Open Access Highly Accessed Study protocol

Home-based reach-to-grasp training for people after stroke: study protocol for a feasibility randomized controlled trial

Ailie J Turton1*, Paul Cunningham1, Emma Heron1, Frederike van Wijck2, Cath Sackley3, Chris Rogers4, Keith Wheatley5, Sue Jowett5, Steven L Wolf6 and Paulette van Vliet7

Author Affiliations

1 Department of Allied Health Professions, University of the West of England, Bristol, BS351NS, UK

2 Glasgow Caledonian University, UK

3 University of East Anglia, UK

4 University of Bristol, UK

5 University of Birmingham, UK

6 Emory University, Atlanta, USA

7 University of Newcastle, Australia

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Trials 2013, 14:109  doi:10.1186/1745-6215-14-109

Published: 25 April 2013

Abstract

Background

This feasibility study is intended to assess the acceptability of home-based task-specific reach-to-grasp (RTG) training for people with stroke, and to gather data to inform recruitment, retention, and sample size for a definitive randomized controlled trial.

Methods/design

This is to be a randomized controlled feasibility trial recruiting 50 individuals with upper-limb motor impairment after stroke. Participants will be recruited after discharge from hospital and up to 12 months post-stroke from hospital stroke services and community therapy-provider services. Participants will be assessed at baseline, and then electronically randomized and allocated to group by minimization, based on the time post-stroke and extent of upper-limb impairment. The intervention group will receive 14 training sessions, each 1 hour long, with a physiotherapist over 6 weeks and will be encouraged to practice independently for 1 hour/day to give a total of 56 hours of training time per participant. Participants allocated to the control group will receive arm therapy in accordance with usual care. Participants will be measured at 7 weeks post-randomization, and followed-up at 3 and 6 months post-randomization. Primary outcome measures for assessment of arm function are the Action Research Arm Test (ARAT) and Wolf Motor Function Test (WMFT). Secondary measures are the Motor Activity Log, Stroke Impact Scale, Carer Strain Index, and health and social care resource use. All assessments will be conducted by a trained assessor blinded to treatment allocation. Recruitment, adherence, withdrawals, adverse events (AEs), and completeness of data will be recorded and reported.

Discussion

This study will determine the acceptability of the intervention, the characteristics of the population recruited, recruitment and retention rates, descriptive statistics of outcomes, and incidence of AEs. It will provide the information needed for planning a definitive trial to test home-based RTG training.

Trial registration

ISRCTN: ISRCTN56716589

Keywords:
Stroke; Hand; Arm; Physical therapy; Occupational therapy; Rehabilitation; Home; Reach; Grasp; Task-specific training