Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain)

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Abstract

Introduction

The Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design.

Methods and analysis

A 2-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed-methods process evaluation and economic evaluation. 48 participants discharged from clinical rehabilitation despite residual physical disability will be individually randomised 1:1 to ReTrain (25 sessions) or control (exercise advice booklet). Outcome assessment at baseline, 6 and 9 months include Rivermead Mobility Index; Timed Up and Go Test; modified Patient-Specific Functional Scale; 7-day accelerometry; Stroke Self-efficacy Questionnaire, exercise diary, Fatigue Assessment Scale, exercise beliefs and self-efficacy questionnaires, SF-12, EQ-5D-5L, Stroke Quality of Life, Carer Burden Index and Service Receipt Inventory. Feasibility, acceptability and process outcomes include recruitment and retention rates; with measurement burden and trial experiences being explored in qualitative interviews (20 participants, 3 intervention providers). Analyses include descriptive statistics, with 95% CI where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis.

Ethics and dissemination

National Health Service (NHS) National Research Ethics Service approval granted in April 2015; recruitment started in June. Preliminary studies suggested low risk of serious adverse events; however (minor) falls, transitory muscle soreness and high levels of postexercise fatigue are expected. Outputs include pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised Trainer and Intervention Delivery manuals for multicentre replication of ReTrain; presentations at conferences, public involvement events; internationally recognised peer-reviewed journal publications, open access sources and media releases.

Trial registration number

NCT02429180; Pre-results.

Related collections

Most cited references 27

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Development of a stroke-specific quality of life scale.

L Williams, M. Weinberger, L E Harris … (1999)

Clinical stroke trials are increasingly measuring patient-centered outcomes such as functional status and health-related quality of life (HRQOL). No stroke-specific HRQOL measure is currently available. This study presents the initial development of a valid, reliable, and responsive stroke-specific quality of life (SS-QOL) measure, for use in stroke trials. Domains and items for the SS-QOL were developed from patient interviews. The SS-QOL, Short Form 36, Beck Depression Inventory, National Institutes of Health Stroke Scale, and Barthel Index were administered to patients 1 and 3 months after ischemic stroke. Items were eliminated with the use of standard psychometric criteria. Construct validity was assessed by comparing domain scores with similar domains of established measures. Domain responsiveness was assessed with standardized effect sizes. All 12 domains of the SS-QOL were unidimensional. In the final 49-item scale, all domains demonstrated excellent internal reliability (Cronbach's alpha values for each domain >/=0.73). Most domains were moderately correlated with similar domains of established outcome measures (r2 range, 0.3 to 0.5). Most domains were responsive to change (standardized effect sizes >0.4). One- and 3-month SS-QOL scores were associated with patients' self-report of HRQOL compared with before their stroke (P<0.001). The SS-QOL measures HRQOL, its primary underlying construct, in stroke patients. Preliminary results regarding the reliability, validity, and responsiveness of the SS-QOL are encouraging. Further studies in diverse stroke populations are needed.

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Outcome and time course of recovery in stroke. Part II: Time course of recovery. The Copenhagen Stroke Study.

Henrik Jørgensen, Hirofumi Nakayama, Hans Raaschou … (1995)

To determine the time course of both neurological and functional recovery from stroke. Prospective, consecutive, and community based. The stroke unit of a hospital in Copenhagen, Denmark. This setting receives all acute stroke patients admitted from a well-defined catchment area of 239,886 inhabitants within the city of Copenhagen. Acute treatment as well as all stages of rehabilitation are cared for within the stroke unit regardless of age, stroke severity, and premorbid condition. 1,197 patients with acute stroke. Weekly examinations of neurological deficits (using the Scandinavian Neurological Stroke Scale) and functional disabilities (Activity of Daily Living (ADL) measured by the Barthel Index) were performed from the time of acute admission to the end of rehabilitation. These evaluations were repeated 6 months poststroke. Time course of recovery was stratified according to initial stroke severity and disability. Functional recovery was completed within 12.5 weeks (95% confidence interval (CI) 11.6 to 13.4) from stroke onset in 95% of the patients. However, 80% of the patients had reached their best ADL function within 6 weeks (CI 5.3 to 6.7) from onset. The time course of functional recovery was strongly related to initial stroke severity. Best ADL function was reached within 8.5 weeks (CI 8 to 9) in patients with initially mild strokes, within 13 weeks (CI 12 to 14) in patients with moderate strokes, within 17 weeks (CI 15 to 19) in patients with severe strokes, and within 20 weeks (CI 16 to 24) in patients with very severe strokes. After these time-points, no significant changes occurred. However, a valid prognosis of functional outcome can be made much earlier. Best ADL function was reached by 80% of the patients with initially mild strokes within 3 weeks (CI 2.6 to 3.4), within 7 weeks (CI 6 to 8) of the patients with moderate strokes, and within 11.5 weeks (CI 10 to 13) of the patients with severe and very severe strokes. The time course of neurological recovery followed a pattern similar to that of functional recovery, but preceeded functional recovery by 2 weeks on average. A reliable prognosis can in all stroke patients be made within 12 weeks from stroke onset. Even in patients with severe and very severe strokes, neurological and functional recovery should not be expected after the first 5 months.

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Self-reported long-term needs after stroke.

Siobhan Crichton, Anita Sheldenkar, Della Forster … (2011)

Development of interventions to manage patients with stroke after discharge from the hospital requires estimates of need. This study estimates the prevalence of self-reported need in community-dwelling stroke survivors across the United Kingdom. We conducted a survey of stroke survivors 1 to 5 years poststroke recruited through Medical Research Council General Practice Research Framework general practices and 2 population-based stroke registers. Levels and type of need were calculated with comparisons among sociodemographic groups, disability level, and cognitive status using the χ2 test or Fisher exact test, as appropriate. From 1251 participants, response rates were 60% (national sample) and 78% (population registers sample) with few differences in levels of reported need between the 2 samples. Over half (51%) reported no unmet needs; among the remainder, the median number of unmet needs was 3 (range, 1 to 13). Proportions reporting unmet clinical needs ranged from 15% to 59%; 54% reported an unmet need for stroke information; 52% reported reduction in or loss of work activities, significantly more from black ethnic groups (P=0.006); 18% reported a loss in income and 31% an increase in expenses with differences by age, ethnic group, and deprivation score. In multivariable analysis, ethnicity (P=0.032) and disability (P=0.014) were associated with total number of unmet needs. Multiple long-term clinical and social needs remain unmet long after incident stroke. Higher levels of unmet need were reported by people with disabilities, from ethnic minority groups, and from those living in the most deprived areas. Development and testing of novel methods to meet unmet needs are required.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2016

Publication date (Electronic): 3 October 2016

Volume: 6

Issue: 10

Electronic Location Identifier: e012375

Affiliations

[1 ]University of Exeter Medical School & PenCLAHRC , Exeter, UK

[2 ]ResearchAcademic Unit of Elderly Care and Rehabilitation, University of Leeds , Bradford, UK

[3 ]Royal Devon & Exeter Hospital , Exeter, UK

[4 ]Torbay and South Devon NHS Foundation Trust , Torquay, UK

[5 ]Department of Clinical Sciences, Brunel University London , Middlesex, UK

[6 ]Department of Sport and Exercise Science, University of Portsmouth, Portsmouth, UK

Author notes

[Correspondence to ] Professor Sarah Dean; s.dean@ 123456exeter.ac.uk

Article

Publisher ID: bmjopen-2016-012375

DOI: 10.1136/bmjopen-2016-012375

PMC ID: 5073546

PubMed ID: 27697876

SO-VID: d79a77fb-182c-4fff-8233-0e5c630378d8

Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

License:

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

History

Date received : 20 April 2016

Date revision received : 30 June 2016

Date accepted : 18 August 2016

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Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain)

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Related collections

Stroke MRI

Most cited references 27

Development of a stroke-specific quality of life scale.

Outcome and time course of recovery in stroke. Part II: Time course of recovery. The Copenhagen Stroke Study.

Self-reported long-term needs after stroke.

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Cited by 10

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