scholarly journals Walking-adaptability therapy after stroke: results of a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
C. Timmermans ◽  
M. Roerdink ◽  
C. G. M. Meskers ◽  
P. J. Beek ◽  
T. W. J. Janssen
Keyword(s):  
Primary Outcome ◽  
Walking Speed ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Group Differences ◽  
Post Intervention ◽  
Physical Context ◽  
Context Specific ◽  
Walking Adaptability

Abstract Background The ability to adapt walking to environmental properties and hazards, a prerequisite for safe ambulation, is often impaired in persons after stroke. Research question The aim of this study was to compare the efficacy of two walking-adaptability interventions: a novel treadmill-based C-Mill therapy (using gait-dependent augmented reality) and the standard overground FALLS program (using physical context). We expected sustained improvements for both treatment groups combined but hypothesized better outcomes for C-Mill therapy than the FALLS program due to its expected greater amount of walking practice. Methods In this pre-registered single-centre parallel group randomized controlled trial, forty persons after stroke (≥ 3 months ago) with walking and/or balance deficits were randomly allocated to either 5 weeks of C-Mill therapy or the FALLS program. The primary outcome measure was the standard walking speed as determined with the 10-meter walking test (10MWT). Additionally, context-specific walking speed was assessed in environments enriched with either stationary physical context (10MWT context) or suddenly appearing visual images (Interactive Walkway obstacles). The walking-adaptability scores of those enriched walking tests served as secondary outcome measures. Furthermore, a cognitive task was added to all three assessments to evaluate dual-task performance in this context. Finally, the participants’ experience and amount of walking practice were scored. The outcome measures were assessed at four test moments: pre-intervention (T0), post-intervention (T1), 5-week post-intervention retention (T2), and 1-year post-intervention follow-up (T3). Results No significant group differences were found between the interventions for the primary outcome measure standard walking speed, but we found a greater improvement in context-specific walking speed with stationary physical context of the C-Mill therapy compared to the FALLS program at the post-intervention test, which was no longer significant at retention. Both interventions were well received, but C-Mill therapy scored better on perceived increased fitness than the FALLS program. C-Mill therapy resulted in twice as many steps per session of equal duration than the FALLS program. The “change-over-time” analyses for participants of both interventions combined showed no significant improvements in the standard walking speed; however, significant improvements were found for context-specific walking speed, walking adaptability, and cognitive dual-task performance. Significance This study showed no between-group differences between the novel treadmill-based C-Mill therapy and the standard overground FALLS program with respect to the primary outcome measure standard walking speed. However, the greater amount of walking practice observed for the C-Mill group, an essential aspect of effective intervention programs after stroke, may underlie the reported increased perceived fitness and observed increased context-specific walking speed for the C-Mill group directly after the intervention. Although the “change-over-time” results for all participants combined showed no improvement in the standard walking speed, context-specific walking speed and walking adaptability showed sustained improvements after the interventions, underscoring the importance of including walking-adaptability training and assessment in rehabilitation post stroke. Trial registration The Netherlands Trial Register NTR4030. Registered 11 June 2013.

scholarly journals Walking-adaptability therapy after stroke: results of a randomized controlled trial

2021 ◽  
Author(s):  
Celine Timmermans ◽  
Melvyn Roerdink ◽  
Carel G.M. Meskers ◽  
Peter J. Beek ◽  
Thomas W.J. Janssen
Keyword(s):  
Randomized Controlled Trial ◽  
Task Performance ◽  
Dual Task ◽  
Walking Speed ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Physical Context ◽  
Dual Task Performance ◽  
Context Specific ◽  
Walking Adaptability

Abstract BackgroundThe ability to adapt walking to environmental properties and hazards, a prerequisite for safe ambulation, is often impaired in persons after stroke. Research questionThe aim of this study was to compare the efficacy of two walking-adaptability interventions: treadmill-based C-Mill therapy (using gait-dependent augmented reality) and the overground FALLS program (using physical context). We hypothesized better outcomes for C-Mill therapy than the FALLS program due to its expected greater amount of walking practice. MethodsIn this randomized controlled trial, forty persons after stroke (≥3 months ago) with walking and/or balance deficits were randomly allocated to either 5 weeks of C-Mill therapy or the FALLS program. The primary outcome measure was the standard walking speed as determined with the 10 Meter Walking Test (10MWT). Additionally, context-specific walking speed was assessed in environments enriched with either stationary physical context (10MWT context) or suddenly appearing visual images (Interactive Walkway). The walking-adaptability scores of those enriched walking tests served as secondary outcome measures. Furthermore, a cognitive task was added to all three assessments to evaluate dual-task performance. Finally, the participants’ experience and amount of walking practice were scored.Results While both interventions did not show significant improvements in the standard walking speed, they did show significant improvements in context-specific walking speed, walking adaptability and cognitive dual-task performance. C-Mill therapy led to a greater improvement in context-specific walking speed with stationary physical context compared to the FALLS program; however, this improvement was no longer significant at retention. Both interventions were well received, but C-Mill therapy scored better on perceived increased fitness than the FALLS program. Moreover, C-Mill therapy resulted in twice as many steps per session of equal duration than the FALLS program.SignificanceBoth interventions led to long term context-specific improvements in walking speed, walking adaptability and dual-tasking.Trial registration: The Netherlands Trial Register (NTR4030). Registered 11-June 2013, https://www.trialregister.nl/trial/3842

scholarly journals Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

scholarly journals Dignity Impact as a Primary Outcome Measure for Dignity Therapy

2018 ◽  
Vol 35 (11) ◽  
pp. 1417-1420 ◽  
Author(s):  
Lisa Scarton ◽  
Sungho Oh ◽  
Ashley Sylvera ◽  
Ralph Lamonge ◽  
Yingwei Yao ◽  
...  
Keyword(s):  
Palliative Care ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Meaning Making ◽  
Controlled Trial ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Care Group ◽  
Dignity Therapy ◽  
Feedback Questionnaire

Background: Feasibility of dignity therapy (DT) is well established in palliative care. Evidence of its efficacy, however, has been inconsistent and may stem from DT’s primary effects differing from the outcomes measured in previous studies. We proposed that DT effects were in the spiritual domain and created a new outcome measure, Dignity Impact Scale (DIS), from items previously used in a large randomized controlled trial (RCT). Objective: The purpose of this secondary analysis study was to examine properties of a new measure of dignity impact. Design: Using the DIS, we conducted reanalysis of posttest data from a large 3-arm, multi-site RCT study. Setting/Participants: Participants were receiving hospice/palliative care (n = 326, 50.6% female, mean age = 65.1 years, 89.3% white, all with a terminal illness with 6 months or less life expectancy). They had been randomized to standard palliative care (n = 111), client-centered care (n = 107), or DT (n = 108). Measurement: The 7-item DIS was derived from selected items in a posttest DT Patient Feedback Questionnaire. The DIS had strong internal consistency (α = 0.85). Results: The DT group mean DIS score (21.4 ± 5.0) was significantly higher than the usual care group mean score (17.7 ± 5.5; t = 5.2, df = 216, P < .001) and a client-centered intervention group mean score (17.9 ± 4.9; t = 5.2, df = 213, P < .001). Conclusion: We found that, compared to both other groups, patients who received DT reported significantly higher DIS ratings, which is consistent with the DT focus on meaning-making, preparation for death, and life completion tasks. We propose that the DIS be used as the primary outcome measure in evaluating the effects of DT.

scholarly journals Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette’s disorder: a pilot randomised controlled trial with long-term follow-up

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024685 ◽  
Author(s):  
Per Andrén ◽  
Kristina Aspvall ◽  
Lorena Fernández de la Cruz ◽  
Paulina Wiktor ◽  
Sofia Romano ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Behaviour Therapy ◽  
Tic Severity ◽  
Randomised Controlled

ObjectiveBehaviour therapy (BT) for Tourette’s disorder (TD) and persistent (chronic) motor or vocal tic disorder (PTD) is rarely available. We evaluated the feasibility of adapting two existing BT protocols for TD/PTD (habit reversal training (HRT) and exposure and response prevention (ERP)) into a therapist-guided and parent-guided online self-help format.DesignA pilot, single-blind, parallel group randomised controlled trial.SettingA specialist outpatient clinic in Sweden.ParticipantsTwenty-three young people with TD/PTD, aged 8–16.InterventionsTwo 10-week therapist-guided and parent-guided internet-delivered programmes (called BIP TIC HRT and BIP TIC ERP).OutcomeThe primary outcome measure was the Yale Global Tic Severity Scale. Blinded evaluators rated symptoms at baseline, post-treatment and 3-month follow-up (primary endpoint). All participants were naturalistically followed up to 12 months after treatment.ResultsPatients and parents rated the interventions as highly acceptable, credible and satisfactory. While both interventions resulted in reduced tic-related impairment, parent-rated tic severity and improved quality of life, only BIP TIC ERP resulted in a significant improvement on the primary outcome measure. Within-group effect sizes and responder rates were, respectively: d=1.12 and 75% for BIP TIC ERP, and d=0.50 and 55% for BIP TIC HRT. The therapeutic gains were maintained up to 12 months after the end of the treatment. Adverse events were rare in both groups. The average therapist support time was around 25 min per participant per week.ConclusionsInternet-delivered BT has the potential to greatly increase access to evidence-based treatment for young people with TD/PTD. Further evaluation of the efficacy and cost-effectiveness of this treatment modality is warranted.Trial registration numberNCT02864589; Pre-results.

scholarly journals The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015111 ◽  
Author(s):  
Mohamed Abdel-Fattah ◽  
Graeme MacLennan ◽  
Mary Kilonzo ◽  
R Phil Assassa ◽  
Kirsty McCormick ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Single Incision ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Female Stress Urinary Incontinence ◽  
Midurethral Slings ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.Methods and analysisA pragmatic, multicentre, non-inferiority randomised controlled trial.Primary outcome measureThe primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months.Secondary outcome measuresThe secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit.Statistical analysisThe statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly.Ethics and disseminationThe North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations.Trial registration numberISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.

Results of the first interim assessment of rEECur, an international randomized controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11007-11007 ◽  
Author(s):  
Martin G. McCabe ◽  
Veronica Moroz ◽  
Maria Khan ◽  
Uta Dirksen ◽  
Abigail Evans ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Objective Response ◽  
Pairwise Comparison ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
The Other ◽  
High Dose ◽  
Interim Assessment

11007 Background: 5-year survival of RR-ES is about 15%. Several chemotherapy regimens are used, but without robust evidence. rEECur, the first randomised controlled trial in this setting, is defining a standard of care, balancing efficacy and toxicity. Methods: Patients aged 4 to 50 with RR-ES and fit to receive chemotherapy were randomised 2, 3 or 4 ways between topotecan & cyclophosphamide (TC), irinotecan & temolozomide (IT), gemcitabine & docetaxel (GD) or high-dose ifosfamide (IFOS). Primary outcome measure was objective response (OR) after 4 cycles by RECIST 1.1. Secondary outcomes included PFS, OS and toxicity. A probability-based Bayesian approach was used. The first interim assessment to determine which arm should be closed occurred when 50 evaluable patients had been recruited to 3 arms and evaluated for the primary outcome measure. Results: 242 patients (89% RECIST-evaluable) recruited between 18/12/14 and 21/06/18 were randomised to TC (n=75), IT (71), GD (66) and IFOS (30). Median age was 21 years (range 4 to 49). Patients had: refractory ES (20%), 1st recurrence (63%), >1st recurrence (17%); initial primary disease arose in bone in 60%; disease progression sites were primary site (17%), pleuropulmonary (29%) or other metastatic (54%). Median follow up was 11.3 months. Outcomes in the GD arm were: response rate 11.5% (95% CI: 4.4 to 23%), median PFS 3.0 months (95% CI: 1.6 to 8.0), median OS 13.7 months (95% CI: 10.1 to 23.9). The table shows, for each pairwise comparison of GD with the other arms (randomly labelled A, B, C to maintain blinding of open arms), the probabilities given the observed data that OR, PFS and OS were better for GD than for each other arm (RR: relative risk, HR: hazard ratio). For OR and PFS, all comparisons favoured the other arms. There were fewer grade 3/4 adverse events with GD than with the other arms pooled (58% v. 74%). Conclusions: rEECur has shown that GD is a less effective treatment than TC, IT or IFOS in reducing tumour burden or prolonging PFS in RR-ES. Recruitment continues to the remaining arms. Clinical trial information: ISRCTN36453794. [Table: see text]

Results of the second interim assessment of rEECur, an international randomized controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma (RR-ES).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 11502-11502 ◽  
Author(s):  
Martin G. McCabe ◽  
Laura Kirton ◽  
Maria Khan ◽  
Nicola Fenwick ◽  
Uta Dirksen ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Objective Response ◽  
Randomised Trial ◽  
Primary Outcome Measure ◽  
The Other ◽  
High Dose ◽  
Interim Assessment ◽  
First Recurrence

11502 Background: Five-year survival of RR-ES is about 15%. Several chemotherapy regimens are used, but without robust evidence. rEECur, the first randomised controlled trial in this setting, is defining a standard of care, balancing efficacy and toxicity. Methods: Patients aged 4 to 50 with RR-ES and fit to receive chemotherapy were randomised between topotecan & cyclophosphamide (TC), irinotecan & temolozomide (IT), gemcitabine & docetaxel (GD) or high-dose ifosfamide (IFOS). Primary outcome measure was objective response (OR) after 4 cycles by RECIST 1.1. Secondary outcomes included PFS, OS and toxicity. A probability-based Bayesian approach was used with multiple pairwise comparisons. At the first interim analysis patients allocated to GD had worse OR and PFS than the other arms and accrual to the GD arm was halted. The second interim assessment was planned to determine which arm should be closed when at least 75 evaluable patients had been recruited to the remaining arms and evaluated for the primary outcome measure. Results: 366 patients (87% RECIST-evaluable), recruited between 18/12/14 and 17/12/19, were randomised to TC (n=124), IT (118), GD (72) and IFOS (53). Median age was 20 years (range 4-49). Patients had: refractory disease (19%), first recurrence (66%), > first recurrence (14%). Initial disease site was bone in (66%). Sites of progression were: primary site only (16%) pleuropulmonary only (32%), other metastatic (52%). At median follow up of 9.2 months, outcome in the IT arm was: response rate 20%, median PFS 4.7 months (95% CI: 3.4 to 5.7), median OS 13.9 months (95% CI: 10.6 to 18.1). The table shows, for each pairwise comparison of IT with the other open arms (randomly labelled A and B to maintain blinding), the probabilities that OR, PFS and OS were better for X than for each other arm (RR = risk ratio, HR = hazard ratio). For OR, PFS and OS, all comparisons favoured arms A and B. The main grade 3/4 adverse events (% patients with an event) for IT (left hand values) compared with A and B pooled were: vomiting (6% v 1%), nausea (6% v 0%), diarrhoea (17% v 0%), fatigue (3% v 1%) and febrile neutropenia (3% v 24%). Conclusions: The first randomised trial in RR-ES has shown that IT, used as a control arm in planned and ongoing randomised phase II studies in RR-ES, is less effective than A and B in achieving tumour shrinkage or prolonging PFS and OS. The remaining two arms are continuing to recruit patients. Clinical trial information: ISRCTN36453794 . [Table: see text]

scholarly journals Transarticular tibiotalocalcaneal nailing versus open reduction and internal fixation for treatment of the elderly ankle fracture: protocol for a multicentre, prospective, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e026360
Author(s):  
Paul Tuckett ◽  
Matthew Hope ◽  
Kevin Tetsworth ◽  
Jerry Van De Pol ◽  
Catherine McDougall
Keyword(s):  
Randomised Controlled Trial ◽  
Elderly Population ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Weight Bearing ◽  
The Elderly ◽  
Primary Outcome Measure ◽  
Ankle Fractures ◽  
Randomised Controlled

IntroductionAnkle fractures are common in the elderly population. Surgical fixation is technically challenging and often results in complications due to high rates of osteoporosis and vascular disease. Open reduction and internal fixation (ORIF) often requires prolonged periods of non-weight bearing increasing the risks of complications. Tibiotalocalcaneal (TTC) nailing has been suggested as an alternative to ORIF which allows immediate weight bearing, and is suggested to result in fewer complications. This study aims to compare the two surgical techniques in the elderly population with ankle fractures.Methods and analysisThe study will be a multicentre, prospective, randomised controlled trial comparing ORIF to TTC nailing in 110 patients with ankle fractures aged 50 or above with a Charlson Comorbidity Index of greater than or equal to four. Participants and assessors will not be blinded to intervention. The primary outcome measure will be overall complication rate. Secondary outcomes include length of hospital stay, mobility at discharge, discharge destination, the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot score, the Olerud-Molander Ankle Score, mortality rate, rate of secondary surgical interventions and number of blood transfusions required postoperatively. Our null hypothesis is that there is no clinically significant difference in the primary outcome measure between the two treatment groups.Ethics and disseminationThe study has been approved by Metro South Hospital and Health Services Human Research Ethics Committee (EC00167) (reference number HREC/17/QPAH/351).DiscussionCompletion of this trial will provide evidence on the effectiveness of TTC nailing versus ORIF in treatment of the elderly ankle fracture. If TTC nailing is found to result in superior outcomes, this trial has the capacity to change current clinical practice.Trial registration numberACTRN12617001588381;Pre-results andU1111-1203-1704.

Utility-weighted modified Rankin Scale: Still too crude to be a truly patient-centric primary outcome measure?

2019 ◽  
Vol 15 (3) ◽  
pp. 268-277 ◽  
Author(s):  
Venesha Rethnam ◽  
Julie Bernhardt ◽  
Helen Dewey ◽  
Marj Moodie ◽  
Hannah Johns ◽  
...  
Keyword(s):  
Construct Validity ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Intraclass Correlation ◽  
Primary Outcome Measure ◽  
Modified Rankin Scale ◽  
Utility Values ◽  
Post Stroke ◽  
Over Time

Background The utility-weighted modified Rankin Scale (UW-mRS) is an outcome measure recently proposed to improve statistical efficiency and interpretability of the mRS. Statistical properties of the UW-mRS have been well investigated, but construct validity has yet to be established. Aims To investigate the construct validity of the UW-mRS as a primary outcome measure by assessing variability in utility values within and between mRS categories, over time post-stroke, and by different derivation methods. Methods UW-mRS was derived using assessment of quality of life (AQoL-4D) and mRS scores at 3 and 12 months ( n = 2030) from a large randomized controlled trial, A Very Early Rehabilitation Trial (AVERT). Receiver operator characteristic (ROC) analysis of AQoL-4D was conducted to differentiate between sequential mRS categories. Intraclass correlation was used to explore variability in utility values over time post-stroke, UW-mRS values, and derivation methods from multiple studies. Results UW-mRS values for mRS categories 0–6 at three months were 0.80, 0.78, 0.63, 0.37, 0.11, 0.03, and 0. Based on AQoL-4D utility values, areas under the ROC curve varied from 0.54 to 0.87. Time post-stroke explained 42%–56% of variability in AQoL-4D utility values in patients with no change in mRS between 3 and 12 months. The choice of the derivation method contributed to 25% of the variability in UW-mRS values. Conclusions The high variability in utility values between and within mRS categories, over time post-stroke, and using different derivation methods is not adequately reflected in the UW-mRS. These threats to construct validity warrant caution when using UW-mRS as a primary outcome measure. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12606000185561).

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