Journal of Physiotherapy 60 (2014) 240 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Clinimetrics Patient-Rated Tennis Elbow Evaluation Questionnaire Summary Instrument description: The Patient-Rated Tennis Elbow together and divided by two to get a function score out of Evaluation Questionnaire (PRTEE), formerly called the Patient- Rated Forearm Evaluation Questionnaire,1 is a 15-item self- 50. Therefore: PRTEE total score = [Pain score (max 50) + Function reported questionnaire to measure perceived pain and disability in people with tennis elbow.2 It has three subscales: pain, usual score (max 100/2 = 50)]. It takes approximately 5 minutes to activities and specific activities. The pain subscale has five items complete the PRTEE.2 about the intensity of pain during various activities. The specific activities subscale has six items tapping into the difficulty Clinical measurement properties: The PRTEE has demonstrated experienced while performing specific activities, like lifting a coffee cup. The four items in the usual activities subscale capture sufficient clinical measurement properties. It has exhibited the difficulty experienced in performing usual daily roles like work and recreation.2 excellent test-retest reliability (ICC = 0.96) in a work-related tennis elbow sample,3 and an ICC of 0.89 in a mixed work-related and Instructions and scoring: Each of the items of the PRTEE is non-work-related tennis elbow sample.2 It also has high reliability in scored on a 0–10 scale, where 0 is ‘no pain’ or ‘no difficulty’ and a sample of tennis players r2 = 0.87.4 In addition, excellent internal 10 is ‘worst ever’ or ‘unable to do’. People are asked to rate the pain and difficulty that they have experienced in the past week because consistency of 0.85 to 0.94 across the subscales indicates that the of tennis elbow by circling the appropriate response that reflects their current state. The total score ranges from 0 to 100, where high items in the PRTEE are tapping into different aspects of the same scores indicate greater pain and disability. Pain and function are concept.4 In their trial that included 78 tennis players, Rompe et al4 equally represented in the total score. To calculate the total score, the raw pain score is taken as a total of 50, and the usual activities found that the PRTEE correlated well with the DASH (Disabilities of subscale and the specific activities subscale scores are added Arm Shoulder and Hand) and the Thomson test. The PRTEE has also demonstrated large standardised response means (SRM) and effect sizes (ES) (SRM = 2.1)4 (SRM = 1; ES = 1)3 indicating high sensitivity to change. The PRTEE has been translated and cross-culturally adapted into different languages such as Italian,5 Swedish6 and Hong Kong Chinese7 and found to have been comparable to the original English version with acceptable levels of clinical measure- ment properties. Commentary The PRTEE is an excellent example of a disease-specific self- Joshua Vincent and Joy C. MacDermid report measure. This is very helpful in capturing aspects of pain Clinical Research Laboratory, University of Western Ontario, and function that are more specific to tennis elbow than a generic joint-specific or region-specific measure. The strong clinical London, Canada measurement properties reported endorse its use in clinical settings. The cross-cultural adaptations of the PRTEE are evidence References of its inclusiveness as an outcome measure. However, none of the studies have determined the minimal detectable change or 1. Macdermid J. J Hand Ther. 2005;18:407–410. the minimal clinically important difference for the PRTEE, which 2. Overend T, et al. J Hand Ther. 1999;12:31–37. could be of great use to clinicians to determine clinically 3. Newcomer K, et al. J Hand Ther. 2005;18:400–406. meaningful change in a patient’s status. 4. Rompe J, et al. J Hand Ther. 2007;20:3–10. 5. Cacchio A, et al. Phys Ther. 2012;92:1036–1045. 6. Nilsson P, et al. BMC Musculoskel Disord. 2008;9:79. 7. Leung H, et al. Hong Kong Med J. 2004;10:172–177. http://dx.doi.org/10.1016/j.jphys.2014.08.002 1836-9553/ß 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.
Journal of Physiotherapy 60 (2014) 181–188 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Invited Topical Review Physiotherapy management of acute exacerbations of chronic obstructive pulmonary disease Anne E Holland La Trobe University, Alfred Health and Institute for Breathing and Sleep, Melbourne, Australia KEY WORDS [Holland AE (2014) Physiotherapy management of acute exacerbations of chronic obstructive pulmonary disease. Journal of Physiotherapy 60: 181–188] Chronic obstructive pulmonary disease ß 2014 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article Physiotherapy Rehabilitation under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/). Disease exacerbation Introduction pollution. In one-third of severe exacerbations the cause may be unknown.1 Exacerbations cluster in time7 and the strongest Acute exacerbations are an important feature of chronic predictor of future exacerbations is a history of exacerbations.8 obstructive pulmonary disease (COPD), with long-term implica- tions for patients and the health system. Physiotherapists play an During an acute exacerbation, exposure to a viral, bacterial or integral role in the treatment of people with exacerbations of environmental trigger causes worsening airway inflammation, COPD, with high-level evidence that physiotherapy interventions which exacerbates the chronic airway inflammation that is can aid recovery and prevent recurrence. This review summarises characteristic of stable COPD. Increased inflammation and oxida- the respiratory and systemic consequences of an acute exacerba- tive stress in the COPD airway are manifested by increased airway tion of COPD (AECOPD); the burden of exacerbations for oedema and mucus hypersecretion, with worsening airway individuals and the health system; management of AECOPD, with obstruction, dynamic hyperinflation, dyspnoea and cough.9 Work a focus on important physiotherapy interventions; prevention of of breathing may be increased and in severe cases type-II AECOPD; and future directions for research and practice. respiratory failure may occur. The inflammatory cascade that occurs during an acute exacerbation is thought to contribute to What is an acute exacerbation of COPD? structural lung damage (eg, alveolar wall thickening, loss of surface area for gas exchange) that is responsible for the progression of The Global Initiative for Obstructive Lung Disease (GOLD) COPD over time. strategy defines an exacerbation of COPD as ‘an acute event characterised by a worsening of the patient’s respiratory symptoms The adverse impact of an exacerbation may not be confined to that is beyond normal day-to-day variations and leads to a change in the lungs. Systemic effects of AECOPD are well documented, with medication’.1 People with COPD experience between one and four increased levels of circulating pro-inflammatory mediators such as exacerbations per year.2 Important symptoms include dyspnoea (in fibrinogen and interleukin-6.10 These systemic effects may 84% of individuals), fatigue (81%), runny nose (59%), changes in contribute to an increased risk of cardiovascular events, with a sputum colour (53%) or amount (47%), and cough (44%).3 As there are 2.27-fold increase in the risk of myocardial infarction during the no biomarkers that can reliably detect a COPD exacerbation, the first five days and a 1.26-fold increase in the risk of stroke during diagnosis depends on patient report and clinical presentation. Whilst the first 49 days after an exacerbation.11 Peripheral muscle may the GOLD definition suggests that a diagnosis of AECOPD requires a also be affected. During and after an exacerbation, people with change in medical management, up to 40% of exacerbations may not COPD demonstrate a decrease in quadriceps force that worsens be reported to health professionals and these untreated exacerba- over the course of hospital admission.12,13 The causes of reduced tions may have a significant impact on health status.4 peripheral muscle force are not fully understood but are thought to include corticosteroid treatment,14 systemic inflammation12 and The most common cause of a COPD exacerbation is thought to low levels of physical activity.15 People with COPD are highly be viral infection, most often rhinovirus.5 Exacerbations with inactive during hospitalisation, with total walking duration as low documented viral infection are associated with more severe as 7 minutes per day.16 symptoms and slower recovery than those without viral infection.5 Bacterial infection is a less common cause of exacerbation. Burden of acute exacerbations of COPD However, as many COPD airways are colonised with bacteria, secondary bacterial infection occurs in up to 60% of cases.6 Acute exacerbations are critical events in the natural history of Exacerbations have also been attributed to environmental COPD. They are associated with a more rapid decline in lung function,17 a sustained reduction in health-related quality of life2 http://dx.doi.org/10.1016/j.jphys.2014.08.018 1836-9553/ß 2014 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/3.0/).
)TD$(_G][erugiIF1182 Holland: Physiotherapy management of COPD exacerbations and increased risk of future exacerbations.7 Approximately 25% of Corticosteroids Early mobilisation Non-invasive ventilation the decline in lung function in COPD is attributed to acute exacerbations,17 which become more frequent as disease pro- Favours intervention Antibiotics if in ICU Rehabilitation after acute exacerbation Several high-quality RCTs gresses.18 An exacerbation that is severe enough to require hospitalisation is an independent predictor of all-cause mortality, Controlled oxygen therapy Breathing exercises Single high-quality RCT with death rates of 22 to 43% at 1 year following admission.19 or several low-quality Inhaled bronchodilators RCTs People with COPD who have frequent exacerbations are particularly at risk of adverse outcomes. Those who experienced Uncontrolled trials or two or three exacerbations per year had faster declines in expert opinion respiratory function, fat free mass, physical activity and quality of life than those with fewer exacerbations.2,8,20,21 The ‘frequent Favours usual care Rehabilitation during acute exacerbation Uncontrolled trials or exacerbator’ phenotype is consistent over time, such that those expert opinion patients who are observed to have frequent exacerbations are likely to continue to have frequent exacerbations in the future.8 Single high-quality RCT These patients are at high risk for adverse outcomes, regardless of or several low-quality the severity of their underlying airflow limitation, and an RCTs aggressive approach to therapy is recommended.1 Several high-quality RCTs The effects of acute exacerbations on muscle strength and physical activity may have important long-term consequences. Figure 1. Interventions for management of acute exacerbations of chronic Previous research has found that walking time in daily life does not obstructive pulmonary disease with associated levels of evidence. spontaneously recover at 1 month following hospital admission, ICU = intensive care unit, RCT = randomised controlled trial. with minimal improvements seen in those who have the largest decline in quadriceps strength.13 Following an exacerbation, low benefit for patients with a COPD exacerbation who are admitted to levels of physical activity are associated with a 50% increase in the intensive care (Peto OR 0.21, 95% CI 0.06 to 0.72). Antibiotics also risk of hospital readmission22 and a longer length of stay in reduce length of hospital stay in this group with severe hospital for all subsequent admissions.13 In people with COPD, exacerbations (mean reduction 9.6 days).30 However, the effects physical inactivity is a stronger predictor of all cause mortality of antibiotics in mild and moderate exacerbations are less clear, than respiratory function, exercise capacity or nutritional status, with no mortality benefit and inconsistent effects across different with an absolute 4-year mortality risk of 31% in inactive patients.23 outcomes. The GOLD standards suggest that antibiotics should be prescribed to patients who have all three cardinal signs of an Exacerbations of COPD also have important consequences for exacerbation (increased dyspnoea, sputum volume, and sputum health systems and societies. Nearly 60% of the global cost of COPD purulence), or to patients with two of the cardinal signs, if one of is associated with managing exacerbations, with the majority of them is sputum purulence.1 Other pharmacological agents may be the financial burden being associated with hospital treatment.24 required for treatment of comorbidities, including diuretics and This equates to costs in excess of A$550 million each year in anticoagulants. Australia,25 over £800 million in the United Kingdom26 and US$4.5 Controlled oxygen therapy billion in the United States of America.27 One percent of all Oxygen therapy is important to prevent severe hypoxaemia hospitalisations in Australia in the 2007–2008 financial year were during exacerbations of COPD, but high levels of supplemental for a primary diagnosis of COPD and the average length of stay was oxygen may contribute to hypercapnia, acidosis and death.31 twice as long as the overall average length of stay for any condition, Oxygen therapy should be titrated to achieve oxyhaemoglobin at 6.9 days compared to 3.3 days.25 In the USA, it is estimated that saturation (SpO2) between 88 and 92%,31 and is usually adminis- 20% of patients with COPD are readmitted within 30 days of tered via nasal prongs or a venturi mask. Oxygen can also be discharge, with an increase in costs of 30% for subsequent delivered using high flow nasal cannulae, which may better meet admissions.27 General practice costs in the UK are doubled for the inspiratory flow demands of severely dyspnoeic patients and is patients who experience two exacerbations per year compared to more tolerable than a face mask. Such systems can also provide those who experience none.28 In the light of the costs of COPD humidification, which may be important to prevent sputum exacerbations to individuals and the health system, there is a clear retention in patients with excess secretions; however, there is no imperative to provide optimal, evidence-based management. evidence to guide practice in this area. Management of exacerbations of COPD Non-invasive ventilation A summary of interventions used in the management of Non-invasive ventilation is highly effective as a supportive AECOPD, along with the level of evidence that underpins their use, therapy for people with AECOPD complicated by type-II respirato- is provided in Figure 1. ry failure. It unloads the respiratory muscles, restores acid-base balance and provides time for pharmaceutical therapies to be Pharmacological management effective. A systematic review and meta-analysis showed that in patients with COPD and acute hypercapnic respiratory failure Short-acting inhaled beta-2 agonists are frequently prescribed (PaCO2 > 45 mmHg, pH < 7.35), non-invasive ventilation reduced during an acute exacerbation of COPD, as consensus indicates that mortality compared to usual care (RR 0.52, 95% CI 0.36 to 0.76) and they are of benefit.1 These are equally effective when administered reduced the need for intubation (RR 0.41, 95% CI 0.33 to 0.53).32 via metered dose inhaler (with or without a spacer) compared to a There are also benefits for the health system, with reduced length nebuliser.1 Systemic corticosteroids are a mainstay of treatment. A of stay in those treated with non-invasive ventilation (MD – systematic review including over 1000 patients found that 3.24 days, 95% CI –4.41 to –2.06).32 corticosteroids halved the risk of return to hospital within 30 days (Peto OR 0.50, 95% CI 0.36 to 0.69).29 Those treated with Physiotherapists are frequently involved in the delivery of non- corticosteroids also had a shorter hospital stay (MD 1.22 days, invasive ventilation, including assessment and referral of appro- 95% CI 0.18 to 2.26) and recovered their lung function more priate patients, establishing patients on treatment, titration of quickly. However, adverse events were more common in those pressures, optimising patient tolerance and monitoring treatment treated with corticosteroids (Peto OR 2.33, 95% CI 1.60 to 3.40), effects.33 Non-invasive ventilation may assist in delivery of other particularly hypoglycaemia.29 Antibiotics provide a clear survival physiotherapy treatments such as early mobilisation. In a group of hospitalised patients who were recovering from acute-on-chronic respiratory failure, most of whom had COPD, the use of non- invasive ventilation and oxygen during walking resulted in clinically significant improvements in walking distance, oxyhae- moglobin saturation and exercise-induced dyspnoea compared to
Invited Topical Review 183 walking on oxygen alone.34 Non-invasive ventilation also im- reduced the need for ventilatory assistance (OR 0.21, 95% CI 0.05 to proved endurance time for unsupported upper limb exercise. 0.85), reduced the duration of ventilatory assistance (MD –2.0 These results were obtained from patients who were as early as days, 95% CI –1.5 to –2.6) and reduced overall hospital length of 2 days into their hospital admission, using inspiratory positive stay (MD –0.75 days, 95% CI –0.1 to –1.4).43 These results were airway pressure ranging from 15 to 18 cmH2O and expiratory heavily influenced by trials using positive pressure techniques, positive airway pressure ranging from 4 to 5 cmH2O. which generally had more favourable outcomes than those that did not use positive pressure. Breathing exercises In addition to the Cochrane review,44 there are two large trials Physiotherapists frequently use breathing exercises to relieve of airway clearance techniques for AECOPD that have implications dyspnoea, improve thoraco-abdominal co-ordination and enhance for practice. A randomised controlled equivalence trial in functional capacity in people with acute exacerbations of COPD. 526 people hospitalised with an AECOPD found no difference in Commonly used techniques include breathing control (also known quality of life at 6 months between those who received manual as diaphragmatic or abdominal breathing) and pursed lip chest physiotherapy (active cycle of breathing technique including breathing (gentle exhalation through lips that are pressed FET, percussion and vibration) and those who received only advice together). Despite their widespread use in clinical practice, about positioning and active cycle of breathing technique.44 There evidence for important benefits of breathing exercises in AECOPD was no difference in hospital length of stay between groups. The is scarce. A Cochrane review including 16 studies and 1233 parti- trial had broad inclusion criteria and participants did not have to cipants with stable COPD found that breathing exercises (pursed be productive of sputum to take part. The results of this study lip breathing, pranayama yoga or diaphragmatic breathing) provide confidence that manual chest physiotherapy techniques improved functional exercise capacity when compared to no do not have a routine role for people with AECOPD. Another treatment.35 Whether these findings are also applicable during randomised trial comparing positive expiratory pressure therapy acute exacerbations is unclear. Recent randomised controlled trials (PEP) and FET to usual physiotherapy care in 90 people hospitalised provide some evidence that breathing exercises may provide with AECOPD found no difference between groups in the primary symptomatic relief in patients who are hospitalised with acute outcome – the Breathlessness, Cough and Sputum Scale – at any exacerbations of COPD. Patients who undertook twice daily time point during the 6-month followup.45 Although dyspnoea sessions of controlled breathing supervised by a physiotherapist, improved more rapidly in the PEP group in the first 8 weeks, by consisting of relaxation exercises, pursed lip breathing and active 6 months there were no clinically relevant or statistically expiration, had greater improvements in anxiety, depression and significant differences between groups. When this trial is combined dyspnoea than those who undertook usual care.36 Similarly, with previous airway clearance technique studies in a meta- respiratory exercises during a hospital admission for AECOPD analysis, the body of evidence no longer suggests an overall benefit (diaphragmatic breathing and pursed lip breathing) resulted in of the techniques during AECOPD in the need for ventilatory lower levels of fatigue compared to usual care.37 It is not clear assistance (Figure 2; for a more detailed forest plot, see Figure 3 on whether ‘usual care’ in either study included other physiotherapy the eAddenda).45–49 The differing results between this trial and interventions that are considered to be standard practice in many previous studies may be related to the population studied, which settings, such as airway clearance techniques, mobilisation or included fewer people who needed ventilatory assistance, or to the exercise training. Outcomes beyond the hospital admission were more active comparison group, where usual physiotherapy care not studied. However, these small trials provide preliminary included early mobilisation.49 evidence that breathing techniques may be useful to aid symptom control in the setting of AECOPD. In summary, current evidence for the effects of airway clearance techniques in AECOPD is inconsistent across trials, but does not Whilst selected breathing techniques such as pursed lip suggest an overall benefit of airway clearance techniques for breathing may prove useful to manage symptoms during an hospitalised patients. Whilst positive outcomes have been AECOPD, this does not extend to breathing techniques that aim to reported in the sickest patients (ie, those requiring or at risk of improve lung volume, such as deep breathing exercises. During an requiring invasive or non-invasive ventilatory assistance) in the AECOPD, where the primary impairments are airflow obstruction, most recent Cochrane review,43 these effects are small and are not expiratory flow limitation and hyperinflation, augmentation of supported by the results of a recent large trial.49 There is no lung volume may have adverse effects. Studies in COPD have evidence that manual chest physiotherapy techniques are useful in shown that although deep breathing exercises may increase AECOPD. However, it should be recognised that many studies do ventilation and improve blood gases, this is accompanied by not account for different COPD phenotypes (eg, those who are increased inspiratory muscle effort, reduced mechanical efficiency of breathing and increased dyspnoea.38,39 As a result, deep ciFI$]([gure_2)TDG opious or regular sputum producers, or who have underlying breathing exercises do not have a role in physiotherapy manage- ment of AECOPD. Study Odds Ratio (95% CI) Newton45 Fixed Airway clearance techniques Bellone46 Inal-Ince47 Increased cough, sputum volume and sputum purulence are key Vargas48 features of AECOPD. Airway clearance techniques involve applica- Osadnik49 tion of physical forces to enhance removal of sputum from the airway.40 Commonly used airway clearance techniques are the Pooled forced expiration technique (FET, also known as huffing), manual chest physiotherapy and positive pressure devices. Assumptions 0.002 0.1 1 10 500 underlying the use of airway clearance techniques are that retained sputum contributes to mucosal injury and airflow Favours ACTs Favours control obstruction, with longer-term impacts on re-exacerbation, hospi- talisation and mortality.41 A recent Australian study found that Figure 2. Effect of airway clearance techniques on need for ventilatory assistance 65% of cardiorespiratory physiotherapists frequently prescribe during acute exacerbation of chronic obstructive pulmonary disease. Data are odds airway clearance techniques for patients hospitalised with ratios. No significant difference in the odds of requiring ventilatory assistance AECOPD.42 This practice was supported by a Cochrane review between those who did and did not receive airway clearance techniques. showing that in people with AECOPD, airway clearance techniques ACTs = airway clearance techniques.
Figu(re[4)TD$IG]_184 Holland: Physiotherapy management of COPD exacerbations bronchiectasis41). Whilst attempts to identify ‘responders’ to Subgroup Odds Ratio (95% CI) airway clearance techniques in AECOPD have not been successful Study Fixed to date,49 this does not exclude a role for the techinques in carefully selected patients in whom excessive sputum production or sputum Rehabilitation in hospital retention are clinically important problems. Behnke55 Early mobilisation and early rehabilitation Eaton57 Early mobilisation, which aims to prevent functional decline and facilitate hospital discharge, is a key element of physiotherapy Greening54 management for AECOPD. This includes early ambulation, commenced within 24 hours of hospital admission, and may also Pooled include targeted strength training and goal-directed practice (eg, stair training) to achieve a safe discharge back to the community. Rehabilitation after discharge There is some evidence to support the efficacy of this low-intensity exercise training as part of a broader package of care. A Cochrane Ko58 review examined the impact of multidisciplinary interventions including exercise programs to improve strength or function in Man59 acute medical inpatients aged 65 years or older.50 Of nine included trials, seven had a substantial proportion of participants with Troosters60 respiratory disease. There was a small but significant reduction in hospital length of stay in participants who received the package of Pooled care including early, low-intensity, exercise training (MD 1.08 days shorter in the intervention group, 95% CI 1.93 to 0.22). Mobility 0.005 0.1 1 10 200 interventions that aim to facilitate discharge are considered to be standard care for people hospitalised with AECOPD. Favours early rehabilitation Favours usual care Early rehabilitation, which is a more intensive approach than Figure 4. Effect of early rehabilitation during acute exacerbations of chronic early mobilisation, may be applied during or after an AECOPD. obstructive pulmonary disease on mortality. Data are odds ratios. Odds of death Early rehabilitation applies the well-established principles of increased in those commencing rehabilitation during hospital admission but pulmonary rehabilitation to patients who are in the initial stages of decreased in those commencing rehabilitation shortly after hospital discharge. recovery from an AECOPD. This includes the use of moderate-to- high intensity endurance training and/or strength training. Initial On closer examination of the Cochrane review,53 it is apparent that studies suggested that this training approach is safe even in the only three of the nine included trials tested a very early early stages of hospitalisation, with no significant adverse events and no increase in markers of systemic inflammation.51,52 A rehabilitation intervention, commencing during the hospitalisa- Cochrane review including nine trials where rehabilitation was tion period.55–57 If meta-analysis is conducted separately for the commenced either during or after treatment for an AECOPD showed a reduction in the odds of future hospital admission of 88% outcomes of the very early rehabilitation trials (defined as those (pooled OR 0.22, 95% CI 0.08 to 0.58) and a reduction in the odds of commencing during hospitalisation for AECOPD), including the death of 72% (OR 0.28, 95% CI 0.10 to 0.84).53 This systematic recently published UK trial,54 there is a clear difference in review provided the first robust evidence that early pulmonary outcomes. Whilst rehabilitation started after hospital discharge rehabilitation could impact on mortality, which was a significant has a positive impact on mortality,58–60 the opposite is true for very advance in the field and provided a strong rationale for its implementation into physiotherapy practice. early rehabilitation started in the inpatient period (Figure 4; for a more detailed forest plot, see Figure 5 on the eAddenda).54,55,57–60 Although the data supporting early rehabilitation presented in the Cochrane review showed clear and consistent effects,53 a The positive impact of early rehabilitation on hospital recent trial suggests a more complex story. In a large trial (n = 389) readmission is no longer evident when trials of very early conducted in the UK, people hospitalised with AECOPD were randomised to receive either very early rehabilitation (aerobic rehabilitation are considered separately (Figure 6; for a more training, strength training and neuromuscular electrical stimula- detailed forest plot, see Figure 7 on the eAddenda).54,55,57–59,61,62 tion), commencing within 48 hours of hospital admission, or usual care, which included routine physiotherapy (airway clearance, In the light of these new data, physiotherapists should mobilisation and smoking cessation).54 The intervention was not prescribe a moderate or high intensity rehabilitation program applied for the duration of the hospital admission (median 5 days), followed by an unsupervised home exercise program until week 6, iF[(igure_6)TD$IG] n the inpatient period during AECOPD. However, given the supported by telephone follow-up. There was no difference between groups in the primary outcome of hospital readmission, Subgroup Odds Ratio (95% CI) nor were there any clinically important differences in functional Study Random outcomes. Importantly, there was also a surprising finding of an increase in mortality for the early rehabilitation group at Rehabilitation in hospital 12 months (25% in the early rehabilitation and 16% in usual care, p = 0.03). Behnke55 It is possible that the increase in mortality following early Eaton57 rehabilitation occurred purely by chance. It is notable, however, that uptake of outpatient pulmonary rehabilitation was signifi- Greening54 cantly lower in the early rehabilitation group (14 vs 22% in usual care group, p = 0.04), so it is possible that the intervention actually Pooled received a lower overall ‘dose’ of rehabilitation than the usual care group. Regardless, the strong design of this trial prompts us to Rehabilitation after discharge reassess the role and outcomes of early rehabilitation for COPD. Ko58 Man59 Murphy61 Seymour62 Pooled 0.01 0.1 1 10 100 Favours early rehabilitation Favours usual care Figure 6. Effect of early rehabilitation during acute exacerbations of chronic obstructive pulmonary disease on hospital readmission during follow-up. Data are odds ratios. Odds of hospital readmission did not differ between those commencing rehabilitation during hospital admission compared to usual care, but decreased in those commencing rehabilitation shortly after hospital discharge.
Invited Topical Review 185 compelling evidence for the benefits of pulmonary rehabilitation (Figure 6; for a more detailed forest plot, see Figure 7 on the delivered following hospital discharge, all efforts should be made eAddenda). to ensure that patients can access a pulmonary rehabilitation program during this period. Pulmonary rehabilitation, which must include whole body exercise training, may provide opportunity to reverse the Referral to outpatient pulmonary rehabilitation, commencing deleterious effects of the AECOPD on skeletal muscle function after the acute admission is complete, should be routine practice and physical activity. The non-exercise components of pulmonary for patients who are discharged from hospital following treatment rehabilitation may also assist in preventing future exacerbations of an AECOPD. However, recent studies have shown that the by providing opportunities to optimise nutritional status; address positive outcomes of clinical trials may not be easy to replicate in psychosocial issues such as anxiety and depression, which are clinical practice. An audit conducted in the UK63 found that out of linked to exacerbation risk;70 encourage recognition and early 448 patients admitted to hospital with an AECOPD, less than two- treatment of exacerbations; and enhance self-management skills. thirds (n = 286) met the criteria for admission to an early Physiotherapists will need to identify and address individual pulmonary rehabilitation program. The most common reasons barriers to attendance to ensure program uptake and completion. for exclusion were cognitive impairment or being unable to walk. Less than one-third of eligible patients were referred to early Self-management programs pulmonary rehabilitation (n = 90) and less than half of those People with COPD often live with ill health for many years and referred went on to complete the program (n = 43). This represents less than 10% of all hospital discharges with AECOPD. Little must engage in complex health-related behaviours to ensure that information is available to explain health professionals’ low rate of their disease is optimally managed. Self-management interven- referral of eligible patients and further work is required to tions aim to encourage healthy behaviours and improve self- understand this failure of research translation. Patient-related management skills, including prevention and early treatment of barriers have received more attention. People with COPD who exacerbations. A meta-analysis including 1749 participants with decline early pulmonary rehabilitation may experience feelings of COPD from nine studies showed that self-management interven- low self-worth, be reluctant to seek help, feel they are doing tions decreased the risk of respiratory-related hospitalisation by enough exercise already and perceive pulmonary rehabilitation as over 40% (OR 0.57, 95% CI 0.43 to 0.75).71 However, a recent large of limited value.64 These factors suggest that supportive and trial of self-management for COPD was stopped early due to flexible referral pathways will be required to facilitate access and increased mortality in the intervention group,72 which has raised uptake of early pulmonary rehabilitation for people recovering concerns regarding the risks of strategies that require patients to from AECOPD. make independent choices regarding identification and treatment of AECOPD. However, when the body of evidence for self- Preventing exacerbations of COPD management programs is considered in its entirety, including this trial,72 the meta-analysis shows no excess mortality risk.73 Exacerbations of COPD have long-term consequences and high Nevertheless, this trial provides a reminder that behavioural costs for individuals, communities and the health system. Whilst interventions may have a powerful impact on outcomes, and that every exacerbation is important, a patient’s second exacerbation adequate support should be provided to ensure that patients can that is severe enough to require hospitalisation may be a sentinel successfully undertake the required behaviours. event that marks an exponential increase in the rate of future severe exacerbations and increased risk of mortality.65 This Action plans suggests that there may be a window of opportunity after the An action plan is an individualised, documented plan for first hospitalisation for AECOPD in which health professionals can intervene to prevent or delay the second severe exacerbation and responding to increased respiratory symptoms. Action plans may modify the disease course. This is an important opportunity for involve early commencement of pharmacotherapy and seeking physiotherapists, who frequently have contact with patients medical care. There is no evidence that use of an action plan alone hospitalised for their first AECOPD and be able to positively can decrease exacerbation rate or reduce healthcare utilisation, influence future management. although it may increase the initiation of antibiotic and corticosteroid treatment at symptom onset.74 Action plans Pharmacotherapy to prevent AECOPD accompanied by the support of a case manager may reduce symptoms and accelerate symptom recovery after AECOPD.75 It is Vaccination and maintenance pharmacotherapy are the main- likely that more intensive support is required for the potential stays of exacerbation prevention in people with COPD. In benefits of action plans to be fully realised, such as that provided in community-dwelling older people, the influenza vaccine reduces comprehensive self-management programs. the risk of hospitalisation for pneumonia and influenza by 27%, with an associated 48% reduction in the risk of death.66 The pneumococcal Other interventions vaccine is also commonly given, although there is less evidence for The impact of mucolytic therapy on rate of AECOPD is its benefits. Large randomised controlled trials have shown convincing reductions in exacerbation risk and hospitalisation inconsistent across trials76 and it is not currently recommended using the combination of inhaled corticosteroids and long-acting for routine use.1 Whilst telemonitoring of symptoms and beta agonists67 or long-acting muscarinic antagonists.68 Current physiological signals in community-dwelling people with COPD treatment protocols indicate that either regimen can be used to had promising initial results,77 a recent large trial in the UK prevent exacerbations, or triple therapy can be given if necessary.1 showed no impact on hospitalisation for AECOPD.78 In this trial Phosphodiesterase inhibitors have been shown to decrease exacer- both the telemonitoring and usual care groups had access to the bations by 17% in moderate-to-severe COPD,69 although adverse same high-quality and accessible clinical care, suggesting that effects are more common than with inhaled medications.1 telemonitoring alone is not enough to improve outcomes. Randomised trials have not shown an impact of long-term oxygen Non-pharmacotherapy to prevent AECOPDs therapy on exacerbation rate or hospitalisation, despite its mortality benefit.79,80 Smoking cessation is a cornerstone of Pulmonary rehabilitation COPD management with a range of benefits for patients, including Delivery of pulmonary rehabilitation after hospitalisation for reduced exacerbation rate81 and reduced hospitalisation.82 Smoking cessation should therefore be encouraged and supported AECOPD reduces the odds of readmission for AECOPD by over 70% in all people with COPD. Like all health professionals, phy- siotherapists should take every opportunity to systematically identify smokers, assess smoking status, offer smoking cessation advice and refer for smoking cessation treatment.
186 Holland: Physiotherapy management of COPD exacerbations Future directions for research and practice hospital discharge. For patients whose attendance at an outpatient In recent years physiotherapy management for AECOPD has program is precluded by dyspnoea or frailty, this may require increasingly focussed on exercise-based rehabilitation, both in the outpatient and inpatient settings. In the light of recent consideration of alternative rehabilitation models, such as well- evidence,54 there is an urgent need for research that helps us to resourced home-based programs.87 Finally, physiotherapists understand the risks versus benefits of very early rehabilitation for AECOPD. Whilst studies in other populations such as critical should take a more active role in prevention of future AECOPD. care and stroke indicates that very early rehabilitation has a greater balance of benefits than harms, this may not be applicable Using evidence-based treatments such as rehabilitation and self- to AECOPD. Future research should carefully investigate the physiological effects of very early rehabilitation, including impact management training, physiotherapists have the tools to make a on inflammatory status, and rigorously document the total dose of rehabilitation achieved over the course of the trial. Usual care long-term impact on the health, wellbeing and longevity of people should be defined in detail. A well-powered study conducted across multiple settings will be required, and a safety monitoring with COPD. board will be mandatory. eAddenda: Figures 3, 5 and 7 can be found online at Although physiotherapists commonly use breathing strategies to manage symptoms and enhance exercise tolerance during doi:10.1016/j.jphys.2014.08.018 AECOPD, the evidence underpinning this practice is not convinc- ing. As hospital admissions for AECOPD become shorter and the Competing interests: Nil. emphasis on achieving readiness for discharge becomes larger, there is a need to demonstrate that breathing techniques Acknowledgements: Nil. contribute to both patient wellbeing and improved function. Future research should examine whether breathing exercises give Correspondence: Anne E Holland, La Trobe University, Alfred rise to clinically meaningful and measurable benefits for patients hospitalised with AECOPD; these include improved functional Health and Institute for Breathing and Sleep, Melbourne, Australia. exercise tolerance, a faster return to independence and improved disease mastery. Similarly, any future trials of airway clearance Email: [email protected] techniques for AECOPD should select clinically meaningful out- comes and include only those phenotypes considered most likely References to benefit (eg, those who are productive of sputum). Multi-centre trials will be required if future studies are to provide definitive 1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global answers regarding the role of these physiotherapy techniques Initiative for Chronic Obstructive Lung Disease (GOLD). http://www.goldcopd.org/. during AECOPD. Accessed 21st August 2014 Many physiotherapy interventions for AECOPD aim to restore 2. Miravitlles M, Ferrer M, Pont A, Zalacain R, Alvarez-Sala J, Masa F, et al. Effect of or maintain function, such that patients can achieve a safe exacerbations on quality of life in patients with chronic obstructive pulmonary discharge and return to an active lifestyle in the community. disease: a 2 year follow up study. Thorax. 2004;59(5):387–395. However, measuring the success of physiotherapy interventions for AECOPD is challenging. Patients may be severely dyspnoeic and 3. Costi S, Brooks D, Goldstein RS. Perspectives that influence action plans for chronic unable to tolerate assessments that are commonly used in an obstructive pulmonary disease. Can Respir J. 2006;13(7):362–368. outpatient setting, such as the 6-minute walk test. Dedicated testing space may not be available in a hospital ward environment. 4. Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy Length of hospital stay is often only a few days and assessment improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am tools must therefore be responsive to changes occurring over a J Respir Crit Care Med. 2004;169(12):1298–1303. short period. Recently several simple tests of functional capacity have been examined in COPD and may prove useful in this setting. 5. Seemungal T, Harper-Owen R, Bhowmik A, Moric I, Sanderson G, Message S, et al. These include the 4-metre gait speed test,83 a number of variants Respiratory viruses, symptoms, and inflammatory markers in acute exacerbations on sit-to-stand tests,84,85 and the Timed-Up-and-Go test.86 These and stable chronic obstructive pulmonary disease. Am J Respir Crit Care Med. tests are reliable, valid and responsive in stable COPD; however, 2001;164(9):1618–1623. their utility in AECOPD has not yet been examined. Whilst these tests may prove to be useful as global measures of function during 6. Mallia P, Footitt J, Sotero R, Jepson A, Contoli M, Trujillo-Torralbo MB, et al. and after an AECOPD, they provide little information about the Rhinovirus infection induces degradation of antimicrobial peptides and secondary impact of exercise on physiological parameters and will not be bacterial infection in chronic obstructive pulmonary disease. Am J Respir Crit Care useful for exercise prescription. Further research is needed to Med. 2012;186(11):1117–1124. identify an optimal assessment tool for physiotherapy interven- tions in the setting of AECOPD. 7. Hurst JR, Donaldson GC, Quint JK, Goldring JJ, Baghai-Ravary R, Wedzicha JA. Temporal clustering of exacerbations in chronic obstructive pulmonary disease. In the clinical setting, physiotherapists have a strong and Am J Respir Crit Care Med. 2009;179(5):369374. growing body of evidence to guide their practice when treating people with AECOPD (Figure 1). The evidence for important 8. Hurst JR, Vestbo J, Anzueto A, Locantore N, Mu¨ llerova H, Tal-Singer R, et al. benefits of pulmonary rehabilitation after AECOPD is strong; Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl referral to pulmonary rehabilitation at hospital discharge should J Med. 2010;363(12):1128–1138. be a priority for physiotherapy care. A clinical challenge that must be addressed is the articulation of inpatient physiotherapy 9. Roca M, Verduri A, Corbetta L, Clini E, Fabbri LM, Beghe B. Mechanisms of acute management with outpatient pulmonary rehabilitation programs. exacerbation of respiratory symptoms in chronic obstructive pulmonary disease. Given the compelling benefits of rehabilitation after AECOPD for Eur J Clin Invest. 2013;43(5):510–521. patients and the healthcare system, and the abysmal uptake of this treatment,63 more efforts must be made to provide flexible and 10. Wedzicha JA, Seemungal TA, MacCallum PK, Paul EA, Donaldson GC, Bhowmik A, et supportive pathways into pulmonary rehabilitation following al. Acute exacerbations of chronic obstructive pulmonary disease are accompanied by elevations of plasma fibrinogen and serum IL-6 levels. Thrombos Haemost. 2000;84(2):210–215. 11. Donaldson GC, Hurst JR, Smith CJ, Hubbard RB, Wedzicha JA. Increased risk of myocardial infarction and stroke following exacerbation of COPD. Chest. 2010;137(5):1091–1097. 12. Spruit MA, Gosselink R, Troosters T, Kasran A, Gayan-Ramirez G, Bogaerts P, et al. Muscle force during an acute exacerbation in hospitalised patients with COPD and its relationship with CXCL8 and IGF-I. Thorax. 2003;58(9):752–756. 13. Pitta F, Troosters T, Probst VS, Spruit MA, Decramer M, Gosselink R. Physical activity and hospitalization for exacerbation of COPD. Chest. 2006;129(3):536–544. 14. Decramer M, acquet LM, Fagard R, Rogiers P. Corticosteroids contribute to muscle weakness in chronic airflow obstruction. Am J Respir Crit Care Med. 1994;150: 11–16. 15. Crul T, Spruit MA, Gayan-Ramirez G, Quarck R, Gosselink R, et al. Markers of inflammation and disuse in vastus lateralis of chronic obstructive pulmonary disease patients. Eur J Clin Invest. 2007;37(11):897–904. 16. Borges RC, Carvalho CR. Physical activity in daily life in Brazilian COPD patients during and after exacerbation. COPD. 2012;9(6):596–602. 17. Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmo- nary disease. Thorax. 2002;57(10):847–852. 18. Hoogendoorn M, Feenstra TL, Hoogenveen RT, Al M, Molken MR. Association between lung function and exacerbation frequency in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2010;5:435–444. 19. Soler-Cataluna JJ, Martinez-Garcia MA, Roman Sanchez P, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005;60(11):925–931. 20. Hopkinson NS, Tennant RC, Dayer MJ, Swallow EB, Hansel TT, Moxham J, et al. A prospective study of decline in fat free mass and skeletal muscle strength in chronic obstructive pulmonary disease. Respir Res. 2007;8:25. 21. Alahmari AD, Patel AR, Kowlessar BS, Mackay AJ, Singh R, Wedzicha JA, et al. Daily activity during stability and exacerbation of chronic obstructive pulmonary dis- ease. BMC Pulm Med. 2014;14(1):98. 22. Garcia-Aymerich J, Farrero E, Felez MA, Izquierdo J, Marrades RM, Anto JM. Risk factors of readmission to hospital for a COPD exacerbation: a prospective study. Thorax. 2003;58(2):100–105.
Invited Topical Review 187 23. Waschki B, Kirsten A, Holz O, Mu¨ ller KC, Meyer T, Watz H, et al. Physical activity is acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care the strongest predictor of all-cause mortality in patients with COPD: a prospective Med. 2010;181(10):1072–1077. cohort study. Chest. 2011;140(2):331–342. 53. Puhan M, Scharplatz M, Troosters T, Walters EH, Steurer J. Pulmonary rehabilita- tion following exacerbations of chronic obstructive pulmonary disease. Cochrane 24. Hilleman DE, Dewan N, Malesker M, Friedman M, Pharmacoeconomic evaluation Database Syst Rev. 2009;(1):CD005305. of COPD. 2000. Chest. 2009;136(5 Suppl):e30. 54. Greening NJ, Williams JE, Hussain SF, arvey-Dunstan TC, Bankart MJ, Chaplin EJ, et al. An early rehabilitation intervention to enhance recovery during hospital 25. Australian Institute of Health and Welfare. Australia’s Health 2010. Australia’s admission for an exacerbation of chronic respiratory disease: randomised con- health no. 12. Cat. no. AUS 122. 2010; Retrieved from http://www.aihw.gov.au/ trolled trial. BMJ. 2014;349:g4315. publication-detail/?id=6442468376&tab=2. Accessed 17th February 2013. 55. Behnke M, Taube C, Kirsten D, Lehnigk B, Jorres RA, Magnussen H. Home-based exercise is capable of preserving hospital-based improvements in severe chronic 26. National Institute for Health and Clinical Excellence (NICE). Chronic obstructive obstructive pulmonary disease. Respir Med. 2000;94(12):1184–1191. pulmonary disease: management of chronic obstructive pulmonary disease in adults in 56. Nava S. Rehabilitation of patients admitted to a respiratory intensive care unit. primary and secondary care. 2010. Arch Phys Med Rehabil. 1998;79(7):849–854. 57. Eaton T, Young P, Fergusson W, Moodie L, Zeng I, O’Kane F, et al. Does early 27. Guarascio AJ, Ray SM, Finch CK, Self TH. The clinical and economic burden of pulmonary rehabilitation reduce acute health-care utilization in COPD patients chronic obstructive pulmonary disease in the USA. ClinicoEconomics and outcomes admitted with an exacerbation? A randomized controlled study Respirol. research: CEOR. 2013;5:235–245. 2009;14(2):230–238. 58. Ko FWS, Dai DLK, Ngai J, Tung A, Ng S, Lai K, et al. Effect of early pulmonary 28. Punekar YS, Shukla A, Mullerova H. COPD management costs according to the rehabilitation on health care utilization and health status in patients hospitalized frequency of COPD exacerbations in UK primary care. Int J Chron Obstruct Pulmon with acute exacerbations of COPD. Respirol. 2011;16:617–624. Dis. 2014;9:65–73. 59. Man WDC, Polkey MI, Donaldson N, Gray BJ, Moxham J. Community pulmonary rehabilitation after hospitalisation for acute exacerbations of chronic obstruc- 29. Walters JA, Gibson PG, Wood-Baker R, Hannay M, Walters EH. Systemic corticoste- tive pulmonary disease: randomised controlled study. BMJ. 2004;329: roids for acute exacerbations of chronic obstructive pulmonary disease. Cochrane 1209–1213. Database Syst Rev. 2009;(1):CD001288. 60. Troosters T, Gosselink R, De Paepe K, Decramer M. Pulmonary rehabilitation improves survival in COPD patients with a recent severe acute exacerbation. 30. Vollenweider DJ, Jarrett H, Steurer-Stey CA, Garcia-Aymerich J, Puhan MA. Anti- Am J Respir Crit Care Med. 2002;165:A16. biotics for exacerbations of chronic obstructive pulmonary disease. Cochrane 61. Murphy N, Bell C, Costello RW. Extending a home from hospital care programme Database Syst Rev. 2012;12:CD010257. for COPD exacerbations to include pulmonary rehabilitation. Respir Med. 2005;99:1297–1302. 31. Austin MA, Wills KE, Blizzard L, Walters EH, Wood-Baker R. Effect of high flow 62. Seymour JM, Moore L, Jolley CJ, Ward K, Creasey J, Steier JS, et al. Outpatient oxygen on mortality in chronic obstructive pulmonary disease patients in pre- pulmonary rehabilitation following acute exacerbations of COPD. Thorax. hospital setting: randomised controlled trial. BMJ. 2010;341:c5462. 2010;65:423–428. 63. Jones SE, Green SA, Clark AL, Dickson MJ, Nolan AM, Moloney C, et al. Pulmonary 32. Ram FS, Picot J, Lightowler J, Wedzicha JA. Non-invasive positive pressure ventila- rehabilitation following hospitalisation for acute exacerbation of COPD: referrals, tion for treatment of respiratory failure due to exacerbations of chronic obstructive uptake and adherence. Thorax. 2014;69(2):181–182. pulmonary disease. Cochrane Database Syst Rev. 2004;(1):CD004104. 64. Harrison SL, Robertson N, Apps L, M CS, Morgan MD, Singh SJ. ‘We are not worthy’ – understanding why patients decline pulmonary rehabilitation following an acute 33. Bott J, Blumenthal S, Buxton M, Ellum S, Falconer C, Garrod R, et al. Guidelines for exacerbation of COPD. Diasbil Rehabil 2014:1–7. the physiotherapy management of the adult, medical, spontaneously breathing 65. Suissa S, Dell’Aniello S, Ernst P. Long-term natural history of chronic obstructive patient. Thorax. 2009;64(Suppl 1):i1–i51. pulmonary disease: severe exacerbations and mortality. Thorax. 2012;67(11): 957–963. 34. Menadue C, Alison JA, Piper AJ, Flunt D, Ellis ER. Bilevel ventilation during exercise 66. Nichol KL, Nordin JD, Nelson DB, Mullooly JP, Hak E. Effectiveness of influenza in acute on chronic respiratory failure: a preliminary study. Respir Med. vaccine in the community-dwelling elderly. N Engl J Med. 2007;357(14): 2010;104(2):219–227. 1373–1381. 67. Calverley PM, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and 35. Holland AE, Hill CJ, Jones AY, McDonald CF. Breathing exercises for chronic survival in chronic obstructive pulmonary disease. N Engl J Med. 2007;356(8): obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;10:CD008250. 775–789. 68. Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, et al. A 4-year trial of 36. Valenza MC, Valenza-Pena G, Torres-Sanchez I, Gonzalez-Jimenez E, Conde-Valero tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008; A, Valenza-Demet G. Effectiveness of controlled breathing techniques on anxiety 359(15):1543–1554. and depression in hospitalized patients with COPD: a randomized clinical Trial. 69. Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ, et al. Respir Care. 2014;59(2):209–215. Roflumilast in symptomatic chronic obstructive pulmonary disease: two random- ised clinical trials. Lancet. 2009;374(9691):685–694. 37. Zakerimoghadam M, Tavasoli K, Nejad AK, Khoshkesht S. The effect of breathing 70. Laurin C, Moullec G, Bacon SL, Lavoie KL. Impact of anxiety and depression on exercises on the fatigue levels of patients with chronic obstructive pulmonary chronic obstructive pulmonary disease exacerbation risk. Am J Respir Crit Care Med. disease. Acta Medica Indonesiana. 2011;43(1):29–33. 2012;185(9):918–923. 71. Zwerink M, Brusse-Keizer M, van der Valk PD, Zielhuis GA, Monninkhof EM, van der 38. Gosselink RA, Wagenaar RC, Rijswijk H, Sargeant AJ, Decramer ML. Diaphragmatic Palen J, et al. Self management for patients with chronic obstructive pulmonary breathing reduces efficiency of breathing in patients with chronic obstructive disease. Cochrane Database Syst Rev. 2014;3:CD002990. pulmonary disease. Am J Respir Crit Care Med. 1995;151:1136–1142. 72. Fan VS, Gaziano JM, Lew R, Bourbeau J, Adams SG, Leatherman S, et al. A comprehensive care management program to prevent chronic obstructive pulmo- 39. Vitacca M, Clini E, Bianchi L, Ambrosino N. Acute effects of deep diaphragmatic nary disease hospitalizations: a randomized, controlled trial. Ann Intern Med. breathing in COPD patients with chronic respiratory insufficiency. Eur Respir J. 2012;156(10):673–683. 1998;11:408–415. 73. Peytremann-Bridevaux I, Taffe P, Burnand B, Bridevaux PO, Puhan MA. Mortality of patients with COPD participating in chronic disease management programmes: a 40. Holland AE, Button BM. Is there a role for airway clearance techniques in chronic happy end? Thorax. 2014;69(9):865–866. obstructive pulmonary disease? Chron Respir Dis. 2006;3(2):83–91. 74. Walters JA, Turnock AC, Walters EH, Wood-Baker R. Action plans with limited patient education only for exacerbations of chronic obstructive pulmonary disease. 41. Osadnik CR, McDonald CF, Holland AE. Clinical issues of mucus accumulation in Cochrane Database Syst Rev. 2010;(5):CD005074. COPD. Int J Chron Obstruct Pulmon Dis. 2014;9:301–302. 75. Trappenburg JC, Monninkhof EM, Bourbeau J, Troosters T, Schrijvers AJ, Verheij TJ, et al. Effect of an action plan with ongoing support by a case manager on 42. Osadnik CR, McDonald CF, Holland AE. Airway clearance techniques in acute exacerbation-related outcome in patients with COPD: a multicentre randomised exacerbations of COPD: a survey of Australian physiotherapy practice. Physiother- controlled trial. Thorax. 2011;66(11):977–984. apy. 2013;99(2):101–106. 76. Poole P, Black PN, Cates CJ. Mucolytic agents for chronic bronchitis or chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;8:CD001287. 43. Osadnik CR, McDonald CF, Jones AP, Holland AE. Airway clearance techniques for 77. Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, et al. Home telehealth for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. chronic obstructive pulmonary disease: a systematic review and meta-analysis. J 2012;3:CD008328. Telemed Telecare. 2010;16(3):120–127. 78. Pinnock H, Hanley J, McCloughan L, Todd A, Krishan A, Lewis S, et al. Effectiveness 44. Cross J, Elender F, Barton G, Clark A, Shepstone L, Blyth A, et al. A randomised of telemonitoring integrated into existing clinical services on hospital admission controlled equivalence trial to determine the effectiveness and cost-utility of for exacerbation of chronic obstructive pulmonary disease: researcher blind, manual chest physiotherapy techniques in the management of exacerbations of multicentre, randomised controlled trial. BMJ. 2013;347:f6070. chronic obstructive pulmonary disease (MATREX). Health Technol Assess. 79. Ringbaek TJ, Viskum K, Lange P. Does long-term oxygen therapy reduce hospita- 2010;14(23):1–147. iii–iv. lisation in hypoxaemic chronic obstructive pulmonary disease? Eur Respir J. 2002;20(1):38–42. 45. Newton DA, Stephenson A. Effect of physiotherapy on pulmonary function. A 80. Is 12-hour oxygen as effective as 24-hour oxygen in advanced chronic obstructive laboratory study. Lancet. 1978;2(8083):228–229. pulmonary disease with hypoxemia? (The nocturnal oxygen therapy trial – NOTT). Chest 1980; 78(3):419-420. 46. Bellone A, Spagnolatti L, Massobrio M, Bellei E, Vinciguerra R, Barbieri A, et al. Short-term effects of expiration under positive pressure in patients with acute exacerbation of chronic obstructive pulmonary disease and mild acidosis requiring non-invasive positive pressure ventilation. Intensive Care Med. 2002;28:581–585. 47. Inal-Ince D, Savci S, Topeli A, Arikan H. Active cycle of breathing techniques in non- invasive ventilation for acute hypercapnic respiratory failure. Aust J Physiother. 2004;50:67–73. 48. Vargas F, Bui HN, Boyer A, Salmi LR, Gbikpi-Benissan G, Guenard H, et al. Intrapul- monary percussive ventilation in acute exacerbations of COPD patients with mild respiratory acidosis: a randomized controlled trial. Crit Care. 2005;9:R382–R389. 49. Osadnik CR, McDonald CF, Miller BR, Hill CJ, Tarrant B, Steward R, et al. The effect of positive expiratory pressure (PEP) therapy on symptoms, quality of life and incidence of re-exacerbation in patients with acute exacerbations of chronic obstructive pulmonary disease: a multicentre, randomised controlled trial. Thorax. 2014;69(2):137–143. 50. de Morton NA, Keating JL, Jeffs K. Exercise for acutely hospitalised older medical patients. Cochrane Database Syst Rev. 2007;(1):CD005955. 51. Tang CY, Blackstock FC, Clarence M, Taylor NF. Early rehabilitation exercise program for inpatients during an acute exacerbation of chronic obstructive pul- monary disease: a randomized controlled trial. J Cardiopulm Rehabil Prevent. 2012;32(3):163–169. 52. Troosters T, Probst VS, Crul T, Pitta F, Gayan-Ramirez G, Decramer M, et al. Resistance training prevents deterioration in quadriceps muscle function during
188 Holland: Physiotherapy management of COPD exacerbations 81. Au DH, Bryson CL, Chien JW, Sun H, Udris EM, Evans LE, et al. The effects of smoking 85. Ozalevli S, Ozden A, Itil O, Akkoclu A. Comparison of the Sit-to-Stand Test with cessation on the risk of chronic obstructive pulmonary disease exacerbations. J Gen 6 min walk test in patients with chronic obstructive pulmonary disease. Respir Intern Med. 2009;24(4):457–463. Med. 2007;101(2):286–293. 82. Godtfredsen NS, Vestbo J, Osler M, Prescott E. Risk of hospital admission for COPD 86. Mesquita R, Janssen DJ, Wouters EF, Schols JM, Pitta F, Spruit MA. Within-day test- following smoking cessation and reduction: a Danish population study. Thorax. retest reliability of the Timed Up & Go test in patients with advanced chronic organ 2002;57(11):967–972. failure. Arch Phys Med Rehabil. 2013;94(11):2131–2138. 83. Kon SS, Patel MS, Canavan JL, Clark AL, Jones SE, Nolan CM, et al. Reliability and 87. Maltais F, Bourbeau J, Shapiro S, Lacasse Y, Perrault H, Baltzan M, et al. Effects validity of 4-metre gait speed in COPD. Eur Respir J. 2013;42(2):333–340. of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2008;149(12): 84. Jones SE, Kon SS, Canavan JL, Patel MS, Clark AL, Nolan CM, et al. The five-repetition 869–878. sit-to-stand test as a functional outcome measure in COPD. Thorax. 2013;68(11): 1015–1020.
Journal of Physiotherapy 60 (2014) 224–231 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research Predictors of non-use of prostheses by people with lower limb amputation after discharge from rehabilitation: development and validation of clinical prediction rules Caroline E Roffman, John Buchanan, Garry T Allison School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University and Royal Perth Hospital, Perth, Australia KEY WORDS ABSTRACT Clinical prediction rule Questions: Can rules be developed to predict the risk of non-use of prostheses by people with lower limb Lower extremity amputation following discharge from rehabilitation? Are these clinical prediction rules valid? Design: Amputation Retrospective and prospective cohort study designs. Participants: Consecutive tertiary rehabilitation Leg prosthesis patients: 135 retrospective (103 males, mean age = 56 years, SD 15) and 66 prospective (58 males, mean Rehabilitation outcome age = 54 years, SD 16). Method: Medical records were audited for potential predictor variables. Retrospective participants were interviewed at a median of 1.9 years after discharge (IQR 1.4 to 2.5) and prospective participants at a median of 1.3 years (IQR 1.1 to 1.4). Results: Clinical prediction rules were identified at 4, 8 and 12 months after discharge, and validated. Amputation levels above transtibial and mobility-aid use were common predictors for all three time frames. At 4 months, if four out of five predictor variables were present (LR+ = 43.9, 95% CI 2.73 to 999+), the probability of non-use increased from 12 to 86% (p < 0.001). At 8 months, if all three predictor variables were present (LR+ = 33.9, 95% CI 2.1 to 999+), the probability of non-use increased from 15 to 86% (p < 0.001). At 12 months, if two out of three predictor variables were present (LR+ = 2.8, 95% CI 0.9 to 6.6), the probability of non-use increased from 17 to 36% (p < 0.031). Conclusions: These validated clinical prediction rules have implications for rehabilitation and service model development. [Roffman CE, Buchanan J, Allison GT (2014) Predictors of non-use of prostheses by people with lower limb amputation after discharge from rehabilitation: development and validation of clinical prediction rules. Journal of Physiotherapy 60: 224–231] Crown Copyright ß 2014 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/3.0/). Introduction Some studies have quantified prosthetic rehabilitation success relative to surgery-related outcomes, the duration that the Multidisciplinary rehabilitation following lower limb amputa- prosthesis is worn as opposed to functional use, or short-term tion plays an important role in restoring function for activities of outcomes while individuals were still participating in rehabilita- daily living, work and recreation. Amputee rehabilitation service tion; other studies have limited their analyses to cohorts with models and clinical practice guidelines for prosthetic prescription limited rehabilitation potential.8–11 None of these quantify long- vary widely throughout the world and have been developed largely term functional prosthetic use following discharge, which is from expert consensus.1,2 In Western Australia, patients achieve important in understanding the quality of life of these people. In independent transfers and wheelchair mobility during inpatient general, for those with atraumatic causes of amputation there is a rehabilitation while prosthetic gait retraining is performed as an decline in health status following discharge and 5-year mortality outpatient service.3 as high as 77%.9,12–14 In some cases, prosthetic gait may impair health and wellbeing through associated morbidity (eg, falls, Limited research exists on long-term outcomes in relation to myocardial infarction) and many individuals stop using their prostheses following discharge from rehabilitation. In particular, prosthesis within 12 months of discharge.12,15 there is a lack of quality evidence to inform clinical decisions that may impact on the continued use of prostheses following lower Factors associated with prosthetic outcome have been consid- limb amputation.4–9 In their literature review, Sansam et al5 called ered in univariate analyses. Pre-operative factors such as comorbid- for further investigation of predictive factors to more accurately ities, age, pre-morbid mobility, medications, skin integrity, estimate walking potential because the studies they reviewed ethnicity, socioeconomic status, cognition and social support have reported different predictors; this was probably due to differences been reported as being associated with outcome.5,6,11,15–18 Weak in methodology, outcome measures and definitions of prosthetic evidence supports an association between psychological factors, rehabilitation success. self-efficacy, motivation and outcome.5 Prosthetic outcome has also http://dx.doi.org/10.1016/j.jphys.2014.09.003 1836-9553/Crown Copyright ß 2014 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/3.0/).
Research 225 been associated with postoperative factors including high-level or participants were monitored through amputee outpatient clinic multiple limb amputation, postoperative complications, wound but remained at K-level 0. healing, oedema, contractures, pain, delay to prosthesis, falls, energy cost of gait, and functional factors.5,6,9,19–26 K-level 0 to 4 participants underwent inpatient rehabilitation to achieve independent transfers, wheelchair mobility and discharge Prosthetic outcome is therefore multifactorial and complex. To home. K-level 1 to 4 participants received the standardised date, no studies have examined the factors that in combination are outpatient prosthetic rehabilitation service, as detailed in Appen- able to identify individuals at risk of prosthetic non-use following dix 1 (see eAddenda). discharge from rehabilitation. A methodological approach of developing clinical prediction rules has been used in similar An independent research assistant contacted potential parti- prognostic studies (eg, ankle fractures, neck pain)27,28 and is yet to cipants from the Amputee Physiotherapy Service database to be established in the area of lower limb amputation. Clinical obtain informed verbal consent for the interview. The interview prediction rules are tools that assist clinicians to make evidence- process involved coordinating telephone interviews with country based decisions and assign patients to interventions and targeted physiotherapists on remote community visits, Aboriginal Health models of care using a parsimonious subset of predictor workers, nurses, and the use of telehealth. variables.27–30 If clinical prediction rules could be generated to accurately identify individuals at risk of early prosthetic non-use, Procedure then rehabilitation teams could intervene with targeted models of care and prosthetic innovations to optimise functional outcome Clinical prediction rules development and allocation of healthcare resources. Therefore the research Medical records were audited for potential predictor variables questions for this study were: and this was undertaken blind to the interviews. Box 1 outlines the 1. Can rules be developed to predict the risk of non-use of predictor variable domains investigated. All potential variables prostheses by people with lower limb amputation following were dichotomised (eg, amputation cause: atraumatic or traumat- discharge from rehabilitation? ic). Receiver Operator Characteristic (ROC) curves were used to generate a threshold for dichotomous classification of continuous 2. Are these clinical prediction rules valid? variables (eg, age). This was performed with an equal weighting for sensitivity and specificity. Table 1 in the eAddenda details the Methods dichotomous variable classifications. Participants Medical comorbidities (including mental health issues and musculoskeletal pathology) were recorded and counted for each Inclusion criteria were: at least one recent major lower limb participant. Charlson Comorbidity Index and Combined Age amputation (ie, transtibial level or above); community dwelling Charlson Comorbidity Index were calculated from medical comor- and ambulant prior to amputation; Medicare Functional Classifi- bidities data.31 cation K-level 1 to 4 (from Gailey et al24); and had participated in and been discharged from prosthetic rehabilitation at Royal Perth In the present study, amputation level was classified as Hospital, which is the state centre for amputee rehabilitation. transtibial or above transtibial. Bilateral lower limb amputation Royal Perth Hospital rehabilitates 85% of all individuals with lower was defined as having undergone two major lower limb amputa- limb amputation in Western Australia.3 Individuals with multiple tions. Participants were classified as able to independently perform limb amputations were included, as this was important for validity the locomotor skill or being dependent (ie, required assistance or of the clinical prediction rules. unable to perform). Mobility aids were either used or not used, and the aid type was not statistically weighted for its level of support. Participants were excluded if they were unable to communi- cate, did not consent, or were not prosthetic candidates (ie, K-level The operational definition of a successful prosthetic user was 0) as assessed collaboratively by the rehabilitation physician and use of the prosthesis for locomotor activities (eg, transfers, senior physiotherapist. Reasons for K-level 0 categorisation standing, walking) on one or more week days. Participants were included comorbidities, cognitive impairment, high-level amputa- asked on which days they used their prosthesis and for one day of tion, multiple limb amputation, remaining limb pathology, normal activity how long they wore the prosthesis, how many sit increased body weight, mental health issues, poor motivation, to stands they performed, and the duration they performed no social support, poor premorbid mobility or falls history. These prosthetic walking and standing activities. Prosthetic non-users did not use their prosthesis for locomotor activities on any days. Individuals who only wore their prosthesis for cosmesis were classified as non-users. Non-users were asked Box 1. Predictor variable domains for prosthetic users and non-users investigated by this study. Intrinsic predictor variables Amputation predictor variables Functional predictor variables gender amputation cause mobility level achieved without a prosthesis: age amputation level indigenous status bilateral lower limb amputation wheelchair mobility, transfers, hopping metropolitan versus country time to second lower limb independence with donning and doffing prosthesis, accommodation at discharge: amputation and monitoring prosthetic fit at discharge home versus residential care time from amputation to mobility aid use at discharge medical comorbidities: diabetes mobility level achieved using a prosthesis at prosthetic milestones: casting, type I or II, peripheral arterial discharge: walking indoors, outdoors, stairs, disease, cardiac condition, fitting and definitive prosthesis slopes, grass, gravel, uneven terrain, high-level renal failure, stroke, transient balance activities and running ischaemic attack, lower limb pathology number of medical comorbidities, including mental health issues and musculoskeletal pathology
IF$DT)1_eruGi([]g226 Roffman et al: Prediction of non-use of prostheses by amputees Patient details: Time since discharge Significant predictor variables: 4 (and 6) 8 12 months months months amputation level above transtibial mobility aid use at discharge dependence walking outdoors on concrete at discharge not having a diagnosis of type II diabetes 19 or more comorbidities (95th percentile) delay to prosthesis ≥ 160 days (95th percentile) Total number of predictor variables: Figure 1. Validated clinical prediction rules for prosthetic non-use in individuals with lower limb amputation at 4, 8 and 12 months after discharge from rehabilitation. If the participant has the predictor variable, they score 1, which is written in the white box, and if they do not have the predictor variable, they score 0. At 4 (and 6) months, scores total out of 5, and at 8 and 12 months, scores total out of 3. Total score (below the line) is used for the risk estimates at each time point. For full details on use, see Appendix 2. their reasons for prosthetic non-use and to recall how many rules for the time frames, the set of variables from the regression was months after physiotherapy discharge they stopped using their used to establish cumulative numbers of items present for any one prosthesis. Important calendar events (eg, last amputee outpatient individual at discharge. A list of likelihood ratios (negative and clinic, birthday, Christmas) were used as verbal prompts to assist positive, 95% CI) were calculated to determine the cumulative effect with recall accuracy. Participants were interviewed with a of having a number of these predictors (1, 2, 3, etc) on non-use. previously piloted survey on their prosthetic use from 4 months onwards after discharge and re-interviewed approximately at 2- Clinical prediction rules validation monthly intervals until data were collected for 12 months. Prospective participants were classified as prosthetic users or Clinical prediction rules validation non-users at 4, 6, 8 and 12 months after discharge. Descriptive The procedure used for clinical prediction rules validation were statistics were generated. Participants were analysed for the absence (score = 0) or presence (score = 1) of significant clinical the same as for the development procedure, except that data were prediction rules variables at 4, 6, 8 and 12 months (see Figure 1, prospectively collected during the participants’ rehabilitation and the clinical prediction rules instructions in Appendix 2 in the using a physiotherapy assessment form. This form was developed eAddenda). Validity and cohort contamination effects of prosthetic and implemented by the senior physiotherapist during clinical use behaviours were compared by plotting pattern of non-use over prediction rules development. time for the retrospective and prospective cohorts. Statistical analyses The retrospective study’s continuous variable thresholds were used to generate dichotomous classification of these continuous Clinical prediction rules development variables in the present prospective study. To validate the clinical The statistical models used in the present study are consistent prediction rules for each of the time frames, chi-square tests were calculated to generate a progressive list of likelihood ratios with clinical prediction rules reports27–30 and are not equivalent to (negative and positive, 95% CI) to determine the cumulative effect a regression analysis. The primary outcome variable was prosthetic of having a number (ie, 1, 2, 3 etc) of these non-use predictors. non-use at 4, 6, 8 and 12 months post-discharge. Descriptive Sensitivity, specificity, positive prediction value, accuracy and statistics were generated. balanced accuracy were calculated to define the accuracy and precision of clinical prediction rules in the prospective cohort.32 The univariate relationship between categorical variables and prosthetic users and non-users was analysed using the chi-square For both the retrospective and prospective statistical analyses, test. For each of the continuous variables, ROC curves were used to in circumstances where zero cases were present in frequency cells determine the threshold at which specificity and sensitivity were of the 2 x 2 contingency tables, 0.5 was added to the cell values to equal to generate dichotomous classification for the univariate enable calculation of the likelihood ratios for the variables.33 analyses. Univariate contingency tables were used to identify a Extreme likelihood ratio upper confidence limits were truncated smaller subset of variables related to prosthetic non-use that had a at 999. significance level of 10% (chi-square p < 0.10). This conservative significance level was selected to avoid missing critical variables. Sensitivity analyses of 29 (16%) retrospective and eight (10%) Sensitivity, specificity, and positive and negative likelihood ratios prospective deceased prosthetic rehabilitation participants who were calculated for the variables. could not be interviewed were performed for 4, 6, 8 and 12 months after discharge to identify the presence or absence of clinical A backwards stepwise logistic regression model was used to prediction rules variables using date of death as the termination reduce these variables to a set of flags or key variables that date for prosthetic use. contributed to predicting non-use. To generate clinical prediction
Research 227 Results level, mobility aid use, and dependence walking outdoors on concrete. Table 2 summarises the consecutive participants’ eligibility for the study. The final response rates were 94% (n = 135) for the Clinical prediction rules: 12 months retrospective cohort and 97% (n = 66) for the prospective cohort. At 12 months, the three variables that were predictive of The retrospective cohort were interviewed at median = 1.9 years (IQR 1.4 to 2.5) and prospective at median 1.3 years (IQR 1.1 to 1.4) prosthetic non-use included: amputation level above transtibial after discharge. Table 3 outlines the geographical distribution of level, mobility aid use, and delay to prosthesis. The multifactorial participants, as measured by Accessibility Remoteness Index of causes of delay to prosthesis included: wound complications Australia.34 (n = 8), comorbidities (n = 3), orthopaedic injuries (n = 2) and deconditioning (n = 1). Clinical prediction rules development interviews with the retrospective cohort were performed by telephone (n = 123), Clinical prediction rules validation telehealth (n = 2) and in person (n = 10). Twelve interviews were performed with carer assistance due to language interpretation, From March 2011 until December 2012, 66 participants were hearing or intellectual disability. Clinical prediction rules valida- interviewed, of whom 55 remained prosthetic users. There were tion interviews with the prospective cohort were performed by eight non-users at 4 and 6 months after discharge from telephone (n = 47) and in person (n = 19). Carers assisted with two rehabilitation, which increased to ten at 8 months and eleven at interviews where participants had a hearing or intellectual 12 months. Similar to the retrospective cohort, prosthetic non- disability. Table 3 shows the retrospective and prospective cohort users and variables were identical for the 4-month and 6-month characteristics. timeframes in the prospective cohort. Clinical prediction rules development Survival curves (Figure 2) demonstrated a high level of concordance between the retrospective and prospective cohorts. From November 2009 until August 2011, 135 participants were From discharge there was rapid progression to prosthetic non-use, interviewed; 94 (70%) were prosthetic users and 41 (30%) were followed by linear decline after 1 month. non-users. At 4, 6, 8 and 12 months after discharge from rehabilitation 15 (11%), 15 (11%), 20 (15%) and 25 (19%) of Associated accuracy statistics for having a combination of participants, respectively, were non-users. As the number of prosthetic non-use predictors (95% CI) for the clinical prediction prosthetic non-users and variables were identical for 4 and rules time frames in the prospective cohort are reported below. 6 months, these data were analysed as one time frame. Full details, including associated accuracy statistics, are presented in Table 6. Of the 40 potential variables investigated for the univariate analysis (Box 1), a total of 16 variables were identified as being Four months significant (p < 0.10) for prosthetic non-use at the 4-, 6- and 8- If four out of five predictors were present (LR+ = 43.9, 95% CI month timeframes, and 15 variables were significant at 12 months after discharge (Table 4, which is available in the eAddenda). 2.73 to 999+), the probability of non-use increased from 12 to 86% (p < 0.001). The predictor variables significant (95% CI) for prosthetic non- use after being entered into the backwards-stepwise logistic Eight months regression model are reported below. Full details, including If all three predictors were present (LR+ = 33.9, 95% CI 2.1 to associated accuracy statistics, are presented in Table 5. 999+), the probability of non-use increased from 15 to 86% (p < 0.001). Clinical prediction rules: 4 months Twelve months At 4 (and 6) months, the five variables that were predictive of If two out of three predictors were present (LR+ = 2.8, 95% CI prosthetic non-use included: amputation level above transtibial 0.9 to 6.6), the probability of non-use increased from 17 to 36% level, mobility aid use, dependence walking outdoors on concrete, (p < 0.031). Three cases of delay to prosthesis included: wound (2) very high number of comorbidities, and not having a diagnosis of and orthopaedic (1) complications. type II diabetes. Figures 3–5 (available in the eAddenda) illustrate the percen- Clinical prediction rules: 8 months tages of true to false positives for the clinical prediction rules time At 8 months, the three variables that were predictive of frames. This shows the clinical utility of using the clinical prediction rules for any one individual and the risk of appropriate prosthetic non-use included: amputation level above transtibial classification. Table 2 Summary of the consecutive retrospective and prospective cohorts. Characteristic Retrospective cohort Prospective cohort Time frame identified from Amputee Physiotherapy Service database June 2006 to June 2009 July 2009 to July 2011 Consecutive tertiary rehabilitation patients identified from Amputee Physiotherapy Service database, n 208 99 K-level 0 participantsa, n (%) K-level 1 to 4 participantsb, n (%) 32 (15) 11 (11) K-level 0 deceased, n (%) 176 (85) 88 (89) K-level 1 to 4 deceased, n (%) 15 (47) 4 (36) Eligible participants, n 29 (16) Ineligible participants, n 8 (9) 143 68 excluded, minor lower limb amputation excluded, still participating in rehabilitation 1 2 did not consent 3 10 Participants contacted, n 3 0 Unable to be contacted as they had moved interstate or overseas, n 138 66 Response rate, n (%) 5 2 Time to outpatient discharge (d)c, median (IQR) 135 (94) 66 (97) 174 (103 to 314) 138 (88 to 201) a Not prosthetic rehabilitation candidates. b Prosthetic users at discharge. c Participants participated in approximately two to three physiotherapy prosthetic gait retraining sessions per week as outpatients.
228 Roffman et al: Prediction of non-use of prostheses by amputees Table 3 Demographic and amputation details of prosthetic users and non-users in the retrospective and prospective cohorts. Demographic and amputation details Retrospective cohort Prospective cohort Users (n = 94) Non-users (n = 41) Users (n = 55) Non-users (n = 11) Gender, male, n (%) 74 (79) 29 (71) 50 (91) 8 (73) Age at amputation, mean (SD) 55.1 (15.8) 58.3 (13.3) 55.3 (15.7) 49.5 (19.9) Indigenous status, Aboriginal, n (%) Accommodation after discharge from inpatient rehabilitation, n (%) 12 (13) 9 (22) 6 (11) 2 (18) home 91 (97) 37 (90) 55 (100) 11 (100) residential care (hostel or nursing home) 3 (3) 4 (10) 0 (0) 0 (0) metropolitan 28 (68) 9 (82) country 56 (60) 13 (32) 34 (62) 2 (18) Social support, lives with others, n (%) 38 (40) 31 (76) 21 (38) Accessibility Remoteness Index of Australiaa 77 (82) 42 (76) 10 (91) major cities of Australia (0 to 1.84) 34 (83) inner regional Australia (> 1.84 to 3.51) 66 (71)a 0 (0) 40 (73) 9 (82) outer regional Australia (> 3.51 to 5.80) 8 (9) 2 (5) 7 (13) 0 (0) remote Australia (> 5.80 to 9.08) 5 (5) 2 (5) 5 (9) 1 (9) very remote Australia (> 9.08 to 12) 0 (0) 3 (7) 2 (4) 0 (0) Charlson Comorbidity Index, median (IQR) 1 (2) 1 (9) Combined Age Charlson Comorbidity Index, median (IQR) 14 (15) 5 (2 to 5) 2 (0 to 4) 3 (0.5 to 5) Comorbidities, n (%) 2 (1 to 4) 7 (3 to 7) 4 (1 to 6) 6 (1 to 7) diabetes type I 4 (1 to 5) diabetes type II 3 (7) 1 (2) 1 (9) peripheral arterial disease 7 (8) 19 (46) 21 (38) 6 (55) cardiac condition 35 (37) 25 (61) 30 (55) 7 (64) renal failure 44 (47) 26 (63) 12 (22) 4 (36) stroke/transient ischaemic attack 33 (35) 10 (24) 4 (36) arthritis 13 (14) 5 (12) 5 (9) 0 (0) remaining lower limb pathology 16 (39) 4 (7) 5 (45) Mental health issues, n (%) 8 (9) 36 (88) 12 (22) 11 (100) Mild cognitive impairment, n (%) 36 (38) 8 (20) 36 (65) 5 (45) Intellectual disability, n (%) 78 (83) 4 (10) 8 (15) 1 (9) Substance abuse, n (%) 24 (26) 2 (4) 0 (0) drugs 0 (0) 1 (2) alcohol 3 (3) 3 (27) current smoker 1 (1) 4 (10) 2 (4) 2 (18) Amputation cause, n (%) 5 (12) 7 (13) 4 (36) circulatory 7 (7) 14 (34) 13 (24) infection 10 (11) 3 (27) trauma 20 (21) 15 (37) 16 (29) 6 (55) cancer 17 (41) 22 (40) 2 (18) Amputation level, n (%) 18 (19) 9 (22) 14 (25) 0 (0) transtibial 42 (45) knee disarticulation 29 (31) 0 (0) 3 (5) 10 (91) transfemoral 0 (0) major bilateral lower limb amputation 5 (5) 25 (61) 50 (91) 5 (45) minor amputation of remaining limb 2 (5) 1 (2) 4 (36) upper limb amputation/s 78 (83) 9 (16) 1 (9) 4 (4) 28 (68) 5 (9) 3 (27) 14 (34) 2 (4) 20 (21) 9 (16) 8 (9) 3 (7) 0 (0) 15 (16) 8 (9) a n = 93. One person was excluded from this retrospective analysis because he moved overseas after discharge. All other retrospective analyses used n = 94. There were no significant associations between having a Discussion number of clinical prediction rules variables for the time frames and cessation of prosthetic use due to death, based on 29 deceased Few studies have examined factors at the time of discharge in participants from the retrospective cohort (p = 0.164) and eight order to determine prosthetic use into the future. This is the first deceased participants from the prospective cohort (p = 0.170). study to propose and validate clinical prediction rules for timelines Table 5 Associated accuracy statistics with 95% CI for having a combination of predictor variables at 4 (and 6), 8 and 12 months for the retrospective cohort. Predictors present for Sensitivity Specificity Positive likelihood Negative likelihood Probability of p-value clinical prediction ratio ratio prosthetic rules time frames (n) 0.97 (0.74 to 1.00) 0.16 (0.13 to 0.16) non-use (%) 0.183 0.97 (0.72 to 1.00) 0.52 (0.48 to 0.52) 1.20 (0.85 to 1.19) 0.20 (0.0 to 2.04) < 0.001 4 (and 6) months 0.80 (0.53 to 0.95) 0.75 (0.72 to 0.77) 2.00 (1.40 to 2.09) 0.06 (0.0 to 0.57) 13 < 0.001 1 0.27 (0.10 to 0.33) 0.99 (0.97 to 1.00) 3.20 (1.87 to 4.08) 0.27 (0.07 to 0.65) 21 < 0.001 2 0.03 (0.00 to 0.06) 0.99 (0.99 to 1.00) 32.00 (3.61 to 748) 0.74 (0.67 to 0.92) 29 3 7.80 (0.00 to 999+) 0.97 (0.94 to 1.01) 80 0.223 4 0 5 0.001 < 0.001 8 months 0.98 (0.78 to 1.00) 0.43 (0.39 to 0.43) 1.70 (1.29 to 1.76) 0.06 (0.00 to 0.55) 23 1 0.90 (0.69 to 0.98) 0.74 (0.70 to 0.75) 3.50 (2.31 to 3.98) 0.14 (0.02 to 0.44) 38 0.013 2 0.15 (0.04 to 0.26) 0.97 (0.96 to 0.99) 5.80 (0.96 to 34.30) 0.87 (0.75 to 1.00) 50 3 < 0.001 < 0.001 12 months 0.96 (0.79 to 0.99) 0.42 (0.38 to 0.43) 1.70 (1.28 to 1.74) 0.10 (0.01 to 0.55) 27 < 0.001 1 0.72 (0.53 to 0.86) 0.76 (0.72 to 0.80) 3.05 (1.88 to 4.25) 0.37 (0.17 to 0.66) 41 2 0.24 (0.12 to 0.28) 0.99 (0.96 to 1.00) 26.40 (3.40 to 580.00) 0.77 (0.72 to 0.91) 86 3
[(Figure_2)TD$IG] Research 229 100 Percentage of study cohort (%) cohorts indicates that non-users were at greater risk of mortality Retrospective cohort (n = 135) from comorbid disease than users.32 95 Prospective cohort (n = 66) Validated predictors for prosthetic non-use common to all three clinical prediction rules were amputation level above transtibial 90 and mobility aid use. High amputation level has been associated in the literature with poor prosthetic outcome.11,36 From a functional 85 perspective, the transtibial prosthesis can be used to facilitate transfers, while the transfemoral prosthesis is only of functional 0 1 2 3 4 5 6 7 8 9 10 11 12 assistance when an individual is standing or walking. This may result in some activities being performed with greater efficiency Time since discharge (months) from a wheelchair or using assistive equipment (eg, individuals with transfemoral amputation may self-propel a commode rather Figure 2. A survival curve for the proportion of individuals using prostheses for than walking to the shower). every month in the year following hospital discharge. Note: The retrospective and prospective cohorts show similar patterns and rates of prosthetic non-use. Mobility aid use at discharge is more common in individuals who premorbidly used aids, are frail, deconditioned, have of 4, 8 and 12 months post-discharge that use statistical optimisa- remaining limb pathology (eg, claudication, osteoarthritis), and tion modelling to select a parsimonious set of variables from the high or multiple limb amputation.37,38 Mobility aids reduce rehabilitation model of care, which predict increased likelihood of functionality of gait by limiting capacity to carry objects, however, prosthetic non-use. Previous research has examined univariate use may be necessary to prevent falls.37,38 As mobility aid use is a associations with poor outcomes.5 In the present study, a much predictor of non-use, future research may investigate interven- wider range of perioperative and demographic factors were tional strategies (eg, mobility aid type, back pack use, prosthetic examined and confirmed that a large number of factors are componentry) that potentially improve functionality of gait. significantly associated with prosthetic non-use. These were grouped into intrinsic, amputation and functional domains. The At 4 months and 8 months after discharge, dependence walking major point of difference from surgical studies12,21,35 was that outdoors on concrete was a significant predictor of prosthetic non- causative factors for amputation were not associated with non-use. use. Validation of this predictor with early prosthetic non-use is important, as many locomotor activities require the ability to walk The key point of this research, however, was that multivariate outdoors on concrete (eg, shopping). Poor prosthetic outcome has predictive models were used to determine a predictive model of been associated with indoors-only ambulation.11,24 outcome at four time points. Three clinical prediction rules were derived and validated, as the results for the 4-month and 6-month Similar to the literature,5 the present study validated a critical outcomes were identical. These results validate that a subgroup of time frame in which gait retraining needs to occur, because at early prosthetic non-users exist and can be targeted. The high level 12 months, a delay of >160 days was predictive of non-use. Wound of concordance between retrospective and prospective prosthetic complications were the commonest delay in both cohorts. Delays non-use survival curves demonstrates that there was no substan- to walking generally result in prolonged wheelchair sitting and tial change in clinical practice (contamination) during the reduced physical activity. Rehabilitation programs may not validation study. These findings call for development of a model provide the exercise intensity to overcome deconditioning or of care that optimises outcome for these individuals. Rehabilitation prevent complications (eg, joint contracture, muscle weakness) may focus on optimising transfers, wheelchair mobility, physical that limit walking capacity. Furthermore, individuals with severe fitness and mental wellbeing rather than prosthetic gait. comorbidities and frailty may adversely or not respond to exercise intervention. The present study found that having a very high number of comorbidities was significantly predictive of prosthetic non-use at Although the proportion of non-users of prostheses is 4 months, but not at later time periods. This was an interesting relatively small, these people are difficult to identify; therefore, finding, as depending on how effectively comorbidities are these clinical prediction rules will assist clinical decisions during managed they may become worse with age.32 However, this rehabilitation and primary healthcare planning following dis- finding suggests that if prosthetic use can be sustained for the first charge. The validated clinical prediction rules for 4 and 8 months 4 months post-discharge in the presence of this disease burden, had positive likelihood ratios of 43.9 and 33.9, respectively. These then such systemic conditions may not be highly related to non- values are consistent with the interpretation that positive use at a later time. The Charlson Comorbidity Index for both likelihood ratios of >5 are clinically significant.28,39,40 In contrast, the 12-month clinical prediction rules were statistically signifi- cant for non-use (p = 0.031) but did not possess the predictive magnitude of the other clinical prediction rules. To improve the Table 6 Associated accuracy statistics with 95% confidence intervals for having a combination of predictor variables at 4 (and 6), 8 and 12 months for the prospective cohort. Predictors present for Sensitivity Specificity Positive Negative Probability of prosthetic Accuracy Balanced p CPR time frames (n) likelihood ratio likelihood ratio non-use (%) (%) accuracy (%) 4 (and 6) months 0.94 (0.61 to 1.0) 0.14 (0.09 to 0.15) 1.09 (0.67 to 1.17) 0.43 (0 to 4.40) 14 24 54 0.519 1 0.93 (0.53 to 1.0) 0.66 (0.61 to 0.67) 2.8 (1.36 to 3.03) 0.10 (0 to 0.77) 26 69 80 0.002 2 0.50 (0.19 to 0.81) 0.86 (0.82 to 0.90) 3.6 (1.02 to 8.5) 0.58 (0.21 to 0.99) 33 82 68 0.013 3 0.38 (0.12 to 0.44) 0.99 (0.96 to 1.0) 43.9 (2.73 to 999+) 0.63 (0.56 to 0.92) 86 92 68 < 0.001 4 0.06 (0 to 0.12) 0.99 (0.98 to 1.0) 0.95 (0.88 to 1.0) 50 87 52 0.259 5 6.9 (0 to 999+) 8 months 0.90 (0.57 to 0.99) 0.50 (0.44 to 0.52) 1.8 (1.0 to 2.06) 0.20 (0.01 to 0.98) 24 56 70 0.019 1 0.70 (0.38 to 0.91) 0.82 (0.76 to 0.86) 3.9 (1.6 to 6.5) 0.37 (0.10 to 0.81) 41 80 76 0.001 2 0.30 (0.09 to 0.35) 0.99 (0.96 to 1.0) 33.9 (2.1 to 999+) 0.71 (0.65 to 0.95) 86 89 65 < 0.001 3 12 months 0.91 (0.60 to 0.99) 0.51 (0.45 to 0.53) 1.85 (1.08 to 2.1) 0.18 (0.009 to 0.9) 27 58 71 0.011 1 0.46 (0.19 to 0.72) 0.84 (0.78 to 0.89) 2.8 (0.9 to 6.6) 0.65 (0.31 to 1.03) 36 77 65 0.031 2 0.09 (0.005 to 0.14) 0.99 (0.97 to 1.0) 10.1 (0.19 to 999+) 0.92 (0.86 to 1.02) 67 84 54 0.095 3
230 Roffman et al: Prediction of non-use of prostheses by amputees clinical utility of the 12-month clinical prediction rules, future 5. Sansam K, Neumann V, O’Connor R, Bhakta B. Predicting walking ability following research may incorporate a follow-up assessment at 6-months lower limb amputation: a systematic review of the literature. J Rehabil Med. post-discharge. 2009;41:593–603. Amputation rate has been reported as being 38 times greater in 6. Adams EFK, Alligood E. A systematic review of clinical predictors of outcomes in Aboriginals who have diabetes.41 In the present study, indigenous adults with recent major lower limb amputation - Final report. VA Technology status, geographical isolation from health services and having Assessment Program. 2005;1–23. diabetes were not predictive of prosthetic non-use. Environmental conditions in Aboriginal communities, where the terrain is rough, 7. Cumming J, Barr S, Howe T. Prosthetic rehabilitation for older dysvascular people sociocultural factors and service model strategies such as following a unilateral transfemoral amputation. Cochrane Database Syst Rev. telehealth may have contributed to sustained prosthetic use. 2006;4:CD005260. The present research had some potential limitations. The 8. Jones L, Hall M, Schuld W. Ability or disability? A study of the functional outcome of prosthetic-use interview relied on participant recall. Missing data 65 consecutive lower limb amputees treated at the Royal South Sydney Hospital in is a potential issue for retrospective research; however, a strength 1988–1989 Disabil Rehabil. 1993;15:184–188. of the present study was that it had minimal missing data. Mortality rate was high within the review period for the 9. Lim TS, Finlayson A, Thorpe JM, Sieunarine K, Mwipatay BP, Brady A, et al. Out- retrospective (16%) and prospective (10%) cohorts; however, the comes of a contemporary amputation series. ANZ J Surg. 2006;76:300–305. sensitivity analyses demonstrated that the deceased sub-groups did not bias clinical prediction rules development or validation. 10. Basu NN, Fassiadis N, McIrvine A. Mobility one year after unilateral lower limb Although further validation could be undertaken at other amputation: a modern, UK institutional report. Interact Cardiovasc Thorac Surg. rehabilitation centres, the use of the prospective cohort in the 2008;7:1024–1026. present study validates the use of these clinical prediction rules by health professionals. 11. Taylor SM, Kalbaugh CA, Blackhurst DW, Hamontree SE, Cull DL, Messich HS, et al. Preoperative clinical factors predict postoperative functional outcomes after major In conclusion, this is the first study to integrate rehabilitation lower limb amputation: an analysis of 553 consecutive patients. J Vasc Surg. 2005; variables into a parsimonious set of predictors that are significant 42:227–234. for prosthetic non-use at 4, 8 and 12 months after discharge, and validate these clinical prediction rules. The research has validated 12. Davies B, Datta D. Mobility outcome following unilateral lower limb amputation. that a sub-group of early prosthetic non-users exists, and Prosthet Orthot Int. 2003;27:186–190. highlights a need to separate causative factors for amputation that impact on surgical outcome, from those related to prosthetic 13. Fortington LV, Geertzen JH, van Netten JJ, Postema K, Rommers GM, Dijkstra PU. non-use. These validated clinical prediction rules may guide Short and long term mortality rates after a lower limb amputation. Eur J Vasc clinical reasoning and rehabilitation service development. Endovasc. 2013;46:124–131. What is already known on this topic: Long-term functional 14. Jones WS, Patel MR, Dai D, Vemulapalli S, Subherwal S, Stafford J, et al. High use of a prosthesis following discharge from hospital is im- mortality risks after major lower extremity amputation in Medicare patients with portant for quality of life for lower limb amputees. peripheral artery disease. Am Heart J. 2013;165:809–815. What this study adds: Clinical prediction rules can provide valid data to help identify people who are at risk of discontinu- 15. Pohjolainen T, Alaranta H, Ka¨ rka¨inen M. Prosthetic use and functional and social ing use of their prosthesis in the year following discharge from outcome following major lower limb amputation. Prosthet Orthot Int. 1990;14: hospital after lower limb amputation. Different predictors 75–79. contribute to these clinical prediction rules, depending on the time frame considered (4, 8 or 12 months). Amputation 16. Kulkarni J, Pande S, Morris J. Survival rates in dysvascular lower limb amputees. Int above the transtibial level and use of a mobility aid were J Surg. 2006;4:217–221. predictors that were common to the clinical prediction rules for all three time frames. 17. Schoppen T, Boonstra A, Groothoff JW, de Vries J, Goeken LN, Eisma WH. Physical, mental, and social predictors of functional outcome in unilateral lower-limb eAddenda: Figures 3, 4 and 5, Tables 1 and 4, and Appendices amputees. Arch Phys Med Rehabil. 2003;84:803–811. 1 and 2 can be found online at doi:10.1016/j.jphys.2014.09.003 18. O’Neill BF, Evans JJ. Memory and executive function predict mobility rehabilitation Ethics approval: This research was approved by the Royal Perth outcome after lower-limb amputation. Disabil Rehabil. 2009;31:1083–1091. Hospital and Curtin University Ethics Committees. 19. Waters RL, Perry J, Antonelli D, Hislop H. Energy cost of walking of amputees: the Source(s) of support: ISPO Australia Research Grant. influence of level of amputation. J Bone Joint Surg Am. 1976;58:42–46. Competing interests: None. Acknowledgements: ISPO Australia, staff and administrators at 20. Bhangu S, Devlin M, Pauley T. Outcomes of individuals with transfemoral and the Department of Physiotherapy, Royal Perth Hospital. contralateral transtibial amputation due to dysvascular etiologies. Prosthet Orthot Correspondence: Caroline Roffman, Faculty of Health Int. 2009;33:33–40. Sciences, Curtin University, School of Physiotherapy & Exercise Science Curtin University of Technology, Perth, Australia. Email: 21. Dillingham TR, Pezzin LE, MacKenzie EJ, Burgess AR. Use and satisfaction with [email protected] prosthetic devices among persons with trauma-related amputations: a long–term outcome study. Am J Phys Med Rehabil. 2001;80:563–571. References 22. Goktepe AS, Cakir B, Yilmaz B, Yazicioglu K. Energy expenditure of walking with 1. van der Linde H, Hofstad CJ, Van Limbeek J, Postema K, Geertzen JH. Use of the prostheses: comparison of three amputation levels. Prosthet Orthot Int. Delphi Technique for developing national clinical guidelines for prescription of 2010;34:31–36. lower-limb prostheses. J Rehabil Res Dev. 2005;42:693–704. 23. Penn-Barwell JG. Outcomes in lower limb amputation following trauma: a sys- 2. Broomhead P, Dawes D, Hale C, Lambert A, Quinlivan D, Shepherd R. Evidence based tematic review and meta-analysis. Injury. 2011;42:1474–1479. clinical guidelines for the physiotherapy management of adults with lower limb prostheses. London: Chartered Society of Physiotherapy; 2003. 24. Gailey RS, Roach KE, Applegate EB, Cho B, Cunniffe B, Licht S, et al. The amputee mobility predictor: an instrument to assess determinants of the lower-limb 3. Department of Health WA. In: Network AC, ed. In: Amputee Services and Rehabili- amputee’s ability to ambulate. Arch Phys Med Rehabil. 2002;83:613–627. tation Model of Care. Perth, Western Australian: Department of Health; 2008. 25. Condie ME, McFadyen AK, Treweek S, Whitehead L. The trans-femoral fitting 4. Campbell WB, Ridler BM. Predicting the use of prostheses by vascular amputees. predictor: a functional measure to predict prosthetic fitting in transfemoral Eur J Vasc Endovasc. 1996;12:342–345. amputees – validity and reliability. Arch Phys Med Rehabil. 2011;92:1293–1297. 26. Raya MA, Gailey RS, Fiebert IM, Roach KE. Impairment variables predicting activity limitation in individuals with lower limb amputation. Prosthet Orthot Int. 2010;34:73–84. 27. Cleland JA, Childs JD, Fritz JM, Whitman JM, Eberhart SL. Development of a clinical prediction rule for guiding treatment of a subgroup of patients with neck pain: use of thoracic spine manipulation, exercise, and patient education. Phys Ther. 2007;87:9–23. 28. Childs JD, Cleland JA. Development and application of clinical prediction rules to improve decision making in physical therapist practice. Phys Ther. 2006;86:122–131. 29. Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010;90: 1239–1250. 30. Laupacis A, Sekar N, Stiell IG. Clinical prediction rules. A review and suggested modifications of methodological standards. JAMA. 1997;277:488–494. 31. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373–383. 32. Brodersen KH, Ong CS, Stephan KE, Buhmann JM. The balanced accuracy and its posterior distribution. Paper presented at 20th International Conference on Pattern Recognition 2010. https://ieeexplore.ieee.org/xpl/mostRecentIssue.jsp?punumber = 5595335 (Accessed 3 Jul 2014). 33. Everitt BS. The analysis of contingency tables. Vol 45. CRC Press; 1992. 34. Trewin D. Australian Standard Geographical Classification (ASGC) 2005. 2005; 1216.0:1 to 240. 35. Dillingham TR, Pezzin LE, Shore AD. Reamputation, mortality, and health care costs among persons with dysvascular lower-limb amputations. Arch Phys Med Rehabil. 2005;86:480–486. 36. Nehler MR, Coll JR, Hiatt WR, Regensteiner JG, Schnickel GT, Klenke WA, et al. Functional outcome in a contemporary series of major lower extremity amputa- tions. J Vasc Surg. 2003;38:7–14.
Research 231 37. Gauthier-Gagnon C, Grise´ MC, Potvin D. Enabling factors related to prosthetic use syndrome who respond to patellar taping. J Orthop Sports Phys Ther. 2006;36: by people with transtibial and transfemoral amputation. Arch Phys Med Rehabil. 854–866. 1999;80:706–713. 40. Jaeschke R, Guyatt G, Sackett DL. Users’ guides to the medical literature. III. How to use an article about a diagnostic test. A. Are the results of the study valid? 38. Franchignoni F, Orlandini D, Ferriero G, Moscato TA. Reliability, validity, and respon- Evidence-Based Medicine Working Group JAMA. 1994;271:389–391. siveness of the locomotor capabilities index in adults with lower-limb amputation 41. Norman PE, Schoen DE, Gurr JM, Kolybaba ML. High rates of amputation among undergoing prosthetic training. Arch Phys Med Rehabil. 2004;85:743–748. Indigenous people in Western Australia. Med J Aust. 2010;192:421. 39. Lesher JD, Sutlive TG, Miller GA, Chine NJ, Garber MB, Wainner RS. Development of a clinical prediction rule for classifying patients with patellofemoral pain
Journal of Physiotherapy 60 (2014) 232 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Trial Protocol PREvention STudy On preventing or reducing disability from musculoskeletal complaints in music school students (PRESTO): protocol of a randomised controlled trial Vera AE Baadjou a,b, Jeanine AMCF Verbunt a,b,c, Marjon DF van Eijsden-Besseling c, Ans LW Samama-Polak d, Rob A de Bie e, Rob JEM Smeets a,b,c a Department of Rehabilitation Medicine, CAPHRI, Maastricht University; b Adelante Centre of Expertise in Rehabilitation and Audiology, Hoensbroek; c Department of Rehabilitation Medicine, Maastricht University Medical Centre; d Postural exercise therapist method Mensendieck, Voorburg; e Department of Epidemiology, Musculoskeletal Disorders research group, CAPHRI, Maastricht University, Maastricht, The Netherlands Abstract Introduction: Up to 87% of professional musicians develop Shoulder and Hand questionnaire). The secondary outcome work-related complaints of the musculoskeletal system during measures are pain, quality of life and changes in health behaviour. their careers. Music school students are at specific risk for Multilevel mixed-effect logistic or linear regression analyses will developing musculoskeletal complaints and disabilities. This study be performed to analyse the effects of the program on the aims to evaluate the effectiveness of a biopsychosocial prevention aforementioned outcome measurements. Furthermore, cost-effec- program to prevent or reduce disabilities from playing-related tiveness, cost-utility and feasibility will be analysed. Discussion: It musculoskeletal disorders. Secondary objectives are evaluation of is believed that this is the first comprehensive randomised cost-effectiveness and feasibility. Methods: Healthy, first or controlled trial on the effect and rationale of a biopsychosocial second year students (n = 150) will be asked to participate in a prevention program for music students. multicentre, single-blinded, parallel-group randomised controlled trial. Students randomised to the intervention group (n = 75) will Trial registration: Nederlands Trial Register. Registration participate in a biopsychosocial prevention program that number: NTR3561. Was this trial prospectively registered: addresses playing-related health problems and provides postural Yes, date: 16-8-2012. Funded by: University Fund Limburg/SWOL, training according to the Mensendieck or Cesar methods of Ans Samama Fund. Funder approval number: not applicable. postural exercise therapy, while incorporating aspects from Anticipated completion: follow-up will continue until June 2016. behavioural change theories. A control group (n = 75) will Correspondence: Vera AE Baadjou, Maastricht University, participate in a program that stimulates a healthy physical activity FHML, Department of Rehabilitation Medicine, Maastricht, The level using a pedometer, which conforms to international Netherlands. Email: [email protected] recommendations. No long-term effects are expected from this control intervention. Total follow-up duration is two years. The Full protocol: Available on the eAddenda at doi:10.1016/ primary outcome measure is disability (Disabilities of Arm, j.jphys.2014.09.001 http://dx.doi.org/10.1016/j.jphys.2014.09.001 ß 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved. Commentary Performing artists experience high rates of musculoskeletal The investigators intend to prevent contamination of the injuries, but research in the area of musculoskeletal injury intervention between participants at the same institution by prevention for performing artists is sparse, particularly so for asking them not to divulge the nature of their intervention to other musicians.1 Musicians have highly repetitive workloads, varied students. However, in an age of social media the intervention musculoskeletal stresses related to particular instruments, individ- secrecy encouraged by the researchers may not be maintained to ual rehearsal and performance schedules, and psychological stresses the desired level. related to public performances. While these loads are similar to those experienced by athletes, the crossover of knowledge from Given the individual nature of each intervention, the aim of sports physiotherapy is limited. Professional musicians have examining the feasibility and cost of such an intervention is expressed a desire for healthcare and injury-prevention education commendable. The necessity of examining the delivery cost of a to be delivered earlier in their training than is currently happening.1 personnel-intensive program against the hoped-for benefit of reduced performance-related musculoskeletal disorders is impor- The protocol by Baadjou et al will fill a large gap in the evidence tant in this age of cost-driven healthcare. about injury prevention programs to reduce performance-related musculoskeletal disorders. The study will not only be one of the Conflict of interest declaration: None. first randomised controlled trials in this population, but also the first to use a biopsychosocial intervention. In musicians training at RI$CNTAMD[FE]S laireMANT.RIF$D[]ES Hiller a tertiary (pre-professional) level, an individual biopsychosocial Faculty of Health Sciences, University of Sydney, Australia prevention intervention will be compared to a general increased physical activity level intervention. Reference 1. Chan C, et al. Front Psychol. 2014;5:1–14. http://dx.doi.org/10.1016/j.jphys.2014.08.010 1836-9553/ß 2014 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association.
Journal of Physiotherapy 60 (2014) 201–208 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Research Standing with electrical stimulation and splinting is no better than standing alone for management of ankle plantarflexion contractures in people with traumatic brain injury: a randomised trial Joan Leung a, Lisa A Harvey b,c, Anne M Moseley b,d, Bhavini Whiteside e, Melissa Simpson f, Katarina Stroud a a Royal Rehabilitation Centre; b Sydney Medical School, University of Sydney; c Rehabilitation Studies Unit, Northern Clinical School, Sydney Medical School, University of Sydney; d The George Institute for Global Health; e Liverpool Health Service; f Westmead Hospital, Sydney, Australia KEY WORDS ABSTRACT Traumatic brain injury Question: Is a combination of standing, electrical stimulation and splinting more effective than standing Contracture alone for the management of ankle contractures after severe brain injury? Design: A multi-centre Splinting randomised trial with concealed allocation, assessor blinding and intention-to-treat analysis. Electrical stimulation Participants: Thirty-six adults with severe traumatic brain injury and ankle plantarflexion contractures. Stretch Intervention: All participants underwent a 6-week program. The experimental group received tilt table standing, electrical stimulation and ankle splinting. The control group received tilt table standing alone. Outcome measures: The primary outcome was passive ankle dorsiflexion with a 12 Nm torque. Secondary outcomes included: passive dorsiflexion with lower torques (3, 5, 7 and 9 Nm); spasticity; the walking item of the Functional Independence Measure; walking speed; global perceived effect of treatment; and perceived treatment credibility. Outcome measures were taken at baseline (Week 0), end of intervention (Week 6), and follow-up (Week 10). Results: The mean between-group differences (95% CI) for passive ankle dorsiflexion at Week 6 and Week 10 were –3 degrees (–8 to 2) and –1 degrees (–6 to 4), respectively, in favour of the control group. There was a small mean reduction of 1 point in spasticity at Week 6 (95% CI 0.1 to 1.8) in favour of the experimental group, but this effect disappeared at Week 10. There were no differences for other secondary outcome measures except the physiotherapists’ perceived treatment credibility. Conclusion: Tilt table standing with electrical stimulation and splinting is not better than tilt table standing alone for the management of ankle contractures after severe brain injury. Trial registration: ACTRN12608000637347. [Leung J, Harvey LA, Moseley AM, Whiteside B, Simpson M, Stroud K (2014) Standing with electrical stimulation and splinting is no better than standing alone for management of ankle plantarflexion contractures in people with traumatic brain injury: a randomised trial. Journal of Physiotherapy 60: 201–208] ß 2014 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/3.0/). Introduction factors such as muscle weakness and spasticity1,5 may explain why passive stretch fails to produce a large or sustained effect. Contractures are a common secondary problem after acquired brain injury.1,2 Traditional treatment for contractures has primari- Effective management of contractures may therefore require a ly involved passive stretch. However, a systematic review found combination of a high dose of passive stretch with treatments that that commonly-used passive stretch interventions do not produce address the underlying causes of contracture. A case report has clinically worthwhile effects.3 Two reasons may explain this described an intensive program of a high dose of passive stretch finding. Firstly, the dose of passive stretch used in the included combined with motor training for the correction of chronic knee trials may be insufficient (median dose: 6 hours a day over contractures.6 However, case reports only provide weak evidence. 30 days). In a randomised controlled trial, 24 hours a day of passive High-quality evidence is needed to verify the effectiveness of this stretch produced a greater effect on joint range than an hour a day approach. of passive stretch (between-group difference of 22 deg, 95% CI 13 to 31), and when the dose of passive stretch was reduced its The purpose of this study was to compare a multimodal effect diminished.4 Secondly, passive stretch focuses primarily on treatment program (combining tilt table standing, splinting and increasing the length of soft tissues but does not address the electrical stimulation) with a single modality treatment program factors that are believed to contribute to contractures, such as (tilt table standing alone). People with severe traumatic brain muscle weakness and spasticity. The continuous presence of injury were targeted because contractures are common in this clinical population. Tilt table standing and splinting were investigated because both are commonly used, and together they http://dx.doi.org/10.1016/j.jphys.2014.09.007 1836-9553/ß 2014 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/3.0/).
202 Leung et al: Multimodal approach for contracture in brain injury increase total stretch dose. Electrical stimulation was used because applied using a digital neuromuscular stimulation unitaaVersports of its potential therapeutic effects on muscle weakness and stimulator, Ausmedic Mobility and Rehab, Australia. through a pair spasticity – the two known contributors to contractures. A of square electrodes (5 cm x 5 cm). The stimulation parameters systematic review7 and a randomised controlled trial8 have suggested that electrical stimulation increases strength after were: pulse width of 300 ms, frequency of 50 Hz, on time of acquired brain injury. Five randomised controlled trials have also reported a decrease in spasticity with electrical stimulation.9–13 In 15 seconds, off time of 15 seconds, and a ramping-up period of addition, people with contractures often have severe motor 1.5 seconds. These parameters were selected to optimise any impairments and therefore very limited ability to participate in strengthening benefits.16 The amplitude of electrical stimulation active treatment. Electrical stimulation can elicit muscle contrac- was set to produce maximum tolerable muscle contractions. For tions in people with little or no ability to voluntarily contract participants who were unable to indicate tolerable levels of muscles.14 Hence, it seems to be an appropriate adjunct treatment stimulation, the amplitude of stimulation was set to generate a for contractures in the target population. Therefore, the research palpable muscle contraction. Participants were encouraged to question for this study was: voluntarily contract their muscles with the electrical stimulation but most were in post-traumatic amnesia and had severe cognitive Is a combination of tilt table standing, electrical stimulation and and motor deficits, which limited their ability to actively ankle splinting more effective than tilt table standing alone in the participate in therapy. Physiotherapists administered both tilt treatment of ankle contractures following severe traumatic brain table standing and electrical stimulation. The experimental group injury? also wore an ankle splintbbFormit ankle resting splint, Ausmedic Mobility and Rehab, Australia. for at least 12 hours a day, 5 days Method per week. The splints positioned the ankles in maximum tolerable dorsiflexion. Physiotherapists, nursing staff or physio- Design therapy assistants, as directed by the treating physiotherapists, applied them. A multi-centre, assessor-blinded, randomised controlled study was undertaken. All participants were randomly allocated to one of Participants in the control group only received tilt table two groups using a blocked randomisation schedule: experimental standing for 30 minutes, three times a week. They did not stand group (tilt table standing, electrical stimulation and ankle with a wedge under the foot. In short, the intervention programs of splinting) or control group (tilt table standing only). The random the two groups differed in three ways. Firstly, the experimental allocation sequence was computer-generated by a person not group received 30 sessions of tilt table standing, while the control involved in participant recruitment. Group allocation was con- group received 18 sessions. Secondly, the experimental group cealed using consecutively numbered, sealed, opaque envelopes, received maximum stretch (by using a wedge where applicable) which were kept off-site. After baseline assessment, the investiga- while standing on the tilt table, while the control group did not tor contacted a person who was not involved in the study to reveal receive stretch beyond a plantigrade position. Thirdly, the the group allocation. End of intervention and follow-up assess- experimental group received electrical stimulation and ankle ments were conducted at Week 6 and Week 10, respectively. splinting, while the control group did not. During the 4-week follow-up period, participants in both groups stood on a tilt table Participants, therapists and centres for 30 minutes, three times a week, without a wedge. No electrical stimulation or splinting was administered to the ankle during this All patients admitted with a traumatic brain injury to one of three time. Over the course of the trial, all participants received usual metropolitan brain injury rehabilitation units in Sydney (namely: multidisciplinary rehabilitation provided by the participating Royal Rehabilitation Centre Sydney, Liverpool Hospital, and units, as appropriate. This consisted of physiotherapy, occupation- Westmead Hospital) were screened between January 2009 and al therapy, speech therapy, recreational therapy and psychological December 2014. They were invited by their physiotherapists to therapy. Physiotherapy included an individualised motor training participate in the study if they fulfilled the following criteria: first program, which, where appropriate, included practice of sitting to documented traumatic brain injury; a score of 4 or less on the standing, walking and standing. The usual care for both groups walking item of Functional Independence Measure (ie, an inability to involved positioning of participants’ feet in dorsiflexion while walk 17 m without physical assistance or 50 m with supervision); seated and lying. No other passive stretch-based interventions presence of an ankle contracture (defined as passive dorsiflexion were administered to the ankle during the trial. Physiotherapists ankle range of motion less than 5 deg at a torque of 12 Nm, measured were assigned to patients on admission (ie, prior to recruitment). using the device specified in the study); ability to participate in the Thus, the physiotherapists managed an arbitrary mix of control assessment and intervention program; no unstable medical condi- and experimental participants. Diaries were used to record all tions or recent ankle fractures; no other neurological conditions interventions. No other passive stretch-based interventions were such as spinal cord injury or cerebrovascular disease; anticipated administered to the ankle. In addition, no botulinum toxin length of stay in hospital of at least 6 weeks; and no botulinum toxin injection was administered to the ankle during the study period. injection to ankle joint within 3 months. Use of anti-spasticity medication was not mandated by the study protocol, but was recorded. Assessors and medical staff were blinded to group allocation, but treating physiotherapists and participants were not. Success of assessor blinding was monitored. Intervention Outcome measures Participants in both groups received a 6-week program. The There were one primary and nine secondary outcomes. The experimental group received 30 minutes of tilt table standing with primary outcome was passive ankle dorsiflexion measured with a electrical stimulation to the ankle dorsiflexor muscles, 5 days per torque of 12 Nm with the knee in extension. This was used to week and ankle splinting 12 hours a day, at least 5 days a week. reflect the extensibility of the bi-articular ankle plantarflexor Participants were stood on the tilt table as vertically as they would muscles. The secondary outcomes were: passive dorsiflexion range tolerate. A wedge was placed under the foot to maximise the at 3, 5, 7 and 9 Nm; spasticity; the walking item of the Functional stretch to the plantarflexor muscles. Electrical stimulation was Independence Measure; walking speed; and physiotherapists’ and applied to the dorsiflexor muscles while participants stood on the participants’ global perceived effect of treatment and perceived tilt table. The electrical stimulation was used like this in an attempt treatment credibility. All outcomes were measured at the to increase the strength of the dorsiflexor muscles in their shortest beginning of the study (Week 0), end of the intervention (Week length, where they are often weakest.15 Electrical stimulation was 6), and follow-up (Week 10). The outcomes were measured by one
Research 203 of the five blinded and trained assessors who assessed participants Walking speed was recorded as 0 m/sec in those who could not of both groups. The end of intervention and follow-up assessments walk without physical assistance. were conducted at least 24 hours and within 3 days after the last session of intervention. The global perceived effect of treatment was rated by the treating physiotherapists and by the participants (or their carers if Passive ankle dorsiflexion was measured using a specially made the participants did not have the capacity to answer the questions). device, with a standardised procedure.17 This torque-controlled Using separate questionnaires, the treating physiotherapists and procedure has a high test-retest reliability (ICC = 0.95). With the participants (or their carers) were initially asked if they thought participant lying supine and the ankle firmly positioned on the the ankle was better, the same or worse. They were then asked to footplate, a standardised torque was applied to the ankle by rate the improvement or deterioration between 1 (a little better/a hanging weights from the rim of the wheel (Figure 1). A pre-stretch little worse) and 6 (a very great deal better/a very great deal was administered by applying a constant ankle dorsiflexion torque worse). These responses were then combined into a single 13-point of 12 Nm for 3 minutes. Passive ankle dorsiflexion range was then scale with –6 reflecting a very great deal worse, 0 reflecting no measured with progressively larger torques: 3, 5, 7, 9 and then change and +6 reflecting a very great deal better. 12 Nm. Various torques were used for two reasons. Firstly, joint angle could change in response to a treatment for a low torque but At Week 6, the participants (or their carers) and treating not a high torque or vice versa. Secondly, multiple torque- physiotherapists evaluated perceived treatment credibility using displacement values could provide information about the torque- separate questionnaires. Participants were asked to provide ratings angle relationship, which cannot be gauged from just one single for tolerance to treatment, perceived treatment worth and measure. The angle of the footplate and the inclination of tibia perceived treatment benefit using 5-point scales. They were also were measured using a digital inclinometer. The procedure was asked if they were willing to continue with the same treatment if it modified for two participants (both in the control group) who were was to be provided (scored as ‘yes’ or ‘no’). Treating physiothera- too restless to comply with the standard procedure. Modifications pists were asked to rate their perceived treatment worth and included exclusion of pre-stretch and reversing the order of treatment effectiveness using 5-point scales, and indicate if they measurements by starting with the largest torque (12 Nm); this would recommend the same protocol to the participants if further was to ensure that the primary outcome measure (joint angle with treatment was needed for the ankle (scored as ‘yes’ or ‘no’). Using 12 Nm) was obtained. The same procedure was used for all of the open-ended questions, the physiotherapists and participants were assessments for these two participants. This modified procedure also asked to report any issues or concerns about the interven- was also used for a third participant (in the control group) who tion(s) and how they were managed. became too agitated in the follow-up assessment to adhere to the standard procedure. No other changes were made to the outcome Data analysis measures or protocol since the commencement of the study. The sample size was calculated a priori based on best estimates. Spasticity of ankle plantarflexor muscles was rated based on the A sample of 36 participants was recruited to provide an 80% reaction to passive stretch at high speed (not angle of catch) using probability of detecting a between-group difference of 5 deg for the 5-point Tardieu Scale.18 The Tardieu Scale has a high the primary outcome, assuming a standard deviation of 5 deg22 percentage agreement with laboratory measures of spasticity.19 and a 10% drop-out rate. The minimum worthwhile treatment Participants were instructed to relax during the test in supine with effect for the primary outcome was set at 5 deg, in line with a the lower leg supported on a roll. The assessor moved the number of previous studies on contractures.23–28 participant’s ankle as fast as possible. Linear regression analyses were performed to assess passive Activity limitation was assessed using the walking item of the dorsiflexion, walking speed and global perceived effect of Functional Independence Measure and the 10-m walk test (ICC treatment. One-factor ANOVA was used to analyse categorical 0.998).20 The Functional Independent Measure has a high inter- data namely the walking item of the Functional Independence rater reliability for all the motor items, including walking (ICC Measure and spasticity. Chi-square tests were used to analyse 0.84 to 0.97).21 The 10-m walk test was only conducted on perceived treatment credibility. The significance level was set at < participants who could walk without physical assistance. Those 0.05. Analyses were conducted separately for the end of interven- who required walking aides on the initial assessment used the tion and follow-up assessments. Missing data were not imputed. same walking aide in all assessments. Participants were asked to All analyses were performed according to ‘intention to treat’. walk over a 14-m walkway as fast as possible. The time taken to walk the middle 10 m was used to calculate walking speed. Results ]GIF$DT)1_erugi([ Flow of participants and therapists through the study Figure 1. The device used to measure passive ankle dorsiflexion. A total of 681 patients with traumatic brain injury were screened between January 2009 and December 2013. Ultimately, 36 patients were randomised. The flow of the participants through the study is illustrated in Figure 2. Table 1 outlines the demographics and injury characteristics of the experimental and control groups; the characteristics of the two groups were similar. The median (IQR) length of post-traumatic amnesia was 180 (143 to 217) and 125 (79 to 171) for the experimental group and control group, respectively. This reflects the severe nature of participants’ brain injury. Most participants were in post- traumatic amnesia at the time of recruitment, as indicated by the median (IQR) time between injury and baseline assessment. In addition, the majority of the participants could not walk or needed a lot of assistance with walking. Only six participants (those who scored 4 for the walking item of the Functional Independence Measure) could participate in the 10-m walk test at baseline. The number of participants who could participate in the walk test increased to 17 and 18 at end of intervention and follow-up
]GIF$DT)_erugi([2204 Leung et al: Multimodal approach for contracture in brain injury Figure 2. Recruitment and flow of participants through the study. Table 1 participated in the walk test or not. Approximately 14 physiothera- Baseline characteristics of participants. pists working in the participating units administered the inter- ventions as per group allocation and provided usual care over the Participant characteristics Exp (n = 17)a Con (n = 18) course of the study. All participants (except one) were assessed in hospital. Data collection was completed in April 2014. Age at injury (yr), mean (SD) 38 (14) 38 (15) Gender, n male (%) 14 (82) 15 (83) Adherence to the study protocol Cause of injury (motor vehicle 10/4/2/1 14/1/2/1 accident/fall/assault/other), n Adherence to the various aspects of the intervention is Time from injury to baseline 140 (96 to 226) 83 (66 to 161) summarised in Table 2. The overall adherence was fairly good assessment (d), median (IQR) but there was considerable variability due to a number of factors; Glasgow Coma Scale score, mean (SD) 5 (3) 5 (3) for instance, adherence with tilt table standing was reduced in the Post-traumatic amnesia duration, 180 (115 to 180) 125 (90 to 180) intervention period due to fainting, storming, fatigue or beha- median (IQR)b vioural issues (10 participants) and tilt table standing was Anti-spasticity medication, n (%) 8 (47) 7 (39) discontinued in the follow-up period due to medical or psycho- FIM scale score for walking, 1 (1 to 1) 1 (1 to 1) logical reasons, or early discharge (three participants). The median (IQR) adherence to electrical stimulation was reduced primarily due Ankle dorsiflexor strength 7/0/6/0/4/0 6/3/1/0/8/0 to the reduced standing time and not related to any intolerance of (grade 0/1/2/3/4/5), n electrical stimulation. The adherence to splinting was reduced because of behavioural issues (three participants), poor tolerance Exp = experimental group, Con = control group, FIM = Functional Independence (one participant) and skin problems (one participant). Measure. One participant violated the protocol and received botulinum a One participant was withdrawn from the experimental group immediately toxin injection for his ankle 4 days into the follow-up period. The use of anti-spasticity medication during the course of the study is following recruitment. summarised in Table 3. Importantly, the doctors prescribing the b Post-traumatic amnesia duration was transcribed as 180 days for the participants medications were blinded to participants’ group allocation. There with protracted (> 6 months) but undetermined length of post-traumatic amnesia. assessments, respectively. Those who could not participate in the walk test (that is, unable to walk 14 m without physical assistance) had their walking speed recorded as 0 m/sec in accordance with the study protocol. The data of all participants were entered into the analysis for walking speed, irrespective of whether they Table 2 Adherence to elements of the study protocol. Protocol element Exp (n = 17) Con (n = 18) Intervention period Protocol Actual median (IQR) Protocol Actual median (IQR) Tilt table standing (min) Electrical stimulation (min) 900 890 (780 to 900) 540 540 (517 to 568) Splinting (hr) 900 870 (800 to 900) n/a n/a 360 359 (197 to 436) (n = 16) n/a n/a Follow-up period Tilt table standing (min) 360 330 (270 to 380) 360 360 (328 to 360) (n = 15) Timing of assessments 6 7 (6 to 8) 6 6 (6 to 7) 6-week assessment (wk) 10 10 (10 to 10) 10 10 (10 to 10) 10-week assessment (wk) Exp = experimental group, Con = control group, n/a = not applicable.
Research 205 Table 3 The use of anti-spasticity medication during the course of the study. Baseline n (%) Intervention period n (%) Follow-up period n (%) Exp (n = 18) Con (n = 18) Exp (n = 17) Con (n = 18) Exp (n = 17) Con (n = 15) On anti-spasticity medication 8 (44) 7 (39) 8 (47) 8 (44) 8 (47) 8 (53) Increased dose n/a n/a 3 (18) 2 (11) 0 (0) 0 (0) Stopped medication n/a n/a 1 (6) 0 (0) 0 (0) 0 (0) Started medication n/a n/a 1 (6) 1 (6) 0 (0) 0 (0) Decreased dose n/a n/a 0 (0) 0 (0) 0 (0) 1 (7) Changed medication n/a n/a 0 (0) 1 (6) 0 (0) 1 (7) [(Figur]e_3)TGDI$Exp = experimental group, Con = control group, n/a = not applicable. End of intervention Discussion (–3, 95% CI –8 to 2) This study compared a multimodal treatment program with a Follow-up single modality treatment program for contracture management. (–1, 95% CI –6 to 4) It was conducted because a systematic review has indicated that passive stretch alone is ineffective.3 It was hypothesised that a –10 –5 0 5 10 program of tilt table standing combined with electrical stimulation and splinting may be more effective than tilt table standing alone (deg) for the treatment of contracture. In the present study, electrical stimulation was added because it may improve strength and harmful no effect minimum beneficial reduce spasticity, and thus address important contributors to contracture. Splinting and additional sessions of tilt table standing worthwhile sessions were provided to the experimental group in order to increase the dose of passive stretch. Contrary to expectations, the treatment present study showed that 6 weeks of regular standing on a tilt table combined with electrical stimulation and ankle splinting did effect not provide added benefits when compared to a less-intensive program of tilt table standing alone, for people with severe Figure 3. The mean between-group difference (and 95% CI) for passive ankle traumatic brain injury and ankle contractures. The upper end of the dorsiflexion at 12 Nm at end of intervention and follow-up. The blue squares 95% CI, associated with the mean between-group difference of represent the mean between-group differences and the horizontal lines represent the ankle range, was below the pre-specified minimally worthwhile 95% CI. treatment effect of 5 deg. This indicates that the failure to detect a treatment effect was not due to an inadequate sample size. Despite were also minor deviations from the protocol related to the timing the findings, the physiotherapists who implemented the multi- of assessments (Table 2). The deviations were due to early modal program scored treatment effectiveness and worth higher discharges, public holidays, medical problems and acute illnesses. than physiotherapists who implemented the tilt table standing The blinding of the assessors was reasonably successful. Assessors alone. They were also twice as willing to recommend the treatment were unblinded in two of the end-of-intervention assessments and they provided compared to those who implemented tilt table one of the follow-up assessments. In two of these assessments, a standing alone. This is possibly a reflection of the physiotherapists’ third person, who was otherwise not involved in the study, was preconceived beliefs and expectations about the multimodal asked to take the readings from the dynamometer for the passive program. ankle range. A number of reasons may explain why our study did not Effect of multimodal treatment demonstrate a treatment effect. Firstly, the control group received some passive stretch (tilt table standing), although in The mean between-group differences (95% CI) for passive ankle a considerably lower dose than the experimental group. This was dorsiflexion with 12 Nm torque at Week 6 and Week 10 were – done because tilt table standing is often used in people with brain 3 deg (–8 to 2) and –1 deg (–6 to 4), respectively (Figure 3). Both injury for purposes other than stretching. For example, it is used were in favour of the control group (ie, the control group had 3 deg to get them upright and to provide initial training for standing so and 1 deg more passive dorsiflexion, on average, compared to the we could not justify depriving participants in the control group of experimental group at Week 6 and Week 10, respectively). this intervention. However, the inclusion of tilt table standing for However, both effects were less than the pre-specified minimum the control group inevitably reduced the treatment contrast worthwhile treatment effect of 5 deg. There was a mean reduction between the experimental and control groups, which may have in spasticity of 1 point (95% CI 0.1 to 1.8) at Week 6, favouring the diluted any possible treatment effects of the multimodal experimental group, but this effect disappeared at Week 10. No program. Secondly, the study recruited participants with severe between-group differences were found for walking speed, the traumatic brain injury and ankle contractures. These participants walking item of the Functional Independence Measure, and often had severe cognitive and behavioural impairments and participants’ and physiotherapists’ global perceived effect of complex medical issues. These characteristics imposed consid- treatment. All the primary and secondary outcome measures are erable challenges for the implementation of the treatment shown in Tables 4 and 5 (individual participant data are presented program. This reduced adherence might have influenced the in Table 6 in the eAddenda). outcome. Overall, there were no differences between groups for Electrical stimulation was used in this study to address the participants’ tolerance to treatment, perceived treatment benefit, contributors to contracture; namely, muscle weakness and perceived treatment worth, and willingness to continue with spasticity. The feedback from participants and physiotherapists treatment. In contrast, the physiotherapists administering the indicated that the use of electrical stimulation was feasible. intervention for the experimental group rated perceived treatment However, the present study did not find an improvement in joint effectiveness and perceived treatment worth higher than the range. Electrical stimulation was applied for 30 minutes a day, physiotherapists administering the control intervention. They 5 days a week over 6 weeks; this dose may have been insufficient. A were also twice as likely as the physiotherapists administering the trial that used a supramaximal dose of electrical stimulation control intervention to recommend the intervention protocol to the participants if further treatment for ankle contracture was indicated (81 versus 39%). Tables 7 and 8 show participants’ and physiotherapists’ perceived treatment credibility, respectively.
Table 4 Mean (SD) of groups, mean (SD) difference within groups, and mean (95% CI) difference between groups for passive a Outcome Groups Week 0 Week 6 Exp (n = 17) Con (n = 18) Exp (n = 16) Con (n = 17) Passive ankle dorsiflexion at 12 Nm (deg) –5 (6) –6 (6) –5 (6) –3 (9) Passive ankle dorsiflexion at 9 Nm (deg) –8 (6) –8 (6) (n = 16) –9 (6) –8 (7) (n = 15 Passive ankle dorsiflexion at 7 Nm (deg) –11 (6) –11 (6) (n = 16) –11 (6) –10 (8) (n = 15 Passive ankle dorsiflexion at 5 Nm (deg) –15 (6) –13 (5) (n = 16) –15 (6) –15 (6) (n = 14 Passive ankle dorsiflexion at 3 Nm (deg) –17 (7) –16 (6) (n = 16) –17 (6) –17 (7) (n = 14 Exp = experimental group, Con = control group, Shaded row = primary outcome. Note: Passive ankle dorsiflexion data for two participants at the end of intervention (one in exp and one in con) were not i before analysing the results. Note: Angle data in the first 6 columns is expressed relative to a neutral position where a negative angle denotes deg Table 5 Mean (SD) of groups and mean (95% CI) between-group difference in change for spasticity, walking speed, walking ite Outcome Week 0 Exp (n = 17) Con (n = 18) Exp (n = 17 Tardieu Scale (0 to 5) 2 (1) 1 (1) 2 (1) Walking speed (m/s) 0.1 (0.2) 0.1 (0.4) 0.3 (0.5) Functional Independence Measure, walking item (1 to 7) Participants’ global perceived effect of treatment (–6 to 6) a 2 (1) 2 (1) 3 (2) Physiotherapists’ global perceived effect of treatment (–6 to 6) n/a n/a 1 (2) (n = 15 n/a n/a 1 (1) Exp = experimental group, Con = control group, n/a = not applicable. Note: A negative between-group difference reflects a treatment effect in favour of the intervention group for the Tard a 55% (11/31) and 54% (15/28) of the responses were provided by carers on behalf of the participants at the end of
ankle dorsiflexion at Weeks 0, 6 and 10. Difference within groups Difference between groups 206 Leung et al: Multimodal approach for contracture in brain injury Week 10 Week 6 minus Week Week 6 minus Week 10 minus Week 0 10 minus Week 0 Week 0 Week 0 ) Exp (n = 16) Con (n = 15) Exp Con Exp Con Exp minus Con Exp minus Con 5) –2 (5) –3 (7) –1 (6) 2 (8) 2 (7) 4 (7) –3 (–8 to 2) –1 (–6 to 4) 5) –7 (5) –6 (8) (n = 13) –1 (5) 0 (5) 2 (6) 2 (7) –1 (–5 to 3) –1 (–6 to 4) 4) –10 (5) –10 (7) (n = 12) 0 (5) 2 (5) 2 (7) 4) –13 (5) –14 (8) (n = 12) 1 (5) –1 (5) 2 (5) 1 (7) 1 (–3 to 5) 0 (–5 to 5) –16 (6) –15 (9) (n = 12) 1 (6) –1 (6) 1 (6) 1 (9) 2 (–2 to 6) 1 (–3 to 6) 1 (7) 2 (–3 to 7) 0 (–6 to 5) included in the analyses because of a technical problem with data collection. The decision to exclude these data was made grees of plantarflexion from neutral. em of the Functional Independence Measure and Global Perceived Effect of treatment at Weeks 0, 6 and 10. Groups Difference between groups Week 6 Week 10 Week 6 minus Week 0 Week 10 minus Week 0 7) Con (n = 18) Exp (n = 17) Con (n = 15) Exp minus Con Exp minus Con 3 (1) 3 (1) 2 (1) –1 (–1.8 to –0.1) 0 (–1.2 to 0.6) –0.1 (–0.4 to 0.2) 0 (–0.4 to 0.4) 0.4 (0.5) 0.4 (0.6) 0.4 (0.5) 0 (–1.9 to 0.9) 0 (–1.4 to 0.9) 3 (2) 3 (3) 3 (3) –1 (–3 to 0) –1 (–3 to 0) 0 (–1 to 2) 0 (–1 to 1) 5) 2 (2) (n = 16) 2 (2) (n = 15) 3 (3) (n = 13) 1 (2) 1 (1) (n = 14) 1 (1) dieu Scale. intervention assessment and at the follow-up assessment, respectively.
Research 207 Table 7 many also did not have the cognitive ability to contract their ankle Feedback from participants on perceived treatment effectiveness and treatment muscles in synchronisation with the electrical stimulation. There is credibility at Week 6. A total of 55% (11/31) of the questionnaires were answered by increasing evidence supporting the combination of electrical carers on behalf of the participants. stimulation with volitional muscle contractions for motor train- ing.29–37 The potential value of electrical stimulation may be Outcome Groups Between-group undermined if participants are unable to work voluntarily with the comparison electrical stimulation. Three other trials have investigated electri- Int Con p-value cal stimulation in people with acquired brain injury and severe (n = 15) (n = 16) motor impairments, and the findings of all three were inconclu- sive.23,38,39 It is possible that electrical stimulation is not effective Considered the treatment beneficial, n (%) 0.886 for contracture management in people with severe traumatic brain 0.563 injury. However, these findings may not be generalisable to other yes 9 (60) 10 (63) 0.157 clinical conditions or people with less-severe brain injury. 6 (37) no 6 (40) 0 (0) 0.583 Our study’s results indicate that there was no difference 0 (0) between a single modality treatment program of tilt table standing did not answer 0 (0) and a multimodal treatment program combining tilt table 8 (50) standing, electrical stimulation and ankle splinting. While it is unsure 0 (0) 6 (37) always tempting to look at within-group changes in trials like this 2 (13) and use the data to conclude that both programs were equally Rating for treatment worth, n (%) 0 (0) effective (or ineffective), this is not a valid interpretation without a 0 (0) control group that had no intervention. No attempt was made to 1 highly worthwhile 4 (27) 0 (0) assess the effectiveness of individual modalities in the present study. The findings, however, did suggest that the addition of 2 reasonably worthwhile 6 (40) 6 (37) splinting was not therapeutic; this is consistent with previous 7 (44) clinical trials on splinting that also failed to demonstrate treatment 3 not sure 2 (13) 1 (6) effects.27,28,40 2 (13) 4 not too worthwhile 1 (7) In summary, this study, along with the many others that have 0 (0) preceded it, does not provide a solution to contractures. Tilt table 5 definitely not worthwhile at all 0 (0) 0 (0) standing, electrical stimulation and ankle splinting were selected because they are commonly used in people with severe brain did not answer 2 (13) 14 (87) injury, and their effectiveness when used in combination has never 2 (13) been investigated. In addition, they are amongst the few modalities Rating for tolerance, n (%) 0 (0) that can be used in people with severe brain injury who have a limited ability to actively participate in treatment. Despite the 1 comfortable 1 (7) failure to demonstrate a treatment effect, the findings of the present study should not deter further research on this topic. 2 slightly uncomfortable 6 (40) Impaired motor control is a main contributor to contractures; thus, treatments that promote activity, such as active movement 3 moderately uncomfortable 3 (20) through range, electromyographically activated electrical stimu- lation or task-specific motor training, may be worth further 4 very uncomfortable but 4 (26) investigation. However, most of these interventions rely on some motor and cognitive abilities, which most people with severe brain still tolerable injury do not have. Therefore, future research for this population may be better directed at combining high dosages of passive 5 intolerable 0 (0) stretching with medical interventions such as anti-spasticity medications or botulinum toxin injections. did not answer 1 (7) Willing to continue the intervention, n (%) yes 14 (93) no 1 (7) did not answer 0 (0) Exp = experimental group, Con = control group. (9 minutes a day over 4 weeks) found a small effect on joint range (5 deg, 95% CI 3 to 8) and spasticity, when compared with a group without electrical stimulation.22 The participants in the present study with severe traumatic brain injury, however, may have not been able to tolerate supramaximal doses or longer durations of electrical stimulation. In addition, electrical stimulation was applied to the ankle dorsiflexor muscles with the ankle in maximal dorsiflexion. This was done to maximise stretch and to strengthen the dorsiflexor muscles in their inner range, where they are often weakest.15 The induced muscle contractions were isometric. It is not clear whether different results would have been obtained if electrical stimulation had been applied in a different way or applied to the gastrocnemius muscles instead. Another possible reason for not finding an effect is that many of the participants (64%) had severe weakness or no muscle activity (Grade 2 or less) in their ankle dorsiflexor muscles at baseline, and Table 8 What is already known on this topic: Contracture is com- Feedback from physiotherapists on perceived treatment effectiveness and mon after acquired brain injury. Commonly used passive- treatment credibility at Week 6. stretch interventions do not have clinically worthwhile effects on contracture, perhaps partly because they do not address Outcome Groups Between-group muscle weakness and spasticity. comparison What this study adds: This trial assessed whether the effect Exp Con p-value of regular standing on a tilt table on ankle plantarflexion by (n = 17) (n = 18) contracture in people with brain injury could be improved by adding electrical stimulation to the dorsiflexors and adding Rating for treatment effectiveness, n (%) 0.046 splinting at other times. Passive dorsiflexion range was not 0.025 increased by the additional interventions. An improvement in 1 very effective 0 (0) 0 (0) 0.009 spasticity occurred but it was small and unsustained. 3 (17) 2 effective 9 (53) 13 (72) Footnote: 2 (11) eAddenda: Table 6 can be found online at doi:10.1016/ 3 unsure 8 (47) 0 (0) j.jphys.2014.09.007. Ethics approval: The study was approved by the ethics 4 ineffective 0 (0) 1 (6) committees of the Northern Sydney Central Coast Area Health 4 (22) Service, Royal Rehab, South Western Sydney Area Health Service 5 very ineffective 0 (0) 7 (39) and Sydney West Area Health Service. Written consent was 6 (33) obtained from all the participants or their legal guardians before Rating for treatment worth, n (%) 0 (0) data collection began. 1 highly worthwhile 0 (0) 7 (39) 11 (61) 2 reasonably worthwhile 12 (70) 3 not sure 4 (24) 4 not too worthwhile 1 (6) 5 definitely not worthwhile at all 0 (0) Recommended the treatment, n (%) yes 14 (82) no 3 (28) Exp = experimental group, Con = control group. Note: n = number of responses from physiotherapists, not the number of physiotherapists.
208 Leung et al: Multimodal approach for contracture in brain injury Competing interests: Nil. 17. Harvey L, Byak A, Ostrovskaya M, Glinsky J. Reliability of a device designed to Source(s) of support: The Rehabilitation and Disability measure ankle mobility. Spinal Cord. 2003;41:559–562. Research Grants of the Royal Rehabilitation Centre Sydney, and the Research Infrastructure Block Grants of the University of 18. Tardieu G, Shentoub S, Delaure R. A la recherche d’une technique de mesure de la Sydney. spasticite. Rev Neurol. 1954;91:143–144. Acknowledgements: We thank the staff and participants of the Royal Rehabilitation Centre Sydney, Liverpool Hospital and 19. Patrick E, Ada L. The Tardieu Scale differentiates contracture from spasticity Westmead Hospital, in particular: Charis Tse, Siobhan Barry, Peter whereas the Ashworth Scale is confounded by it. Clin Rehabil. 2006;20:173–182. Zhu, Lakshmi Arunachalam, Rajeevan Yoganathan and Shivani Bansal. A special thanks to the Department of the Assistive 20. van Loo MA, Moseley AM, Bosman JM, de Bie RA, Hassett L. Inter-rater reliability Technology and Seating of the Royal Rehabilitation Centre Sydney, and concurrent validity of walking speed measurement after traumatic brain especially James Puttock, the Senior Technical Officer, for injury. Clin Rehabil. 2003;17:775–779. manufacturing the measuring devices. Correspondence: Joan Leung, Physiotherapy, Brain Injury 21. Donaghy S, Wass PJ. Interrater reliability of the Functional Assessment Measure in Unit, Royal Rehabilitation Centre Sydney, Australia. E-mail: a brain injury rehabilitation program. Arch Phys Med Rehabil. 1998;79:1231–1236. [email protected], [email protected] 22. Bakhtiary AH, Fatemy E. Does electrical stimulation reduce spasticity after stroke? References A randomized controlled study Clin Rehabil. 2008;22:418–425. 1. Kwah LK, Harvey LA, Diong JH, Herbert RD. Half of the adults who present to 23. Leung J, Harvey LA, Moseley AM, Tse C, Bryant J, Wyndham S, et al. Electrical hospital with stroke develop at least one contracture within six months: an stimulation and splinting were not clearly more effective than splinting alone for observational study. J Physiother. 2012;58:41–47. contracture management after acquired brain injury: a randomised trial. J Physi- other. 2012;58:231–240. 2. Fergusson D, Hutton B, Drodge A. The epidemiology of major joint contractures: a systematic review of the literature. Clin Orthop Relat Res. 2007;22–29. 24. Harvey LA, Batty J, Crosbie J, Poulter S, Herbert RD. A randomized trial assessing the effects of 4 weeks of daily stretching on ankle mobility in patients with spinal cord 3. Katalinic OM, Harvey LA, Herbert RD. Effectiveness of stretch for the treatment and injuries. Arch Phys Med Rehabil. 2000;81:1340–1347. prevention of contractures in people with neurological conditions: a systematic review. Phys Ther. 2011;91:1–14. 25. Harvey LA, Byak AJ, Ostrovskaya M, Glinsky J, Katte L, Herbert RD. Randomised trial of the effects of four weeks of daily stretch on extensibility of hamstring muscles in 4. Moseley AM, Hassett LM, Leung J, Clare JS, Herbert RD, Harvey LA. Serial casting people with spinal cord injuries. Aust J Physiother. 2003;49:176–181. versus positioning for the treatment of elbow contractures in adults with traumatic brain injury: a randomized controlled trial. Clin Rehabil. 2008;22:406–417. 26. 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. 5. Ada L, O’Dwyer N, O’Neill E. Relation between spasticity, weakness and contracture 2007;53:239–245. of the elbow flexors and upper limb activity after stroke: an observational study. Disabil Rehabil. 2006;28:891–897. 27. Lannin NA, Cusick A, McCluskey A, Herbert RD. Effects of splinting on wrist contracture after stroke: a randomized controlled trial. Stroke. 2007;38:111–116. 6. Leung J, Harvey LA, Moseley AM. An intensive programme of passive stretch and motor training to manage severe knee contractures after traumatic brain injury: a 28. Lannin NA, Horsley SA, Herbert R, McCluskey A, Cusick A. Splinting the hand in the case report. Physiother Can. 2013;65:223–228. functional position after brain impairment: a randomized, controlled trial. Arch Phys Med Rehabil. 2003;84:297–302. 7. Glinsky J, Harvey L, Van Es P. Efficacy of electrical stimulation to increase muscle strength in people with neurological conditions: a systematic review. Physiother 29. Taylor L, Lewis GN, Taylor D. Short-term effects of electrical stimulation and Res Int. 2007;12:175–194. voluntary activity on corticomotor excitability in healthy individuals and people with stroke. J Clin Neurophysiol. 2012;29:237–243. 8. Rosewilliam S, Malhotra S, Roffe C, Jones P, Pandyan AD. Can surface neuromuscu- lar electrical stimulation of the wrist and hand combined with routine therapy 30. Alon G, Levitt AF, McCarthy PA. Functional electrical stimulation (FES) may modify facilitate recovery of arm function in patients with stroke? Arch Phys Med Rehabil. the poor prognosis of stroke survivors with severe motor loss of the upper 2012;93:1715-1721 e1. extremity: a preliminary study. Am J Phys Med Rehabil. 2008;87:627–636. 9. Malhotra S, Pandyan AD, Rosewilliam S, Roffe C, Hermens H. Spasticity and 31. Bolton DA, Cauraugh JH, Hausenblas HA. Electromyogram-triggered neuromuscu- contractures at the wrist after stroke: time course of development and their lar stimulation and stroke motor recovery of arm/hand functions: a meta-analysis. association with functional recovery of the upper limb. Clin Rehabil. 2011; J Neurol Sci. 2004;223:121–127. 25:184–191. 32. Chan MK, Tong RK, Chung KY. Bilateral upper limb training with functional electric 10. Yan T, Hui-Chan CW, Li LS. Functional electrical stimulation improves motor stimulation in patients with chronic stroke. Neurorehabil Neural Repair. 2009; recovery of the lower extremity and walking ability of subjects with first acute 23:357–365. stroke: a randomized placebo-controlled trial. Stroke. 2005;36:80–85. 33. de Kroon JR, van der Lee JH, IJzerman MJ, Lankhorst GJ. Therapeutic electrical 11. Sabut SK, Sikdar C, Kumar R, Mahadevappa M. Functional electrical stimulation of stimulation to improve motor control and functional abilities of the upper ex- dorsiflexor muscle: effects on dorsiflexor strength, plantarflexor spasticity, and tremity after stroke: a systematic review. Clin Rehabil. 2002;16:350–360. motor recovery in stroke patients. NeuroRehabilitation. 2011;29:393–400. 34. de Kroon JR, Ijzerman MJ, Chae J, Lankhorst GJ, Zilvold G. Relation between 12. Sahin N, Ugurlu H, Albayrak I. The efficacy of electrical stimulation in reducing the stimulation characteristics and clinical outcome in studies using electrical stimu- post-stroke spasticity: a randomized controlled study. Disabil Rehabil. 2012;34: lation to improve motor control of the upper extremity in stroke. J Rehabil Med. 151–156. 2005;37:65–74. 13. Lin Z, Yan T. Long-term effectiveness of neuromuscular electrical stimulation for 35. Ng SS, Hui-Chan CW. Transcutaneous electrical nerve stimulation combined with promoting motor recovery of the upper extremity after stroke. J Rehabil Med. task-related training improves lower limb functions in subjects with chronic 2011;43:506–510. stroke. Stroke. 2007;38:2953–2959. 14. Landau WM, Sahrmann SA. Preservation of directly stimulated muscle strength in 36. Shindo K, Fujiwara T, Hara J, Oba H, Hotta F, Tsuji T, et al. Effectiveness of hybrid hemiplegia due to stroke. Arch Neurol. 2002;59:1453–1457. assistive neuromuscular dynamic stimulation therapy in patients with subacute stroke: a randomized controlled pilot trial. Neurorehabil Neural Repair. 2011; 15. Ada L, Canning CG, Low SL. Stroke patients have selective muscle weakness in 25:830–837. shortened range. Brain. 2003;126:724–731. 37. Stein RB, Everaert DG, Roy FD, Chong S, Soleimani M. Facilitation of corticospinal 16. Bowman BR, Baker LL. Effects of waveform parameters on comfort during trans- connections in able-bodied people and people with central nervous system dis- cutaneous neuromuscular electrical stimulation. Ann Biomed Eng. 1985;13:59–74. orders using eight interventions. J Clin Neurophysiol. 2013;30:66–78. 38. de Jong LD, Dijkstra PU, Gerritsen J, Geurts AC, Postema K. Combined arm stretch positioning and neuromuscular electrical stimulation during rehabilitation does not improve range of motion, shoulder pain or function in patients after stroke: a randomised trial. J Physiother. 2013;59:245–254. 39. Malhotra S, Rosewilliam S, Hermens H, Roffe C, Jones P, Pandyan AD. A randomized controlled trial of surface neuromuscular electrical stimulation applied early after acute stroke: effects on wrist pain, spasticity and contractures. Clin Rehabil. 2012;27:579–590. 40. Harvey L, de Jong I, Goehl G, Mardwedel S. Twelve weeks of nightly stretch does not reduce thumb web-space contractures in people with a neurological condition: a randomised controlled trial. Aust J Physiother. 2006;52:251–258.
Journal of Physiotherapy 60 (2014) 245 Journal of PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys Appraisal Media Stroke4Carers: training modules to help the carers of people following stroke Stroke4Carers website: www.stroke4carers.org the more time you spend using it, the easier it becomes to navigate around it. This website is primarily intended for the carers of people following stroke; however, it would also be of interest to The screens are nicely laid out with good use of images, videos physiotherapists, students or other healthcare professionals who and the occasional interactive activity that requires users to drop- are interested in learning about the implications of stroke on all and-drag answers to questions or hover over parts of a screen for aspects of a person’s life. The website was developed by a Scottish more information. Some of the screens are more text heavy and group, although it was surprisingly difficult to find out exactly who detailed than others. The screens with less text and more visual wrote the content. The website is in the format of training modules props are probably more effective, especially for the intended that users can move through to increase their knowledge and audience. The videos are high quality and very informative; for understanding about different aspects of stroke management. The example, they include re-enactments of what a carer can do if a emphasis is on practical issues to help people who have had a person falls at home, as well as instructional videos showing carers stroke and are living in the community and, in particular, their how to transfer or help a person following stroke. Sometimes, the carers. conversations between people on the videos or the commentaries are a bit staged, which at times makes them a little tedious to This is a sensible and obvious use of the web, and might help watch. However, carers would no doubt find them useful, and they reduce the current duplication of efforts, whereby hospitals and reflect a lot of good work by the creators of the website. health services generate their own pamphlets, fact sheets or booklets for patients and carers.1 Instead, carers or health profes- The information throughout is very good and has obviously sionals could be directed to this comprehensive website. Use of the been written by experienced clinicians, with input from consumers. site does, however, require carers to have some degree of computer The website does, however, sometimes suffer from inconsistency in literacy. In addition, some of the content is quite UK-specific, so the style and depth, which probably reflects the use of different content may need supplementing in other healthcare contexts. contributors and authors. There is a detailed section about physical handling and physiotherapy-specific aspects of management. There The website contains seven modules. The titles of the modules are videos on most of these screens. Some of the physiotherapy- are: causes and effects of stroke; the hospital team; practical specific content reflects a particular approach to neurological advice and tips for carers; care at home; money, benefits and legal physiotherapy that might not appeal to all physiotherapists issues; support for carers; and carers’ rights. Each module consists worldwide. However, this is unavoidable and physiotherapists with of between one and 13 lessons, and each lesson has between five differing opinions on some of the finer details of management and 25 screens; in total, there are 340 screens of material. It is not probably need to look past this and see the website for what it is: a clear how long it would take to navigate through all of the content, wonderful online and free resource for carers of people following but it is estimated that it would take between 6 and 12 hours. stroke. Therefore, this is not a website that someone could move through in one sitting. My guess is that not many users would complete the Lisa A Harvey modules systematically; they would probably peruse the different Rehabilitation Studies Unit, Kolling Institute, modules to identify content of interest. It is therefore unfortunate Sydney Medical School/Northern, University of Sydney, Australia that the navigation around the website is not easier. It is quite easy E-mail address: [email protected] to move from one lesson to the next, because the last screen of each lesson provides click-through options. However, if a user gets half Reference way through a lesson and wants to opt out, then it is not quite so obvious what to do. This is not a major issue and like any website, 1. McCartney M. BMJ. 2013;347:f4748. http://dx.doi.org/10.1016/j.jphys.2014.08.009 1836-9553/ß 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.
Journal of Physiotherapy 60 (2014) 239 Appraisal Journal of Clinimetrics PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys The Muscle Power Sprint Test The Muscle Power Sprint Test is a simple field test to evaluate defined as the highest calculated power, while mean power (MP) is anaerobic performance in children and adolescents who are able to defined as average power over the sprints. walk/run or self propel a wheelchair.1,2 It takes a few minutes to complete and only requires an open space, a stopwatch and two Reliability, validity and responsiveness: The version of the cones. The Muscle Power Sprint Test is similar to the ‘gold Muscle Power Sprint Test that requires children to walk/run standard’ Wingate Anaerobic Test in that it provides measure- (six 15-m sprints) is highly reliable with ICC values for PP and ments of anaerobic power. MP > 0.98.1,3 For children with cerebral palsy, this version also has good construct validity when validated against the cycling Before performing the Muscle Power Sprint Test, each partici- Wingate Anaerobic Test. Very strong significant correlations pant performs the test at a slow speed, which serves as both a are seen for PP and MP values between the Muscle Power Sprint warm-up and a habituation for the participant to ensure that he/ Test and Wingate Anaerobic Test (PP: r = 0.731, p < 0.001; she understands how to perform the test. The warm-up is followed MP: r = 0.903, p < 0.001).4 by a 3-minute rest period. The Muscle Power Sprint Test requires the child or adolescent to undertake several 15-m sprints with The version of the Muscle Power Sprint Test that requires children 10 seconds of recovery between each sprint. Two lines taped to the to manually propel the wheelchair is highly reliable with ICC values floor mark the 15-m distance; cones can be placed at the end of for PP and MP of 0.99.2 For this version of the Muscle Power Sprint each of the lines. Test, the variables demonstrate very strong significant positive correlations for PP and MP between the MPST and arm-cranking The participants who are able to walk/run have to complete six version of the Wingate Aanerobic Test (PP: r = 0.91, p < 0.001; 15-m sprints at maximum pace. The children who self propel MP: r = 0.88, p < 0.001), which supports the construct validity.2 wheelchairs have to perform three 15-m sprints. The participants who use wheelchairs are instructed to propel the wheelchairs as The Muscle Power Sprint Test has also been shown to be fast as possible from one line to the other, and to be sure to cross sensitive to change in children with cerebral palsy.1 Change in a each line with all wheels. child’s performance on the MP of the Muscle Power Sprint Test that exceeds the –22.1 to 19.4 Limits of Agreement (LOA) for the Between each sprint, the participants are given a 10-second running-based version, or the –7.1 to 6.4 LOA interval for MP on the period to turn around and prepare for the next sprint. Power propelling version can be attributed to real change.1,2 output for each sprint can be calculated using total mass (body mass and, if a wheelchair has been used, wheelchair weight) and For the Muscle Power Sprint Test that requires running, running/propelling times, where: power = (total mass  15 m2)/ normative values have been established for children and time3. Power can be calculated for each sprint. Peak power (PP) is adolescents with cerebral palsy,5 and for children who are typically developing between 6 and 12 years of age.3 Commentary The advantage of using the Muscle Power Sprint Test to measure The Muscle Power Sprint Test is an anaerobic field test for anaerobic power is that it allows the performance of movements running, and propelling a wheelchair. Adenosine triphosphate, more specific to sporting events that use running or propelling a phosphocreatine and glycogen are the dominant fuel sources for wheelchair as their principal form of locomotion. It is also easy for this type of short-term high-intensity exercise. The total exercise therapists, trainers and coaches in a field-based training setting to time between the tests is very similar: 20 to 36 seconds for the administer. different versions of the Muscle Power Sprint Test and 30 seconds in the Wingate Anaerobic Test. Both tests require all anaerobic Olaf Verschurena and Tim Takkenb energy sources, making the Muscle Power Sprint Test an anaerobic aBrain Center Rudolf Magnus and Center of Excellence for performance test for children and adolescents. Rehabilitation Medicine, University Medical Center Utrecht and De Anaerobic testing has some intrinsic methodological limita- Hoogstraat Rehabilitation, The Netherlands tions. The Muscle Power Sprint Test is largely dependent on bChild Development and Exercise Center, University Medical Center participant motivation. Currently, there are no objective physio- logical criteria that can be used to establish a ‘true’ maximal Utrecht, Utrecht, The Netherlands anaerobic effort. Therefore, the researcher or the clinician must rely on the co-operation of the individual performing the exercise. References Encouragement and a child-friendly and exercise-friendly envi- ronment are also important for ensuring participants perform the 1. Verschuren O, et al. Ped Phys Ther. 2007;19:108–115. test to the best of their abilities. 2. Verschuren O, et al. Dev Med Child Neurol. 2013;55(12):1129–1135. 3. Douma-van Riet D, et al. Ped Phys Ther. 2012;24(4):327–332. The Muscle Power Sprint Test is inexpensive, easily adminis- 4. Verschuren O, et al. Ped Phys Ther. 2013;25(1):25–28. tered and can be performed in a relatively short timeframe. Its 5. Verschuren O. Dev Med Child Neurol. 2010;(10):e222–e228. results can be readily interpreted with available reference values. http://dx.doi.org/10.1016/j.jphys.2014.08.001 1836-9553/ß 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.
Search
