT Randomised controlled trial Question: In adults undergoing rehabilitation after stroke, does 1 hour of additional active repetitive Stroke reaching per day prevent or reduce upper limb contracture? Design: Multi-centre, randomised controlled Contracture trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Participants: Fifty adults Upper extremity undergoing rehabilitation after stroke who were unable to actively extend the affected wrist past neutral or Active motor training were unable to flex the affected shoulder to 90 deg. Setting: Three inpatient rehabilitation units in Australia. Intervention: Both groups received usual upper limb therapy 5 days a week for 5 weeks. In addition, the experimental group received up to 1 hour a day of active, intensive, repetitive upper limb training using the SMART Arm device 5 days a week for 5 weeks. Outcome measures: Measures were collected at baseline (Week 0), after intervention (Week 5) and at follow-up (Week 7). The primary outcomes were passive range of wrist extension, elbow extension, and shoulder flexion at Week 5. The secondary outcomes were: the three primary outcomes measured at Week 7; passive range of shoulder external rotation; arm function; and pain at rest, on movement and during sleep measured at Weeks 5 and 7. Results: Following an average of 2310 reaching repetitions, the mean effect at Week 5 on passive range of wrist extension was 1 deg (95% CI –6 to 8), elbow extension –6 deg (95% CI –12 to –1), and shoulder flexion 5 deg (95% CI –8 to 17). There were no statistically significant or clinically important effects of the intervention on any secondary outcomes. Conclusion: In adults who are already receiving task-specific motor training for upper limb rehabilitation following stroke, 5 weeks of up to 1 hour of additional daily active repetitive motor training using the SMART Arm device did not prevent or reduce contracture in upper limb muscles. Trial registration: ACTRN12614001162606. [Horsley S, Lannin NA, Hayward KS, Herbert RD (2019) Additional early active repetitive motor training did not prevent contracture in adults receiving task-specific upper limb training after stroke: a randomised trial. Journal of Physiotherapy 65:88–94] © 2019 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 Interventions that were previously widely used, including passive stretching18–20 and splinting,21–23 have little or no effect on Failure to regain use of the arm is a cause of long-term disability following stroke.1–3 Contracture or loss of passive joint range of contracture in people undergoing rehabilitation following stroke. motion is common:4–7 approximately half of all patients develop at least one contracture within 6 months of stroke.4 Contractures result Serial casting only reduces contractures after traumatic brain injury from changes in the mechanical properties of soft tissues that cross in the short term.24 Trials investigating the effects of electrical the joint,8–11 such as a reduction in resting length or increase in stiffness of muscles, tendons, joint capsule or ligaments.9,12–15 By stimulation after stroke and in cerebral palsy suggest that it may limiting the available range of joint movement, upper limb contrac- reduce contracture,25–27 but have failed to definitively demonstrate tures not only impact performance of functional activities in the long clinically worthwhile effects. Consistent with this literature, the 2010 term, but also interfere with practice of hand or arm movements, which could in turn interfere with regaining upper limb function clinical practice guidelines for stroke state: ‘the most appropriate during rehabilitation following stroke.8,16,17 intervention to prevent or manage contracture is currently unclear’.28 They do not recommend the use of stretching or splinting, but rather No intervention has been shown, in randomised trials, to prevent or produce sustained reductions in contracture after stroke. conventional therapy. In 2017, the revised guidelines recommended provision of active motor training to prevent contracture.29 However, this recommendation is based only on expert opinion because the effect of active motor training on contracture has not been tested in a clinical trial. https://doi.org/10.1016/j.jphys.2019.02.005 1836-9553/© 2019 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 89 Muscle contractures occur when muscles are immobilised in Intervention shortened positions,14,15 and severe muscle weakness has been shown to be associated with development of contracture after stroke. Experimental group Therefore, it appears plausible that intensive practice of active re- Participants in the experimental group were encouraged to com- petitive movements or intensive active motor training after stroke could prevent the development of contracture or reverse existing plete repetitive active reaching training using the SMART Arm device contracture. The challenge for the people at greatest risk of contrac- for up to 1 hour per day, 5 days a week for 5 weeks (a goal of 25 ture after stroke – those with little to no arm movement (severe sessions, 1500 minutes), in addition to the usual upper limb therapy upper limb weakness) – is to undertake intensive active practice. provided by treating occupational therapists and physiotherapists. The SMART Arm provides visual and auditory feedback of perfor- The SMART Arm device30,31 combines a non-robotic device with mance and external support to achieve physical practice using electrical stimulation to make it possible to retrain intensive, repet- outcome-triggered electrical stimulation. It enables repetitive prac- itive upper limb movements in patients with severe weakness after tice of forward reaching involving shoulder flexion, external rotation stroke. This study examined the effectiveness of intensive active and elbow extension with the hand and forearm supported in the motor retraining with the SMART Arm device on contracture after functional position by a splint. It can also incorporate practice of hand stroke. tasks such as grasp/release involving forearm supination, wrist extension, radial deviation and hand movements. The effectiveness of Therefore, the research questions for this multi-centre, rando- the device in promoting upper limb recovery following stroke has mised controlled trial were: previously been demonstrated.31,32 1. In adults undergoing rehabilitation after stroke, does 1 hour of For each training session using the SMART Arm device, a record daily practice of intensive, active, repetitive reaching prevent or was kept of the time spent training (including set up) and the reduce upper limb contracture, decrease pain, or improve upper number of reaching repetitions completed. Time taken to set up limb function? the device was usually 5 to 10 minutes, but varied between par- ticipants and decreased after the initial sessions. Time spent 2. If so, are these effects maintained two weeks after cessation of the participating in usual upper limb therapy was recorded daily, and intervention? was categorised as either active (eg, practice of active movements); passive (eg, stretching, splinting, passive ranging, oedema man- Methods agement, electrical stimulation without targets or counting repeti- tions); functional (eg, part or whole task practice, tasks that Design actively included affected arm); or electrical stimulation for shoulder subluxation. A multi-centre, parallel-group, randomised controlled trial with Control group blinding of assessors and concealed allocation was conducted. The Participants in the control group received usual upper limb ther- study was conducted in accordance with the Declaration of Helsinki. In addition to prospective registration, the detailed research protocol apy from occupational therapists and physiotherapists for the 5-week is available in Appendix 1 on the eAddenda. Participants were intervention period. Upper limb therapy usually involved both group randomised to an experimental or control group. Participants in the and individual sessions conducted 5 days a week, and consisted of experimental group received active repetitive motor training in strengthening and task-specific practice of upper limb activities. addition to usual upper limb therapy for 5 weeks. Participants in the control group received usual upper limb therapy only. The primary For the 2 weeks immediately after the 5-week intervention outcomes were passive range of wrist extension, elbow extension, period, participants in both the control group and experimental and shoulder flexion at 5 weeks. group received only the usual upper limb therapy provided by occupational therapists and physiotherapists. Participants Outcome measures Participants were recruited to the trial on admission to one of three participating inpatient rehabilitation units located at Caloundra All outcome measures were collected by therapists trained in the Hospital, The Townsville Hospital, and Sunshine Coast University measurement procedures and blind to group allocation. Baseline Hospital. All patients with stroke or stroke-like brain injury were measures were collected prior to randomisation (Week 0). After 5 screened for eligibility. Patients were included if they were: aged 18 weeks, the intervention was ceased and outcome measures for both years, at least 10 days and no more than 6 months post-onset, and groups were collected (Week 5). Follow-up outcome measures were unable to actively extend the affected wrist past neutral or unable to collected 2 weeks after cessation of the intervention (Week 7). flex the affected shoulder to . 90 deg with the elbow extended. Further detail about the outcome measures than that provided below Patients were excluded if they: had language, comprehension or is available in Appendix 2 on the eAddenda. cognitive problems that prevented informed consent; had co-existing upper-limb problems that directly affected movement (eg, fractures, Primary outcomes inflammatory arthritis, peripheral nerve injury or burns); or were The co-primary outcomes were passive range of wrist extension, unable to participate in upper limb rehabilitation. elbow extension, and shoulder flexion at Week 5. Torque-controlled Randomisation measures of passive wrist extension were obtained using the pro- cedure described by Harvey et al.33 The procedure has been used in A person who was not otherwise involved in the day-to-day previous research investigating contracture following stroke.20,22,23 conduct of the trial generated the allocation schedule using the ‘ral- Passive range of shoulder flexion and torque-controlled passive loc’ user-written routine in Stata. Allocation was in random permuted range of elbow extension were measured with an Acumar digital blocks. The allocation schedule was concealed in sealed envelopes goniometera using standardised procedures. The procedure for kept by a person who was remote from the study site and not torque-controlled measurement of elbow extension has been previ- involved in recruitment. Participant allocation was revealed to the ously used to investigate upper limb contracture.24 local site trainer, by telephone, after eligibility and consent had been confirmed and baseline measures had been collected. Secondary outcomes The secondary outcomes were passive wrist extension, elbow extension, and shoulder flexion at Week 7, as well as passive range of movement of shoulder external rotation, arm function (upper limb items 6, 7 and 8 of the Motor Assessment Scale), and measures of pain
90 Horsley et al: Does early active repetitive motor training after stroke prevent upper limb contracture? Screened (n = 359) Excluded (n = 309) • ineligible (n = 297) • did not consent (n = 9) • other reasons (n = 3) Measured range of motion, pain and arm function (n = 50) Week 0 Randomised (n = 25) (n = 25) Lost to follow-up (n = 0) Experimental Group Control Group Lost to follow-up (n = 2) • repetitive active •usual upper limb reaching training therapy with SMART Arm up •5 weeks to 1 hour per day • usual upper limb therapy • 5 weeks Measured range of motion, pain and arm function Week 5 (n = 25) (n = 23) Lost to follow-up (n = 2) Lost to follow-up (n = 1) Measured range of motion, pain and arm function Week 7 (n = 23) (n = 22) Figure 1. Design and flow of participants through the trial. at rest, pain on movement (during measurement), and the effect of The primary analyses estimated the mean effect of the interven- pain on sleep at Weeks 5 and 7. Torque-controlled passive range of tion on passive wrist extension, elbow extension and shoulder flexion shoulder external rotation was measured with an Acumar digital at Week 5. The mean effect of the experimental intervention was goniometer using a standardised procedure. Upper limb function was estimated from the difference between the mean outcomes of the measured using a composite score of the three upper limb items of experimental and control groups. The mean effects and their 95% the Motor Assessment Scale,34,35 upper arm function (Motor Assess- confidence intervals were estimated using a linear regression model ment Scale Item 6), hand function (Motor Assessment Scale item 7), in which the independent variables included a dummy coded group and advanced hand function (Motor Assessment Scale item 8). A variable and the baseline value of the outcome. All analyses were score between 0 points (no function) and 18 points (best possible conducted on an intention-to-treat basis. score/good functional ability) was obtained. The Motor Assessment Scale is widely used by clinicians to monitor upper limb function, has Table 1 been used in previous studies investigating effectiveness of in- Characteristics of participants at baseline. terventions to improve upper limb function following stroke (eg, the studies by Horsley et al20 and Lannin et al23), and has demonstrated Characteristic Exp Con validity and reliability in this population.36–39 Pain at rest and on (n = 25) (n = 25) movement (during each of the upper limb range of motion measures) was measured using a 10-cm vertical visual analogue scale,40 which is Gender (male:female) 16:9 12:13 a valid and reliable measure in stroke and elderly populations.41–44 n 64:36 48:52 The effect of pain on ability to sleep at night was assessed using % 65.9 (12.7) 68.5 (13.0) the relevant question contained in the DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire.45 Age (years), mean (SD) 1:24 0:25 Indigenous:non-Indigenous 4:96 0:100 Data analysis 28.3 (27.1) 24.9 (14.1) n The minimum clinically worthwhile effect on the primary % 18 (72) 23 (92) outcome measures (ie, maximum passive range of wrist extension, Time since onset (days), mean (SD) 7 (28) 2 (8) elbow extension and shoulder flexion) was nominated a priori to be Diagnosis, n (%) 10 deg. The sample size of 50 was designed to give a 90% power to ischaemic stroke 53.6 (22.9) 44.7 (14.9) detect a 10-deg effect (ie, a 10-deg between-group difference in haemorrhagic stroke 24.7 (6.6) 23.1 (8.0) means) on each of the primary outcome variables, assuming a SD of FIM on admission, mean (SD) 10 deg and a two-tailed alpha of 0.05. Mini-mental score on admission, mean (SD) 9:16 10:15 Affected arm (right:left) 36:64 40:60 n % Con = control group, Exp = experimental group, FIM = Functional Independence Measure.
Research 91 Table 2 Compliance with the intervention Median (IQR) compliance with the intervention and usual therapy by group. Overall compliance with the intervention was good, but there Characteristic Exp Con was variation with respect to the total number of reaching repe- Median (IQR) (n = 25) (n = 25) titions completed by participants (IQR 1790 to 2840) (Table 2). On average, participants in the experimental group completed 100 Amount of usual therapy (days) 23 (18 to 24) 23 (17 to 25) reaching repetitions per session, 100% of the allotted SMART Arm Active time in usual therapy, 1075 (450 to 1310) 955 (580 to 1530) training sessions and 70% of allotted SMART Arm training time total (min) 260 (120 to 525) (median 1065 minutes, IQR 805 to 1430). The median amount of Passive time in usual therapy, 165 (75 to 375) usual upper limb therapy provided to the two groups was similar total (min) 25 (22 to 25) 0 (control group 955 minutes, intervention group 1075 minutes) Amount of SMART Arm training 0 (Table 2). (days) 1065 (805 to 1430) 0 Time in SMART Arm training, 2310 (1790 to 2840) Effect of the intervention total (min) Reaches in SMART Arm training, total (n) Con = control group, Exp = experimental group. The secondary analysis estimated the mean effect of intervention On average, both groups lost small amounts of passive range at the on passive wrist extension, elbow extension and shoulder flexion at shoulder and wrist over the 7-week trial period. There were no Week 7, as well as the effects, at both Weeks 5 and 7, on passive range clinically significant effects of the intervention on the three primary of movement of shoulder external rotation, pain at rest, pain on outcome measures at Week 5 (Table 3). However, the intervention movement, effect of pain on sleep, and arm function (composite of may have had a small negative effect on passive range of elbow scores for upper limb items of the Motor Assessment Scale). extension. At the elbow, the control group maintained passive range of elbow extension at the end of the treatment period and at follow- The statistical analysis code is available as Appendix 3 on the up, while the experimental group lost a small amount of range at eAddenda. both Weeks 5 and 7. Results After intervention, at the end of Week 5, there was no significant difference in mean passive range of wrist extension between the Compliance with the study protocol control and experimental group. The non-significant mean effect was 1 deg (95% CI –6 to 8, p = 0.79) in favour of the experimental group. The protocol states that the Halo goniometer was used for passive There was a small negative mean effect on passive range of elbow range of motion measures; however, the Halo goniometer was not extension of –6 deg (95% CI –12 to –1) in favour of the control group, available at the time of commencement of the study so an Acumar which was statistically significant (p = 0.03) but not clinically digital goniometer was used. important given it did not reach the pre-specified 10-deg threshold. The mean effect on passive range of shoulder flexion at Week 5 was 5 Flow of participants through the trial deg (95% CI –8 to 17) in favour of the experimental group, which was also not significant (p = 0.45). These effects decreased between Week The flow of participants through the trial is shown in Figure 1. 5 (post intervention) and Week 7 (follow-up). For passive range of Across the three participating inpatient rehabilitation units, 359 pa- wrist extension, the effect at Week 7 was –5 deg (95% CI –12 to 2, p = tients consecutively admitted following stroke or stroke-like brain 0.16) in favour of the control group. The effect on passive elbow injury were screened for eligibility. Of the 297 patients excluded, the extension at Week 7 was –11 deg (95% CI –21 to –1) in favour of the majority (n = 249) were ineligible because upper limb movement was control group, which was marginally significant (p = 0.04). The esti- not severely affected. The first participant was randomised on 28 July mated effect on range of passive shoulder flexion at Week 7 was 2 deg 2015 and the last participant’s Week-7 follow-up was on 26 October (95% CI –10 to 14) in favour of the experimental group and not sta- 2017. The two groups appeared to be well matched except that more tistically significant (p = 0.72). participants with haemorrhagic stroke were allocated to the experi- mental group (28%) than the control group (8%) (Table 1). Outcome There were no statistically significant or clinically important ef- measures were obtained from 96% of participants at Week 5 and from fects of the intervention on any of the secondary outcome measures 90% at Week 7. (passive range of shoulder external rotation; pain at rest, sleep or on movement; and upper limb function) at Weeks 5 or 7 (Table 3). In- dividual participant data are available in Table 4 on the eAddenda. Table 3 Mean (SD) of groups and mean (95% CI) difference between groups for all outcomes. Outcome Groups Difference between groups Week 5 Week 0 Week 7 Week 5 Week 7 Exp Con Exp Con Exp Con Exp minus Con Exp minus Con (n = 25) (n = 25) (n = 25) (n = 23) (n = 23) (n = 22) Passive range of motion (deg) 56 (18) 58 (16) 53 (19) 54 (14) 49 (16) 54 (14) 1 (–6 to 8) –5 (–12 to 2) wrist extension 183 (10) 188 (8) 181 (13) 189 (6) 175 (22) 188 (8) –6 (–12 to –1) –11 (–21 to –1) elbow extension 128 (33) 140 (24) 122 (26) 126 (27) 121 (21) 125 (24) shoulder flexion 39 (34) 37 (31) 33 (27) 26 (27) 27 (29) 21 (31) 5 (–8 to 17) 2 (–10 to 14) 6 (–7 to 19) 2 (–14 to 19) shoulder external rotation 44 (25) 37 (24) 47 (22) 48 (24) 52 (24) 53 (23) 15 (20) 8 (16) 16 (24) 11 (19) 18 (27) 22 (26) –3 (–16 to 11) –3 (–17 to 12) Pain VAS (0 to 100 mm) 2 (1) 2 (2) 5 (–8 to 19) –3 (–20 to 15) on movement 2 (1) 0.8 (1.4) 2 (1) 2.7 (4.4) 2 (1) 2 (1) –1 (–2 to 0) at rest 1.5 (3.6) 3.7 (5.4) 4.4 (5.4) 3.1 (4.9) 0 (0 to 1) 0.2 (–1.7 to 2.0) 0.4 (–1.7 to 2.5) Pain on sleeping (1 to 5) a Arm function (0 to 18) b Effects are differences in means adjusted for baseline scores (95% confidence intervals). The shaded cells indicate the primary outcomes. Con = control group, Exp = experimental group, VAS = visual analogue scale. a Item 29 on the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire. b Composite score of the three upper limb items of the Motor Assessment Scale.
92 Horsley et al: Does early active repetitive motor training after stroke prevent upper limb contracture? 100 80 Wrist extension (deg) 60 40 20 0 5 7 0 Time (weeks) 200 Shoulder flexion (deg) 150 100 50 0 5 7 0 Time (weeks) 200 Elbow extension (deg) 150 100 Control 50 Experimental 0 5 7 0 Time (weeks) Figure 2. Primary outcomes by time. Symbols show individual participants’ outcomes. Lines join group means at baseline and at Weeks 5 and 7. Control and experimental group data have been slightly offset for clarity.
Research 93 Discussion completed per session was not prescribed in the research protocol, the individual therapist providing or supervising the training was The main finding of this trial was that in adults undergoing able to influence the intensity of practice within each session. rehabilitation following stroke, active repetitive motor training using Different therapists had different levels of experience, skills and the SMART Arm device in addition to usual upper limb therapy did knowledge, and may have had differing opinions about what they not prevent or reduce contracture in upper limb muscles more than considered high intensity (in this case, high numbers of repetitions usual upper limb therapy alone. This finding is fairly clear, given the within a session). It is also possible that the variation between precision of the estimates (Table 3). The results are in line with a participants in the number of reaching repetitions completed on the previous trial, which found no effect of active repetitive motor SMART Arm may have been influenced by a corresponding variation training using electrical stimulation and splinting in addition to tilt- in upper limb pain. The development of upper limb pain during this table standing compared with tilt-table standing alone on ankle trial was similar to that reported following stroke in previous contracture after brain injury.46 studies (Gustafsson and McKenna 2006, Horsley et al 2007).20,51 While there were no between-group differences, both groups The results of this trial also demonstrated a small negative effect demonstrated small, non-significant increases in pain at rest and of the intervention on passive range of elbow extension (–6 deg). pain on movement over the intervention and follow-up periods However, since both groups had on average . 180 deg of elbow (Table 3). extension at baseline and after intervention (Week 5), and even at Week 7 the experimental group still had an average of 175 deg of While this trial protocol included concealed allocation and passive elbow extension, the mean effect is probably of little func- blinding of assessors, which minimised possible bias, patients were tional importance. Figure 2 shows that three participants in the aware if they were receiving SMART Arm training or not. We experimental group lost a substantial range of elbow motion. It is acknowledge that this is a potential source of bias. A further limita- unlikely that upper limb pain contributed to the difference in passive tion to this study is that usual therapy was not standardised and daily range of elbow extension because there was no between-group dif- activity data were not collected, so the possible influence on out- ference for any of the pain measures over the study period or at comes of variations between participants regarding these factors follow-up, and there was no correlation between pain and range of cannot be determined. motion (data not shown). There have now been many clinical trials that have investigated This study investigated the effect of providing additional intensive the effects of physical interventions involving stretch and movement active motor training on upper limb contracture early after stroke. on development of contracture after stroke. Most have found little or These findings do not necessarily contradict the recommendations of no effect of intervention.19 Like previous trials, the current trial found the Australian Clinical Guidelines for Stroke Management 2017 little or no effect of physical intervention. Given the failure of so many Practice Statement that ‘for stroke survivors at risk of developing trials to find a beneficial effect of physical interventions designed to contracture or who have developed contracture, active motor training prevent and treat contracture, it may be necessary to more closely or electrical stimulation to elicit muscle activity should be pro- examine the presumed mechanisms of contracture. Intervention vided’.29 However, the findings of the present study do suggest that research may need to be informed by more research on the mecha- the provision of additional intensive active motor training using the nisms of muscle contracture. SMART Arm device after stroke, over and above current standard care, does not prevent or reduce contracture. In summary, provision of up to 1 hour of additional repetitive motor training using the SMART Arm in conjunction with usual care It is possible that the duration and/or the intensity of the addi- did not reduce or prevent contracture after stroke compared to usual tional intervention were insufficient to produce an effect on care alone. contracture. The SMART Arm device enabled participants with severe upper limb weakness to participate in high-intensity, active, upper- What was already known on this topic: Contracture is limb motor training that would otherwise be impossible. It was ex- common after stroke. No intervention has been shown, in rand- pected that participants in the experimental group would complete omised trials, to prevent or produce sustained reductions in high numbers of reaching repetitions in each training session (250 to contracture after stroke. Muscle contractures occur when mus- 350 repetitions per session); however, there was significant between- cles are immobilised in shortened positions. person variation in the number of repetitions performed (Table 2) and What this study adds: In adults who are already receiving the average number of repetitions completed per session was only task-specific motor training of the upper limb rehabilitation 100. Given that the amount and type of ‘usual upper limb therapy’ following stroke, adding up to 1 hour of additional daily active completed by both groups was similar, the difference in the intensity repetitive motor training using the SMART Arm device for 5 of motor training between the experimental and control groups was, weeks did not prevent or reduce contracture in the arm. on average, 100 repetitions per session. Such a between-group dif- ference may be insufficient to have a therapeutic effect. Higher Footnotes: a Acumar, Lafayette Instrument Company, Lafayette, numbers of repetitions47,48 and larger differences in the amount of USA. intervention49 may be required to improve motor function following stroke. Similarly, large numbers of repetitions may be needed to eAddenda: Table 4 and Appendices 1, 2 and 3 can be found online prevent or reduce contracture. While we speculate that a larger at DOI: https://doi.org/10.1016/j.jphys.2019.02.005. duration or intensity of intervention may have been necessary to induce a beneficial effect, this speculation was based on our inter- Ethics approval: Townsville Hospital and Health Service Human pretation of data from outside the trial. The trial data do not and Research Ethics Committee approved the study protocol (HREC cannot demonstrate that more intervention would have been effec- reference number: HREC/14/QTHS/124). All participants gave written tive. Indeed, it is possible that no amount of additional intervention informed consent before data collection began. would be effective, and it is even possible (though we think unlikely) that additional intervention may have been harmful, for example, by Competing interests: KS Hayward is a research consultant for reducing elbow extension range of motion. SMART Arm Pty Ltd. Previous research has shown that robotics can provide the op- Source(s) of support: Funding for the conduct of this trial was portunity for more intensive practice.50 The current study demon- provided by the Sunshine Coast Health Foundation Wishlist Research strates that use of the SMART Arm does not guarantee a consistent Grant Scheme. and large increase in intensity in isolation. The variation in intensity of training on the SMART Arm may have been influenced by both Acknowledgements: KS Hayward is supported by the National patient and therapist factors. Since the number of repetitions to be Health and Medical Research Council of Australia (GNT1088449). RD Herbert is supported by the National Health and Medical Research Council of Australia (RG153190). Provenance: Not invited. Peer reviewed.
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Key Issues in Neurological Physio- 41. Jensen M, Karoly P, Braver S. The measurement of clinical pain intensity: a com- therapy. Oxford: Butterworth-Heinemann; 1990. parison of six methods. Pain. 1986;27:117–126. 15. Gossman MR, Sahrmann SA, Rose SJ. Review of length-associated changes in muscle. 42. Ohnhaus E, Adler R. Methodological problems in the measurement of pain: a Experimental evidence and clinical implications. Phys Ther. 1982;62:1799–1808. comparison between the verbal rating scale and the visual analogue scale. Pain. 16. Ada L, O’Dwyer N, O’Neill E. Relation between spasticity, weakness and contracture 1975;1:379–384. of the elbow flexors and upper limb activity after stroke: an observational study. 43. Price C, Curless R, Rodgers H. Can stroke patients use visual analogue scales? Disabil Rehabil. 2006;28:891–897. Stroke. 1999;30:1357–1361. 17. Malhotra S, Pandyan AD, Rosewilliam S, Roffe C, Hermens H. Spasticity and con- 44. Tiplady B, Jackson S, Maskrey V, Swift C. Validity and sensitivity of visual analogue tractures at the wrist after stroke: time course of development and their associ- scales in young and older healthy subjects. Age Ageing. 1998;27:63–66. ation with functional recovery of the upper limb. Clin Rehabil. 2011;25:184–191. 45. Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity 18. Katalinic OM, Harvey LA, Herbert RD. Effectiveness of stretch for the treatment and outcome measure: the DASH (disabilities of the arm, shoulder and hand) prevention of contractures in people with neurological conditions: a systematic [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. review. Phys Ther. 2011;91:11–24. 1996;29:602–608. 19. Katalinic OM, Harvey LA, Herbert RD, Moseley AM, Lannin NA, Schurr K. Stretch 46. Leung J, Harvey LA, Moseley AM, Whiteside B, Simpson M, Stroud K. Standing with interventions for the treatment and prevention of contractures. Cochrane Database electrical stimulation and splinting is no better than standing alone for manage- Syst Rev. 2010;9:CD007455. ment of ankle plantarflexion contractures in people with traumatic brain injury: a randomized trial. J Physiother. 2014;60:201–208. 20. Horsley SA, Herbert RD, Ada L. Four weeks of daily stretch has little or no effect on wrist contracture after stroke: a randomised controlled trial. Aust J Physiother. 47. Dean C, Channon E, Hall J. Sitting training early after stroke improves sitting ability 2007;53:239–245. and quality and carries over to standing up but not to walking: a randomised controlled trial. Aust J Physiother. 2007;53:97–102. 21. Lannin NA, Ada L. Neurorehabilitative splinting: theory and principles of clinical use. Neurorehabilitation. 2011;28:21–28. 48. Dean C, Shepherd R. Task-related training improves performance of seated reaching tasks after stroke: a randomized controlled trial. Stroke. 1997;28:722– 22. Lannin NA, Horsley SA, Herbert R, McCluskey A, Cusick A. Splinting the hand in the 728. functional position after brain impairment: a randomised, controlled trial. Arch Phys Med Rehabil. 2003;84:297–302. 49. Schneider EJ, Lannin NA, Ada L, Schmidt J. Increasing the amount of usual reha- bilitation improves activity after stroke: a systematic review. J Physiother. 23. Lannin NA, Cusick A, McCluskey A, Herbert RD. Effects of splinting on 2016;62:182–187. wrist contracture following stroke: A randomized controlled trial. Stroke. 2007;38:111–116. 50. Norouzi-Gheidari N, Archambault P, Fung J. Effects of robot-assisted therapy on stroke rehabilitation in upper limbs: systematic review and meta-analysis of the 24. Moseley AM, Hassett LM, Leung J, Clare JS, Herbert RD, Harvey LA. Serial casting literature. J Rehab Res Dev. 2012;49:479–496. versus positioning for the treatment of elbow contractures in adults with trau- matic brain injury: a randomized controlled trial. Clin Rehabil. 2008;22:406–417. 51. Gustafsson L, McKenna K. A programme of static positional stretches does not reduce hemiplegic shoulder pain or maintain shoulder range of motion – a ran- domized controlled trial. Clin Rehabil. 2006;20:277–286.
Journal of Physiotherapy 65 (2019) 112 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Appraisal of Clinical Practice Guideline: Interventions to Prevent Falls in Community-Dwelling Older Adults: U.S. Preventive Services Task Force Recommendation Statement Date of latest update: April 2018. Patient group: Community- care to prevent falls and fall-related morbidity and mortality in dwelling older adults aged 65 years without known osteoporosis community-dwelling adults aged 65 years without osteoporosis or vitamin D deficiency. Intended audience: Clinicians who manage or vitamin D deficiency. The guideline is an update on the 2012 older adults at risk of falls, and older adults at risk of falls. Additional recommendations. The focus of the guideline is on summarising versions: The current version is an update of the 2012 U.S. Preventive the evidence and providing recommendations for exercise Services Task Force recommendation on the prevention of falls in interventions, multifactorial interventions, and vitamin D supple- community-dwelling older adults. Expert working group: The U.S. mentation. Other interventions such as environmental modification, Preventive Services Task Force comprising medical doctors, a regis- medication management and psychological interventions are briefly tered nurse and clinical psychologist. Funded by: The U.S. Preventive discussed, but the lack of available literature limited any definitive Services Task Force is an independent, voluntary body; however, it is conclusions. For each recommendation provided the level of cer- supported by the Agency for Healthcare Research and Quality. The tainty is rated as high, moderate or low. The guideline is highly Agency for Healthcare Research and Quality staff had no role in relevant to physiotherapists working with community-dwelling approving the final recommendations. Consultation with: A draft older adults. version was posted for public comment on the U.S. Preventive Services Task Force website from 26 September 2017 to 24 October 2017. Provenance: Invited. Not peer reviewed. Location: The guidelines and links to additional documents are avail- able at: https://jamanetwork.com/journals/jama/fullarticle/2678104. Mark Hancock Macquarie University, Australia Description: This guideline and associated systematic review (https://jamanetwork.com/journals/jama/fullarticle/2678103) aim to https://doi.org/10.1016/j.jphys.2019.01.001 assess the effectiveness and harms of interventions used in primary Appraisal of Clinical Practice Guideline: EULAR revised recommendations for the management of fibromyalgia Date of latest update: May 2015. Date of next update: Within the Evaluation system was used for making these recommendations on a next 5 years. Patient group: Patients diagnosed with fibromyalgia. four-point scale: strong for/weak for/weak against/strong against or Intended audience: All clinicians (medical doctors, physiotherapists, use only for research. Recommendations for assessment and treatment nurse practitioners, occupational therapists, kinesiologists, psychol- are provided and backed up by strong evidence. The authors compared ogists) who treat fibromyalgia. Expert working group: The Expert the current document with previous guidelines and outlined the dif- Panel comprised 18 clinicians, from 12 European countries, with ferences. This practice guideline provides evidence to support different expertise in rheumatology, internal medicine, pain medicine, and pharmacological and non-pharmacological approaches to manage fi- epidemiology. The aim was to review the evidence and formulate bromyalgia. The clinical practice guideline carries relevant information recommendations for fibromyalgia. Funded by: European League for physiotherapy practice, especially the recommendations covering against Rheumatism (EULAR) Location: The guidelines and assessment of pain and function, and non-pharmacological first-line additional documents are available at: https://doi.org/10.1136/ treatment in the management of fibromyalgia. annrheumdis-2016-209724. Provenance: Invited. Not peer reviewed. Description: This practice guideline is a journal article that provides evidence and recommendations surrounding fibromyalgia-related Vanitha Arumugam and Joy C MacDermid pain, and an overall summary of evidence behind the different in- Clinical Research Laboratory, terventions used. This replaces the previous guideline published in 2008. The quality of the included studies was evaluated by using Roth-MacFarlane Hand and Upper Limb Centre, Assessing the Methodological Quality of Systematic Reviews (AMSTAR) St. Joseph Health Centre, tool. The article includes tables outlining the recommendations. The Grading of Recommendations Assessment, Development and University of Western Ontario, London, ON, Canada https://doi.org/10.1016/j.jphys.2019.01.003 1836-9553/© 2019 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 65 (2019) 112 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Appraisal of Clinical Practice Guideline: Interventions to Prevent Falls in Community-Dwelling Older Adults: U.S. Preventive Services Task Force Recommendation Statement Date of latest update: April 2018. Patient group: Community- care to prevent falls and fall-related morbidity and mortality in dwelling older adults aged 65 years without known osteoporosis community-dwelling adults aged 65 years without osteoporosis or vitamin D deficiency. Intended audience: Clinicians who manage or vitamin D deficiency. The guideline is an update on the 2012 older adults at risk of falls, and older adults at risk of falls. Additional recommendations. The focus of the guideline is on summarising versions: The current version is an update of the 2012 U.S. Preventive the evidence and providing recommendations for exercise Services Task Force recommendation on the prevention of falls in interventions, multifactorial interventions, and vitamin D supple- community-dwelling older adults. Expert working group: The U.S. mentation. Other interventions such as environmental modification, Preventive Services Task Force comprising medical doctors, a regis- medication management and psychological interventions are briefly tered nurse and clinical psychologist. Funded by: The U.S. Preventive discussed, but the lack of available literature limited any definitive Services Task Force is an independent, voluntary body; however, it is conclusions. For each recommendation provided the level of cer- supported by the Agency for Healthcare Research and Quality. The tainty is rated as high, moderate or low. The guideline is highly Agency for Healthcare Research and Quality staff had no role in relevant to physiotherapists working with community-dwelling approving the final recommendations. Consultation with: A draft older adults. version was posted for public comment on the U.S. Preventive Services Task Force website from 26 September 2017 to 24 October 2017. Provenance: Invited. Not peer reviewed. Location: The guidelines and links to additional documents are avail- able at: https://jamanetwork.com/journals/jama/fullarticle/2678104. Mark Hancock Macquarie University, Australia Description: This guideline and associated systematic review (https://jamanetwork.com/journals/jama/fullarticle/2678103) aim to https://doi.org/10.1016/j.jphys.2019.01.001 assess the effectiveness and harms of interventions used in primary Appraisal of Clinical Practice Guideline: EULAR revised recommendations for the management of fibromyalgia Date of latest update: May 2015. Date of next update: Within the Evaluation system was used for making these recommendations on a next 5 years. Patient group: Patients diagnosed with fibromyalgia. four-point scale: strong for/weak for/weak against/strong against or Intended audience: All clinicians (medical doctors, physiotherapists, use only for research. Recommendations for assessment and treatment nurse practitioners, occupational therapists, kinesiologists, psychol- are provided and backed up by strong evidence. The authors compared ogists) who treat fibromyalgia. Expert working group: The Expert the current document with previous guidelines and outlined the dif- Panel comprised 18 clinicians, from 12 European countries, with ferences. This practice guideline provides evidence to support different expertise in rheumatology, internal medicine, pain medicine, and pharmacological and non-pharmacological approaches to manage fi- epidemiology. The aim was to review the evidence and formulate bromyalgia. The clinical practice guideline carries relevant information recommendations for fibromyalgia. Funded by: European League for physiotherapy practice, especially the recommendations covering against Rheumatism (EULAR) Location: The guidelines and assessment of pain and function, and non-pharmacological first-line additional documents are available at: https://doi.org/10.1136/ treatment in the management of fibromyalgia. annrheumdis-2016-209724. Provenance: Invited. Not peer reviewed. Description: This practice guideline is a journal article that provides evidence and recommendations surrounding fibromyalgia-related Vanitha Arumugam and Joy C MacDermid pain, and an overall summary of evidence behind the different in- Clinical Research Laboratory, terventions used. This replaces the previous guideline published in 2008. The quality of the included studies was evaluated by using Roth-MacFarlane Hand and Upper Limb Centre, Assessing the Methodological Quality of Systematic Reviews (AMSTAR) St. Joseph Health Centre, tool. The article includes tables outlining the recommendations. The Grading of Recommendations Assessment, Development and University of Western Ontario, London, ON, Canada https://doi.org/10.1016/j.jphys.2019.01.003 1836-9553/© 2019 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 65 (2019) 65–74 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Research Aquatic exercise improves motor impairments in people with Parkinson’s disease, with similar or greater benefits than land-based exercise: a systematic review Lucia Cugusi a, Andrea Manca b, Marco Bergamin c, Andrea Di Blasio d, Marco Monticone a, Franca Deriu b, Giuseppe Mercuro a a Department of Medical Sciences and Public Health, University of Cagliari, Cagliari; b Department of Biomedical Sciences, University of Sassari, Sassari; c Department of Medicine, Sport and Exercise Medicine Division, University of Padova; d Department of Medicine and Aging Sciences, Endocrine Section, ‘G. d’Annunzio’ University of Chieti - Pescara, Chieti, Italy KEY WORDS ABSTRACT Parkinson’s disease Questions: What are the effects of aquatic exercise on disease severity, (non-)motor impairments, activity Hydrokinesitherapy performance, fear of falling, and quality of life in people with Parkinson’s disease (PD)? Does aquatic exercise Rehabilitation have greater effects on these outcomes than other forms of exercise in people with PD? Design: Systematic Balance review and meta-analysis of randomised controlled trials. Participants: People with idiopathic PD. Quality of life Intervention: Supervised aquatic exercise programs 2 weeks. Outcomes measures: The primary out- comes were disease severity, motor impairments, activity performance, and fear of falling. The secondary outcomes were non-motor impairments and quality of life. Results: Of the 129 identified records, seven trials met the inclusion criteria and six were meta-analysed (159 participants). One trial assessed the effect of aquatic exercise compared with control and found a significant improvement in the Unified Parkinson’s Disease Rating Scale Part III (MD 24.6, 95% CI 27.5 to 21.7) in favour of aquatic exercise. Six studies compared aquatic exercise with land-based exercise after intervention (mean 7.2 weeks of training (SD 2.2); 159 participants). The effect of aquatic exercise was superior to land-based exercise on the Berg Balance Scale (MD 2.7, 95% CI 1.6 to 3.9), the Falls Efficacy Scale (MD 24.0, 95% CI 26.1 to 21.8) and the 39-item Parkinson’s Disease Questionnaire (MD 26.0, 95% CI 211.3 to 20.6), with no other significant effects identified. The significant benefit on the Berg Balance Scale was maintained at the follow-up assessment (MD 6.3, 95% CI 2.1 to 10.5, 54 participants). Conclusion: Aquatic exercise improves motor impairments in people with PD significantly more than no intervention. It also has slightly to moderately greater benefits than land-based exercise on balance capacity, fear of falling, and health-related quality of life. On other outcomes, the ben- efits of aquatic exercise are similar to those of land-based exercise. Trial registration: PROSPERO CRD42017077370. [Cugusi L, Manca A, Bergamin M, Di Blasio A, Monticone M, Deriu F, Mercuro G (2019) Aquatic exercise improves motor impairments in people with Parkinson’s disease, with similar or greater benefits than land-based exercise: a systematic review. Journal of Physiotherapy 65:65–74] © 2019 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 PD.4–9 These reviews suggest that conventional exercise training Parkinson’s disease (PD) is a progressive, neurodegenerative positively affects disease severity, motor impairments and activity movement disorder characterised by the motor symptoms bradyki- nesia, tremor, rigidity, and postural instability. These are commonly performance, in addition to non-motor impairments, social di- associated with non-motor disturbances, neurobehavioural symp- mensions and the quality of life of participants.4–9 toms and reduced quality of life.1 Recent studies have observed promising health effects following Exercise is currently recommended as an additional strategy to less conventional forms of exercise, including dance,10 Tai Chi,11 manage PD-induced disability and is a key component of rehabilita- Nordic walking,12,13 and other complementary therapies14,15 to tion programs for people with PD.2–4 Systematic reviews of rando- mised controlled trials involving exercise have extensively counteract the functional deterioration induced by PD. investigated the effects of conventional exercise-based protocols, including aerobic and strength training programs, in people with Aquatic exercise is another form of non-conventional exercise that has been growing in popularity in the context of neuro- rehabilitation.16 The aquatic setting offers specific mechanical ad- vantages due to the hydrostatic and hydrodynamic principles of buoyancy, viscosity and drag.16 Buoyancy offloads weight-bearing,17 https://doi.org/10.1016/j.jphys.2019.02.003 1836-9553/© 2019 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/).
66 Cugusi et al: Aquatic exercise for Parkinson’s disease Box 1. Inclusion criteria. training’, ‘aquatic therapy’) and the population (‘Parkinson’s disease’). The detailed search strategy for each database is presented in Design Appendix 1 on the eAddenda. Each database was searched from the Randomised trial earliest available record up to December 2017. Only randomised Published in English controlled trials published in English-language31 journals were selected, and the references of all the included articles were checked Participants for further relevant publications. People with idiopathic Parkinson’s disease The initial search was undertaken by one of the authors (LC). The Intervention titles and abstracts of the retrieved studies were then independently Aquatic exercise assessed by two authors (LC and MB); duplicates and records that Exercise program duration 2 weeks were clearly ineligible were excluded at this stage. When the title or Supervision provided by a physiotherapist or other exercise abstract presented insufficient information to determine eligibility, the full-text papers were evaluated. Based on the information pre- professional sented in the full manuscripts, eligible studies were included in the No co-interventions alongside the exercise unless they were systematic review. In cases of disagreement, consensus was reached by discussion and, if necessary, a third author (AM) contributed to the equal in both groups final decision. Studies were included if they satisfied the inclusion criteria based on the Patient, Intervention, Comparison, Outcome Outcome measures (PICO) model32 shown in Box 1. No co-interventions alongside the Primary outcomes: disease severity, motor impairments, exercise were allowed unless they were equal in both groups. activity performance, and fear of falling Assessment of characteristics of studies Secondary outcomes: non-motor impairments and quality of Risk of bias and quality of evidence life The included studies were assessed independently by two authors Comparisons (LC and MB) for methodological quality and risk of bias, employing Aquatic exercise versus control (ie, no exercise intervention) the Physiotherapy Evidence Database (PEDro) scale.33 A trial with a Aquatic exercise versus other (eg, land-based) exercise score 4 was considered of poor methodological quality. Disagree- ments between the two authors were resolved by discussion. If which, when combined with the warmth of the water, has been consensus could not be reached, a third reviewer was consulted (AM). associated with decreased pain and stiffness.18,19 The viscosity of water is an exceptional source of natural resistance and viscous drag The Grading of Recommendation, Assessment, Development and can facilitate different motor training tasks20 by providing an ac- Evaluation (GRADE) system was used to assess the risk of bias among commodating resistance for muscle strengthening.17 These features trials for each meta-analysis.34 The quality level of each body of ev- of the aquatic setting allow some people with postural instability, idence was downgraded or upgraded from the baseline ‘high quality’ high risk of falling, leg weakness and gait disturbance to exercise (given that all studies were randomised controlled trials) according to successfully when this is unfeasible or unsafe on land.21,22 pre-defined criteria.35 Quality was downgraded by one level if: most trials scored 6 on the PEDro scale (Risk of bias); they reported wide- Due to its ability to enhance functional mobility whilst also being ranging participant populations or interventions (Indirectness); an I2 enjoyable,23,24 aquatic exercise has become a very popular form of statistic 50% that could not be explained in sensitivity analyses physical training in the management of neurodegenerative disor- indicated substantial heterogeneity (Inconsistency); large confidence ders.25–28 Previous systematic reviews25–28 have reported that intervals were found (Imprecision); and asymmetry of a funnel plot, aquatic exercise is safe and improves aspects of activity performance, which was only assessed if 10 trials were included in the meta- quality of life and balance in people with PD, although safety criteria analysis (Publication bias).36 Evidence was downgraded two places were generally under-reported.28 However, these reviews had various if most trials scored 4 on the PEDro scale. Lastly, evidence quality limitations, such as the inclusion of non-randomised trials and failure was upgraded one place if the effect size was large.35 The evidence to conduct any meta-analysis. Therefore, effects of aquatic exercise in was then ranked into one of four levels: very low (the true effect is people with PD still need to be summarised rigorously, given how probably markedly different from the estimated effect), low (the true frequently it is used in the management of PD-related disability. effect might be markedly different from the estimated effect), mod- erate (the authors believe that the true effect is probably close to the Therefore, the research questions for this systematic review and estimated effect), or high (the authors have a lot of confidence that meta-analysis were: the true effect is similar to the estimated effect). 1. What are the effects of aquatic exercise on disease severity, (non-) Participants, intervention and outcome measures motor impairments, activity performance, fear of falling, and A customised data extraction form was applied to each trial by one quality of life in people with PD? author (AM) and the extracted data were checked for accuracy by a 2. Does aquatic exercise have greater effects on these outcomes than second author (LC). The extracted data included information other forms of exercise in people with PD? regarding the study design, participants (age, gender, disease severity, On/Off phase), intervention (type of exercise, length of exercise ses- Methods sion, frequency of sessions per week, duration of intervention, and supervision of intervention), aquatic setting (pool depth and water The Preferred Reporting Items for Systematic Reviews and Meta- temperature), outcome measures, timing of assessments (post- Analyses (PRISMA) guidelines and flow chart diagram were used as treatment and follow-up), adherence, adverse events, number of a reporting structure for this systematic review.29,30 dropouts, and the main findings. Identification and selection of studies Primary outcome data were extracted from each included study if they pertained to disease severity (eg, the Unified Parkinson’s Disease The following databases were systematically searched: Physio- Rating Scale (UPDRS) Total score, that ranged from 0 ‘no symptoms’ to therapy Evidence Database (PEDro), PubMed, Scopus, and the 199 ‘severe symptoms’), motor impairments (eg, UPDRS–III, scoring Cochrane Central Register of Controlled Trials (CENTRAL). The search from 0 to 108), activity performance (eg, Berg Balance Scale, BBS, combined Medical Subject Headings, keywords and matching syno- which assesses balance capacity with scores ranging from 0 to 56, nyms relevant to the intervention (eg, ‘aquatic-based exercise’, ‘wa- with higher values indicating better balance; or Timed Up and Go test ter-based exercise’, ‘hydrokinesitherapy’, ‘balneotherapy’, ‘water
Research 67 Records identified (n = 129) by a single study. A leave-one-out approach was performed by ● database searches (n = 125) removing the outlying study. To this aim, box and whisker plots were ● other sources (n = 4) constructed to verify whether data of the outlying study were 1.5 times the interquartile range below the first quartile or above the Records excluded (n = 107) third quartile.43 Publication bias was planned to be examined through ● non-English language (n = 5) visual inspection of funnel plot asymmetry and the Egger’s ● abstract only (n = 4) regression-based method. When outcomes were assessed at multiple ● duplicates (n = 28) time points (post-treatment and follow-up assessment), data from ● ineligible based on title and each time point were extracted to be included in separate meta- abstract (n = 70) analyses. Full-text articles assessed (n = 22) Results Full-text articles excluded (n = 15) Flow of studies through the review ● not randomised trial (n = 10) ● no control group (n = 2) The search strategy identified 129 potentially relevant records, 22 ● aquatic exercise was combined of which were assessed in full text. Seven trials were eligible and with land-based exercise (n = 2) were included in the review.44–50 The reasons for exclusion of other ● comparison group was another studies are presented in Figure 1. A comprehensive list of the form of aquatic exercise (n = 1) excluded studies with the main reasons for exclusion is presented in Appendix 2 on the eAddenda. Studies included in qualitative data synthesis (n = 7) Characteristics of the included trials ● aquatic exercise versus control (n = 1) Of the seven trials included in the review,44–50 one assessed the ● aquatic exercise versus land-based effect of aquatic exercise compared to usual care.44 The remaining six trials reported data for the same comparison (aquatic exercise versus exercise (n = 6) land-based exercise) and outcome measures45–50; these were there- fore included in meta-analyses for the various outcome measures. All Studies included in quantitative data contributed data to meta-analyses of post-treatment data; three also synthesis (n = 6) presented follow-up results,45,47,49 which allowed further meta- analyses of data recorded subsequent to the completion of the Figure 1. Flow of studies through the review. intervention phase. to assess functional mobility) and fear of falling (eg, Falls Efficacy Quality Scale, ranging from 16 to 64, with higher scores indicating greater PEDro scores were downloaded from the PEDro website for five fear of falling). The secondary outcomes were related to non-motor impairments and quality of life (eg, the 39-item Parkinson’s Disease trials44–47,49 and scored by the authors for the other two trials.48,50 Questionnaire, PDQ-39, which assesses PD-specific health-related The PEDro scores ranged from 4 to 8 (mean 6.4, SD 1.3, median quality of life, where lower scores reflect better quality of life). 7.0), as presented in Table 1. No trial reported blinding of participants and therapists, while blinding of assessors was reported in three Data analysis trials.46,47,49 All seven trials reported data from between-group ana- lyses and provided point estimates and measures of variability for at A meta-analysis was performed if at least two studies reported least one primary outcome. A follow-up assessment was scheduled data for the same outcome measure.27,28 RevMan software was used and reported in all the included trials except one.43 Intention-to-treat to meta-analyse the data, where possible.37 Raw data (means and SD) analysis was performed in four studies44,46,48,50 and allocation was were extracted or calculated from other statistics in the paper.38 In concealed in five studies.44,46–48,50 Aquatic exercise and control/ cases of missing data, a formal request was sent to the corresponding comparison groups were similar at baseline in all of the included and first author of the study under consideration. When available (or studies except one.49 calculable) in the full-text or from the authors, change data were used.39 To account for potential methodological differences in the Participants assessment and training protocols across studies, a random-effects The seven included trials were conducted between 2011 and 2018, model was used for all meta-analyses.40 To allow interpretation of the pooled estimate of an effect, a mean difference with 95% CI was and involved a total of 187 people with PD. In one study,46 gender calculated. A weighted mean difference was calculated when pooling data were not reported (34 participants, 18%). The remaining six trials data from the same outcome measure, whereas a standardised mean (153 participants) enrolled 99 males (65%) and 54 females difference was calculated when pooling homogeneous outcome data (35%).44,45,47–50 The mean age of the participants in each trial ranged from similar outcome measures.41 from 61 to 71 years. Five trials reported data on the duration of PD since diagnosis, ranging from 6 to 9.2 years.44–47,49 Different ranges of Data homogeneity was assessed using the chi-square test and I2 Hoehn and Yahr stages51 were set in the individual trials as inclusion statistic, where a value 50% indicated substantial heterogeneity.42 criteria: from 1 to 3,44,49 from 2 to 3,45,48,50 from 2.5 to 3,46 and up to In case of heterogeneity exceeding this threshold, sensitivity ana- 3.47 On average, participants had a mild to moderate degree of lyses were conducted to check whether the heterogeneity was caused disability (from 1 to 3 on the Hoehn and Yahr scale). Four trials stated that participants were in the On phase,44,46,50 and three in the Off phase of medication.45,48,49 Four trials clearly reported types and doses of medications used.46–48,50 Further details are presented in Table 2. Interventions One trial compared aquatic exercise training to a control of usual medical therapy and normal activities of daily living without pre- scribed exercise (11 versus 10 participants, respectively).44 The
68 Cugusi et al: Aquatic exercise for Parkinson’s disease Table 1 PEDro Scale ratings for the included trials (n = 7). Trial Random Concealed Groups Participant Therapist Assessor , 15% Intention-to-treat Between-group Point estimates Total allocation allocation similar at blinding blinding difference and variability (0 to 10) Carrol44 baseline blinding dropouts analysis reported Vivas45 reported Volpe46 Y Y Y N N NY Y Y Volpe47 Y N N N N NY N Y Y7 Shahmohammadi48 Y Y Y N N YY Y Y Y4 Pérez de la Cruz49 Y Y Y N N YN N Y Y8 Kurt50 Y Y Y N N NY Y Y Y6 Y N Y N N YY N Y Y7 Y Y Y N N NY Y Y Y6 Y7 N = no, PEDro = Physiotherapy Evidence Database, Y = yes. remaining six trials compared aquatic exercise training to land-based order to provide an indication of the precision around this estimate of exercise training (166 participants).45–50 the effect of aquatic exercise, we converted the non-parametric data from the original paper (reproduced in Table 3 on the eAddenda) into The intervention periods among the included trials had a duration parametric data using the methods of Hozo et al.38 The between- of 4 to 10 weeks (mean 7, SD 2). Different weekly frequencies and group comparison using the parametric data was a mean difference session durations of aquatic exercise training were tested in the of 4.6 (95% CI 1.7 to 7.5) in favour of the experimental group. There studies, ranging from 2 to 5 times/week (mean 3.4, SD 1.5) and from were no significant differences among the remaining outcomes: 45 to 60 minutes/session (mean 54, SD 8). Freezing of Gait questionnaire, the 10-m walk test with gait analysis, or the PDQ-39. The data for all outcomes are presented in Table 3 on Aquatic exercise training consisted of a group class supervised by a the eAddenda. There were no follow-up assessment points in that physiotherapist and involved a warm-up phase, a central main phase study. (aerobic/endurance training performed in water) and a cool-down phase. In two studies,49,50 the central phase of the aquatic exercise Aquatic exercise versus land-based exercise training was characterised by a set of Ai Chi exercise movements, which is a form of aquatic exercise used for recreation, relaxation, Post-intervention fitness and physical rehabilitation combining exercises including The meta-analyses of the studies that evaluated UPDRS outcomes trunk rotation, standing balance and single-leg balance. Aquatic ex- ercise was conducted in low-depth hydrotherapy pools (range 0.6 to (Total score, Part-II and Part-III) revealed no significant between- 1.45 m). The water temperature was set at 32 C in three trials,44,45,50 group differences in UPDRS Total score (two studies, 41 partici- and 30 C in two.48,49 Water-depth levels and temperature were not pants, MD 20.1, 95% CI 27.7 to 7.5),45,49 or in UPDRS-II (two studies, reported in two trials.46,47 Further details are presented in Table 2. 64 participants, MD 0.7, 95% CI 21.2 to 2.5).46,49 In the meta-analysis of the UPDRS-III data, a trend towards decrease, which failed to reach In the one trial (21 participants) that compared aquatic exercise to significance, was observed (four studies, 128 participants, MD 21.1, no prescribed exercise program, both groups continued usual care 95% CI 22.2 to 0.0).46,47,49,50 These meta-analyses are presented in (medical therapy and normal activities of daily living).44 In the six Figure 2, with a more detailed forest plot available in Figure 3 on the trials that compared aquatic exercise to land-based exercise (166 eAddenda. participants),45–50 the land-based exercise consisted of a physiotherapist-supervised group class mainly comprising aerobic In the meta-analyses of the studies reporting BBS results, pooled training (walking or stationary cycling), strengthening exercises, data from five studies (139 participants) revealed a significant calisthenics and stretching exercises. Further details are presented in between-group difference in favour of aquatic exercise (MD 2.7, 95% Table 2. CI 1.6 to 3.9).45–47,49,50 (Figure 4, with a more detailed forest plot available in Figure 3 on the eAddenda). Data pooling from the same Outcome measures five studies that reported Timed Up and Go test results (139 partici- All trials assessed participants at the end of the intervention pants) showed excessive heterogeneity (I2 . 50%) across the tri- als.45–47,49,50 Sensitivity analyses were therefore conducted, which period, and three trials then performed a follow-up assessment after revealed that the pooled estimate was highly influenced by the study a further 17 days,45 1 month49 and 8 weeks.47 Activity performance of Kurt et al (2018; 40 participants).50 This study was removed, was analysed by all the included trials,44–50 disease severity by two employing a leave-one-out approach,39 resulting in a moderate het- trials,45,49 motor impairments by five trials,44,46,47,49,50 fear of falling erogeneity (I2 = 41%) and no significant between-group difference by two trials,46,47 quality of life by five trials,44,46–48,50 and non-motor (four studies, 99 participants after sensitivity analyses; MD 20.8 impairments (pain severity) by one trial.49 One trial reported adverse seconds, 95% CI 22.2 to 0.5).45–47,49 Figure 5 shows the final forest events and dropouts during the aquatic exercise training.47 One plot, with more detailed forest plots of before and after exclusion of participant dropped out due to hydrostatic hypotension and one due the outlying trial available in Figure 3 on the eAddenda. to pulmonary disease. The general adherence of participants was described as high in all trials, although it was only clearly reported in Two studies (58 participants) reported data for the Activities- two trials48,49 at 80 and 100%, respectively. Further details are pre- specific Balance Confidence Scale and Falls Efficacy Scale.46,47 Meta- sented in Table 2. analysis of the Activities-specific Balance Confidence Scale results showed excessive heterogeneity (I2 = 71%) across the two trials and no Aquatic exercise versus control significant between-group difference (MD 6.5, 95% CI 28.9 to 21.9).46,47 Meta-analysis favoured aquatic exercise for the Falls Efficacy Scale One trial compared the outcomes of an experimental group (n = score (MD 24.0, 95% CI 26.1 to 21.8).46,47 (See Figures 6 and 7, with 11) who performed aquatic exercise with a control group (n = 10) who more detailed forest plots available in Figure 3 on the eAddenda). maintained their usual medical therapy and were prescribed no additional exercise.40 Due to loss to follow-up, data were available for Meta-analysis of the data from the four studies that reported 18 participants. After 6 weeks of aquatic exercise training, the quality of life outcomes (assessed by the Parkinson’s Disease Quality experimental group improved on the UPDRS-III score from a median of Life Questionnaire,48 and PDQ-39)46,47,50 showed excessive het- of 17.5 down to a median of 13 (median difference 4.5), whereas the erogeneity (I2 . 50%) across the trials.46–48,50 Sensitivity analyses control group was unchanged (median difference 0.0), which was were therefore performed, which revealed that the pooled estimate statistically significant on the Mann-Whitney U test (p = 0.01).44 In was highly influenced by the study of Shahmohammadi et al
Research 69 Table 2 Detailed characteristics of the included trials (n = 7). Trial Participantsa Intervention Outcome measures Country Experimental Control Carrol44 n = 21 Aquatic exercise No change to usual FOGQ Ireland Age (y) = 71 45 min, 2/wk, 6 wks exercise routine UPDRS-III Gender = 14 M, 7 F Water temp (C) = 32 10-m WT with gait analysis PD duration (y) z 8.7 Depth (m) = 0.60 to 1.30 H & Y = 1 to 3 (step length, step time, step width) Phase = On PDQ-39 Baseline and post-intervention Vivas45 n = 12 Aquatic exercise Land-based exercise UPDRS Total score Spain Mean age (y) = 67 45 min, 2/wk, 4 wks 45 min, 2/wk, 4 wks BBS Gender = 8 M, 4 F Water temp (C) = 32 TUG PD duration (y) z 6 Depth (m) = 1.30 FRT H & Y = 2 to 3 5-m WT with gait analysis (turn time, velocity, Phase = Off cadence and step amplitude) Volpe46 n = 34 Aquatic exercise Land-based exercise Baseline, post-intervention, and 17 days later Italy Mean age (y) = 67 60 min, 5/wk, 8 wks 60 min, 5/wk, 8 wks Gender = NR Water temp = NR UPDRS-II and III PD duration (y) z 7.5 Depth = NR FES H & Y = 2.5 to 3 ABC Phase = On BBS TUG Postural analysis (COPSwayOE, COPSwayCE at FRT) PDQ-39 Baseline and post-intervention Volpe47 n = 30 Aquatic exercise Land-based exercise UPDRS-III Italy Mean age (y) = 70 60 min, 5/wk, 8 wks 60 min, 5/wk, 8 wks FES Gender = 19 M, 11 F Water temp = NR ABC PD duration (y) z 9.2 Depth = NR BBS H&Y3 TUG Phase = On Postural analysis (cervical/dorsal flexion and angle of lateral inclination of the trunk) PDQ-39 Baseline, post-intervention and 8 wks later Shahmohammadi48 n = 20 Aquatic exercise Land-based exercise Postural analysis (sway range, mean velocity, Iran Mean age (y) = 61 60 min, 3/wk, 8 wks 60 min, 3/wk, 8 wks sway area, mean frequency in a standing position Gender = 20 M, 0 F Water temp (C) = 30 for 90 s) PD duration (y) z NR Depth = waist deep H & Y = 2 to 3 PDQL Phase = Off Baseline and post-intervention Pérez de la Cruz49 n = 30 Aquatic exercise with aquatic Land-based exercise UPDRS-I, II, III, IV and Total Spain Mean age (y) = 67 Ai Chi component 45 min, 2/wk, 10 wks BBS Gender = 14 M, 16 F TUG PD duration (y) z 6.5 45 min, 2/wk, 10 wks FTSST H & Y = 1 to 3 Water temp (C) = 30 Tinetti Scale Phase = Off Depth (m) = 1.10 to 1.45 VAS Kurt50 n = 40 Aquatic exercise with Land-based exercise Baseline, post-intervention, and 1 mth later Turkey Mean age (y) = 63 aquatic Ai Chi component 60 min, 5/wk, 5 wks Gender = 24 M, 16 F UPDRS-III PD duration (y) z NR 60 min, 5/wk, 5 wks BBS H & Y = 2 to 3 Water temp (C) = 32 TUG Phase = On Depth (m) = 1.20 Dynamic balance (antero-posterior index, medio-lateral index, overall balance index) PDQ-39 Baseline, post-intervention ABC = Activities-specific Balance Confidence scale, BBS = Berg Balance Scale, COPSwayOE = centre of pressure sway area with open eyes, COPSwayCE = centre of pressure sway area with closed eyes, F = female, FES = Falls Efficacy Scale, FOGQ = Freezing of Gait Questionnaire, FRT = Functional Reach Test, FTSST = Five Times Sit-to-Stand test, H & Y = Hoehn and Yahr scale, M = male, NR = not reported, PD = Parkinson’s disease, PDQL = Parkinson’s Disease Quality of Life Questionnaire, PDQ-39 = 39-item Parkinson’s Disease Questionnaire, QOL = quality of life, TUG = Timed Up and Go test, UPDRS = Unified Parkinson’s Disease Rating Scale, VAS = visual analogue scale, WT = walk test. a Age and PD duration are reported as means. (20 participants).48 This study was excluded using a leave-one-out of the intervention period (MD 21.2, 95% CI 22.0 to 20.4) and at the approach,39 which allowed the MD to be calculated, because the follow-up evaluation (MD 21.5, 95% CI 22.2 to 20.8).49 other studies all employed the PDQ-39. This resulted in moderate Follow-up heterogeneity (I2 = 38%) and a significant between-group difference The meta-analyses of the studies that evaluated UPDRS outcomes (MD 26.0, 95% CI 211.3 to 20.6) in favour of aquatic exercise compared to land-based exercise (three studies, 98 partici- revealed no significant between-group differences in UPDRS Total pants).46,47,50 Figure 8 shows the final forest plot, with more detailed score (two studies, 41 participants, MD 0.5, 95% CI 29.1 to 10.0),45,49 forest plots of before and after exclusion of the outlying trial available or UPDRS-III (two studies, 54 participants, MD 0.8, 95% CI 23.5 to 5.1).47,49 These meta-analyses are presented in Figure 9, with a more in Figure 3 on the eAddenda. detailed forest plot available in Figure 10 on the eAddenda. One trial compared the effects of the two training programs on Data pooling from the three studies reporting BBS results pain severity using a 10-cm visual analogue scale.49 The aquatic ex- (65 participants) showed excessive heterogeneity across the trials (I2 . 50%).45,47,49 Sensitivity analyses revealed that the pooled ercise group showed a significant improvement in the visual analogue scale compared to the land-based exercise group at the end
70 Cugusi et al: Aquatic exercise for Parkinson’s disease Outcome MD (95% CI) Study MD (95% CI) study Random Kurt50 a Random Pérez de la Cruz49 UPDRS-Total Vivas45 Pérez de la Cruz49 Volpe46 Vivas45 Volpe47 Pooled Pooled UPDRS-II Pérez de la Cruz49 –10 –5 0 5 10 Volpe46 (sec) Pooled Favours Favours aquatic land-based exercise exercise UPDRS-III Figure 5. Weighted mean difference (95% CI) in the effect of aquatic exercise versus Kurt50 Pérez de la Cruz49 land-based exercise on the Timed Up and Go test at the end of the intervention period. Volpe46 a The data from the study by Kurt et al50 are omitted due to heterogeneity – see main Volpe47 text and eAddenda for details. Pooled Figure 12, with a more detailed forest plot available in Figure 10 on –10 –5 0 5 10 the eAddenda. (points) Favours Favours One trial compared the effects of the two training programs on aquatic land-based pain severity using a 10-cm visual analogue scale.49 The significant exercise benefit that this study observed at the end of the treatment period exercise was also present 1 month after the end of the intervention period (MD 21.5, 95% CI 22.2 to 20.8). Figure 2. Weighted mean difference (95% CI) in the effect of aquatic exercise versus land-based exercise on components of the Unified Parkinson’s Disease Rating Scale at GRADE assessment the end of the intervention period. The GRADE assessment of the quality of evidence is summarised estimate was highly influenced by the study of Vivas et al (11 in Table 4. All the analysed outcomes were scored as very low to low participants).45 This study was removed by a leave-one-out quality of evidence, except for PDQ-39, which was scored as high, and approach,39 resulting in a moderate heterogeneity across the tri- BBS at the end of the treatment period, which was scored as als (I2 = 30%). The significant between-group difference favouring moderate. aquatic exercise compared to land-based exercise that had been Discussion observed at the end of the treatment period was maintained at the The first question of this systematic review examined the effects of aquatic exercise in people with PD. Only one randomised trial44 follow-up evaluation (two studies, 54 participants after sensitivity compared aquatic exercise to usual care and it did not find any sta- analysis, MD 6.3, 95% CI 2.1 to 10.5).47,49 This result is presented in tistically significant between-group differences in activity perfor- mance and quality of life outcomes except for the UPDRS-III. Based on Figure 11, with a more detailed forest plot available in Figure 10 on the Hoehn and Yahr stages, the mean UPDRS-III ranged from a low of 11.2 (SD 4.9) for participants in stage 1 to a high of 35.9 (SD 9.3) for the eAddenda. participants in stage 3.51 Following aquatic exercise training, Carroll et al44 detected an MD of 4.6 points on the UPDRS-III score. Changes Similarly, the meta-analysis of the three trials reporting Timed Up of 2.5 to 5.2 points on the UPDRS-III and 4.5 to 9.1 points on the UPDRS Total score have been previously established by Shulman and Go test data (65 participants) was non-significant but with et al52 as clinically meaningful differences for these variables. excessive heterogeneity (I2 = 65%). When the outlying study by Perez de la Cruz was omitted, the pooled result remained non-significant (two studies, 35 participants after sensitivity analysis, I2 = 28%, MD 0.9 seconds, 95% CI 22.8 to 4.6).45,47,49 This result is presented in Study MD (95% CI) Kurt50 Random Pérez de la Cruz49 Vivas45 Study MD (95% CI) Volpe46 Volpe46 Random Volpe47 Volpe47 Pooled Pooled –10 –5 0 5 10 –50 –25 0 25 50 (points) (points) Favours Favours Favours Favours land-based aquatic land-based aquatic exercise exercise exercise exercise Figure 4. Weighted mean difference (95% CI) in the effect of aquatic exercise versus Figure 6. Weighted mean difference (95% CI) in the effect of aquatic exercise versus land-based exercise on the Berg Balance Scale at the end of the intervention period. land-based exercise on the Activities-specific Balance Confidence score at the end of the intervention period.
Research 71 Study MD (95% CI) Outcome MD (95% CI) Volpe46 Random Study Random Volpe47 UPDRS-Total Pooled Pérez de la Cruz49 Vivas45 –10 –5 0 5 10 Pooled (points) Favours Favours aquatic land-based UPDRS-III exercise Pérez de la Cruz49 exercise Volpe47 Pooled Figure 7. Weighted mean difference (95% CI) in the effect of aquatic exercise versus land-based exercise on the Falls Efficacy Scale at the end of the intervention period. Therefore, we considered the effect of 4.6 points on the UPDRS-III to –20 –10 0 10 20 be a moderately clinically important difference. (points) Favours Favours Although the effect of aquatic exercise on the UPDRS-III appears aquatic land-based clinically important, further evidence from adequately powered trials exercise would be necessary to fully recommend this therapeutic approach. exercise Indeed, the small amount of data from only one trial may have affected the ability to detect significant changes in the other analysed Figure 9. Weighted mean difference (95% CI) in the effect of aquatic exercise versus outcomes. Moreover, because land-based exercise is already well land-based exercise on components of the Unified Parkinson’s Disease Rating Scale at established as a beneficial form of rehabilitation, it is undoubtedly follow-up. more relevant to consider whether aquatic exercise effects are different from those induced by land-based exercise. Accordingly, this this outcome. However, the small size of the pooled sample and the review’s second question was to establish if aquatic exercise had relative low quality of evidence on the GRADE assessment warrant greater health effects than other forms of exercise in people with PD. cautious interpretation and the need for further studies to refine the estimate of the relative effects of the two types of exercise on this The findings of our meta-analyses showed that aquatic exercise outcome. and land-based exercise had similar effects on disease severity, motor impairments and functional mobility, and that aquatic exercise had High-quality evidence was detected in quality of life outcomes significantly greater benefit than land-based exercise on the BBS assessed by PDQ-39, supporting the valuable effect of aquatic exercise values and Falls Efficacy Scale score. Taken together, these results in improving the health-related quality of life of people with seem to suggest that aquatic exercise may be particularly helpful in PD.46,47,50 The results of this meta-analysis revealed a significant people with PD presenting with specific balance disorders and fear of between-group difference in favour of aquatic exercise, with an falling. average decrease (ie, improvement) of 6.0 points (95% CI 211.3 to 20.6) in the PDQ-39 in favour of the aquatic exercise group. No differences between the two interventions were observed in the UPDRS Total score,45,49 UPDRS-II,46,49 UPDRS-III,46,47,49,50 and The significant between-group difference in the BBS score Timed Up and Go test results.45–47,49 Furthermore, the 95% CIs around observed at the end of treatment in favour of the aquatic exercise these results were relatively narrow, suggesting that aquatic exercise training was maintained at the follow-up assessment (MD 6.3, 95% CI is as effective as land-based exercise for these outcomes. The UPDRS- 2.1 to 10.5). This suggests that the greater benefit of aquatic exercise III score decreased by an average of 4.4 points from baseline to the than land-based exercise on balance capacity is likely to persist over post-treatment evaluation both in the aquatic and land-based exer- time.53 cise groups, with a trend towards greater improvement observed in favour of aquatic exercise. Although a statistically significant differ- It is certainly important to consider whether the statistically ence was not reached (p = 0.06), the 95% CI indicates that aquatic significantly greater effects of aquatic exercise over land-based ex- exercise is likely to be as good or better than land-based exercise for ercise on BBS, Falls Efficacy Scale and quality of life are clinically important. Ideally, this should be judged by whether the extra benefit outweighs any extra cost, risk, effort and inconvenience involved in undertaking aquatic exercise instead of land-based exercise. Although Study MD (95% CI) Kurt50 Random Shahmohammadi48 a Volpe46 Study MD (95% CI) Volpe47 Pérez de la Cruz49 Random Vivas45 a Pooled Volpe47 Pooled –20 –10 0 10 20 –20 –10 0 10 20 Favours (points) Favours (points) Favours aquatic land-based aquatic exercise Favours exercise exercise land-based exercise Figure 8. Weighted mean difference (95% CI) in the effect of aquatic exercise versus Figure 11. Weighted mean difference (95% CI) in the effect of aquatic exercise versus land-based exercise on the 39-item Parkinson’s Disease Questionnaire test at the end land-based exercise on the Berg Balance Scale at follow-up. of the intervention period. a The data from the study by Vivas et al45 are omitted due to heterogeneity – see main a The data from the study by Shahmohammadi et al48 are omitted due to heterogeneity – text and eAddenda for details. see main text and eAddenda for details.
72 Cugusi et al: Aquatic exercise for Parkinson’s disease Study MD (95% CI) In line with these considerations, some of the strengths of this Pérez de la Cruz49 a Random review, particularly in comparison with previous reviews on this Vivas45 topic, are that it appraised evidence from randomised trials only, and Volpe47 also gathered information on the safety, feasibility, pool depth, water temperature and the amount of supervision provided by the aquatic Pooled physiotherapists. Overall, the included trials indicated that aquatic exercise is a safe and feasible approach for people with PD, with only –20 –10 0 10 20 two out of 187 participants dropping out of the study due to adverse (sec) events reported following aquatic exercise training (orthostatic hy- Favours Favours potension or respiratory problems).47 Moreover, supervision by a aquatic land-based physiotherapist was well documented in all the included studies. Pool exercise depth and water temperature need to be taken into account in PD exercise rehabilitation to ensure the safety of the intervention that is administered.20 For instance, water temperature is of importance Figure 12. Weighted mean difference (95% CI) in the effect of aquatic exercise versus because people with PD are at greater risk of orthostatic hypoten- sion,54 which can affect their capacity to exercise safely in water.20 land-based exercise on the Timed Up and Go test at follow-up. The pool depth is also a factor that needs to be controlled because a The data from the study by Pérez de la Cruz et al49 are omitted due to heterogeneity – the increased hydrostatic pressure with deeper water20 may result in see main text and eAddenda for details. some patients experiencing respiratory problems.55 such thresholds have not been determined, the low ends of CIs (ie, 1.6 Despite a comprehensive search strategy, the present study on the BBS, 1.8 on the Falls Efficacy Scale and 0.6 on the PDQ-39) highlights that further data on aquatic exercise in people with PD are would all not exceed even a very low threshold. Therefore, regard- still needed, with six studies eligible for meta-analysis. Other limi- less of the threshold chosen, it is not possible to state with certainty tations of this review were: a limited number of participants; het- that aquatic exercise should be actively recommend over land-based erogeneity of training programs and follow-up characteristics; testing exercise to obtain greater benefits that patients would typically say at different therapy phases (On/Off); and the absence of agreement outweigh any extra drawbacks of the aquatic format. However, if on a core set of outcomes. patients are equally happy to do aquatic exercise or land-based ex- ercise, or if they only have access to aquatic exercise, then they can be These findings are consistent with the observation that evaluation assured that it is very unlikely that they will have any less benefit of non-motor impairments is frequently lacking in clinical practice from the aquatic format and they are likely to get some small to and intervention trials,56 with only one study investigating pain moderate extra benefits. severity using the visual analogue scale for pain assessment.49 Even if PD is typically classified as a movement disorder, non-motor im- pairments such as depression, pain, apathy, fatigue and cognitive Table 4 Grades of Recommendation, Assessment, Development and Evaluation (GRADE) quality of evidence. Outcome Design Risk of bias Indirectness Inconsistency Imprecision Publication bias Effect size GRADE quality 2 RCTs 22a 0 0 22b 0 0 Very low UPDRS Total score at end of treatment I2 = 0%, MD 20.1, 95% CI 27.7 to 7.5 2 RCTs 21c 0 0 22b 0 0 Very low UPDRS-II at end of treatment 4 RCTs 21c 0 0 21d 0 0 Low I2 = 0%, MD 0.7, 95% CI 21.2 to 2.5 5 RCTs 21c 0 00 0 0 Moderate UPDRS-III at end of treatment I2 = 0%, MD 21.1, 95% CI 22.2 to 0.0 4 RCTs 21c 0 0 22b 0 0 Very low BBS at end of treatment 2 RCTs 21c 0 21e 22b 0 0 Very low I2 = 0%, MD 2.7, 95% CI 1.6 to 3.9 2 RCTs 21c 0 0 21d 0 0 Low TUG at end of treatment I2 = 41%, MD 20.8, 95% CI 22.2 to 0.5 ABS at end of treatment I2 = 71%, MD 6.5, 95% CI 28.9 to 21.6 FES at end of treatment I2 = 0%, MD 24.0, 95% CI 26.1 to –1.8 QOL outcomes (PDQ-39) at end of treatment 3 RCTs 0 0 00 0 0 High I2 = 38%, MD 26.0, 95% CI 211.3 to –0.6 2 RCTs 22a 0 0 0 Very low 2 RCTs 21c 0 21e 22b 0 0 Very low UPDRS Total score at follow-up 2 RCTs 21c 0 0 0 Low I2 = 54%, MD 0.5, 95% CI 29.1 to 10.0 2 RCTs 21c 0 0 22b 0 0 Very low UPDRS-III at follow-up 0 21d I2 = 0%, MD 0.8, 95% CI 23.5 to 5.1 0 22b BBS at follow-up I2 = 30%, MD 6.3, 95% CI 2.1 to 10.5 TUG at follow-up I2 = 28%, MD 0.9, 95% CI 22.8 to 4.6 Risk of bias was estimated using the Physiotherapy Evidence Database (PEDro) Scale. ABC = Activities-specific Balance Confidence, BBS = Berg Balance Scale, FES = Falls Efficacy Scale, I2 = inconsistency statistic, MD = weighted mean difference, PDQ-39 = 39-item Parkinson’s Disease Questionnaire, PEDro = Physiotherapy Evidence Database scale, QOL = quality of life, RCT = randomised controlled trial, SMD = standardised mean difference, TUG = Timed Up and Go test, UPDRS = Unified Parkinson’s Disease Rating Scale. a Downgraded two places as most of the trials scored 4 on the PEDro scale. b Downgraded two places due to very large confidence interval and imprecision. c Downgraded one place as most of the trials scored 6 on the PEDro scale. d Downgraded one place due to large confidence interval. e Downgraded one place due to an inconsistency statistic (I2) 50%.
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Efficacy and safety of Tai Chi for Parkinson’s disease: a considered case by case in this clinical decision. systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014;9:e99377. What was already known on this topic: Various forms of land-based exercise have been shown to be beneficial for people 12. Cugusi L, Manca A, Dragone D, Deriu F, Solla P, Secci C, et al. Nordic walking for the with Parkinson’s disease. Water-based exercise has also become management of people with Parkinson Disease: a systematic review. PM R. very popular in the management of disease severity and motor 2017;9:1157–1166. impairments in people with Parkinson’s disease, but the evidence for it has not been adequately summarised. 13. Bombieri F, Schena F, Pellegrini B, Barone P, Tinazzi M, Erro R. Walking on four What this study adds: The existing limited evidence seems to limbs: A systematic review of Nordic Walking in Parkinson disease. Parkinsonism suggest that aquatic-based exercise may improve motor impair- Relat Disord. 2017;38:8–12. ments in people with Parkinson’s disease significantly more than no intervention. Overall, aquatic-based exercise has effects that 14. Kwok JY, Choi KC, Chan HY. Effects of mind-body exercises on the physiological and are at least as good as those of land-based exercise. The addi- psychosocial well-being of individuals with Parkinson’s disease: A systematic re- tional benefits of aquatic exercise over land-based exercise may view and meta-analysis. Complement Ther Med. 2016;29:121–131. occur with balance capacity, fear of falling and health-related quality of life, although the magnitude of each extra benefit 15. Alves Da Rocha P, McClelland J, Morris ME. Complementary physical therapies for may be small. movement disorders in Parkinson’s disease: a systematic review. Eur J Phys Rehabil Med. 2015;51:693–704. eAddenda: Figures 3 and 10, Table 3 and Appendices 1 and 2 can be found online at https://doi.org/10.1016/j.jphys.2019.02.003. 16. Denning WM, Bressel E, Dolny D, Bressel M, Seeley MK. A review of biophysical differences between aquatic and land-based exercise. Int J Aquatic Res Educ. Ethics Approval: Not applicable. 2012;6:46–67. Competing interest: The authors declare that there is no conflict of interest. 17. Edlich RF, Towler MA, Goitz RJ, Wilder RP, Buschbacher LP, Morgan RF, et al. Source of support: Nil. Bioengineering principles of hydrotherapy. J Burn Care Rehabil. 1987;8:580–584. Acknowledgements: The authors would like to thank Prof. Jamile Vivas Costa and Prof. Javier Cudeiro for the data supplied upon 18. Hall J, Swinkels A, Briddon J, McCabe CS. Does aquatic exercise relieve pain in request. adults with neurologic or musculoskeletal disease? A systematic review and meta- Provenance: Not invited. Peer reviewed. analysis of randomized controlled trials. Arch Phys Med Rehabil. 2008;89:873–883. Correspondence: Lucia Cugusi, Department of Medical Sciences and Public Health, University of Cagliari, Italy. Email: [email protected] 19. Hinman RS, Heywood SE, Day AR. Aquatic physical therapy for hip and knee osteoarthritis: results of a single-blind randomized controlled trial. Phys Ther. References 2007;87:32–43. 1. Hughes AJ, Daniel SE, Lees AJ. Improved accuracy of clinical diagnosis of Lewy body 20. Skinner AT, Thomson AM, Duffield M. Duffield’s exercise in water. Sidcup, United Parkinson’s disease. Neurology. 2001;57:1497–1499. Kingdom: Bailliere Tindall; 1983. 2. Horstink M, Tolosa E, Bonuccelli U, Deuschl G, Friedman A, Kanovsky P, et al. Re- 21. Becker BE. Aquatic therapy: scientific foundations and clinical rehabilitation ap- view of the therapeutic management of Parkinson’s disease. Report of a joint task plications. PM R. 2009;1:859–872. force of the European Federation of Neurological Societies (EFNS) and the Move- ment Disorder Society European Section (MDS ES). Part II: late (complicated) 22. Batterham SI, Heywood S, Keating JL. Systematic review and meta-analysis Parkinson’s disease. Eur J Neurol. 2006;13:1186–1202. comparing land and aquatic exercise for people with hip or knee arthritis on func- tion, mobility and other health outcomes. BMC Musculoskelet Disord. 2011;12:123. 23. Neto MG, Conceição CS, de Jesus FL, Oliveira Carvalho V. Hydrotherapy on exercise capacity, muscle strength and quality of life in patients with heart failure: A meta- analysis. Int J Cardiol. 2015;198:216–219. 24. Cugusi L, Cadeddu C, Nocco S, Orrù F, Bandino S, Deidda M, et al. Effects of an aquatic-based exercise program to improve cardiometabolic profile, quality of life, and physical activity levels in men with type 2 diabetes mellitus. PM R. 2015;7:141–148. 25. Plecash AR, Leavitt BR. Aquatherapy for neurodegenerative disorders. J Huntingtons Dis. 2014;3:5–11. 26. Methajarunon P, Eitivipart C, Diver CJ, Foongchomcheay A. Systematic review of published studies on aquatic exercise for balance in patients with multiple scle- rosis, Parkinson’s disease, and hemiplegia. Hong Kong Physiother J. 2016;35:12–20. 27. Ayán Pérez C, Cancela JM. Effectiveness of water-based exercise in people living with Parkinson’s disease: a systematic review. Eur Rev Aging Phys Act. 2014;11:107–118. 28. Terrens AF, Soh S, Morgan PE. The efficacy and feasibility of aquatic physiotherapy for people with Parkinson’s disease: a systematic review. Disabil Rehabil. 2018;40:2847–2856. 29. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009;62:1–34. 30. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. Int J Surg. 2010;8:336–341. 31. Moher D, Pham B, Klassen TP, Schulz KF, Berlin JA, Jadad AR, et al. What contri- butions do languages other than English make on the results of meta-analyses? J Clin Epidemiol. 2000;53:964–972. 32. Heneghan C, Badenoch D. Evidence-based medicine toolkit. London: BMJ Books; 2002. 33. Elkins MR, Herbert RD, Moseley AM, Sherrington C, Maher C. Rating the quality of trials in systematic reviews of physical therapy interventions. Cardiopulm Phys Ther J. 2010;21:20–26. 34. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epi- demiol. 2011;64:383–394.
74 Cugusi et al: Aquatic exercise for Parkinson’s disease 35. Ryan R, Hill S. How to GRADE the quality of the evidence. Cochrane Consumers and life in people with Parkinson’s disease: a randomized controlled pilot study. Sport Communication Group; 2016. Available from http://cccrg.cochrane.org/author- Sci Health. 2017;13:341–348. resources. Version 3.0 December 2016. Accessed 18 November, 2018. 49. Pérez de la Cruz S. Effectiveness of aquatic therapy for the control of pain and increased functionality in people with Parkinson’s disease: a randomized clinical 36. Sterne JA, Sutton AJ, Ioannidis JP, Terrin N, Jones DR, Lau J, et al. Recommendations trial. Eur J Phys Rehabil Med. 2017;53:825–832. for examining and interpreting funnel plot asymmetry in meta-analyses of rand- 50. Kurt EE, Büyükturan B, Büyükturan Ö, Erdem HR, Tuncay F. Effects of Ai Chi on omised controlled trials. BMJ. 2011;343:d4002. balance, quality of life, functional mobility, and motor impairment in patients with Parkinson’s disease. Disabil Rehabil. 2018;40:791–797. 37. Review Manager (RevMan) [Computer program]. Version 5.3. Copenhagen: The 51. Hoehn MM, Yahr MD. Parkinsonism: Onset, progression and mortality. Neurology. Nordic Cochrane Centre, The Cochrane Collaboration; 2014. 1967;17:427–442. 52. Shulman LM, Gruber-Baldini AL, Anderson KE, Fishman PS, Reich SG, Weiner WJ. 38. Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, The clinically important difference on the Unified Parkinson’s Disease Rating Scale. range, and the size of a sample. BMC Med Res Methodol. 2005;5:13. Arch Neurol. 2010;67:64–70. 53. Mak MK, Wong-Yu IS, Shen X, Chung CL. Long-term effects of exercise and physical 39. Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of In- therapy in people with Parkinson disease. Nat Rev Neurol. 2017;13:689–703. terventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration; 54. Velseboer DC, de Haan RJ, Wieling W, Goldstein DS, de Bie RM. Prevalence of 2011. Available from www.handbook.cochrane.org (Section 9.4.5.2). Accessed orthostatic hypotension in Parkinson’s disease: a systematic review and meta- 18 November, 2018. analysis. Parkinsonism Relat Disord. 2011;17:724–729. 55. Forsyth D, Torsney KM. Respiratory dysfunction in Parkinson’s disease. J R Coll 40. Borenstein M, Hedges LV, Higgins JP, Rothstein HR. A basic introduction to fixed-effect Physicians Edinb. 2017;47:35–39. and random-effects models for meta-analysis. Res Synth Methods. 2010;1:97–111. 56. Chaudhuri KR, Schapira AH. Non-motor symptoms of Parkinson’s disease: dopa- minergic pathophysiology and treatment. Lancet Neurol. 2009;8:464–474. 41. Cohen J. Statistical power analysis for the behavioural sciences. 2nd ed. Hillsdale; NJ: 57. Stegemöller EL, Nocera J, Malaty I, Shelley M, Okun MS, Hass CJ, NPF Quality Lawrence Earlbaum Associates; 1988. Improvement Initiative Investigators. Timed up and go, cognitive, and quality-of- life correlates in Parkinson’s disease. Arch Phys Med Rehabil. 2014;95:649–655. 42. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta- 58. Cugusi L, Solla P, Serpe R, Carzedda T, Piras L, Oggianu M, et al. Effects of a Nordic analyses. BMJ. 2003;327:557–560. Walking program on motor and non-motor symptoms, functional performance and body composition in patients with Parkinson’s disease. NeuroRehabilitation. 43. Tukey JW. Exploratory data analysis. Reading, Mass: Addison-Wesley Pub. Co; 1977. 2015;37:245–254. 59. Cugusi L, Solla P, Zedda F, Loi M, Serpe R, Cannas A, et al. Effects of an adapted 44. Carroll LM, Volpe D, Morris ME, Saunders J, Clifford AM. Aquatic exercise therapy physical activity program on motor and non-motor functions and quality of life in for people with Parkinson Disease: a randomized controlled trial. Arch Phys Med patients with Parkinson’s disease. NeuroRehabilitation. 2014;35:789–794. Rehabil. 2017;98:631–638. Websites 45. Vivas J, Arias P, Cudeiro J. Aquatic therapy versus conventional land-based therapy for Parkinson’s disease: an open-label pilot study. Arch Phys Med Rehabil. PEDro www.pedro.org.au 2011;92:1202–1210. 46. Volpe D, Giantin MG, Maestri R, Frazzitta G. Comparing the effects of hydrotherapy and land-based therapy on balance in patients with Parkin- son’s disease: a randomized controlled pilot study. Clin Rehabil. 2014;28:1210–1217. 47. Volpe D, Giantin MG, Manuela P, Filippetto C, Pelosin E, Abbruzzese G, et al. Water- based vs. non-water-based physiotherapy for rehabilitation of postural deformities in Parkinson’s disease: a randomized controlled pilot study. Clin Rehabil. 2017;31:1107–1115. 48. Shahmohammadi R, Sharifi GR, Melvin JMA, Sadeghi-Demneh E. A comparison between aquatic and land-based physical exercise on postural sway and quality of
Journal of Physiotherapy 65 (2019) 110 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Clinimetrics: Patient-Reported Outcomes Measurement Information System (PROMIS®) Summary Description: The Patient-Reported Outcomes Measurement Infor- PROMIS instrument scores are standardised and expressed as T-scores. mation System (PROMIS®) consists of a universal, non-disease-specific, applicable set of instruments that have been designed to measure A score of 50 generally represents the mean score of the general pop- ulation with a standard deviation of 10, enabling easy interpretation.3 patient-reported health across different adult and paediatric (patient) populations in a more efficient way than traditional patient-reported Moreover, clinically relevant classifications of PROMIS T-scores have outcome measures (PROMs).1,2 The PROMIS instruments have been been suggested for some PROMIS instruments (eg, T-score thresholds developed using Item Response Theory and consist of item banks. An for severity levels like ‘within normal limits’, ‘mild problems’, ‘moderate item bank is a large (20 to 1001) set of items (questions) with responses problems’, and ‘severe problems’). PROMIS Short Forms can be (answers) measuring one common domain (construct) (eg, physical administered on paper or in digital format and are free of charge. The functioning, pain interference, fatigue or depression).2 PROMIS in- total score has to be converted to a T-score using a conversion table that struments can be applied as Short Forms or computer adaptive tests is available in the manual at issue4 or by uploading the response data to (CATs).2 Short Forms consist of a fixed number of 4 to 10 highly infor- the online HealthMeasures Scoring Service. PROMIS CATs can, at a fee, mative items out of the bank. CATs consist of computer-administered be administered by computer or app and are scored automatically.2 As shown above, PROMIS instruments have better content validity and are tests that, supported by an Item Response Theory-based algorithm, present items based on the responses to previous items. Consequently, more precise than traditional PROMs, and their scores are easily interpretable. patients respond to a small and flexible number (about 3 to 7) of highly informative and relevant items. PROMIS instruments, applied as Short Example: The PROMIS Physical Function (PROMIS-PF) item bank is an example of a PROMIS instrument that measures the domain Forms or CATs, are relatively short and the administration time is much physical functioning.5 This domain is highly relevant to physiother- less compared with traditional PROMs. In summary, PROMIS consists of apists and their patients. PROMIS-PF Short Forms have shown a universally applicable set of instruments that measure health effi- stronger content validity, higher precision, and other desirable psy- ciently and are less burdensome to patients. chometric properties compared to traditional PROMs such as the Psychometric properties and score interpretation: PROMIS in- Short Form-36 Health Survey Physical Functioning scale and the struments have been carefully developed in collaboration with patients Health Assessment Questionnaire-Disability Index.6 Sufficient psy- and experts to ensure content validity.2 The CAT application results in an chometric properties of the bank have been shown in patients estimate of the patient score with high precision (reliability). The receiving physiotherapy.7 Commentary An advantage of PROMIS is that its domain framework is compre- Provenance: Invited. Not peer reviewed. hensive and comprises physical, mental and social health, and includes domains that are highly relevant to patients with different (chronic) health Leo D Roordaa, Martine HP Crinsa and Caroline B Terweeb conditions.2 Another advantage is its universal applicability, as patients aAmsterdam Rehabilitation Research Center j Reade, Amsterdam increasingly have multiple conditions. Other advantages are their sound psychometric properties, broad measurement range, and small floor and The Netherlands ceiling effects. PROMIS scores are also easy to interpret and can be used to bAmsterdam UMC, Vrije Universiteit Amsterdam, Department of compare (patient) populations. PROMIS instruments were developed in Epidemiology and Biostatistics, Amsterdam Public Health Research the United States and have been translated into over 40 languages.2 PROMIS instruments are increasingly being used and implemented in Institute, Amsterdam, The Netherlands clinical practice and research worldwide.8 However, the main advantage of PROMIS instruments is that they take much less time to administer than References other PROMs without compromising their psychometric properties. 1. Cella D, et al. J Clin Epidemiol. 2010;63:1179–1194. Limitations: The disadvantages of PROMIS CATs are the need to 2. Northwestern University, PROMIS; viewed 30 October, from http://www. use a computer or an app and the fees related to the use of CATs. Also, the responsiveness of PROMIS instruments has not yet been exten- healthmeasures.net/explore-measurement-systems/promis sively studied. 3. Northwestern University, Interpret Scores; viewed 30 October, from http://www. Overall, applying PROMIS Short Forms and the highly efficient healthmeasures.net/score-and-interpret/interpret-scores/promis PROMIS CATs in clinical practice and research is considered feasible, 4. Northwestern University, Scoring Manuals; viewed 30 October, from http://www. with little administration time, and has the potential for standardised and routine patient monitoring across a wide range of disorders, healthmeasures.net/promis-scoring-manuals including patients receiving physiotherapy. 5. Rose M, et al. J Clin Epidemiol. 2014;67:516–526. 6. Fries JF, et al. Arthritis Res Ther. 2011;13:R147. 7. Crins MHP, et al. PLoS One. 2018;13:e0192187. 8. Northwestern University, Applications of Health Measures; viewed 30 October, from http://www.healthmeasures.net/applications-of-healthmeasures/overview https://doi.org/10.1016/j.jphys.2018.11.009 1836-9553/© 2019 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 65 (2019) 111 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Clinimetrics: Single Assessment Numeric Evaluation Summary Description: The Single Assessment Numeric Evaluation (SANE) is activities of the knee. Similar to the SANE, it consists of a scale from 0 to a single-item, global, patient-reported outcome measure.1–3 Patients 100, with 100 meaning no limitation with activities.2,5 Overall, there is provide a whole number response to the question ‘On a scale from 0 to minimal difference in correlation within patient groups based on age or 100, how would you rate your (eg, injured limb) today, with 100 being sex for the SANE and International Knee Documentation Committee.1,2,5 normal?’.1,2 It is typically used as a global rating of function, although this is not specifically stated in the question, and the definition of The SANE has also been measured for internal validity by assessing the normality is determined by the individual patient. As the question is floor (, 15%) and ceiling (, 15%) effects compared with the American rated at baseline and follow-up, it can be used as a measure that cap- Shoulder and Elbow Surgeons, Western Ontario Osteoarthritis of the Shoulder, and Constant–Murley shoulder outcome scores.6,7 tures the change in function (ie, recovery) over this period. Patients The SANE has also displayed a similar responsiveness to the Amer- tend to define their recovery based on their basic function, pain, per- formance, and expectations for ‘normal’ function.1 The construct of the ican Shoulder and Elbow Surgeons score when used for upper limb ex- SANE is similar to the Patient-Specific Functional Scale, which also reports patients’ functional change on an 11-point scale for a variety of tremities, with the minimal detectable change ranging from 7 to 9%, musculoskeletal disorders.4 (However, the Patient-Specific Functional depending on treatment.6 The reported minimum clinically important Scale is often administered only at follow-up, yielding a retrospective difference of the SANE is similar to that reported for the American score of the change/recovery over the period from baseline to follow- Shoulder and Elbow Surgeons (11%), and averages 15% across a variety of up). Overall, the shortness of the SANE reduces the burden of gath- shoulder conditions.6 Regarding lower extremities, the minimum clini- ering outcome data and is simpler for clinical practice use.3 cally important difference for the SANE is consistent with that of the Validity, responsiveness and reliability: The SANE is expressed on International Knee Documentation Committee.1 The minimum clinically a scale of 0 to 100 and has been compared with other 100-point scales such as the Lysholm or Rowe.1–3 Regarding validity, the SANE is reported important difference for the SANE was found to be 7 for a 6-month follow-up appointment, and 19 for a 12-month follow-up appointment.5 to have a correlation of 0.83 at 3 and 6 months postoperatively when compared with the International Knee Documentation Committee.5 The When assessed amongst patients with shoulder disorders, the International Knee Documentation Committee is an 18-question eval- SANE reports good reliability (ICC = 0.76, SE 3.4) and agreement uation that focuses on symptoms, activities of daily living and sports across a variety of treatment groups (rotator cuff repair, ICC = 0.85, SE 3.4; total shoulder arthroplasty, ICC = 0.72, SE 5.2; physiotherapy, ICC = 0.82, SE 2.9).6,7 However, reliability has yet to be evaluated for lower limb extremities. Commentary While the SANE is used to supplement current patient-reported Provenance: Invited. Not peer reviewed. outcome measures, it is not recommended to be a replacement. Similar Rochelle Furtadoa,b and Joy MacDermida,b,c aPhysiotherapy, Health and Rehabilitation Science; bCollaborative to the Patient-Specific Functional Scale and Global Perceived Effect scale, Program in Musculoskeletal Health Research, Bone and Joint Institute, these short patient-reported outcome measures are intended to be easy Western University; cRoth McFarlane Hand and Upper Limb Centre, for the patient to understand, rate the aspects of recovery that are most St. Joseph’s Hospital, London, Canada important to them, and be used as an external criterion to test the mea- References surement properties of other outcome measures.4,8 Due to its simple 1. Shelbourne KD, et al. Am J Sports Med. 2012;40:2487–2491. nature, the SANE lacks specificity as to which areas of function are limited, 2. Williams GN, et al. Clin Orthop Relat Res. 2000;373:184–192. which lessens the clinician’s understanding of a patient’s limitations and 3. Cunningham G, et al. J Arthroscopy. 2015;31:1688–1692. its application within rehabilitation treatment plans.1,8 However, the 4. Stratford PW, et al. Physiother Can. 1995;47:258–263. 5. Winterstein AP, et al. Sports Health. 2013;5:523–529. SANE can alert clinicians about a patient’s overall perceptions, and when 6. Thigpen CA, et al. Orthop J Sports Med. 2017;5. used in combination with other tools can help to identify variance be- 7. Sciascia AD, et al. Orthopedics. 2017;40:513–519. tween these global perceptions and specific measured impairments.1,4,6,8 8. Kamper S, et al. J Clin Epi. 2010;63:760–766. 9. Bottoni CR, et al. Am J Sports Med. 2008;36:656–662. Overall, the SANE has proven to be a simplified means for collecting 10. Bradbury M, et al. Physiother Theory Pract. 2013;29:531–535. outcome data in patient populations of the ankle, knee and shoul- 11. Sueyoshi T, et al. Arthroplast Today. 2018;4:99–102. der.1–4,6–8 Therefore, studies have demonstrated the SANE to be a reliable reflection of patients’ perceptions regarding their recovery.9–11 However, further validation is required on the psychometric properties of the SANE across other body areas, diagnoses and therapeutic interventions. Further validation is also required to evaluate the concurrent validity between the SANE, Patient-Specific Functional Scale, and Global Perceived Effect scale, as they measure similar constructs. https://doi.org/10.1016/j.jphys.2019.02.001 1836-9553/© 2019 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 65 (2019) 117 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Correspondence: Transparency to fully understand randomised controlled trials I have read the research article conducted by Antônio et al,1 which Acknowledgements examines the effect of pelvic floor muscle training in groups stratified by hormonal therapy use. I appreciate the authors’ effort to conduct The author did not receive any specific grant from funding agencies in this randomised controlled study. Since the intervention was the public, commercial, or not-for-profit sectors. described in detail, readers might be able to apply the training protocol to their clinical settings. Takashi Ariie Takagi Hospital, Rehabilitation Department, Okawa, Fukuoka, Japan However, I have two concerns about inadequate reporting of the method in this study. First, sample size calculation of par- https://doi.org/10.1016/j.jphys.2019.01.009 ticipants was not mentioned; therefore, readers cannot anticipate the impact of a Type II error on statistically non-significant References results.2 1. Antônio FI, Herbert RD, Bø K, Rosa-e-Silva ACJS, Lara LAS, Franco MdM, et al. Pelvic Second, there was no information about adverse events. Although floor muscle training increases pelvic floor muscle strength more in post- the intervention itself is non-invasive, a previous study reported menopausal women who are not using hormone therapy than in women who are some adverse events such as pain.3 If the reasons for dropout from using hormone therapy: a randomised trial. J Physiother. 2018;64:166–171. the intervention group (such as illness) were related to intervention, caution should be exercised. 2. Freedman KB, Back S, Bernstein J. Sample size and statistical power of randomised, controlled trials in orthopaedics. J Bone Joint Surg Br. 2001;83:397–402. These two points are important components to fully understand the study, as described in the Consolidated Standards of Reporting 3. Dumoulin C, Hay-Smith J, Mac Habée-Séguin G. Pelvic floor muscle training versus Trials (CONSORT) statement.4 Readers should be aware of the no treatment, or inactive control treatments, for urinary incontinence in women. concerns when they interpret the results. Cochrane Database Syst Rev. 2014;5:CD005654. 4. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10:28–55. 1836-9553/© 2019 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/). Correspondence: Author response to Ariie We appreciate Mr Takashi Ariie’s interest and comments Flávia Ignácio Antônioa, Robert D Herbertb, Kari Bøc regarding our publication. Ana Carolina Japur Sá Rosa-e-Silvad, Lúcia Alves Silva Larad Maira de Menezes Francoa and Cristine Homsi Jorge Ferreiraa The first concern raised by Mr Ariie is not justified because we rejected the null hypothesis.1 Our study showed that pelvic floor aDepartment of Health Sciences, Ribeirão Preto Medical School, muscle training increases pelvic floor muscle strength more in University of São Paulo, Ribeirão Preto, Brazil women not using hormone therapy than in women using it (interaction p = 0.018). There could not have been a Type II error bNeuroscience Research Australia (NeuRA), Sydney, Australia because we found an interaction. cNorwegian School of Sport Sciences Department of Sports Medicine, The second concern was regarding pelvic floor muscle training Oslo and Akershus University Hospital, side effects. The systematic review cited by Mr Ariie included 21 Department of Obstetrics and Gynecology, trials involving 1281 women (665 pelvic floor muscle training, 616 controls).2 From these trials, only one reported adverse events Lørenskog, Norway with pelvic floor muscle training.3 This specific trial included 66 dDepartment of Obstetrics and Gynecology, participants, among whom only four mentioned side effects Ribeirão Preto Medical School, University of São Paulo, related to treatment: ‘one mentioned pain and three an uncomfortable feeling during the exercises’. It is unclear Ribeirão Preto, Brazil whether the pain and discomfort was caused by the pelvic floor muscle training itself; it could be related, for example, to the https://doi.org/10.1016/j.jphys.2019.01.010 women’s posture during the exercise. Considering this information from the available trials related to this topic, we References believe that it is unlikely that there are significant side effects of pelvic floor muscle training. However, we agree that side effects 1. Antônio FI, Herbert RD, Bø K, Rosa-e-Silva ACJS, Lara LAS, Franco MdM, et al. Pelvic should be investigated, reported and better discussed in future floor muscle training increases pelvic floor muscle strength more in post- studies. menopausal women who are not using hormone therapy than in women who are using hormone therapy: a randomised trial. J Physiother. 2018;64:166–171. 2. Dumoulin C, Hay-Smith J, Mac Habée-Séguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2014;5:CD005654. 3. Lagro-Janssen TLM, Debruyne FMJ, Smits AJA, van Weel C. Controlled trial of pelvic floor exercises in the treatment of urinary stress incontinence in general practice. Brit J Gen Pract. 1991;41:445–449. 1836-9553/© 2019 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 65 (2019) 117 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Correspondence: Transparency to fully understand randomised controlled trials I have read the research article conducted by Antônio et al,1 which Acknowledgements examines the effect of pelvic floor muscle training in groups stratified by hormonal therapy use. I appreciate the authors’ effort to conduct The author did not receive any specific grant from funding agencies in this randomised controlled study. Since the intervention was the public, commercial, or not-for-profit sectors. described in detail, readers might be able to apply the training protocol to their clinical settings. Takashi Ariie Takagi Hospital, Rehabilitation Department, Okawa, Fukuoka, Japan However, I have two concerns about inadequate reporting of the method in this study. First, sample size calculation of par- https://doi.org/10.1016/j.jphys.2019.01.009 ticipants was not mentioned; therefore, readers cannot anticipate the impact of a Type II error on statistically non-significant References results.2 1. Antônio FI, Herbert RD, Bø K, Rosa-e-Silva ACJS, Lara LAS, Franco MdM, et al. Pelvic Second, there was no information about adverse events. Although floor muscle training increases pelvic floor muscle strength more in post- the intervention itself is non-invasive, a previous study reported menopausal women who are not using hormone therapy than in women who are some adverse events such as pain.3 If the reasons for dropout from using hormone therapy: a randomised trial. J Physiother. 2018;64:166–171. the intervention group (such as illness) were related to intervention, caution should be exercised. 2. Freedman KB, Back S, Bernstein J. Sample size and statistical power of randomised, controlled trials in orthopaedics. J Bone Joint Surg Br. 2001;83:397–402. These two points are important components to fully understand the study, as described in the Consolidated Standards of Reporting 3. Dumoulin C, Hay-Smith J, Mac Habée-Séguin G. Pelvic floor muscle training versus Trials (CONSORT) statement.4 Readers should be aware of the no treatment, or inactive control treatments, for urinary incontinence in women. concerns when they interpret the results. Cochrane Database Syst Rev. 2014;5:CD005654. 4. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10:28–55. 1836-9553/© 2019 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/). Correspondence: Author response to Ariie We appreciate Mr Takashi Ariie’s interest and comments Flávia Ignácio Antônioa, Robert D Herbertb, Kari Bøc regarding our publication. Ana Carolina Japur Sá Rosa-e-Silvad, Lúcia Alves Silva Larad Maira de Menezes Francoa and Cristine Homsi Jorge Ferreiraa The first concern raised by Mr Ariie is not justified because we rejected the null hypothesis.1 Our study showed that pelvic floor aDepartment of Health Sciences, Ribeirão Preto Medical School, muscle training increases pelvic floor muscle strength more in University of São Paulo, Ribeirão Preto, Brazil women not using hormone therapy than in women using it (interaction p = 0.018). There could not have been a Type II error bNeuroscience Research Australia (NeuRA), Sydney, Australia because we found an interaction. cNorwegian School of Sport Sciences Department of Sports Medicine, The second concern was regarding pelvic floor muscle training Oslo and Akershus University Hospital, side effects. The systematic review cited by Mr Ariie included 21 Department of Obstetrics and Gynecology, trials involving 1281 women (665 pelvic floor muscle training, 616 controls).2 From these trials, only one reported adverse events Lørenskog, Norway with pelvic floor muscle training.3 This specific trial included 66 dDepartment of Obstetrics and Gynecology, participants, among whom only four mentioned side effects Ribeirão Preto Medical School, University of São Paulo, related to treatment: ‘one mentioned pain and three an uncomfortable feeling during the exercises’. It is unclear Ribeirão Preto, Brazil whether the pain and discomfort was caused by the pelvic floor muscle training itself; it could be related, for example, to the https://doi.org/10.1016/j.jphys.2019.01.010 women’s posture during the exercise. Considering this information from the available trials related to this topic, we References believe that it is unlikely that there are significant side effects of pelvic floor muscle training. However, we agree that side effects 1. Antônio FI, Herbert RD, Bø K, Rosa-e-Silva ACJS, Lara LAS, Franco MdM, et al. Pelvic should be investigated, reported and better discussed in future floor muscle training increases pelvic floor muscle strength more in post- studies. menopausal women who are not using hormone therapy than in women who are using hormone therapy: a randomised trial. J Physiother. 2018;64:166–171. 2. Dumoulin C, Hay-Smith J, Mac Habée-Séguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2014;5:CD005654. 3. Lagro-Janssen TLM, Debruyne FMJ, Smits AJA, van Weel C. Controlled trial of pelvic floor exercises in the treatment of urinary stress incontinence in general practice. Brit J Gen Pract. 1991;41:445–449. 1836-9553/© 2019 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 65 (2019) 107 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Education plus exercise, and corticosteroid injection, are superior to a wait-and-see approach for gluteal tendinopathy Synopsis Summary of: Mellor R, Bennell K, Grimaldi, A, Nicolson P, Kasza J, Hodges dichotomised, with success defined as ‘moderately better’ to ‘very much bet- P, Wajswelner H, Vicenzino B. Education plus exercise versus corticoste- ter’; and hip pain intensity on a 0-to-10 numerical rating scale. Numerous roid injection use versus a wait and see approach on global outcome and secondary outcomes were also included. Results: A total of 189 (93%) partici- pain from gluteal tendinopathy: prospective, single blinded, randomised pants completed the study. At 8 weeks, both education plus exercise and clinical trial. BMJ. 2018;361:k1662. corticosteroid injection showed higher success rates on global improvement than wait and see: risk difference 49% (95% CI 35 to 64) and 29% (95% CI Question: Is education plus exercise, and corticosteroid injection, more effec- 13 to 45), respectively. Education plus exercise showed higher success than tive than wait and see on global changes in hip conditions and pain in people corticosteroid injection (20%, 95% CI 5 to 35). Both interventions reduced pain with gluteal tendinopathy? Design: Multicentre, three-arm randomised intensity at 8 weeks compared to wait and see: MD –2.2 (95% CI –2.9 to –1.5) controlled trial with concealed allocation. Setting: Two university departments and –1.2 (–1.9 to –0.5), respectively. At 52 weeks, the 79% success rate in global in Australia. Participants: Community-dwelling participants from Brisbane improvement for education plus exercise was better than 58% with cortico- and Melbourne. Inclusion criteria were age 35 to 70 years, lateral hip pain (. 3 steroid injection (risk difference 20%, 95% CI 5 to 36), and better than 52% with months) of intensity at least 4/10 on a numerical rating scale, and gluteal ten- wait and see (risk difference 27%, 95% CI 11 to 42). Both interventions showed dinopathy confirmed by clinical diagnosis and magnetic resonance imaging. less pain than the wait-and-see approach: MD –1.1 (95% CI –1.9 to –0.3) and Low back, sciatic, or groin pain, corticosteroid injection (previous 12 months), –0.9 (–1.7 to –0.1), respectively. Pain intensity did not differ significantly be- and current physiotherapy treatment were exclusion criteria. Randomisation of tween education plus exercise and corticosteroid injection at 52 weeks. 204 participants allocated 66 to corticosteroid injection, 69 to education plus Conclusion: Both education plus exercise and corticosteroid injection resulted exercise, and 60 to wait and see. Interventions: Education plus exercise in higher rates of global improvement and lower pain intensity than a wait- comprised 14 sessions with a physiotherapist over 8 weeks (60 minutes initial, and-see approach at 8 weeks. At 52 weeks, education plus exercise was more otherwise 30 minutes) and involved education on tendon care and loading, and effective on global improvement, but not pain, than corticosteroid injection. daily home exercises (hip abductor strengthening; dynamic control of hip adduction). The corticosteroid injections were ultrasound-guided by a radiol- Provenance: Invited. Not peer reviewed. ogist. The wait-and-see approach included one session with a physiotherapist for information about gluteal tendinopathy, risk factors, advice regarding Britt Elin Øiestad continuation of activity, and reassurance. Outcome measures: Primary out- Department of Physiotherapy, Oslo Metropolitan University, Norway comes were: global change in hip condition (numerical rating scale), https://doi.org/10.1016/j.jphys.2019.01.006 1836-9553/© 2019 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/). Commentary Newer treatment approaches for tendinopathy, typically for the achilles education and exercise over corticosteroid injection, providing a safe and and patellar tendons, have emphasised loading management and strength practical treatment approach for patients with gluteal tendinopathy. On training as the most important content of treatment, due to promising clinical average, participants completed over 80% of the prescribed exercises each results.1 Management of gluteal tendinopathy has usually included week, which illustrates that it was feasible. The article’s supplementary file corticosteroid injection, exercise, shock wave therapy, or surgery.2 A provides clear instructions for the exercise program, which can be readily favourable response to education plus exercise over corticosteroid injection implemented in clinics today and with little need for expensive equipment. means that clinicians and patients can opt for a low-risk treatment Therefore, this is clinically relevant research, which encourages evidence- approach.3 In addition, active rehabilitation has further benefits for the patient. informed practice for physiotherapists. An education plus exercise program offered within a supportive environment, where patients understand the reasons for performing the exercises, can Provenance: Invited. Not peer reviewed. increase self-efficacy. This may partly explain the reported improvements in functional outcomes and quality of life (secondary outcomes) observed over Sophie E Steenstrup the first 6 months with education plus exercise compared to corticosteroid Department of Physiotherapy, Oslo Metropolitan University, Norway injection. Unfortunately, Mellor et al did not measure return to previous ac- tivity levels. Future research could include more functional/sport-specific ex- https://doi.org/10.1016/j.jphys.2019.01.002 ercises in later stages of rehabilitation, and evaluate the impact on return to activity/sport. Evidence to support the effects of rehabilitation on return to References activity/sport is limited, and including such measures in the trial would have been of importance to patients and clinicians.4 Nonetheless, the results of this 1. Couppe C, et al. J Orthop Sports Phys Ther. 2015;45:853–863. trial are of great clinical relevance, supporting the use of load management 2. Grimaldi A, et al. Sports Med. 2015;45:1107–1119. 3. Coombes BK, et al. Lancet. 2010;20:1751–1767. 4. Ardern CL, et al. Br J Sports Med. 2016;50:853–864. 1836-9553/© 2019 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 65 (2019) 107 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Education plus exercise, and corticosteroid injection, are superior to a wait-and-see approach for gluteal tendinopathy Synopsis Summary of: Mellor R, Bennell K, Grimaldi, A, Nicolson P, Kasza J, Hodges dichotomised, with success defined as ‘moderately better’ to ‘very much bet- P, Wajswelner H, Vicenzino B. Education plus exercise versus corticoste- ter’; and hip pain intensity on a 0-to-10 numerical rating scale. Numerous roid injection use versus a wait and see approach on global outcome and secondary outcomes were also included. Results: A total of 189 (93%) partici- pain from gluteal tendinopathy: prospective, single blinded, randomised pants completed the study. At 8 weeks, both education plus exercise and clinical trial. BMJ. 2018;361:k1662. corticosteroid injection showed higher success rates on global improvement than wait and see: risk difference 49% (95% CI 35 to 64) and 29% (95% CI Question: Is education plus exercise, and corticosteroid injection, more effec- 13 to 45), respectively. Education plus exercise showed higher success than tive than wait and see on global changes in hip conditions and pain in people corticosteroid injection (20%, 95% CI 5 to 35). Both interventions reduced pain with gluteal tendinopathy? Design: Multicentre, three-arm randomised intensity at 8 weeks compared to wait and see: MD –2.2 (95% CI –2.9 to –1.5) controlled trial with concealed allocation. Setting: Two university departments and –1.2 (–1.9 to –0.5), respectively. At 52 weeks, the 79% success rate in global in Australia. Participants: Community-dwelling participants from Brisbane improvement for education plus exercise was better than 58% with cortico- and Melbourne. Inclusion criteria were age 35 to 70 years, lateral hip pain (. 3 steroid injection (risk difference 20%, 95% CI 5 to 36), and better than 52% with months) of intensity at least 4/10 on a numerical rating scale, and gluteal ten- wait and see (risk difference 27%, 95% CI 11 to 42). Both interventions showed dinopathy confirmed by clinical diagnosis and magnetic resonance imaging. less pain than the wait-and-see approach: MD –1.1 (95% CI –1.9 to –0.3) and Low back, sciatic, or groin pain, corticosteroid injection (previous 12 months), –0.9 (–1.7 to –0.1), respectively. Pain intensity did not differ significantly be- and current physiotherapy treatment were exclusion criteria. Randomisation of tween education plus exercise and corticosteroid injection at 52 weeks. 204 participants allocated 66 to corticosteroid injection, 69 to education plus Conclusion: Both education plus exercise and corticosteroid injection resulted exercise, and 60 to wait and see. Interventions: Education plus exercise in higher rates of global improvement and lower pain intensity than a wait- comprised 14 sessions with a physiotherapist over 8 weeks (60 minutes initial, and-see approach at 8 weeks. At 52 weeks, education plus exercise was more otherwise 30 minutes) and involved education on tendon care and loading, and effective on global improvement, but not pain, than corticosteroid injection. daily home exercises (hip abductor strengthening; dynamic control of hip adduction). The corticosteroid injections were ultrasound-guided by a radiol- Provenance: Invited. Not peer reviewed. ogist. The wait-and-see approach included one session with a physiotherapist for information about gluteal tendinopathy, risk factors, advice regarding Britt Elin Øiestad continuation of activity, and reassurance. Outcome measures: Primary out- Department of Physiotherapy, Oslo Metropolitan University, Norway comes were: global change in hip condition (numerical rating scale), https://doi.org/10.1016/j.jphys.2019.01.006 1836-9553/© 2019 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/). Commentary Newer treatment approaches for tendinopathy, typically for the achilles education and exercise over corticosteroid injection, providing a safe and and patellar tendons, have emphasised loading management and strength practical treatment approach for patients with gluteal tendinopathy. On training as the most important content of treatment, due to promising clinical average, participants completed over 80% of the prescribed exercises each results.1 Management of gluteal tendinopathy has usually included week, which illustrates that it was feasible. The article’s supplementary file corticosteroid injection, exercise, shock wave therapy, or surgery.2 A provides clear instructions for the exercise program, which can be readily favourable response to education plus exercise over corticosteroid injection implemented in clinics today and with little need for expensive equipment. means that clinicians and patients can opt for a low-risk treatment Therefore, this is clinically relevant research, which encourages evidence- approach.3 In addition, active rehabilitation has further benefits for the patient. informed practice for physiotherapists. An education plus exercise program offered within a supportive environment, where patients understand the reasons for performing the exercises, can Provenance: Invited. Not peer reviewed. increase self-efficacy. This may partly explain the reported improvements in functional outcomes and quality of life (secondary outcomes) observed over Sophie E Steenstrup the first 6 months with education plus exercise compared to corticosteroid Department of Physiotherapy, Oslo Metropolitan University, Norway injection. Unfortunately, Mellor et al did not measure return to previous ac- tivity levels. Future research could include more functional/sport-specific ex- https://doi.org/10.1016/j.jphys.2019.01.002 ercises in later stages of rehabilitation, and evaluate the impact on return to activity/sport. Evidence to support the effects of rehabilitation on return to References activity/sport is limited, and including such measures in the trial would have been of importance to patients and clinicians.4 Nonetheless, the results of this 1. Couppe C, et al. J Orthop Sports Phys Ther. 2015;45:853–863. trial are of great clinical relevance, supporting the use of load management 2. Grimaldi A, et al. Sports Med. 2015;45:1107–1119. 3. Coombes BK, et al. Lancet. 2010;20:1751–1767. 4. Ardern CL, et al. Br J Sports Med. 2016;50:853–864. 1836-9553/© 2019 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 65 (2019) 108 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Exercise interventions improve some walking-related outcomes in people with Parkinson’s disease Synopsis Summary of: Ni M, Hazzard JB, Signorile JF, Luca C. Exercise guidelines interventions – including balance training, cycling, physiotherapy, resis- for gait function in Parkinson’s disease: A systematic review and tance training, treadmill training, Tai Chi, and yoga – demonstrated su- meta-analysis. Neurorehabil Neural Repair. 2018;32:872–886. perior outcomes for comfortable gait speed (standardised mean difference (Hedges’ g) 0.45, 95% CI 0.23 to 0.66), fast gait speed (0.43, 95% CI 0.06 to Objective: To review the evidence of whether exercise improves walking- 0.80), stride/step length (0.38, 95% CI 0.11 to 0.65), and Timed Up and Go related outcomes in people with Parkinson’s disease. Data sources: test (20.46, 95% CI 20.71 to 20.21). For the majority of gait outcomes there MEDLINE, CINAHL Plus, PubMed, and SPORTDiscus were searched up to were no significant differences in treatment effects when exercise in- June 2017. Study selection: Randomised controlled trials involving people terventions were compared against active exercise control groups. Exer- with Parkinson’s disease, and in which exercise interventions were cise interventions had no significant effect across both exercise and non- compared to non-exercise control interventions or another form of exer- exercise comparators on double-leg support time, 6-minute walk test, cise. Outcome measures were: gait speed (comfortable and fast), stride/ Dynamic Gait Index, and Freezing of Gait questionnaire. Subanalyses step length, cadence, double-leg support time (percentage of the gait cycle evaluated effects of cueing and exercise duration as treatment effect duration), Timed Up and Go test, 6-minute walk test, Freezing of Gait moderators, and found no significant effect of either on the vast majority of questionnaire, and the Dynamic Gait Index. Data extraction: Two re- outcomes. Conclusion: Exercise interventions can improve gait speed, viewers extracted data. Methodological quality was assessed using the stride/step length, and Timed Up and Go test in people with Parkinson’s PEDro Scale, with differences in ratings resolved through discussion. Data disease, but at the time of this literature search there was little evidence synthesis: Of 669 trials initially identified, 40 were included in the meta- that one form of exercise training was superior to another. analysis, with a total of 1656 participants ranging in Hoehn and Yahr stages I to IV. PEDro scores ranged from 3 to 8 points, indicating low to high Provenance: Invited. Not peer reviewed. methodological quality. The studies evaluated a vast array of exercise in- terventions, including balance training, physiotherapy, resistance training, Prudence Plummer treadmill and overground gait training, Tai Chi, yoga, boxing, cycling, and Division of Physical Therapy, University of North Carolina at Chapel Hill, aquatic therapy. When compared to non-exercise control groups, exercise USA https://doi.org/10.1016/j.jphys.2019.01.004 1836-9553/© 2019 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/). Commentary Although there is no cure for Parkinson’s disease, exercise in- In future exercise trials, the stage of disease progression needs be terventions are thought to help slow the rate of disease progression.1 The controlled, as well as Parkinson’s disease medication status, move- ment disorders and co-morbidities. As Ni et al highlight, Parkinson’s systematic review by Ni et al recommends particular exercises to improve disease exercise literature is currently hampered by many small trials with low power, and therefore needs to be cautiously interpreted walking in Parkinson’s disease, and concludes that ‘gait-specific training, when making recommendations for clinical guidelines. rather than a general exercise program, should be emphasized if gait is the Provenance: Invited. Not peer reviewed. outcome of interest.’ This recommendation may be premature, given recent large randomised controlled trials of physiotherapy for Meg E Morris Parkinson’s disease not included in the review (eg, 2–5). Collectively, this Healthscope & School of Allied Health, La Trobe University, Bundoora, work indicates that rather than prescribing gait-specific training only to improve walking in Parkinson’s disease, a range of exercise choices are Australia available for patients to improve their walking. https://doi.org/10.1016/j.jphys.2019.01.005 Given the complexity and wide individual differences in movement References disorders experienced by people with Parkinson’s disease, contemporary physiotherapy aims to personalise exercise and physical activities. Phys- 1. Abbruzzese G, et al. Parkinsonism Relat Disord. 2016;22(Suppl 1):S60–S64. 2. Canning CG, et al. Neurology. 2015;84:304–312. iotherapists also help motivate and support people with Parkinson’s dis- 3. Maidan I, et al. Neurorehabil Neural Repair. 2018;32:200–208. ease to keep moving every day. Gait-specific training is one choice within a 4. Morris ME, et al. Neurorehabil Neural Repair. 2015;29:777–785. complex array of person-centred therapies that need to be regularly 5. Schenkman M, et al. JAMA Neurol. 2018;75:219–226. 6. Shanahan J, et al. Arch Phys Med Rehabil. 2017;98:1744–1751. reviewed and adjusted over the course of the disease. Moreover, there are 7. Song J, et al. Clini Rehabil. 2018;32:299–311. 8. Furnari A, et al. Int J Neurosci. 2017;127:996–1004. now many randomised trials on less ‘conventional’ exercises for Parkin- son’s disease – such as dancing,6 video-gaming,7 boxing-type exercises, and robotics8 – that may be considered when individualising programs. 1836-9553/Crown Copyright © 2019 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 65 (2019) 108 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Exercise interventions improve some walking-related outcomes in people with Parkinson’s disease Synopsis Summary of: Ni M, Hazzard JB, Signorile JF, Luca C. Exercise guidelines interventions – including balance training, cycling, physiotherapy, resis- for gait function in Parkinson’s disease: A systematic review and tance training, treadmill training, Tai Chi, and yoga – demonstrated su- meta-analysis. Neurorehabil Neural Repair. 2018;32:872–886. perior outcomes for comfortable gait speed (standardised mean difference (Hedges’ g) 0.45, 95% CI 0.23 to 0.66), fast gait speed (0.43, 95% CI 0.06 to Objective: To review the evidence of whether exercise improves walking- 0.80), stride/step length (0.38, 95% CI 0.11 to 0.65), and Timed Up and Go related outcomes in people with Parkinson’s disease. Data sources: test (20.46, 95% CI 20.71 to 20.21). For the majority of gait outcomes there MEDLINE, CINAHL Plus, PubMed, and SPORTDiscus were searched up to were no significant differences in treatment effects when exercise in- June 2017. Study selection: Randomised controlled trials involving people terventions were compared against active exercise control groups. Exer- with Parkinson’s disease, and in which exercise interventions were cise interventions had no significant effect across both exercise and non- compared to non-exercise control interventions or another form of exer- exercise comparators on double-leg support time, 6-minute walk test, cise. Outcome measures were: gait speed (comfortable and fast), stride/ Dynamic Gait Index, and Freezing of Gait questionnaire. Subanalyses step length, cadence, double-leg support time (percentage of the gait cycle evaluated effects of cueing and exercise duration as treatment effect duration), Timed Up and Go test, 6-minute walk test, Freezing of Gait moderators, and found no significant effect of either on the vast majority of questionnaire, and the Dynamic Gait Index. Data extraction: Two re- outcomes. Conclusion: Exercise interventions can improve gait speed, viewers extracted data. Methodological quality was assessed using the stride/step length, and Timed Up and Go test in people with Parkinson’s PEDro Scale, with differences in ratings resolved through discussion. Data disease, but at the time of this literature search there was little evidence synthesis: Of 669 trials initially identified, 40 were included in the meta- that one form of exercise training was superior to another. analysis, with a total of 1656 participants ranging in Hoehn and Yahr stages I to IV. PEDro scores ranged from 3 to 8 points, indicating low to high Provenance: Invited. Not peer reviewed. methodological quality. The studies evaluated a vast array of exercise in- terventions, including balance training, physiotherapy, resistance training, Prudence Plummer treadmill and overground gait training, Tai Chi, yoga, boxing, cycling, and Division of Physical Therapy, University of North Carolina at Chapel Hill, aquatic therapy. When compared to non-exercise control groups, exercise USA https://doi.org/10.1016/j.jphys.2019.01.004 1836-9553/© 2019 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/). Commentary Although there is no cure for Parkinson’s disease, exercise in- In future exercise trials, the stage of disease progression needs be terventions are thought to help slow the rate of disease progression.1 The controlled, as well as Parkinson’s disease medication status, move- ment disorders and co-morbidities. As Ni et al highlight, Parkinson’s systematic review by Ni et al recommends particular exercises to improve disease exercise literature is currently hampered by many small trials with low power, and therefore needs to be cautiously interpreted walking in Parkinson’s disease, and concludes that ‘gait-specific training, when making recommendations for clinical guidelines. rather than a general exercise program, should be emphasized if gait is the Provenance: Invited. Not peer reviewed. outcome of interest.’ This recommendation may be premature, given recent large randomised controlled trials of physiotherapy for Meg E Morris Parkinson’s disease not included in the review (eg, 2–5). Collectively, this Healthscope & School of Allied Health, La Trobe University, Bundoora, work indicates that rather than prescribing gait-specific training only to improve walking in Parkinson’s disease, a range of exercise choices are Australia available for patients to improve their walking. https://doi.org/10.1016/j.jphys.2019.01.005 Given the complexity and wide individual differences in movement References disorders experienced by people with Parkinson’s disease, contemporary physiotherapy aims to personalise exercise and physical activities. Phys- 1. Abbruzzese G, et al. Parkinsonism Relat Disord. 2016;22(Suppl 1):S60–S64. 2. Canning CG, et al. Neurology. 2015;84:304–312. iotherapists also help motivate and support people with Parkinson’s dis- 3. Maidan I, et al. Neurorehabil Neural Repair. 2018;32:200–208. ease to keep moving every day. Gait-specific training is one choice within a 4. Morris ME, et al. Neurorehabil Neural Repair. 2015;29:777–785. complex array of person-centred therapies that need to be regularly 5. Schenkman M, et al. JAMA Neurol. 2018;75:219–226. 6. Shanahan J, et al. Arch Phys Med Rehabil. 2017;98:1744–1751. reviewed and adjusted over the course of the disease. Moreover, there are 7. Song J, et al. Clini Rehabil. 2018;32:299–311. 8. Furnari A, et al. Int J Neurosci. 2017;127:996–1004. now many randomised trials on less ‘conventional’ exercises for Parkin- son’s disease – such as dancing,6 video-gaming,7 boxing-type exercises, and robotics8 – that may be considered when individualising programs. 1836-9553/Crown Copyright © 2019 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 65 (2019) 109 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Home-based versus centre-based cardiac rehabilitation have similar outcomes Synopsis Summary of: Anderson L, Sharp GA, Norton RJ, Dalal H, Dean SJ, Jolly K, pooled data, there were no differences in the effects of home-based and et al. Home-based versus centre-based cardiac rehabilitation. Cochrane centre-based programs on: mortality up to 12 months (RR 1.19, 95% CI 0.65 Database Syst Rev. 2017;6:CD007130. to 2.16, 11 studies, 1505 participants, very low-quality evidence), exercise capacity up to 12 months (SMD –0.13, 95% CI –0.28 to 0.02, 22 studies, 2255 Objective: To review the evidence of whether home-based and centre- participants, low-quality evidence), and health-related quality of life up to based cardiac rehabilitation have similar outcomes in patients with heart 24 months (in 61/67 domains, 14 studies, 2079 participants, moderate- disease. Data sources: Cochrane Central Register of Controlled Trials, quality evidence). Similarly, there were no between-group differences in MEDLINE, Embase, PsycINFO and CINAHL, searched up to September 2016. cardiac events, total cholesterol, low-density lipoprotein cholesterol, blood This search was supplemented by searching of trials registers and citation pressure, proportion of smokers at follow-up, and costs. Small differences in tracking. Study selection: Randomised controlled trials involving patients favour of centre-based programs were demonstrated for high-density li- with recent myocardial infarction, revascularisation or heart failure, in poprotein cholesterol and triglycerides. Conversely, there were marginally which home-based and centre-based cardiac rehabilitation were higher levels of program completion (RR 1.04, 95% CI 1.00 to 1.08, 22 studies, compared. Outcome measures were mortality, cardiac events, exercise ca- 2615 participants, low-quality evidence) and adherence in home-based pacity, health-related quality of life, program completion, modifiable car- programs. Conclusion: Home-based programs represent an alternative to diac risk factors, adherence and cost. Data extraction: Two reviewers widen access and improve completion of cardiac rehabilitation. extracted data, and discrepancies were resolved by discussion. Methodo- logical quality was assessed using the Cochrane Risk of Bias tool. Data Provenance: Invited. Not peer reviewed. synthesis: Of 10 482 studies initially identified by the search, 23 with a total of 2890 patients were included in the review. A number of trials provided Mark Elkins insufficient detail to assess methodological quality, contributing to a low- Centre for Education & Workforce Development, to-moderate level of evidence overall. The majority of home-based pro- grams used walking with phone support, while centre-based programs Sydney Local Health District, Australia typically incorporated supervised cycle and treadmill exercise. Based on the https://doi.org/10.1016/j.jphys.2019.01.007 1836-9553/© 2019 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/). Commentary Traditionally, cardiac rehabilitation is delivered face-to-face in hospi- clinical and health-related quality of life outcomes between the two programs tals, universities or community centres, with participants attending a in patients with heart disease. This finding, in conjunction with a lack of median of 20 sessions (two sessions/week over 9 weeks).1 While cardiac between-group difference in healthcare costs, supports that the program rehabilitation is recognised as a beneficial and cost-effective mitigation choice should be based on local resources and patient preferences. With ad- strategy,2 participation remains sub-optimal.3 Interest in home-based vances in technology, there are growing opportunities to deliver home-based programs has increased because of their potential to widen access and programs as demonstrated by recent studies in telerehabilitation.7,8 Future improve participation. These home-based programs may involve self-help studies should continue to expand on innovative models for home-based manuals, supervised or unsupervised exercise, and use of technology such cardiac rehabilitation. as video-based telerehabilitation. The majority of patients who need exercise-based rehabilitation are willing and confident to use such tech- Provenance: Invited. Not peer reviewed. nology for telerehabilitation in their homes.4–6 It is therefore helpful to have this review to confirm the effectiveness of home-based cardiac Rita Hwang rehabilitation. Department of Physiotherapy, Princess Alexandra Hospital, This review used robust methods, including the Grading of Recommen- Metro South Health, Brisbane, Australia dations Assessment, Development and Evaluation (GRADE) approach and assessment of small study and publication biases. One limitation is that most of https://doi.org/10.1016/j.jphys.2019.01.008 the included trials were conducted in high-income countries so it may be difficult to generalise the results. Furthermore, it is unclear if these short-term References effects are sustainable, as only three trials reported outcomes beyond 12 months. Lastly, inconsistent reporting of some trials may hinder the confidence 1. Pesah E, et al. Prog Cardiovasc Dis. 2017;60:267–280. in and generalisability of the results. 2. Anderson L, et al. Database Syst Rev. 2016;1:CD001800. 3. Doll JA, et al. JAMA Internal Medicine. 2015;175:1700–1701. Home-based programs represent an alternative to widen access and 4. Seidman Z, et al. J Physiother. 2017;63:175–181. improve completion of cardiac rehabilitation. These programs offer patients an 5. Gallagher R, et al. JMIR mHealth and uHealth. 2017;5:e161. opportunity to exercise in the comfort of their homes, while alleviating 6. Bonnevie T, et al. J Physiother. 2019;65:28–36. transport barriers. There appears to be similar effectiveness in improving 7. Hwang R, et al. J Physiother. 2017;63:101–107. 8. Kraal JJ, et al. Eur J Prev Cardiol. 2017;24:1260–1273. 1836-9553/Crown Copyright © 2019 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 65 (2019) 109 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Home-based versus centre-based cardiac rehabilitation have similar outcomes Synopsis Summary of: Anderson L, Sharp GA, Norton RJ, Dalal H, Dean SJ, Jolly K, pooled data, there were no differences in the effects of home-based and et al. Home-based versus centre-based cardiac rehabilitation. Cochrane centre-based programs on: mortality up to 12 months (RR 1.19, 95% CI 0.65 Database Syst Rev. 2017;6:CD007130. to 2.16, 11 studies, 1505 participants, very low-quality evidence), exercise capacity up to 12 months (SMD –0.13, 95% CI –0.28 to 0.02, 22 studies, 2255 Objective: To review the evidence of whether home-based and centre- participants, low-quality evidence), and health-related quality of life up to based cardiac rehabilitation have similar outcomes in patients with heart 24 months (in 61/67 domains, 14 studies, 2079 participants, moderate- disease. Data sources: Cochrane Central Register of Controlled Trials, quality evidence). Similarly, there were no between-group differences in MEDLINE, Embase, PsycINFO and CINAHL, searched up to September 2016. cardiac events, total cholesterol, low-density lipoprotein cholesterol, blood This search was supplemented by searching of trials registers and citation pressure, proportion of smokers at follow-up, and costs. Small differences in tracking. Study selection: Randomised controlled trials involving patients favour of centre-based programs were demonstrated for high-density li- with recent myocardial infarction, revascularisation or heart failure, in poprotein cholesterol and triglycerides. Conversely, there were marginally which home-based and centre-based cardiac rehabilitation were higher levels of program completion (RR 1.04, 95% CI 1.00 to 1.08, 22 studies, compared. Outcome measures were mortality, cardiac events, exercise ca- 2615 participants, low-quality evidence) and adherence in home-based pacity, health-related quality of life, program completion, modifiable car- programs. Conclusion: Home-based programs represent an alternative to diac risk factors, adherence and cost. Data extraction: Two reviewers widen access and improve completion of cardiac rehabilitation. extracted data, and discrepancies were resolved by discussion. Methodo- logical quality was assessed using the Cochrane Risk of Bias tool. Data Provenance: Invited. Not peer reviewed. synthesis: Of 10 482 studies initially identified by the search, 23 with a total of 2890 patients were included in the review. A number of trials provided Mark Elkins insufficient detail to assess methodological quality, contributing to a low- Centre for Education & Workforce Development, to-moderate level of evidence overall. The majority of home-based pro- grams used walking with phone support, while centre-based programs Sydney Local Health District, Australia typically incorporated supervised cycle and treadmill exercise. Based on the https://doi.org/10.1016/j.jphys.2019.01.007 1836-9553/© 2019 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/). Commentary Traditionally, cardiac rehabilitation is delivered face-to-face in hospi- clinical and health-related quality of life outcomes between the two programs tals, universities or community centres, with participants attending a in patients with heart disease. This finding, in conjunction with a lack of median of 20 sessions (two sessions/week over 9 weeks).1 While cardiac between-group difference in healthcare costs, supports that the program rehabilitation is recognised as a beneficial and cost-effective mitigation choice should be based on local resources and patient preferences. With ad- strategy,2 participation remains sub-optimal.3 Interest in home-based vances in technology, there are growing opportunities to deliver home-based programs has increased because of their potential to widen access and programs as demonstrated by recent studies in telerehabilitation.7,8 Future improve participation. These home-based programs may involve self-help studies should continue to expand on innovative models for home-based manuals, supervised or unsupervised exercise, and use of technology such cardiac rehabilitation. as video-based telerehabilitation. The majority of patients who need exercise-based rehabilitation are willing and confident to use such tech- Provenance: Invited. Not peer reviewed. nology for telerehabilitation in their homes.4–6 It is therefore helpful to have this review to confirm the effectiveness of home-based cardiac Rita Hwang rehabilitation. Department of Physiotherapy, Princess Alexandra Hospital, This review used robust methods, including the Grading of Recommen- Metro South Health, Brisbane, Australia dations Assessment, Development and Evaluation (GRADE) approach and assessment of small study and publication biases. One limitation is that most of https://doi.org/10.1016/j.jphys.2019.01.008 the included trials were conducted in high-income countries so it may be difficult to generalise the results. Furthermore, it is unclear if these short-term References effects are sustainable, as only three trials reported outcomes beyond 12 months. Lastly, inconsistent reporting of some trials may hinder the confidence 1. Pesah E, et al. Prog Cardiovasc Dis. 2017;60:267–280. in and generalisability of the results. 2. Anderson L, et al. Database Syst Rev. 2016;1:CD001800. 3. Doll JA, et al. JAMA Internal Medicine. 2015;175:1700–1701. Home-based programs represent an alternative to widen access and 4. Seidman Z, et al. J Physiother. 2017;63:175–181. improve completion of cardiac rehabilitation. These programs offer patients an 5. Gallagher R, et al. JMIR mHealth and uHealth. 2017;5:e161. opportunity to exercise in the comfort of their homes, while alleviating 6. Bonnevie T, et al. J Physiother. 2019;65:28–36. transport barriers. There appears to be similar effectiveness in improving 7. Hwang R, et al. J Physiother. 2017;63:101–107. 8. Kraal JJ, et al. Eur J Prev Cardiol. 2017;24:1260–1273. 1836-9553/Crown Copyright © 2019 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 65 (2019) 106 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Nasal continuous positive airway pressure for infants with meconium aspiration syndrome reduces the need for mechanical ventilation in the first seven days of life Synopsis Summary of: Pandita A, Murki S, Oleti TP, Tandur B, Kiran S, Narkhede was weaned from nasal continuous positive airway pressure when S, Prajapati A. Effect of Nasal Continuous Positive Airway Pressure on oxygen saturation was consistently . 90%, the fraction of inspired Infants With Meconium Aspiration Syndrome: A Randomized Clinical oxygen , 0.25 and there was no respiratory distress (respiratory rate , Trial. JAMA Pediatr. 2018;172:161-165. 60 breaths/minute, and no grunting). After weaning, oxygen was administered, if needed, via a hood or binasal oxygen prongs. The Question: Does nasal continuous positive airway pressure reduce the control group was started on hood oxygen, administered at 5 to 10 l/ need for mechanical ventilation in the first 7 days of life in neonates minute. Infants whose hood oxygen failed (ie, oxygen saturation , 90% with respiratory failure due to meconium aspiration syndrome? for . 15 minutes on fraction of inspired oxygen = 1) were rescued either Design: Randomised controlled trial with concealed allocation and with nasal continuous positive airway pressure or mechanical venti- blinded outcome assessment. Setting: Three tertiary care neonatal lation. Outcome measures: The primary outcome was the need for intensive care units in India. Participants: Inclusion criteria were in- mechanical ventilation in the first 7 days of life. Secondary outcome fants: born with meconium staining of amniotic fluid; . 35 weeks’ measures included need for surfactant. Results: A total of 135 partici- gestation and birth weight . 2000 g; admitted to the neonatal inten- pants completed the study (67 in the intervention group and 68 in the sive care unit in the first 24 hours of birth due to respiratory distress; control group). At 7 days, the intervention group had reduced need for and chest radiograph suggestive of meconium aspiration syndrome. mechanical ventilation (odds ratio [95% CI], 0.09 [0.02 to 0.43]) and Exclusion criteria were: intubation at admission; severe asphyxia (5- reduced need for surfactant (0.24 [0.05 to 0.87]). Conclusion: minute Apgar score , 3 and cord potential of hydrogen level , 7); Compared with hood oxygen, starting nasal continuous positive airway pneumothorax and/or air leak (visible on the admission chest radio- pressure early in neonates with meconium aspiration syndrome graph); and major malformations. Randomisation of 135 participants reduced the need for mechanical ventilation and surfactant. allocated 67 to an intervention group and 68 to a control group. In- terventions: The intervention group was started on a bubble nasal Provenance: Invited. Not peer reviewed. continuous positive airway pressure generator (Fisher and Paykel Care) using short binasal prongs. The starting pressure was 5 cmH2O. Both Vinicius Cavalheri the pressure and the fraction of inspired oxygen were adjusted to School of Physiotherapy and Exercise Science, Curtin University, Australia maintain target oxygen saturation between 90% and 95%. The neonate https://doi.org/10.1016/j.jphys.2018.11.011 Commentary Respiratory management of meconium aspiration syndrome is the healthcare system, especially in lower resourced settings. It is also complex, as the syndrome involves a combination of atelectasis, less invasive for the neonates and their families. However, it remains airflow obstruction and lung inflammation, along with the high risk controversial as to whether nasal continuous positive airway pressure of coexistent pulmonary hypertension.1 Whilst most neonates with will become routine management for all neonates with meconium meconium aspiration syndrome will have the mild form, when aspiration syndrome who do not require ventilation at birth, as some severe it can affect morbidity and mortality.2 may see that this is increased intervention compared with current standard care, where most infants only require head-box oxygen.1 Given that atelectasis is one of the main complications, the role of early Further research to determine which neonates with meconium nasal continuous positive airway pressure in the management of infants aspiration syndrome would benefit from nasal continuous airway with mild/moderate respiratory distress to prevent the need for me- pressure would be beneficial given the spectrum of the severity. chanical ventilation warrants further investigation. This well designed, multi-centre, moderate size randomised controlled trial examined the role Provenance: Invited. Not peer reviewed. of early continuous positive airway pressure (administered within a mean of 1.2 hours after birth) compared with standard care. The intervention Alicia Jane Spittle considerably reduced the need for mechanical ventilation, showing that Department of Physiotherapy, University of Melbourne; with every five newborns with meconium aspiration syndrome started on Victoria Infant Brain Studies, Murdoch Children’s Research Institute, early nasal continuous positive airway pressure, one was protected from requiring mechanical ventilation. It should be noted that treatment was Melbourne, Australia not without complication: one of the two infants in the intervention group went on to require mechanical ventilation and sustained a pneumothorax. https://doi.org/10.1016/j.jphys.2018.11.010 Although cost-effectiveness analysis was not part of this study, the References use of continuous positive airway pressure compared with more intensive care involving mechanical ventilation may reduce costs to 1. Dargaville PA. Int J Pediatr. 2012:e965159. 2. Singh BS, et al. J Perinatol. 2009;29:497–503. 1836-9553/© 2019 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 65 (2019) 106 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Nasal continuous positive airway pressure for infants with meconium aspiration syndrome reduces the need for mechanical ventilation in the first seven days of life Synopsis Summary of: Pandita A, Murki S, Oleti TP, Tandur B, Kiran S, Narkhede was weaned from nasal continuous positive airway pressure when S, Prajapati A. Effect of Nasal Continuous Positive Airway Pressure on oxygen saturation was consistently . 90%, the fraction of inspired Infants With Meconium Aspiration Syndrome: A Randomized Clinical oxygen , 0.25 and there was no respiratory distress (respiratory rate , Trial. JAMA Pediatr. 2018;172:161-165. 60 breaths/minute, and no grunting). After weaning, oxygen was administered, if needed, via a hood or binasal oxygen prongs. The Question: Does nasal continuous positive airway pressure reduce the control group was started on hood oxygen, administered at 5 to 10 l/ need for mechanical ventilation in the first 7 days of life in neonates minute. Infants whose hood oxygen failed (ie, oxygen saturation , 90% with respiratory failure due to meconium aspiration syndrome? for . 15 minutes on fraction of inspired oxygen = 1) were rescued either Design: Randomised controlled trial with concealed allocation and with nasal continuous positive airway pressure or mechanical venti- blinded outcome assessment. Setting: Three tertiary care neonatal lation. Outcome measures: The primary outcome was the need for intensive care units in India. Participants: Inclusion criteria were in- mechanical ventilation in the first 7 days of life. Secondary outcome fants: born with meconium staining of amniotic fluid; . 35 weeks’ measures included need for surfactant. Results: A total of 135 partici- gestation and birth weight . 2000 g; admitted to the neonatal inten- pants completed the study (67 in the intervention group and 68 in the sive care unit in the first 24 hours of birth due to respiratory distress; control group). At 7 days, the intervention group had reduced need for and chest radiograph suggestive of meconium aspiration syndrome. mechanical ventilation (odds ratio [95% CI], 0.09 [0.02 to 0.43]) and Exclusion criteria were: intubation at admission; severe asphyxia (5- reduced need for surfactant (0.24 [0.05 to 0.87]). Conclusion: minute Apgar score , 3 and cord potential of hydrogen level , 7); Compared with hood oxygen, starting nasal continuous positive airway pneumothorax and/or air leak (visible on the admission chest radio- pressure early in neonates with meconium aspiration syndrome graph); and major malformations. Randomisation of 135 participants reduced the need for mechanical ventilation and surfactant. allocated 67 to an intervention group and 68 to a control group. In- terventions: The intervention group was started on a bubble nasal Provenance: Invited. Not peer reviewed. continuous positive airway pressure generator (Fisher and Paykel Care) using short binasal prongs. The starting pressure was 5 cmH2O. Both Vinicius Cavalheri the pressure and the fraction of inspired oxygen were adjusted to School of Physiotherapy and Exercise Science, Curtin University, Australia maintain target oxygen saturation between 90% and 95%. The neonate https://doi.org/10.1016/j.jphys.2018.11.011 Commentary Respiratory management of meconium aspiration syndrome is the healthcare system, especially in lower resourced settings. It is also complex, as the syndrome involves a combination of atelectasis, less invasive for the neonates and their families. However, it remains airflow obstruction and lung inflammation, along with the high risk controversial as to whether nasal continuous positive airway pressure of coexistent pulmonary hypertension.1 Whilst most neonates with will become routine management for all neonates with meconium meconium aspiration syndrome will have the mild form, when aspiration syndrome who do not require ventilation at birth, as some severe it can affect morbidity and mortality.2 may see that this is increased intervention compared with current standard care, where most infants only require head-box oxygen.1 Given that atelectasis is one of the main complications, the role of early Further research to determine which neonates with meconium nasal continuous positive airway pressure in the management of infants aspiration syndrome would benefit from nasal continuous airway with mild/moderate respiratory distress to prevent the need for me- pressure would be beneficial given the spectrum of the severity. chanical ventilation warrants further investigation. This well designed, multi-centre, moderate size randomised controlled trial examined the role Provenance: Invited. Not peer reviewed. of early continuous positive airway pressure (administered within a mean of 1.2 hours after birth) compared with standard care. The intervention Alicia Jane Spittle considerably reduced the need for mechanical ventilation, showing that Department of Physiotherapy, University of Melbourne; with every five newborns with meconium aspiration syndrome started on Victoria Infant Brain Studies, Murdoch Children’s Research Institute, early nasal continuous positive airway pressure, one was protected from requiring mechanical ventilation. It should be noted that treatment was Melbourne, Australia not without complication: one of the two infants in the intervention group went on to require mechanical ventilation and sustained a pneumothorax. https://doi.org/10.1016/j.jphys.2018.11.010 Although cost-effectiveness analysis was not part of this study, the References use of continuous positive airway pressure compared with more intensive care involving mechanical ventilation may reduce costs to 1. Dargaville PA. Int J Pediatr. 2012:e965159. 2. Singh BS, et al. J Perinatol. 2009;29:497–503. 1836-9553/© 2019 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 65 (2019) 81–87 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Research Exercises using a touchscreen tablet application improved functional ability more than an exercise program prescribed on paper in people after surgical carpal tunnel release: a randomised trial Jesús Blanquero a, María Dolores Cortés-Vega a, María Ángeles García-Frasquet b, Pablo Rodríguez Sánchez-Laulhé c, María Isabel Nieto Díaz de los Bernardos b, Alejandro Suero-Pineda c a Physiotherapy Department, University of Seville; b Hand Surgery Division, Virgen Macarena University Hospital; c Andalusian Public Foundation for the Management of Health Research of Seville FISEVI, Seville, Spain KEY WORDS ABSTRACT Carpal tunnel syndrome Question: In people who have undergone surgical carpal tunnel release, do sensorimotor-based exercises Exercise therapy performed on the touchscreen of a tablet device improve outcomes more than a conventional home Feedback sensory exercise program prescribed on paper? Design: Randomised, parallel-group trial with concealed Mobile applications allocation, assessor blinding, and intention-to-treat analysis. Participants: Fifty participants within 10 days of surgical carpal tunnel release. Intervention: Each participant was prescribed a 4-week home exercise program. Participants in the experimental group received the ReHand tablet application, which administered and monitored exercises via the touchscreen. The control group was prescribed a home exercise program on paper, as is usual practice in the public hospital system. Outcome measures: The primary outcome was functional ability of the hand, reported using the shortened form of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Secondary outcomes were grip strength, pain intensity measured on a 10-cm visual analogue scale, and dexterity measured with the Nine-Hole Peg Test. Outcomes were measured by a blinded assessor at baseline and at the end of the 4-week intervention period. Results: At Week 4, functional ability improved significantly more in the experimental group than the control group (MD –21, 95% CI –33 to –9) on the QuickDASH score (0 to 100). Although the mean estimates of effect on the secondary outcome also all favoured the experimental group, none reached statistical significance: grip strength (MD 5.6 kg, 95% CI –0.5 to 11.7), pain (MD –1.4 cm, 95% CI –2.9 to 0.1), and dexterity (MD –1.3 seconds, 95% CI –3.7 to 1.1). Conclusion: Use of the ReHand tablet application for early rehabilitation after carpal tunnel release is more effective in the recovery of functional ability than a conventional home exercise program. It remains unclear whether there are any benefits in grip strength, pain or dexterity. Trial registration: ACTRN12618001887268. [Blanquero J, Cortés-Vega MD, García-Frasquet MÁ, Sánchez-Laulhé PR, Nieto Díaz de los Bernardos MI, Suero-Pineda A (2019) Exercises using a touchscreen tablet application improved functional ability more than an exercise program prescribed on paper in people after surgical carpal tunnel release: a randomised trial. Journal of Physiotherapy 65:81–87] © 2019 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 should be used is controversial.3 Post-surgical immobilisation, despite a lack of scientific evidence reporting its value3–5 and the Carpal tunnel syndrome is a focal and compressive neuropathy in existence of Level 1 evidence of its lack of benefit,6 is still employed which raised pressure in the carpal canal results in median nerve compression and impaired nerve perfusion, leading to by approximately half of surgeons, although the number of discomfort and paraesthesia in the hand.1,2 Conservative treatments professionals advocating for it is decreasing annually.6 Several groups are recommended as initial management, whereas surgery is generally recommended in refractory cases.2 of authors have found that there is no beneficial effect obtained from Carpal tunnel decompression is the accepted surgical treatment postoperative immobilisation compared to soft dressing allowing when conservative measures fail,1 with the rate of surgical movement after carpal tunnel release.7–9 Other studies have reported intervention after initial conservative management being between 57 and 66%.2 Open carpal tunnel release is the standard surgical that early mobilisation results in an improvement in pain, grip and technique.1 However, the method of post-surgical rehabilitation that pinch strength,10 as well as a reduction in the time to return to activities of daily living and work,10,11 compared to immobilisation. In light of this evidence, the European guidelines12 state that exercises should be considered for the postoperative period. https://doi.org/10.1016/j.jphys.2019.02.008 1836-9553/© 2019 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/).
82 Blanquero et al: Tablet-based exercise after carpal tunnel release A systematic review identified that home exercise programs have Participants, therapists, centres similar effects as face-to-face rehabilitation on function, dexterity and strength after carpal tunnel release.4 In one of the reviewed People aged between 18 and 65 years old who had undergone studies, Provinciali et al compared a multimodal rehabilitation surgical carpal tunnel release were consecutively screened at Virgen program against a 2-week home exercise program in a sample of Macarena and Virgen del Rocio University Hospitals, Seville, Spain. 100 participants; no significant between-group differences were Two experienced hand surgeons performed screening against these found in the Boston Carpal Tunnel Questionnaire, Jebsen-Taylor test, inclusion criteria: diagnosis of carpal tunnel syndrome was based on and 9-Hole Peg Test after 3 months of follow-up.13 Pomerance et al history, examination, and nerve conduction studies; open carpal compared, in a sample of 150 participants, the treatment by a tunnel release with a standard surgical approach was no more than hand therapist against a home exercise program; they found no 10 days prior to the baseline measurement; and a tablet device was significant differences in pain, grip and pinch strength or the Dis- accessible to the person for the study period. Potential participants abilities of the Arm, Shoulder and Hand (DASH) questionnaire after were excluded if they had: a history of neurological, psychiatric or 3 and 6 months of follow-up.14 They also made an observation cognitive disorder; or a plan to receive physiotherapy during the about the relative cost-effectiveness of home exercise programs and 4-week study period. face-to-face rehabilitation, concluding that the latter seems to be unjustified for uncomplicated patients with conventional short After confirmation of eligibility and completion of the baseline incisions.14 measurements, an independent researcher randomly allocated participants via a computer-generated, random allocation schedule Carpal tunnel syndrome is not just a peripheral problem; it has a without knowledge of the baseline measurement results. This central involvement, which rehabilitation (including home exercise researcher also: explained how to carry out the randomly allocated programs) ought to address. This central involvement is characterised intervention; asked the participant not to reveal this intervention to by cortical reorganisation caused by chronic median nerve any of the study’s investigators; answered any questions from the dysfunction and altered somatosensory afference.15 In people with participant; and provided telephone support. In addition, this carpal tunnel syndrome, this impacts sensorimotor integration and independent researcher oversaw the weekly monitoring of the motor performance,16,17 resulting in deficits in dextrous manipulation participants. Since it was not possible to blind participants, efforts and finger force distribution control.18,19 Those abilities are basic for were made to keep participants unaware of the details of the activities of daily living, relating directly to the impairment of intervention being allocated to the opposite group. For this reason, functionality and quality of life in people with carpal tunnel the two interventions were described in the information sheet as syndrome. home-based exercise programs with differing formats. Some recent preliminary studies have shown that an exercise Interventions application (app) on a tablet device can improve dexterity and corticospinal drive to spinal motoneurons.20,21 This study is part of a Participants in both groups were advised to carry out their larger body of research that has studied the effectiveness of a allocated exercise intervention autonomously at home, completing sensorimotor approach for the recovery of hand trauma pathologies, one session a day on at least 5 days a week, for 4 weeks. The exercise through the enhancement of neuromuscular control and the effect at program lasted approximately 25 minutes per session. The cortical level.22 Therefore, one way to expand this field of knowledge differences between the two groups were the exercise program is through a new sensorimotor modality via a tablet touchscreen employed and how adherence to treatment was measured. using the ReHand app. ReHand is an app specifically developed for the trauma approach of the wrist, hand and fingers through exercises Experimental group that are performed on the touchscreen. The app has been developed Participants in the experimental group performed the home by and under the supervision of healthcare professionals, including surgeons, physiotherapists and occupational therapists, so the exercise program using the ReHand tablet app. This app was functionalities seek to meet the needs that these professionals developed under the guidance of several healthcare professionals identified through their patients in practice. (surgeons, physiotherapists and occupational therapists) for use on Android and iOS tablets to enhance, through controlled active work, Therefore, the research question for this randomised trial was: the dexterity and functionality of the wrist, hand and fingers after traumatic injury. ReHand has a range of specific exercises for these In people who have undergone surgical carpal tunnel release, do purposes, which can be configured into an exercise program sensorimotor-based exercises performed on the touchscreen of a according to the pathology and progress of the patient. All of the tablet device improve outcomes more than a conventional home exercises are performed on the tablet touchscreen (Figure 1). For the exercise program prescribed on paper? experimental group, a specific program was designed for rehabilitation after carpal tunnel release consisting of exercises for Method mobility, co-ordination and dexterity of the hand, wrist and fingers, as described in detail in Table 1. The exercises are performed by Design making taps and movements while touching the touchscreen and guided by feedback, thereby enabling sensorimotor-based, controlled, An assessor-blinded, parallel-group, randomised controlled trial active exercise. To assist users to understand each exercise on the app, was undertaken in people who had undergone surgical carpal tunnel it gives both step-by-step real-time instructions and a video release. The study was conducted from November 2018 to January demonstration of the exercise being performed. The explanation of 2019. Participants were randomly allocated to an experimental group this intervention to the participants randomised to the experimental or a control group using a computer-generated, concealed allocation group included: a 5-minute demonstration of how to use the ReHand schedule. All participants received a 4-week home exercise program. app on a tablet; information about how to download the app from Participants in the experimental group were allocated a program that Android and iOS sources; provision of a username and password; and included sensorimotor-based exercises performed using a tablet telephone support. touchscreen. Participants in the control group received a home exercise program conventionally provided on paper for rehabilitation Data were transferred from the app to a web management panel, after carpal tunnel release in the public healthcare system. Data were which allowed monitoring of adherence to the prescribed exercise collected by a blinded assessor prior to randomisation and 4 weeks program. In this group, this system was used by the researcher in later. charge of monitoring. Those participants who did not use the app in the first 5 days were telephoned to ensure that they were not experiencing technical difficulties.
Research 83 Figure 1. Example of performance of an exercise in the experimental intervention. Secondary outcomes Grip strength measurement was performed using a hydraulic grip Control group The participants of this group received a home exercise program dynamometera. Participants were seated comfortably upright, with both feet on the ground, shoulders adducted and neutrally rotated, on paper. This program is conventionally used in the public hospital elbow flexed at 90 deg, forearm in neutral rotation, and wrist system for early rehabilitation after carpal tunnel release. The between 0 deg and 30 deg dorsiflexion and between 0 deg and 15 deg exercises are focused on mobility of the entire upper limb, with ulnar deviation. Three successive trials were recorded for each test, greater emphasis on those exercises relating to the hand. These with 30 seconds of rest between each measurement. The average of exercises are detailed in Table 2. A researcher monitored the exercises the three measurements was used in the analysis. This procedure has performed by the participant through a weekly telephone call. been well documented as reliable.26 Outcome measures Pain severity was assessed on a visual analogue scale of 0 to 10 cm, where a score of 0 equated to ‘no pain’ and 10 equated to the ‘most Baseline measures were collected between 7 and 10 days after severe pain’. surgery and prior to random allocation to a study group. Final measures were collected 4 weeks later, at the end of the intervention The Nine-Hole Peg Test is one of the most commonly used tools for period. All measures were assessed in each participant individually assessing dexterity.27 The test uses a square board with nine holes, with a and face-to-face. The measurements were made by a single container holding nine pegs attached to it. The participant must pick up physiotherapist with extensive clinical experience, who was blinded one peg at a time and put it into a hole until all the holes are filled in any to each participant’s allocated group. Participants were also blind to order. Then, the participant must remove all the pegs one at a time and allocation during the baseline measurements and subsequently they return them to the container. Standard instructions for the test were given were instructed not to reveal to the assessor the group to which they along with a brief demonstration.28 Participants performed a brief belonged. practice test prior to the actual test. Primary outcome Assessor blinding was evaluated at the end of the trial by asking Changes in self-reported functional ability were measured on the the assessor if any of the participants had indicated to which group they had been allocated. DASH questionnaire, which is considered to be one of the main measurements in carpal tunnel research.3 The DASH questionnaire Data analysis has been shown to be reliable and valid, and has been successfully translated into Spanish.3,23 Functional ability was measured through The intention-to-treat principle was used for data analysis. Mean the shortened form of the DASH questionnaire (QuickDASH), which scores, SDs and between-group differences (95% CIs) were calculated has a discriminant ability, cross-sectional reliability and test-retest for all outcomes at baseline and at the end of the 4-week intervention reliability similar to the DASH questionnaire,24 which further period. The between-group differences and their respective 95% CIs demonstrates its validity and practical utility in people who have were calculated using linear mixed models with group, time and group- undergone carpal tunnel release.25 versus-time interaction terms. The confidence level adopted was 5% and statistical analyses were performed using commercial softwareb. Results Flow of participants Of 72 screened subjects, 50 met the selection criteria and completed the study. The flow of participants is detailed in Figure 2. The mean age of the participants was 50 years (SD 8), of whom nine (18%) were men and 41 (82%) were women. The mean age of the participants in the experimental group was 51 years (SD 8), of whom three were male and 22 were female. The mean age of participants in the control group was 49 years (SD 7), of whom six were male and 19 were female. The groups had similar baseline scores on all the outcome measures. Baseline demographic and clinical characteristics of participants are presented in Table 3. Compliance with the study protocol All participants were allocated the treatment in line with their random allocation. All participants underwent baseline and final Table 1 Repetitions Description of experimental intervention (app-based exercises) for rehabilitation after carpal tunnel release. 4 Exercise (each repetition of the exercise lasts 25 seconds) 4 4 1. Pinch exercise with the index finger, performing a controlled movement in a painless range guided by feedback 4 2. Pinch exercise with the middle finger, performing a controlled movement in a painless range guided by feedback 4 3. Pinch exercise with the ring finger, performing a controlled movement in a painless range guided by feedback 4 4. Flexion-extension exercise of the index finger, performing a controlled movement in a painless range guided by feedback 4 5. Flexion-extension exercise of the middle finger, performing a controlled movement in a painless range guided by feedback 6. Hand-eye co-ordination exercise, making taps on the screen with each finger as the circles change colour 4 7. Hand opened and fingers extended, wrist stabilisation and little finger in contact with the tablet screen. Controlled wrist flexion-extension movement in painless range guided by feedback 8. Closed fist holding a stylus, wrist stabilisation and stylus in contact with the tablet screen. Controlled wrist flexion- extension movement in painless range guided by feedback
84 Blanquero et al: Tablet-based exercise after carpal tunnel release Sets Repetitions Table 2 3 15 Description of control intervention (home exercise program) conventionally used in public health services. 3 15 3 15 Exercise 3 15 3 15 1. Make a fist and then extend the fingers 3 15 2. With the hand opened and fingers extended, maximally extend the wrist 3 15 3. With the hand opened and fingers extended, maximally abduct the fingers 3 10 4. Contact each finger’s pad with the thumb pad 3 10 5. With a (semi-) closed fist, flex and extend the wrist 3 10 6. With the hand opened and fingers extended, deviate the hand towards radius and ulna 7. With a semi-closed fist, perform rotating movements of the fist 8. Standing or sitting in a chair, extend the elbow so that the upper limb hangs beside the body 9. From the previous position, slowly raise the upper limb to the horizontal plane with the elbow in extension 10. From the previous position, flex the elbow and touch the same shoulder with your fingers measures. No participants revealed their group allocation to the format of rehabilitation through movements and taps on dynamic assessor. touchscreen targets might provide more effective rehabilitation after carpal tunnel release than the results obtained with a home exercise Effect of intervention program prescribed on paper. At Week 4, functional ability improved significantly more in the It is important to consider whether the effect observed on the experimental group than the control group (MD –21, 95% CI –33 to primary outcome is likely to be clinically worthwhile. The protocol for –9) on the QuickDASH score (0 to 100). Summary data are presented this study did not prospectively nominate the smallest effect on the in Table 4 and individual-participant data are presented in Table 5 on primary outcome that would make using the app (as opposed to the eAddenda. using the paper handout) to carry out the home program worthwhile. It seems reasonable to assume that this smallest worthwhile effect Although the mean estimates of effect on the secondary would be marginal, given that the costs, risks and inconveniences of outcome also all favoured the experimental group, none reached the experimental and control interventions in the study were not statistical significance: grip strength (MD 5.6kg, 95% CI –0.5 to 11.7), very different. Specifically, apps are generally relatively inexpensive, pain (MD –1.4 cm, 95% CI –2.9 to 0.1), and dexterity (MD –1.3 seconds, the risk of adverse effects was low in both groups (neither group 95% CI –3.7 to 1.1). Summary data are presented in Table 4 reported any adverse events), and the time and effort involved in and individual-participant data are presented in Table 5 on the performing the exercises was very similar in both groups. One factor eAddenda. that would increase the cost of the experimental intervention would be providing a tablet to patients who do not have one. However, Discussion many patients already have at least temporary access to a tablet and an institution may be able to loan a tablet with the experimental app The main finding of this study was that an exercise program loaded on it to successive patients after carpal tunnel release. administered via an app on a tablet produced a significantly greater Therefore, the authors consider that the mean estimate of the effect improvement in self-reported functional ability than an exercise (21 points extra benefit on the 100-point QuickDASH from using the program prescribed on paper. This result suggests that the innovative app instead of the paper handout) would make using the app worthwhile. Arguably, even the lower end of the confidence interval Screened (n = 72) Excluded (n = 22) • > 10 days since surgery (n = 18) • history of neurological disorder (n = 2) • declined (n = 2) Measured functional ability, pain, dexterity and grip strength Week 0 Randomised (n = 50) (n = 25) (n = 25) Lost to follow-up (n = 0) Experimental group Control group Lost to follow-up (n = 0) • sensorimotor-based • conventional home exercises performed exercise program on the touchscreen prescribed on of a tablet device at paper • ≥ 5 days per week home • ≥ 5 days per week • 4 weeks • 4 weeks Measured functional ability, pain, dexterity and grip strength Week 4 (n = 25) (n = 25) Figure 2. Design and flow of participants through the trial.
Research 85 Table 3 However, the less favourable end of the confidence interval must also Baseline characteristics of participants (n = 50). be considered. This negligible adverse effect (ie, 0.5 kg less improvement in grip strength) is reassuring because, even in the Characteristics Exp Con worst-case scenario, it shows that the improvement in the primary (n = 25) (n = 25) outcome was obtained without substantial detriment to the recovery of grip strength. Age (yr), mean (SD) 51 (8) 49 (7) Gender, n female (%) 22 (88) 19 (76) The next secondary outcome was dexterity assessed using the Functional ability (QuickDASH) (0 to 100), mean (SD) 73 (14) 66 (24) Nine-Hole Peg Test, which (like grip strength) was non-significant, Pain (VAS) (0 to 10), mean (SD) 5.1 (2.6) 4.8 (2.9) had a mean estimate that favoured the experimental treatment, Dexterity (NHPT) (s), mean (SD) 22.7 (3.9) 23.4 (5.3) and had a confidence interval that only extended a relatively small Grip strength (kg), mean (SD) 17.6 (12.0) 17.4 (14.7) way into the detrimental range (ie, at worst, 1 second less improvement on a test that takes 20 seconds on average). It is Con = control group, Exp = experimental group, NHPT = Nine-Hole Peg Test, therefore possible, but uncertain, that the improvement in QuickDASH = shortened form of the Disabilities of the Arm, Shoulder, and Hand self-reported functional ability might be due to improved dexterity questionnaire, VAS = Visual Analogue Scale. (which would be plausible, given that many of the items on the QuickDASH contain a dexterity component). We suggest that any (ie, 9 points extra improvement from using the app) might be amelioration of critical hand variables, such as pain, weakness or considered worthwhile by some patients, especially those who reduced functional ability, could arise from enhancement of the already have a tablet. sensorimotor system at both peripheral and central levels, achieving greater and more controlled ability to fire motor units, optimising It is also important to consider whether the results on the primary recruitment of the muscles involved. Manual dexterity is related to and secondary outcomes are believable and consistent with other the optimal development and function of the corticospinal system.30 research. The believability of the primary outcome is well supported The major contributor to the corticospinal system in primates is the by the robustness of the study’s methods, which included concealed primary motor cortex, which is related directly to primary somato- allocation, assessor blinding, complete follow-up and intention-to- sensory cortex. Thus, alteration in the primary somatosensory cortex treat analysis. The statistically significant result on the primary conditions the performance of the primary motor cortex.31 To assess outcome is unlikely to be a Type-I error (ie, a chance finding) because this relationship, coherence between cortical activity recorded by it was prospectively registered and only four statistical tests were electroencephalography and muscular activity recorded by electro- conducted in total. It is notable that the primary outcome was a myography has been used elsewhere, providing data on the status of subjective measure and the benefit was not also demonstrated on the information sent from the motor cortex and its transmission to another objective measure, which raises the possibility of a ‘polite the spinal motoneurons during muscle activation.32 Previous studies patient’ effect. However, participants were kept unaware of have shown that the performance of tasks that require great attention the opposite group’s intervention, which should have minimised the and precision33 and are influenced by practice34 (such as the activities potential for such an effect. Furthermore, further insight about included in the tablet app) influences this coherence, generating the secondary outcomes can be obtained by considering each one changes at the corticospinal level that reflect an optimisation in the individually. sensorimotor integration between the cortex and the muscle,34 achieving improvements in motor performance.35 This was one of The grip strength data are quite consistent with existing evidence. the results obtained by Larsen et al21 through tablet-based motor In the present study, grip strength increased from 17.4 to 25.9 kg in practice (3 3 10 minutes) with the non-dominant hand in 16 healthy the control group. This value in the control group after 4 weeks of females. Thus, it is proposed that through performing this type of intervention corresponds to data observed by Pomerance et al,14 task, communication between the motor cortex and motoneurons can where, after 4 weeks of home therapy exercises, a grip strength of be facilitated, inducing and strengthening synaptic plasticity between 24 kg was observed. The mean between-group difference in change in both networks and a higher coherence.35 A significant effect on grip strength in the present study was 5.6 kg in favour of the dexterity will be necessary to demonstrate the relevance of this experimental group. While this result was non-significant, the mechanism, which could be the focus of future research. In the confidence interval includes the possibility that the true mean effect meantime, it can be assumed that the improvement in self-reported could be over 11 kg. This could be partly explained by conclusions functional ability may or may not come from improved dexterity, drawn by Kamath et al,29 whereby the improvement in grip strength but it certainly does not come at the expense of substantial detriment was greatest from the tenth day to the third month after the to dexterity. operation. Our hypothesis was that the sensorimotor-based, controlled and early work that ReHand allows might accelerate the The remaining secondary outcome is pain, which has a recovery of strength. Early recovery of strength may also be related to fundamental role in this cortical synchrony. As one of the main the enhancement of other measures, such as functional ability and generators of the alterations in the primary somatosensory cortical pain, aligning with findings from previous studies. For example, representations,36 pain creates a redistribution of activity within a Pomerance et al found an average DASH and self-reported pain scores muscle37 and changes the mechanical behaviour of the movement.38 of 18 and 1 points, respectively, after 6 months of home exercises This suggests that controlled painless activities (such as those after carpal tunnel release.14 This progression of the DASH score implemented in ReHand through previous pain-free movement aligns with the results obtained in the current control group, calibration) are appropriate because they seek to avoid the where this functional score improved from 66 to 53 points during 1 month of conventional exercises, suggesting that a similar evolution to Pomerance et al would be followed at 6 months. Table 4 Mean (SD) of groups, mean (SD) difference within groups, and mean (95% CI) difference between groups. Outcome Groups Difference within groups Difference between groups Week 4 minus Week 0 Week 4 minus Week 0 Week 0 Week 4 Exp (n = 25) Con (n = 25) Exp (n = 25) Con (n = 25) Exp Con Exp minus Con Functional ability (QuickDASH) (0 to 100) 73 (14) 66 (24) 39 (24) 53 (24) –34 (18) –13 (24) –21 (–33 to –9) Pain (VAS) (0 to 10) 5.1 (2.6) 4.8 (2.9) 4.0 (2.7) 5.0 (3.2) –1.2 (2.8) 0.2 (2.3) –1.4 (–2.9 to 0.1) Dexterity (NHPT) (s) 22.7 (3.9) 23.4 (5.3) 18.1 (2.3) 20.1 (4.7) –4.6 (3.6) –3.3 (4.6) –1.3 (–3.7 to 1.1) Grip strength (kg) 17.6 (12.0) 17.4 (14.7) 31.6 (12.7) 25.9 (13.1) 14.1 (12.2) 8.5 (8.9) 5.6 (–0.5 to 11.7) Con = control group, Exp = experimental group, VAS = visual analogue scale, NHPT = Nine-Hole Peg Test, QuickDASH = shortened format of the Disabilities of the Arm, Shoulder, and Hand questionnaire.
86 Blanquero et al: Tablet-based exercise after carpal tunnel release mechanisms that cause alteration of the sensorimotor system and Footnotes: a Baseline, Irvington, NY, USA. b SPSS, IBM Corporation, provide a stimulus to return to the initial pattern. Therefore, a Armonk, NY, USA. significant reduction of pain in the experimental group would be expected to have contributed to improvement in functional ability. eAddenda: Table 5 can be found online at https://doi.org/10.1016/j. Again, however, the result was non-significant, the mean estimate jphys.2019.02.008. favoured the experimental group, and the confidence interval excluded all but the most trivial of detrimental effects (ie, 0.1 points Ethics approval: The Virgen Macarena and Virgen del Rocio Uni- less improvement on the 10-point visual analogue scale). Therefore, versity Hospitals Ethics Committee approved this study. All applicable to summarise all the secondary outcome results: it is unknown institutional and governmental regulations concerning the use of whether the improvement in self-reported functional ability might human volunteers were followed. All participants gave written have been due to improvements in pain, dexterity and/or strength, informed consent before data collection began. but it is clear that the significant benefit on the primary outcome was achieved without substantial detriment to recovery on the three Competing interests: Andalusian Health Service (SAS) has a secondary outcomes. collaboration agreement concerning the ReHand solution, and may benefit financially if this research generates a successful marketing Another possible explanation for the presence of an effect on the value related to ReHand. The terms of this agreement have been primary outcome but not elsewhere could be greater variability in reviewed and approved by Andalusian Health Service in accordance the secondary outcomes. For example, the fundamental action the with its policy on Financial Conflict of Interest. Alejandro Suero and Nine-Hole Peg Test entails grapping small objects. This action Jesús Blanquero were the initiators of the project and founded a spin- involves two movements: a controlled and precise movement of the off. index finger and thumb to perform the pinch, and another action transporting the executing hand.39 In people with carpal tunnel Source(s) of support: This study was supported by the Innovation syndrome, the disorganisation at the central level16 may cause an Projects Grant #0143-2017 of the Health Council of Andalusian alteration in the function of the entire upper limb, which would Government. This study is part of an activity that has received correspond to an increase in the transport variability of the executing funding from the European Institute of Innovation and Technology hand.40 In the present study, the intervention of the control group (EIT). This body of the European Union receives support from the involved a series of exercises not only at the wrist, hand and finger (as European Union’s Horizon 2020 research and innovation program. in the experimental group) but also at the elbow and shoulder level. This can have an effect on the kinematics of the entire upper limb in Acknowledgements: We thank to the entire ReHand research the control group, since co-ordinated movements of the entire upper team, and to the engineering team that developed ‘ReHand’: José limb (including the elbow and shoulder) are involved in hand Manuel López, Antonio García and Nieves Sánchez-Laulhé. transport in the Nine-Hole Peg Test. Furthermore, there was considerable improvement in the experimental group (from 22.7 to Provenance: Not invited. Peer reviewed. 18.1 seconds) and in the control group (from 23.4 to 20.1 seconds), Correspondence: María Dolores Cortés-Vega, Physiotherapy which brought the participants – especially those in the experimental Department, University of Seville, Seville, Spain. Email: [email protected] group – close to the normative values of 19 seconds in men and 17.7 seconds in women.27 This may have caused a ceiling effect in the References experimental group but not in the control group. 1. Badger SA, O’Donnell ME, Sherigar JM, Connolly P, Spence RAJ. Open carpal tunnel Some limitations of this study must be acknowledged. No release–still a safe and effective operation. Ulster Med J. 2008;77:22–24. measurements were made during the treatment period or at a post-intervention follow-up. Such measures would have helped to 2. Burton CL, Chesterton LS, Chen Y, van der Windt DA. 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Journal of Physiotherapy 65 (2019) 95–98 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Research Goal-oriented instructions increase the intensity of practice in stroke rehabilitation compared with non-specific instructions: a within-participant, repeated measures experimental study Tessa Hillig a, Haotian Ma a, Simone Dorsch a,b a School of Allied Health, Australian Catholic University; b StrokeEd collaboration, Sydney, Australia KEY WORDS ABSTRACT Stroke Questions: In stroke rehabilitation, do goal-oriented instructions increase the intensity of practice during Practice therapy compared to a non-specific instruction? Is one type of goal-oriented instruction more effective at Communication increasing the intensity of practice achieved by stroke survivors during therapy? Design: A within- Rehabilitation participant, repeated measures experimental study. Participants: Twenty-four adults undertaking stroke Physical therapy rehabilitation at a metropolitan hospital as an inpatient or outpatient. Intervention: Participants were observed performing exercises across 3 days. On each day, they performed an exercise with a non-specific instruction (‘do some [exercise]’) as a baseline measure and the same exercise with one of three goal- oriented instructions, delivered in a randomised order. The three goal-oriented instructions were: ‘do [ex- ercise] 25 times’ (instruction A), ‘do [exercise] 25 times as fast as you can’ (instruction B), and ‘do [exercise] 25 times, as fast as you can, aiming for a personal best’ (instruction C). The last instruction included verbal encouragement during the exercise. Outcome measures: The time taken to complete 25 repetitions under the baseline condition and each instruction was recorded and converted into repetitions per minute. Results: All of the goal-oriented instructions resulted in a significant increase in the rate of repetitions of the exercise being performed compared to the baseline measure: percentage increase from baseline (95% CI) was 62% (31 to 93) with instruction A, 116% (67 to 165) with instruction B, and 128% (84 to 171) with instruction C. In- struction C had a significantly greater effect than instruction A: mean difference in percentage increase 65% (95% CI 13 to 118). Conclusion: Goal-oriented instructions can result in significant increases in the rate of repetitions of exercise in stroke rehabilitation. The use of goal-oriented instructions is a simple, no-cost strategy that can be used to increase the intensity of practice in stroke rehabilitation. Trial registration: ACTRN12619000146190. [Hillig T, Ma H, Dorsch S (2019) Goal-oriented instructions increase the in- tensity of practice in stroke rehabilitation compared with non-specific instructions: a within- participant, repeated measures experimental study. Journal of Physiotherapy 65:95–98] © 2019 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 resonance imaging.3 Scrivener et al established that completing a Following a stroke, there is clear evidence that people who do higher dose of lower limb exercise repetitions (. 703 repetitions in larger amounts of task-specific practice achieve better activity out- the first week after stroke) resulted in faster recovery of unassisted comes. The first systematic review to suggest this dose-response walking and that the number of lower limb exercise repetitions relationship calculated that an additional 16 hours of therapy early after stroke could result in small to moderate improvements in ac- completed in the first week could predict stroke survivors’ walking tivity.1 A recent systematic review calculated that at least a 240% speed at discharge from rehabilitation.4 increase in usual therapy time is needed to produce significant im- provements in activity outcomes.2 In addition to increased time, it Despite current literature and clinical guidelines recommending appears that a high intensity of practice (ie, a high number of repe- titions) is required to improve activity outcomes.3,4 Carey et al found large doses of therapy after stroke, this is not being achieved in that intensive finger tracking training (involving almost 7000 repe- clinical practice.2,5,6 A systematic review of activity during physio- titions over 20 sessions) resulted in improved tracking accuracy and grasp and release function, and these improvements were accom- therapy sessions found that therapy sessions are 50 minutes long and panied by neuroplastic changes seen on functional magnetic that stroke survivors are active for an average of only 60% of a ses- sion.7 During these short therapy sessions, a stroke patient may perform as few as 32 repetitions of upper limb exercise,6 202 steps of walking practice, or 11 stand-ups.8 These amounts of practice are unlikely to cause neuroplastic changes that are sufficient to improve clinical outcomes after stroke. https://doi.org/10.1016/j.jphys.2019.02.007 1836-9553/© 2019 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/).
96 Hillig et al: Goal-oriented instructions in stroke rehabilitation Strategies are needed to help achieve larger therapy doses within Box 1. Format of instructions given to the participants, using sit the rehabilitation setting. A scoping review of studies in which extra to stand as an example exercise. practice was done in stroke rehabilitation found that generally this was done with full supervision by extra staff.9 This is not a sustainable Baseline ‘Do some sit to stands’ solution in usual clinical settings, where lack of time is the most Instruction A commonly cited reason for not being able to increase therapy dos- Instruction B ‘Stand up and sit down 25 times’ ages.10 The authors of that scoping review suggest that the use of ‘Stand up and sit down 25 times as fast as goal-oriented instructions could increase dosages of practice by Instruction C you can’ increasing the intensity at which stroke survivors work within a ‘Stand up and sit down 25 times as fast as session. However, the use of goal-oriented instructions to increase you can. Aim for your personal best!’ The practice intensity does not appear to have been examined in stroke researcher provided additional encouragement rehabilitation. There are studies that have examined the effect of whilst the participant performed the exercise modifying instructions in order to modify the speed of stroke survi- such as ‘go, go, go!’, ‘over halfway there’ and vors’ task performance.11–13 These studies have demonstrated in- a countdown over the final 10 repetitions. creases in the speed of task performance in response to different instructions. However, they were not aiming to examine changes in could complete more than 50 times without verbal prompting or intensity of practice and therefore only examined the change in speed physical assistance. The selected exercise and environment set-up of one repetition of a task. There are currently no studies that have remained the same across the 3 days. A new baseline was investigated the effect of goal-oriented instructions on increasing the measured each day to account for the potential learning effect and intensity of practice done over a sustained period. If using goal- increased efficiency of performance over the 3 days. When possible, oriented instructions has a significant impact on the intensity of the data were collected at a similar time each day to reduce the risk of practice achieved (ie, intensity in terms of rate of repetitions ach- fatigue affecting task performance. Participants were given the ieved) during a therapy session, this could increase therapy doses baseline instruction first, and the time taken to complete 25 repeti- without additional staff, equipment, cost or time. tions was recorded. Following the baseline instruction, participants were given one of the three goal-oriented instructions, and the time Therefore, the research questions for this within-participant, taken to complete 25 repetitions was recorded. The goal-oriented repeated measures experimental study were: instructions were adjusted according to the lower limb exercise performed by the participant. Using sit to stand as an example, the 1. In stroke rehabilitation, do goal-oriented instructions increase the instructions were as shown in Box 1. intensity of practice achieved by stroke survivors during therapy? The instruction delivered on each day was dependent on the 2. Is one type of goal-oriented instruction more effective at randomised instruction order the participant was allocated prior to increasing the intensity of practice achieved by stroke survivors starting data collection. There were six possible orders in which the during therapy? three instructions could be delivered: ABC, ACB, BAC, BCA, CAB and CBA. If for example, a participant was allocated ABC, instruction A was Method delivered on Day 1, instruction B on Day 2 and instruction C on Day 3. Design In order to test each instruction order four times, four blocks of the six possible orders were used. Hence, 24 participants were This was a within-participant, repeated measures experimental recruited for this study. Within each block, the order in which the six study. All participants received the same three instructions in rand- possible instruction orders appeared was randomised using the omised order while doing one of their usual lower limb exercises. random number generator function on commercial spreadsheet Prior to receiving the instructions, participants were blinded from the softwarea. Participants were blinded to the instructions and the in- types of instructions and the instruction order. struction order prior to data collection. Participants, therapists, centres Outcome measures The study was conducted in the stroke unit of a large metropolitan The primary outcome measure was the rate at which repetitions hospital. Patients admitted with a clinical diagnosis of stroke were were completed under each instruction. A stopwatch was used to screened for inclusion, and approached to participate if they met the time how long it took the participants to complete 25 repetitions following criteria: aged 18 years; inpatients with an expected under each instruction. A hand-held tally counter was used to count length of stay likely . 1 week or outpatients expected to attend at the number of repetitions. The results were converted into repetitions least five more therapy sessions; able to perform 50 repetitions of a per minute. Preliminary data revealed significant variability in the lower limb exercise without physical assistance (eg, sit to stand, tilt amount of time taken to do different exercises; hence, rate of repe- table strengthening exercises, stepping exercises); sufficient English titions was chosen as the primary outcome rather than the time taken to understand simple instructions; and adequate cognition to follow to complete 25 repetitions. simple instructions. Patients were excluded if they did not require inpatient physiotherapy and/or were not medically stable enough to Data analysis participate in rehabilitation exercises. All participants provided written informed consent before participating in the study. One Preliminary analysis of data collected from a sample of 11 stroke researcher (SD) performed the block randomisation prior to the survivors revealed that to have an 80% chance of detecting a 25% commencement of the study. Two researchers (TH and HM) per- change in rate of repetitions with an alpha value of 5%, 20 participants formed participant recruitment and data collection. were required. In order to test each order of instructions four times, it was decided to measure 24 participants. Intervention All data analyses were performed using statistical softwareb. The Data collection occurred during the participant’s normal therapy mean difference and 95% CI between baseline and each goal-oriented sessions in the rehabilitation gym and spanned across 3 consecutive instruction was calculated and the mean percentage increase in the therapy days. The selected lower limb exercise was one that partici- repetition rate with each goal-oriented instruction was calculated pants had been performing as part of their normal rehabilitation and relative to that day’s baseline. To ascertain statistically significant differences between the instructions, repeated measures analysis of
Assessed for eligibility (n = 120) Research 97 Excluded (n = 96) Table 1 Participants Characteristics of participants. (n = 24) • ineligible (n = 94) • declined to participate (n = 2) Characteristic 70 (15) 13 (54) Randomised (n = 24) Age (yr), mean (SD) Gender, n females (%) 9 (38) • received instructions as Type of stroke, n (%) 12 (50) randomly allocated (n = 24) left CVA 1 (4) right CVA 1 (4) Assessed (n = 24) brainstem 1 (4) cerebellar • underwent all assessments as multiple CVA 4 (17) Disability (Modified Rankin Scale), n (%) 2 (8) planned (n = 24) 2 18 (75) 3 70 (182) 4 Time since stroke (days), mean (SD) 8 (33) Exercises used in the instructions, n (%) 4 (17) sit to stand 6 (25) sit and reach 3 (13) tilt table knee extension 1 (4) stepping forward 1 (4) bilateral calf raises 1 (4) knee flexion with slide sheet alternate foot taps CVA = cerebral vascular accident. Analysed (n = 24) Comparisons between goal-oriented instructions Figure 1. Flow of participants through the study. Differences in the percentage increase in the rate of repetitions was compared pairwise between the three goal-oriented instructions, variance (ANOVA) was applied to the percentage change. Bonferroni as presented in Table 5. Instruction C had a significantly greater adjustment was used for multiple comparisons. percentage increase in repetition rate than instruction A, with a 65% mean difference (95% CI 13 to 118). No statistically significant differ- Results ences were observed between instruction A and B, with a mean dif- ference of 54% (95% CI –3 to 111), or instructions B and C, with a mean Flow of participants through the study difference of 12% (95% CI –53 to 76). The flow of the participants through the study is shown in Discussion Figure 1. A total of 120 stroke patients were screened for inclusion, of whom 24 participated in the study. Each of the six instruction orders All goal-oriented instructions resulted in a large increase in the was tested four times. All participants were administered their rate of repetitions of exercise compared to the baseline non-specific baseline and goal-oriented instructions in the allocated order. There instruction. Participants increased their rate of repetitions by 62% to were no dropouts. There were no adverse effects during the study. 128% when given the goal-oriented instructions. The most effective Participant demographic and clinical characteristics are reported in instruction was an instruction that encouraged speed and to achieve a Table 1. The mean age of the participants was 70 years (SD 15). The personal best, ‘Do [exercise] 25 times as fast as you can. Aim for your average time after stroke was 70 days (SD 182). Most participants personal best!’ with an increase of 128% over the baseline rate of were moderately severely disabled, with 75% of the participants repetitions. Goal-oriented instructions can therefore be used to in- scoring 4 on the modified Rankin Scale.14 crease intensity of practice in stroke rehabilitation. Change in rate of repetitions Three other studies have examined the use of instructions in stroke rehabilitation to establish whether stroke survivors can in- Statistically significant increases in the number of repetitions crease their speed of task performance. Two studies measured completed per minute were observed for each instruction compared movement speed, with participants asked to perform a reaching task to its baseline (Table 2). Individual participant data are presented in at a comfortable speed and then with specific instructions that Table 3, which is available on the eAddenda. The mean increase (95% encouraged greater speed.11,12 The first study measured a 30% in- CI) in repetition rate from baseline to the goal-oriented instruction crease in movement speed11 and the second study measured a 14% was: 6 repetitions per minute (4 to 9) for instruction A; 13 repetitions increase in movement speed12 in the respective reaching tasks. The per minute (9 to 16) for instruction B; and 15 repetitions per minute third study measured walking speed with four different instructions (12 to 18) for instruction C. Data on outcome measures were normally about speed, and demonstrated a 26% increase in walking speed with distributed as indicated by the Shapiro-Wilk test. the ‘maximum speed’ instruction.13 The changes in single-task Percentage increase in rate of repetitions Table 2 Repetitions per minute for baseline non-specific instructions and goal-oriented Statistically significant differences in the percentage increases instructions, and difference (95% CI) between instructions (n = 24). between the instructions were found, as determined by repeated measures ANOVA (F(2,46) = 4.668, p = 0.014). The mean percentage Instruction Repetitions per minute Between-group difference increase of each instruction from baseline is shown in Table 4. The mean (SD) mean (95% CI) greatest percentage increase was instruction C, with a mean increase of 128% (SD 85) from baseline. Baseline Goal-oriented Goal-oriented instruction instruction minus baseline A 16 (11) 23 (13) 6 (4 to 9) B 16 (9) 28 (12) 13 (9 to 16) C 15 (7) 30 (11) 15 (12 to 18)
98 Hillig et al: Goal-oriented instructions in stroke rehabilitation Table 4 What was already known on this topic: Following stroke, Percentage increase from baseline in number of repetitions with goal-oriented people who do larger amounts of task-specific practice achieve instructions (n = 24). better activity outcomes. Despite this, many people undertaking stroke rehabilitation do not achieve high repetitions of their Instruction Percentage increase in repetitions (%) exercises. What this study adds: Goal-oriented instructions can result in Mean (SD) Range 95% CI significant increases in the rate of repetitions of exercise in stroke rehabilitation. An instruction oriented to the goals of doing A 62 (74) –7 to 266 31 to 93 a specified number of repetitions, doing them as fast as possible, and aiming for a personal best, increases the number of repeti- B 116 (117) –15 to 500 67 to 165 tions more effectively than when only a target number of repe- titions is included. C 128 (85) 32 to 416 84 to 171 Footnotes: a Excel, Microsoft, USA. b SPSS v25, IBM, Australia. performance with goal-oriented instructions in these three studies eAddenda: Table 3 can be found online at DOI: https://doi.org/10.1 were statistically significant, but substantially lower than the changes 016/j.jphys.2019.02.007. in rate of repetitions found in the present study. In the present study, Ethics approval: The South Western Sydney Local Health District the smallest average increase in the rate of repetitions with any of the Human Research Ethics Committee approved this study (HREC/17/ effective goal-oriented instructions was more than double the highest LPOOL/86). All participants gave written informed consent before increase of 30% reported in the previous studies. However, the pre- data collection began. vious studies were investigating stroke survivors’ capacity to increase Competing interests: Nil. the speed of a single performance of a task, whereas the current study Source(s) of support: This research did not receive any specific was designed to examine a strategy for increasing the intensity of grant from funding agencies in the public, commercial, or not-for- practice (ie, intensity in terms of rate of repetitions achieved) of a task profit sectors. over a sustained period. The clinical significance of the current study Acknowledgements: Nil. is that it shows that the use of goal-oriented instructions can result in Provenance: Not invited. Peer reviewed. stroke survivors increasing their intensity of practice over a sustained Correspondence: Simone Dorsch, School of Allied Health, Faculty period, and this increase in intensity is large. of Health Sciences, Australian Catholic University, Sydney, Australia. Email: [email protected] Importantly, this increase in practice intensity can be obtained without requiring extra time, staff, equipment or costs, and is References therefore an effective and feasible strategy that can be implemented into current clinical settings. Lack of time is reported to be the 1. Kwakkel G, van Peppen R, Wagenaar R, Wood Dauphinee S, Richards C, Ashburn A, greatest limitation to achieving larger dosages of therapy in rehabil- et al. Effects of augmented exercise therapy time after stroke: a meta-analysis. itation after stroke.10 Providing goal-oriented instructions that can Stroke. 2004;35:2529–2539. more than double the rate of repetitions should result in more rep- etitions being performed in the available therapy time. It is therefore 2. Schneider EJ, Lannin NA, Ada L, Schmidt J. Increasing the amount of usual important for staff to be aware of and to carefully consider the in- rehabilitation improves activity after stroke: a systematic review. J Physiother. structions they use during therapy sessions. While this seems 2016;62:182–187. evident, observational studies have shown that therapists do not generally use communication that contains specific information.15,16 3. Carey J, Kimberley T, Lewis S, Auerbach EJ, Dorsey L, Rundquist P, et al. Analysis of fMRI and finger tracking training in subjects with chronic stroke. Brain. In the present study, there was no objective measure of change in 2002;125:773–788. quality of movement. This was a limitation because encouraging speed can potentially result in kinematic changes in task performance. How- 4. Scrivener K, Sherrington C, Schurr K. Amount of exercise in the first week after ever, one study found that instructions that emphasised speed in upper stroke predicts walking speed and unassisted walking. Neurorehabil Neural Repair. limb reaching tasks after stroke actually improved target accuracy and 2012;26:932–938. resulted in smoother movement.11 It is possible that instructions that encourage speed may result in better movement strategies as well as 5. Kimberley T, Samargia S, Moore L, Shakya J, Lang C. Comparison of amounts and increased intensity of practice. Subjectively, the researchers in our study types of practice during rehabilitation for traumatic brain injury and stroke. did not observe any decrease in quality or perceived safety of the J Rehabil Res Dev. 2010;47:851–861. measured exercise or subsequent exercises with the increased intensity of practice. Another limitation was that the control condition (ie, the 6. Lang C, MacDonald J, Reisman D, Boyd L, Kimberley TJ, Schindler-Ivens SM, et al. non-specific baseline instruction) was not randomised among the other Observation of amounts of movement practice provided during stroke rehabilita- randomly ordered interventions (ie, the goal-oriented instructions). tion. Arch Phys Med Rehabi. 2009;90:1692–1698. Further research, with a control group that does not receive goal- oriented instructions and that examines the effect of goal-oriented in- 7. Kaur G, English C, Hillier S. How physically active are people with stroke in structions over a whole therapy session or a whole admission, could physiotherapy sessions aimed at improving motor function? A systematic review. provide further evidence about the effect of goal-oriented instructions Stroke Res Treat. 2012. on intensity of practice and clinical outcomes in stroke rehabilitation. 8. Tyson S, Woodward-Nutt K, Plant S. How are balance and mobility problems after It is well established in current literature that larger therapy doses stroke treated in England? An observational study of the content, dose and context are required to maximise activity outcomes after stroke, yet large of physiotherapy. Clin Rehabil. 2018;32:1145–1152. doses of therapy are not being achieved in clinical practice. This study demonstrated that stroke patients can complete significantly greater 9. Stewart C, McCluskey A, Ada L, Kuys S. Structure and feasibility of extra practice intensities of practice in response to a goal-oriented instruction. Thus, during stroke rehabilitation: A systematic scoping review. Aust Occup Ther J. clinicians can use goal-oriented instructions to help increase dosages 2017;64:204–217. of practice in stroke rehabilitation. 10. Bayley M, Hurdowar A, Richards C, Korner-Bitensky N, Wood-Dauphinee S, Eng JJ, Table 5 et al. Barriers to implementation of stroke rehabilitation evidence: findings from a Pairwise mean differences between instructions in the percentage increase in rate of multi-site pilot project. Disabil Rehabil. 2012;34:1633–1638. repetitions (n = 24). 11. Massie C, Malcolm M. Instructions emphasizing speed improves hemi- Instruction Difference in percentage increase between instructions (%) paretic arm kinematics during reaching in stroke. NeuroRehabilitation. 2012;30:341–350. B relative to A Mean (95% CI) C relative to A 12. Gauggel S, Fischer S. The effect of goal setting on motor performance and motor C relative to B 54 (–3 to 111) learning in brain-damaged patients. Neuropsychol Rehabil. 2001;11:33–44. 65 (13 to 118) 12 (–53 to 76) 13. Nascimento L, Caetano L, Freitas D, Morais T, Polese J, Teixeira-Salmela L. Different instructions during the ten-meter walking test determined significant increases in maximum gait speed in individuals with chronic hemiparesis. Braz J Phys Ther. 2012;16:122–127. 14. Banks J, Marotta C. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007;38:1091–1096. 15. Stanton R, Ada L, Dean C, Preston E. Feedback received while practicing everyday activities during rehabilitation after stroke: an observational study. Physiother Res Int. 2015;20:166–173. 16. Durham K, Van Vliet P, Badger F, Sackley C. Use of information feedback and attentional focus of feedback in treating the person with a hemiplegic arm. Phys- iother Res Int. 2009;14:77–90.
Journal of Physiotherapy 65 (2019) 75–80 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Research Massage therapy slightly decreased pain intensity after habitual running, but had no effect on fatigue, mood or physical performance: a randomised trial Paula Urio Bender a, Clarissa Medeiros da Luz a, Jonatan M Feldkircher a, Guilherme S Nunes a,b a Department of Physiotherapy, Center of Health and Sport Sciences, Santa Catarina State University, Florianópolis, Brazil; b La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, La Trobe University, Melbourne, Australia KEY WORDS ABSTRACT Musculoskeletal manipulations Question: Does massage therapy reduce pain and perceived fatigue in the quadriceps, and improve the mood Musculoskeletal pain and physical performance of runners after habitual sporting activity (10-km run)? Design: Randomised Athletes controlled trial with concealed allocation, intention-to-treat analysis and blinded assessment. Participants: Quadriceps muscle Seventy-eight runners after sporting activity (10-km run). Intervention: The experimental group received 10 Physical therapy minutes of massage to the quadriceps aimed at recovery following sport practice, and the control group received a sham joint mobilisation. Outcome measures: Pain and perceived fatigue were each assessed using a 0-to-10 numerical rating scale; pain behaviour via the McGill Pain Questionnaire; mood profile via Brunel Mood Scale; quadriceps muscle flexibility using maximal knee flexion angle via inclinometer; isometric muscle strength of knee extensors via hand-held dynamometry; and vertical jump performance using jump height via My Jump 2 app. Evaluations were carried out immediately before and after the intervention, and at 24, 48 and 72 hours after the intervention. Generalised estimating equations were used to estimate a between-group difference (95% CI) using data across all time points. Results: The experimental group had significantly lower scores than the control group on the numerical rating scale for pain by 0.7 points (95% CI 0.1 to 1.3). There were no significant between-group differences for any of the other outcome measures. Conclusion: Massage therapy was effective at reducing pain intensity after application to the quadriceps of runners compared to a sham technique, but the magnitude of the effect was small. There were no significant effects on perceived fatigue, flexibility, strength or jump performance. Trial registration: Brazilian Registry of Clinical Trials, RBR-393m7m. [Bender PU, Luz CM, Feldkircher JM, Nunes GS (2019) Massage therapy slightly decreased pain intensity after habitual running, but had no effect on fatigue, mood or physical performance: a randomised trial. Journal of Physiotherapy 65:75–80] © 2019 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 Most studies investigating the effects of massage therapy on Massage therapy is widely used to treat patients with different athlete recovery have applied the intervention in cases of extreme conditions.1 Reports have suggested that massage therapy acts by: blocking noxious stimuli, in line with the gate-control theory;2 fatigue, which does not reflect the typical state of many participants increasing blood and lymphatic flow, which may accelerate the in many sports.6,7,10,11 In clinical practice, clinicians use massage elimination of catabolites;3 and releasing endorphins that promote a feeling of well-being.4 therapy to assist athletes to recover from less fatiguing sports such In sports, massage therapy is often used in physical recovery after as competitive running and soccer. To date, no study has evaluated activities, to promote pain relief and prevent delayed-onset muscle soreness (DOMS).4,5 A previous study reported that massage therapy the effects of massage therapy on athlete recovery after sporting reduced acute pain and fatigue in the quadriceps of triathletes after a long-distance Ironman race.6 Some research has also suggested that activity that does not induce extreme fatigue and may not cause massage therapy may decrease DOMS.7,8 Imtiyaz et al found that massage therapy applied before the induction of fatigue in the arms DOMS. may reduce DOMS in healthy non-athletic females.8 Although mas- sage therapy may be beneficial to athlete recovery, its use in clinical Engaging in very strenuous sport can negatively affect the mood practice for sports is not supported by strong evidence.5,9 and performance of athletes12,13 and, according to massage effect theories, massage therapy may also ameliorate these effects.14,15 Arroyo-Morales et al14 applied massage therapy after strenuous physical activity and found that massage therapy may improve perceived vigour using a mood questionnaire in healthy active stu- dents. Kargarfard et al15 reported that massage therapy applied to the quadriceps of bodybuilders after fatiguing activity may enhance vertical jump performance. However, methodological issues related https://doi.org/10.1016/j.jphys.2019.02.006 1836-9553/© 2019 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/).
76 Bender et al: Massage therapy after habitual sporting activity to sample size10,16 or blinding14,15 have been identified in previous study prepared these envelopes. The study design is presented in studies investigating the impact of massage therapy on mood and Figure 1. physical performance. Additionally, the effects of massage therapy on these aspects after less fatiguing sports are yet to be studied. Participants, therapists, centres Some research indicates that massage therapy is a useful tech- Seventy-eight runners from the metropolitan area of a state cap- nique in athlete recovery;6,9–11 however, the short-term and long- ital in Brazil took part in this study. To be eligible for inclusion in the term effects of massage therapy are still unclear.5,9 Additionally, study, athletes had to run a minimum of 10 km continuously and be little is known about the effect of massage therapy applied after aged between 18 and 60 years. They also had to have engaged in habitual sporting activity because no study has used methods that running practice for at least 1 year prior to data collection and be incorporate a real, habitual, sporting activity as the intervention. training at least twice per week. The exclusion criteria were the presence of any medical condition not compatible with the study Therefore, the research question for this randomised controlled procedures, severe metabolic or cardiorespiratory disorders, muscu- trial was: loskeletal disorders in the lower limbs in the last 6 months, abrasions in the thigh, cramps during evaluations and/or any sensation change Does massage therapy reduce pain and perceived fatigue in the in the thigh. quadriceps and improve the mood and physical performance of runners after habitual sporting activity (10-km run)? The evaluations and interventions were carried out at the par- ticipants’ training sites. First, the participants were assessed in terms Method of the eligibility criteria and data were collected about their anthro- pometric characteristics. Next, the participants were instructed to run Design 10 km as fast as possible, reproducing their competition pace. Immediately after the run, the first evaluation session was carried out This was a randomised clinical trial in which the participants (pre-intervention) and the participants were evaluated for pain, fa- were allocated to an experimental group or a control group. The tigue, mood and physical performance. The measurements were experimental group received massage therapy to the quadriceps taken in relation to the most painful quadriceps muscle, as reported muscle aimed at recovery after sporting activity, and the control using a numerical rating scale. If participants reported the same pain group received sham hip and knee joint mobilisations. The ran- level in both thighs or no pain, the side to be evaluated and treated domisation was conducted using sealed and opaque envelopes to was randomly selected by a coin toss. conceal each upcoming allocation during recruitment. A researcher who was not involved in the evaluations or interventions of this In order to maintain assessor blinding, after the pre-intervention assessment the participants were directed to a different location for Assessed for eligibility (n = 80) Excluded (n = 2) • recent ankle injury (n = 2) Completed 10-km run Pre Measured pain, perceived fatigue, McGill, BRUMS, flexibility, strength and vertical jump Randomised (n = 78) (n = 39) (n = 39) Experimental group Control group • quadriceps massage • sham hip and • 10 minutes knee mobilisation • 10 minutes Measured pain, perceived fatigue, McGill, BRUMS, flexibility, strength and vertical jump 0 hr (n = 39) (n = 39) 24 hr Measured pain, perceived fatigue, McGill and BRUMS (via telephone) (n = 39) (n = 39) 48 hr Measured pain, perceived fatigue, McGill, BRUMS, flexibility, strength and vertical jump (n = 39) (n = 39) 72 hr Measured pain, perceived fatigue, McGill and BRUMS (via telephone) (n = 39) (n = 39) Figure 1. Design and flow of participants through the study. BRUMS = Brunel Mood Scale, McGill = McGill Pain Questionnaire.
Research 77 group allocation and the application of interventions. The same Mood profile blinded assessor revaluated the participants immediately after the Mood was evaluated using the Brunel Mood Scale.20 The scale interventions (post-intervention), as well as at 24 hours, 48 hours and 72 hours after the intervention (Figure 1). The evaluations at 24 hours includes 24 descriptors divided in six subscales: fatigue, tension, and 72 hours were conducted by telephone, to determine pain, fa- vigour, mental confusion, depression and anger. Each descriptor is tigue and mood. At the immediate post-intervention assessment, the ranked according to the question ‘How do you feel now?’ on a participants were instructed not to take anti-inflammatory or anal- 5-point rating scale between 0 and 4 points, in which 0 indica- gesic medications and not to perform other physical recovery tech- tes ‘none’ and 4 indicates ‘extremely’. The total score of each subscale niques or additional physical activities during the data collection is given by the sum of the points and varies between 0 and 16; high period. The participants were also given a leaflet containing the in- scores mean greater presence of the respective mood parameter.20 structions and the questions that would be asked during the tele- phone calls. Flexibility Quadriceps flexibility was evaluated using the maximal knee Intervention flexion angle.21 The participant lay prone with the hips in a neutral After the run, the experimental group received a 10-minute position. The assessor passively flexed the participant’s knee until end massage, aimed at physical and mood recovery,5 from a therapist feel was perceived or the participant’s pelvis began to move. The knee who was not involved in the measurements. Further detail is pro- flexion angle was measured once using an inclinometera positioned vided in Appendix 1, part A (see eAddenda for Appendix 1). The 15 cm distal to the tibial tuberosity. This measure has adequate reli- intervention consisted of the following procedures: 1 minute of su- ability (ICC = 0.94).21 perficial effleurage, in which the therapist slid both hands in the di- rection of the muscle fibres from distal to proximal with a gentle Vertical jump performance pressure on the thigh; 3 minutes of deep effleurage, in which the Jump height was evaluated using a mobile phone appb.22 The therapist performed the same movement but applied more pressure to the thigh; 3 minutes of petrissage, in which the therapist used the participants were instructed to perform a countermovement jump as entire surface of the palm of the hands to compress and lift the tissue high as possible, with arm swings permitted, and were recorded sequentially; 1 minute of tapotement, in which the therapist agitated using a mobile phonec. Three jumps were performed, with a mini- the tissues of the thigh with cupped hands; and 2 minutes of su- mum 30-second interval between trials and the highest trial was perficial effleurage to finish the intervention. A video demonstration used in statistical analysis.23 The app was validated and has adequate of the techniques is presented in Appendix 2 (see eAddenda for reliability (ICC = 0.99).22 Appendix 2). Hypoallergenic skin oil was used to reduce friction be- tween the therapist’s hands and the participant’s skin. Isometric strength Maximum knee extensor isometric strength was assessed using a The control group received sham hip and knee joint mobilisations from the same therapist. Further detail is provided in Appendix 1, hand-held dynamometerd. The participants were lying in supine part B (see eAddenda for Appendix 1). The mobilisations served no position with hips and knees flexed at approximately 60 deg. An therapeutic purpose and were applied only to promote a feeling of image of the strength assessment is presented in Appendix 4 (see slight pressure on the skin without proper joint mobilisation. The eAddenda for Appendix 4). An inelastic strap was positioned participants were in supine with the knee flexed at 90 deg. For sham around their ankles and the examination table, and the dynamometer hip joint mobilisation, a belt was placed on the participant’s inguinal was placed between the strap and the ankle of the assessed lower region and around the therapist’s lumbar region. For sham knee joint limb.21 The participants were verbally encouraged to generate mobilisation, a belt was placed around the proximal region of the maximal effort against the strap as if extending their knee. One trial participant’s tibia and around the therapist’s lumbar region. From was performed before data collection for familiarisation purposes. these positions, the therapist projected his/her body in order to move Three 5-second trials were performed, with a minimum 30-second away from the participants, producing a slight and oscillatory pres- interval between each trial. Maximal isometric force was converted sure on the skin for 5 minutes in each mobilisation (images of the into torque: force in Newtons x leg length in metres (distance be- sham techniques are presented in Appendix 3 (see eAddenda for tween the lateral femoral epicondyle and the lateral malleolus); and Appendix 3). At the end of the sham mobilisations, the same oil used then, torque was normalised by body mass in kg ([Nm/kg]*100 = % in the experimental group was applied to the participants’ leg in body mass).21 This procedure has adequate reliability (ICC = 0.98).21 order to keep the assessor blinded to group allocation. Data analysis Outcome measures Sample size was calculated to allow for statistical power of 80%, an Pain and perceived fatigue alpha of 5% and potential loss to follow-up of 5%. This indicated that The pain and perceived local fatigue in the quadriceps muscle at least 38 participants would be necessary to identify a between- group difference in pain of 2 points (SD = 3 points)7 and in fatigue were each measured using a numerical rating scale.17,18 The scale of 1 point (SD = 1.5 points),10 using the numerical rating scale. The consisted of a numerical sequence between 0 and 10 points, in which calculation was performed using the software G*Powere. 0 indicated no pain or fatigue and 10 points indicated the worst possible pain or extreme fatigue. This numerical rating scale has The intention-to-treat approach was adopted in all analyses. Five adequate reliability for pain assessments (ICC = 0.91)17 and is participants were not assessed on knee extensor strength and the responsive to fatigue changes.18 missing data were processed using the multiple imputation method.24 Twenty imputed data sets were created using the Pain behaviour anthropometric and strength data from all the assessments to predict The intensity and behaviour of pain were evaluated using the the missing data; the imputed data sets were pooled into mean values for analysis.24,25 short form of the McGill Pain Questionnaire.19 The questionnaire in- cludes 15 pain descriptors, which describe different pain character- The differences from baseline were used in the analysis. Analysis istics. Each descriptor is ranked on a 4-point rating scale between of variance with a linear mixed model was used to compare the effect 0 and 3 points, in which 0 indicates ‘none’ and 3 indicates ‘severe’. of massage therapy between the experimental and control groups. The total score is given by the sum of the points and varies between Mean difference and 95% CI were also calculated for each comparison. 0 and 45; high scores mean worse pain sensation.19 The effect of the intervention on the primary outcome was estimated using generalised estimating equation with a linear mixed model that incorporated data from all the assessment time points into a single result.26 The secondary outcomes underwent a similar analysis based on the available assessment time points. The analyses were adjusted
78 Bender et al: Massage therapy after habitual sporting activity Table 1 Exp Con Discussion Characteristics of participants. (n = 39) (n = 39) This study aimed to evaluate the impact of massage therapy on Characteristic 34 (9) 34 (10) athlete recovery after habitual sporting activity. The results indicate 23:16 28:11 that massage therapy reduced pain severity compared to a sham Age (yr), mean (SD) 1.72 (0.08) 1.74 (0.09) technique, but no statistically significant effects were identified on Gender, males:females 70.8 (11.2) 74.2 (11.8) any of the other outcome measures. These results appear to be Height (m), mean (SD) 56.7 (8.3) 54.7 (8.2) believable because the study used robust methods (true random- Weight (kg), mean (SD) isation, concealed allocation, assessor blinding, intention-to-treat Time to complete 10-km run on the 5.3 (4.8) 5.4 (5.3) analysis, follow-up of all participants, and a low risk of type-I error). day of data collection (minutes), mean (SD) Running experience (yr), mean (SD) Several factors suggest that the effect on pain intensity is not clinically worthwhile. The estimate of the effect on pain and the 95% Exp = experimental group, Con = control group. CI around that estimate were below the effect of 2 points on the 0-to- 10 scale, which was nominated as the smallest worthwhile effect in for baseline values as a covariate. A significance level of p 0.05 was the sample size calculation. The McGill Pain Questionnaire did not adopted and the statistical analysis was performed using the software show corresponding improvements in overall pain behaviour. SPSSf. Perhaps most importantly – from the perspective of athlete recovery, at least – the effect on pain was not enough to permit improvements Results in knee extensor strength, quadriceps flexibility or jump height. Flow of participants, therapists, centres through the study Although the effect on pain severity does not appear to be clini- cally worthwhile, it is interesting to consider the pattern of the effect All participants (n = 78) completed the planned evaluations be- and the possible mechanisms behind this analgesic effect. Inspection tween March and September 2018 (Figure 1). Two participants in the of the data in Table 2 shows that the largest effect occurred imme- experimental group and three participants in the control group did not diately after the intervention was applied. This acute pain reduction have their muscle strength evaluated due to equipment failure. The may be due to the possible action of massage therapy on neurological groups were similar with respect to anthropometric data, running aspects.2,9,27 The mechanical stimuli from massage therapy may experience and 10-km running performance (Table 1), as well as inhibit pain by ‘closing the pain gate’, inducing instant analgesia baseline score on the outcome measures (first two columns of Table 2). (gate-control theory).2,9,27 Another potential explanation for the acute effect of massage therapy on pain is its impact on physiological Compliance with the study protocol aspects.9,28,29 The stimuli from massage therapy may cause an im- mediate feeling of relaxation and consequent analgesia, due to the No ineligible participants were randomised. No assessors were unblinded during the study. All participants received the designated realise of b-endorphins9,28,29 and/or a decline in the level of stress intervention and were analysed in the group to which they had been randomly allocated. hormones.29 Massage therapy may also influence psychological as- pects,30 although no effect on mood parameters was observed in the Effect of the massage intervention present study. Perhaps the instrument used (the Brunel Mood Scale) is not sensitive enough to detect the influence of an immediate Means and standard deviations for all the measures at each feeling of well-being on the mood parameters, making this a possible assessment time point are shown in Table 2. Individual participant reason for our results. It is important to underscore that the expla- data are presented in Table 3 (see eAddenda for Table 3). A significant nations for massage therapy effects are based on theories, and no between-group difference was identified for pain assessed using the biochemical or neurophysiologic analyses were performed in this 0-to-10-point numerical rating scale (Table 2). The generalised esti- study to investigate the mechanisms of massage therapy effects. mating equation indicated that the overall between-group difference Nonetheless, the acute effect of massage therapy on pain identified due to the massage therapy was 0.7 points lower pain intensity (95% here corroborates previous research and demonstrates its effective- CI 0.1 to 1.3). ness in acute pain relief in athletes.6,7,11 No significant between-group differences were identified for fa- The acute analgesic effect showed some persistence through the tigue, pain behaviour, mood profile or physical performance (Table 2). later assessment time points and then disappeared by 72 hours. The impact of massage therapy on delayed pain could occur via physio- logical mechanisms.9,31,32 It is suggested that DOMS is caused by the increased production and accumulation of free radicals after Table 2 Mean (SD) of groups, and between-group difference estimated across available assessment time points using a generalised estimating equation (95% CI). Outcomes Pre Post 24 h 48 h 72 h Between-group difference (95%) Exp Con Exp Con Exp Con Exp Con Exp Con Exp – Con Pain (0 to 10), mean (SD) 1.2 (1.6) 0.7 (1.2) 0.2 (0.6) 0.5 (1.3) 0.8 (1.5) 1.0 (1.7) 0.4 (1.3) 0.5 (0.9) 0.2 (0.7) 0.1 (0.3) –0.7 (–1.3 to –0.1) Perceived fatigue (0 to 10), mean (SD) 3.2 (2.3) 2.6 (2.4) 0.8 (1.2) 0.5 (1.1) 1.1 (1.9) 1.2 (1.6) 0.5 (1.4) 0.4 (0.8) 0.2 (0.7) 0.2 (0.4) –0.1 (–0.3 to 0.2) McGill Pain Questionnaire (0 to 45), 3.3 (2.9) 3.5 (2.9) 1.0 (1.2) 1.2 (1.9) 1.7 (2.2) 2.2 (2.2) 1.0 (2.6) 1.0 (1.7) 0.5 (1.2) 0.5 (1.1) –0.1 (–0.6 to 0.4) mean (SD) BRUMS fatigue (0 to 16), mean (SD) 4.2 (3.3) 3.9 (3.6) 1.8 (1.9) 2.1 (2.3) 2.2 (3.2) 2.2 (2.3) 1.2 (1.7) 1.9 (2.5) 1.5 (2.1) 1.1 (1.9) –0.2 (–0.9 to 0.5) BRUMS tension (0 to 16), mean (SD) 1.0 (2.3) 1.3 (1.9) 0.4 (1.2) 0.8 (1.2) 0.9 (1.8) 1.7 (1.9) 1.0 (2.3) 1.1 (1.5) 0.9 (2.2) 1.5 (1.9) –0.3 (–1.0 to 0.3) BRUMS vigour (0 to 16), mean (SD) 10.3 (3.6) 10.5 (3.3) 10.0 (3.6) 10.2 (3.5) 9.1 (3.5) 9.6 (3.7) 9.2 (4.0) 10.0 (3.9) 10.0 (4.0) 10.8 (3.8) –0.5 (–1.7 to 0.6) BRUMS mental confusion (0 to 16), 1.2 (2.8) 0.8 (2.0) 0.3 (0.6) 0.2 (0.7) 0.4 (1.0) 0.4 (1.3) 0.4 (0.9) 0.3 (0.8) 0.4 (1.2) 0.5 (1.4) –0.0 (–0.4 to 0.3) mean (SD) BRUMS depression (0 to 16), mean (SD) 0.4 (1.2) 0.6 (2.3) 0.1 (0.2) 0.3 (1.5) 0.4 (1.4) 0.6 (1.9) 0.4 (1.8) 0.5 (1.6) 0.5 (1.7) 0.5 (1.6) –0.1 (–0.6 to 0.4) BRUMS anger (0 to 16), mean (SD) 0.3 (1.5) 0.5 (1.8) 0.1 (0.2) 0.1 (0.7) 0.1 (0.3) 0.3 (1.1) 0.2 (0.7) 0.5 (1.4) 0.2 (0.9) 0.4 (1.3) –0.2 (–0.5 to 0.1) Knee extensor strength (%), mean (SD) 162 (39) 163 (36) 170 (43) 165 (40) 180 (38) 177 (41) Quadriceps flexibility (deg), mean (SD) 142 (7) 142 (8) 143 (7) 142 (9) N/A N/A 142 (7) 140 (9) N/A N/A 5 (–3 to 13) Jump height (cm), mean (SD) 28.7 (8.2) 31.2 (8.8) 27.5 (7.6) 29.1 (7.9) N/A N/A 28.0 (7.8) 30.0 (7.6) N/A N/A 1 (–1 to 2) N/A N/A N/A N/A 0.4 (–0.8 to 1.5) BRUMS = Brunel Mood Scale, Con = control group, Exp = experimental group, N/A = not applicable.
Research 79 exercise.31,33 Thus, massage therapy may raise lymphatic and blood mechanisms of massage therapy effects on pain and to determine flow, accelerating the elimination of catabolites.9,31,32 Previous whether the effect of massage therapy depends on the level of studies have also reported positive effects of massage therapy on fatigue. delayed pain.7,34,35 Hilbert et al35 reported that massage therapy applied 2 hours after DOMS induction in the hamstring using What was already known on this topic: In sports, massage eccentric exercise may reduce pain intensity 48 hours after the is often used to reduce pain and promote physical recovery. intervention. Of note, the current study identified lower DOMS in- Massage can reduce pain and fatigue after very intense, pro- tensity compared to previous studies.11,15,35 This indicates that mas- longed exercise. sage therapy may be effective at mitigating DOMS, regardless of pain What this study adds: After a habitual 10-km run, massage level, although the effect was weak in the present study where DOMS therapy applied to the quadriceps muscle reduces the intensity of intensity was low. Several causal factors have been suggested for pain, but the effect is mild and may not be considered clinically DOMS, including muscle damage and the inflammatory process.31,36 worthwhile by many people. In this setting, massage therapy Future investigations should verify the impact of massage therapy does not affect fatigue, mood, quadriceps muscle flexibility, knee on these DOMS-related factors. extension strength or vertical jump performance. Previously, Nunes et al6 reported that massage therapy is effective Footnotes: a RS Pro, Corby, UK; b My Jump 2 app, version 3.9.5, at reducing perceived fatigue after strenuous exercise, which was not Madrid, Spain; c iPhone 7, Apple Inc, California, USA; d Lafayette In- observed in the present study. In the study by Nunes et al,6 partici- struments, IN, USA; e G*Power Version 3.1.9.2, Düsseldorf, Germany; pants presented a higher fatigue level compared to the present study, f SPSS Inc. Version 17.0, Chicago, IL, USA. which may explain this inconsistency. Perhaps massage therapy is only effective at lowering perceived fatigue in exhausted athletes eAddenda: Table 3 and Appendices 1-4 can be found online at with important metabolic alterations. Additional research is needed DOI: https://doi.org/10.1016/j.jphys.2019.02.006. to understand the influence of massage therapy on athlete fatigue and develop clinical prediction rules to determine whether fatigue Ethics approval: The Human Research Ethics Committee of Uni- level is a decisive factor in the effectiveness of massage therapy on versidade do Estado de Santa Catarina approved this study (approval muscle fatigue. number CAAE 68038817.7.0000.0118). All participants gave written informed consent before data collection began. In opposition to previous studies,7,37,38 the current study found that massage therapy had no effect on assessments related to physical Competing interests: Nil. performance (flexibility, strength and jump performance). Hopper Source(s) of support: Nil. et al37 reported that massage therapy may improve hamstring flexi- Acknowledgements: The authors would like to acknowledge bility immediately after application in hockey players; Shin and Dr Anamaria Fleig Mayer (NUREAB research group) who gave the Sung38 observed that massage therapy applied after eccentric exer- permission to use the hand-held dynamometer. cise increased ankle plantar flexion strength in healthy people; and Provenance: Not invited. Peer reviewed. Mancinelli et al7 found that massage therapy applied 48 hours after a Correspondence: Guilherme S Nunes, Department of Physio- high-intensity training session increased jump height in volleyball therapy, Center of Health and Sport Sciences, Santa Catarina State athletes. A 10-km run impairs the physical and physiological function University, Florianópolis, Brazil. 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Journal of Physiotherapy 65 (2019) 118 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Media: Facingdisability.com: a unique video library reflecting the experiences of people with spinal cord injuries and their families Background Facebook group is moderated by the website and can only be accessed by people with SCI and their families. An example of the type of con- Spinal cord injury (SCI) affects not only the lives of those who are versations that occur within the group is provided on the website. The injured but also the lives of their families and caregivers. Sharing life Facebook group and how to join is clearly described on the website. The experiences with peers and peer support are both common following website mentions a peer counselling service in the ‘About’ and ‘Media’ SCI and are thought to enhance well-being and self-efficacy in people tabs; however, this link takes the user to the Facebook page so this with SCI and their families.1 This is in line with the World Health aspect of the website may have been superseded. Report on Disability that recommends ‘people with disabilities and their families can support other people with disabilities through peer Key strengths support, health information and advice’.2 Evidence about the best way to provide this information and support is still emerging; The website is very easy to navigate on a variety of devices, however, commonly used methods for sharing life experiences and including tablet, PC or smartphone. It is beautifully produced with providing peer support include websites and Facebook chat groups.3 high-quality videos and sound. Importantly, the resource is free and This review appraises one such website: Facingdisability.com the website contains no advertisements. The most unique contribu- tion of the Facingdisability.com website is that in addition to assisting Origins of the website people with SCI, it also helps families. Resources for families of people with SCI are clearly important but not widely available. Facingdisability.com was launched in 2011 by the Hill foundation: a not-for-profit organisation in the United States of America (USA). Limitations The website was established following the positive experience of one family whose daughter benefited from peer counselling following her The website has one key limitation: it does not capture the SCI. For this reason, the founders were motivated to establish a perspectives of those living outside the USA. To increase worldwide website that offered education and peer-support not only to people appeal, videos of individuals across continents would be ideal. with SCI but also to their families. Interestingly, the Facebook group is open to people with SCI and their families from across the world, although presumably it is only useful Content on the website to those who speak English. Perhaps the global nature of the Facebook group will provide opportunities for the website to link in From the home page it is easy to navigate to the different layers of with people experiencing SCI in countries other than the USA. content. The content includes: videos sharing the lived experiences of people with SCI and their families; videos of interviews with SCI Summary experts; general information about SCI; a blog; links to useful resources; and a closed Facebook group. Physiotherapists and physiotherapy students are an integral part of the team working in partnership with people with disabilities. The video library of over 100 people with SCI or their families is a Listening to and understanding the diverse opinions and perspectives highlight of the website. The videos present diverse perspectives on 48 of people with disabilities and their families is essential for these questions across 13 important topics for people with SCI. Usefully, these partnerships to be successful. For this reason, Facingdisability.com is videos can be filtered by type of injury, relationship, age and gender, or not only useful for people with SCI and their families, it is also a great browsed by topic. While many videos of people with SCI exist on the resource for physiotherapists and physiotherapy students. Internet, these videos stand apart because they are concise, of high quality, and contain both the perspectives of people with SCI and their families. Provenance: Invited. Not peer reviewed. The video library of interviews with experts (including physiotherapists) working with adults and children with SCI is equally impressive and Joanne Glinsky provides credible information for families. The interviews with experts John Walsh Centre for Rehabilitation Research, University of Sydney; that treat children with SCI provide unique insights that are not easy to access outside the few specialist centres that treat children with SCI. Kolling Institute, Royal North Shore Hospital, Australia The general information pages about SCI are necessary and References engaging. On occasion, accuracy has been compromised for simplicity and accessibility. For example, the description of incomplete and 1. Gassaway J. Arch Phys Med Rehabil. 2018;99:1691–1692. complete injuries is not strictly correct as per the widely accepted 2. World Health Organization. World Report on Disability. Geneva: WHO Press; 2011. definitions provided by the International Standards for Neurological Classification of Spinal Cord Injury. P. 23. 3. Lynch J, Cahalan R. Spinal Cord. 2017;55:964–978. The ‘Join the conversation’ tab invites people with SCI and their families to connect with peers through a closed Facebook group. This https://doi.org/10.1016/j.jphys.2019.02.009 1836-9553/Crown Copyright © 2019 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 65 (2019) 99–105 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Research People who identify as LGBTIQþ can experience assumptions, discomfort, some discrimination, and a lack of knowledge while attending physiotherapy: a survey Megan H Ross, Jenny Setchell School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Australia KEY WORDS ABSTRACT Sexual and gender minorities Questions: What are the experiences of people who identify as lesbian, gay, bisexual, transgender, intersex, Health queer or related identities (LGBTIQþ) and attend physiotherapy? How could those experiences of physio- Communication therapy be improved? Design: Primarily qualitative design using a purpose-built online survey. Participants: Gender identity People aged 18 years or older, who self-identified as LGBTIQþ, and had attended physiotherapy in Australia. Physical therapy Methods: Open responses were analysed with thematic analysis and quantitative responses with descriptive statistics. Results: One hundred and fourteen participants responded to the survey, with 108 meeting all eligibility criteria. Four main themes were identified in the analysis, with almost all participants reporting experiences during physiotherapy interactions relating to at least one of the following themes: ‘assumptions’ about participants’ sexuality or gender identity; ‘proximity/exposure of bodies’, including discomfort about various aspects of physical proximity and/or touch and undressing and/or observing the body; ‘discrimina- tion’, including reports of overt and implicit discrimination as well as a fear of discrimination; and ‘lack of knowledge about transgender-specific health issues’. Positive experiences were also evident across the first, third and fourth themes. Participants suggested or supported a number of ways to improve LGBTIQþ ex- periences with physiotherapy, including: LGBTIQþ diversity training for physiotherapists, education specific to the LGBTIQþ population (particularly transgender health), and open options for gender provided on forms. Conclusion: People who identify as LGBTIQþ can experience challenges when attending physiotherapy, including: erroneous assumptions by physiotherapists, discomfort, explicit and implicit discrimination, and a lack of knowledge specific to their health needs. Positive findings and participant-suggested changes offer ways to improve physiotherapy for LGBTIQþ people across educational and clinical settings. [Ross MH, Setchell J (2019) People who identify as LGBTIQD can experience assumptions, discomfort, some discrimination, and a lack of knowledge while attending physiotherapy: a survey. Journal of Physio- therapy 65:99–105] © 2019 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 One third of Australians who identify as LGBTIQþ do not disclose their sexuality or gender identity when accessing healthcare,15 with A significant, and increasing, number of Australians identify as not being heterosexual (3 to 11%)1 and/or gender diverse. Lesbian, gay, reasons largely unresearched but proposed to be due to fear of bisexual, transgender, intersex, queer and related identities discrimination, including receiving poorer care.16 Research has (LGBTIQþ) civil rights have become a topic of increased social and political debate in Australia and other countries over recent years. highlighted that LGBTIQþ patients feel judged and receive subopti- Although this debate has resulted in reduced discrimination, mal care from a variety of health professions, including medicine and including policy changes such as legalisation of same-sex marriage in nursing,17 mental health,16,18 and peri-natal care.19 However, there some countries, stigma and inequity still exist.2 has been no research investigating how people who identify as Health and access to healthcare remain an important area of inequity for LGBTIQþ people.3 Globally, LGBTIQþ people experience LGBTIQþ experience physiotherapy. significantly poorer health and greater barriers to healthcare. While similarities between physiotherapy and other health Research consistently highlights poorer mental health,4–6 including much higher suicide rates than in the general population.7,8 Physical professions exist, and previously identified barriers may apply health is also poorer,9 with those identifying as LGBTIQþ more likely to all forms of healthcare, it is likely that there are barriers to be diagnosed with cardiovascular disease,10,11 cancer,12 diabetes,13 unique to physiotherapy.20 Physiotherapy can be innately inti- and disability.11,14 mate, with undressing, critical observation and touch common during treatment.21,22 These aspects can be difficult to negotiate, with some physiotherapy patients feeling uncom- fortable or judged.23 There may be similar effects for LGBTIQþ people. https://doi.org/10.1016/j.jphys.2019.02.002 1836-9553/© 2019 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/).
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