Physiotherapy - Research Publications
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ItemRationale for Intervention and Dose Is Lacking in Stroke Recovery Trials: A Systematic Review(HINDAWI LTD, 2018)BACKGROUND: The ineffectiveness of most complex stroke recovery trials may be explained by inadequate intervention design. The primary aim of this review was to explore the rationales given for interventions and dose in stroke rehabilitation randomised controlled trials (RCTs). METHODS: We searched the Cochrane Stroke Group library for RCTs that met the following criteria: (1) training based intervention; (2) >50% participants who were stroke survivors; (3) full peer-reviewed text; (4) English language. We extracted data on 16 quality items covering intervention dose (n= 3), trial design (n= 10), and risk of bias (n= 3) and 18 items related to trial method. Logistic regression analyses were performed to determine whether (1) reporting of trial quality items changed over time; (2) reporting of quality items was associated with the likelihood of a positive trial, adjusted for sample size and number of outcomes. RESULTS: 27 Cochrane reviews were included, containing 9,044 participants from 194 trials. Publication dates were 1979 to 2013, sample size was median 32 (IQR 20,58), and primary outcome was reported in 49 trials (25%). The median total quality score was 4 (IQR 3,6) and improved significantly each year (OR 1.12, 95% CI 1.07, 1.16, p<0.001). Total quality score was not associated with likelihood of a positive trial, but trials containing a biological rationale for the intervention were more likely to find a difference in patient outcome (OR 2.18, 95% CI 1.14, 4.19, p=0.02). CONCLUSION: To develop breakthrough treatments we need to build the rationale for research interventions and testing of intervention dosage. This will be achieved through a collective research agenda to understand the mechanistic principles that drive recovery and identification of clearer targets for clinical trials.
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ItemEnhancing physical activity in older adults receiving hospital based rehabilitation: a phase II feasibility study(BMC, 2012-06-08)BACKGROUND: Older adults receiving inpatient rehabilitation have low activity levels and poor mobility outcomes. Increased physical activity may improve mobility. The objective of this Phase II study was to evaluate the feasibility of a randomized controlled trial (RCT) of enhanced physical activity in older adults receiving rehabilitation. METHODS: Patients admitted to aged care rehabilitation with reduced mobility were randomized to receive usual care or usual care plus additional physical activity, which was delivered by a physiotherapist or physiotherapy assistant. The feasibility and safety of the proposed RCT protocol was evaluated. The primary clinical outcome was mobility, which was assessed on hospital admission and discharge by an assessor blinded to group assignment. To determine the most appropriate measure of mobility, three measures were trialled; the Timed Up and Go, the Elderly Mobility Scale and the de Morton Mobility Index. RESULTS: The protocol was feasible. Thirty-four percent of people admitted to the ward were recruited, with 47 participants randomised to a control (n = 25) or intervention group (n = 22). The rates of adverse events (death, falls and readmission to an acute service) did not differ between the groups. Usual care therapists remained blind to group allocation, with no change in usual practice. Physical activity targets were met on weekdays but not weekends and the intervention was acceptable to participants. The de Morton Mobility Index was the most appropriate measure of mobility. CONCLUSIONS: The proposed RCT of enhanced physical activity in older adults receiving rehabilitation was feasible. A larger multi-centre RCT to establish whether this intervention is cost effective and improves mobility is warranted. TRIAL REGISTRATION: The trial was registered with the ANZTCR (ACTRN12608000427370).
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ItemMeasuring Activity Levels at an Acute Stroke Ward: Comparing Observations to a Device(HINDAWI LTD, 2013)BACKGROUND: If a simple system of instrumented monitoring was possible early after stroke, therapists may be able to more readily gather information about activity and monitor progress over time. Our aim was to establish whether a device containing a dual-axis accelerometer provides similar information to behavioural mapping on physical activity patterns early after stroke. METHODS: Twenty participants with recent stroke ≤ 2 weeks and aged >18 were recruited and monitored at an acute stroke ward. The monitoring device (attached to the unaffected leg) and behavioural mapping (observation) were simultaneously applied from 8 a.m. to 5 p.m. Both methods recorded the time participants spent lying, sitting, and upright. RESULTS: The median percentage and interquartile range (IQR) of time spent lying, sitting, and upright recorded by the device were 36% (15-68), 51% (28-72), and 2% (1-5), respectively. Agreement between the methods was substantial: Intraclass Correlation Coefficient (95% CI): lying 0.74 (0.46-0.89), sitting 0.68 (0.36-0.86), and upright 0.72 (0.43-0.88). CONCLUSION: Patients are inactive in an acute stroke setting. In acute stroke, estimates of time spent lying, sitting, and upright measured by a device are valid.
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ItemExercise Preferences Are Different after Stroke(HINDAWI LTD, 2012)Objective. To explore exercise preferences in stroke survivors and controls. Methods. A novel scale-the Exercise Preference Questionnaire-was developed for this study. This questionnaire, together with established assessments of physical activities, mood, and quality of life, was completed in a single assessment session. Results. Twenty-three adult stroke survivors (mean age 63, 65% male) and 41 healthy controls (mean age 61, 66% male) participated. The groups differed on 4 of the 5 a priori exercise preference factors: relative to controls, stroke survivors preferred exercise to be more structured, in a group, at a gym or fitness centre, and for exercises to be demonstrated. Factor analysis yielded 6 data-driven factors, and these factors also differentiated stroke and control groups. There was evidence that group differences were diminished when activity levels and psychological wellbeing were accounted for. Individual variability in exercise preferences and reported barriers to exercise are outlined. Conclusion. Stroke survivors have different exercise preferences, and a better understanding of these preferences can be used to inform rehabilitation programs and increase adherence.
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ItemEvaluating the effects of increasing physical activity to optimize rehabilitation outcomes in hospitalized older adults (MOVE Trial): study protocol for a randomized controlled trial.(BioMed Central, 2015-01-15)Background: Older adults who have received inpatient rehabilitation often have significant mobility disability at discharge. Physical activity levels in rehabilitation are also low. It is hypothesized that providing increased physical activity to older people receiving hospital-based rehabilitation will lead to better mobility outcomes at discharge. Methods/design: A single blind, parallel-group, multisite randomized controlled trial with blinded assessment of outcome and intention-to-treat analysis. The cost effectiveness of the intervention will also be examined. Older people (age >60 years) undergoing inpatient rehabilitation to improve mobility will be recruited from geriatric rehabilitation units at two Australian hospitals. A computer-generated blocked stratified randomization sequence will be used to assign 198 participants in a 1:1 ratio to either an 'enhanced physical activity' (intervention) group or a 'usual care plus' (control) group for the duration of their inpatient stay. Participants will receive usual care and either spend time each week performing additional physical activities such as standing or walking (intervention group) or performing an equal amount of social activities that have minimal impact on mobility such as card and board games (control group). Self-selected gait speed will be measured using a 6-meter walk test at discharge (primary outcome) and 6 months follow-up (secondary outcome). The study is powered to detect a 0.1 m/sec increase in self-selected gait speed in the intervention group at discharge. Additional measures of mobility (Timed Up and Go, De Morton Mobility Index), function (Functional Independence Measure) and quality of life will be obtained as secondary outcomes at discharge and tertiary outcomes at 6 months follow-up. The trial commenced recruitment on 28 January 2014. Discussion: This study will evaluate the efficacy and cost effectiveness of increasing physical activity in older people during inpatient rehabilitation. These results will assist in the development of evidenced-based rehabilitation programs for this population.
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ItemNo Preview AvailableCHRISTMAS 2015: PROFESSIONAL CONSIDERATIONS AVERT2 (a very early rehabilitation trial, a very effective reproductive trigger): retrospective observational analysis of the number of babies born to trial staff(BMJ PUBLISHING GROUP, 2015-12-11)OBJECTIVE: To report the number of participants needed to recruit per baby born to trial staff during AVERT, a large international trial on acute stroke, and to describe trial management consequences. DESIGN: Retrospective observational analysis. SETTING: 56 acute stroke hospitals in eight countries. PARTICIPANTS: 1074 trial physiotherapists, nurses, and other clinicians. OUTCOME MEASURES: Number of babies born during trial recruitment per trial participant recruited. RESULTS: With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average. CONCLUSION: The staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators' meetings and helped maintain a cohesive collaborative group. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry no 12606000185561. DISCLAIMER: Participation in a rehabilitation trial does not guarantee successful reproductive activity.
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ItemNo Preview AvailableEfficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial(ELSEVIER SCIENCE INC, 2015-07-04)BACKGROUND: Early mobilisation after stroke is thought to contribute to the effects of stroke-unit care; however, the intervention is poorly defined and not underpinned by strong evidence. We aimed to compare the effectiveness of frequent, higher dose, very early mobilisation with usual care after stroke. METHODS: We did this parallel-group, single-blind, randomised controlled trial at 56 acute stroke units in five countries. Patients (aged ≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who met physiological criteria were randomly assigned (1:1), via a web-based computer generated block randomisation procedure (block size of six), to receive usual stroke-unit care alone or very early mobilisation in addition to usual care. Treatment with recombinant tissue plasminogen activator was allowed. Randomisation was stratified by study site and stroke severity. Patients, outcome assessors, and investigators involved in trial and data management were masked to treatment allocation. The primary outcome was a favourable outcome 3 months after stroke, defined as a modified Rankin Scale score of 0-2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561. FINDINGS: Between July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (99%) patients were included in the 3 month follow-up assessment. 965 (92%) patients were mobilised within 24 h in the very early mobilisation group compared with 623 (59%) patients in the usual care group. Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group (n=480 [46%] vs n=525 [50%]; adjusted odds ratio [OR] 0·73, 95% CI 0·59-0·90; p=0·004). 88 (8%) patients died in the very early mobilisation group compared with 72 (7%) patients in the usual care group (OR 1·34, 95% CI 0·93-1·93, p=0·113). 201 (19%) patients in the very early mobilisation group and 208 (20%) of those in the usual care group had a non-fatal serious adverse event, with no reduction in immobility-related complications with very early mobilisation. INTERPRETATION: First mobilisation took place within 24 h for most patients in this trial. The higher dose, very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months. Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide, and our findings should affect clinical practice by refining present guidelines; however, clinical recommendations should be informed by future analyses of dose-response associations. FUNDING: National Health and Medical Research Council, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, UK Stroke Association, National Institute of Health Research.