Abstract
BackgroundThis 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/designThis 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.DiscussionThis 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 registrationISRCTN: ISRCTN56716589
Highlights
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
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 adverse events (AEs)
The review concluded that high-quality randomized controlled trials (RCTs) of therapy programs targeting the upper limb are needed, and that these should be interventions in which participants are visited by health professionals at home
Summary
Recovery of the upper limb after stroke may take many months, in those more severely affected [46]. Few studies have evaluated home-based therapy for the upper limb [13], and designing a trial to be conducted in a community setting can present new challenges. Careful planning to overcome the challenges of community-based stroke-rehabilitation research is essential to prepare for a trial of adequate size and quality to assess a home-based upper-limb therapy program. Before designing and conducting an adequately powered, high-quality RCT of home-based upper-limb repetitive task training, a feasibility study should be completed to provide the information necessary. This paper has defined the aims and objectives of a feasibility study of home-based RTG training for people after stroke, and provided a detailed description of the intervention and study design. Additional file 3: Intervention group Recovery after Stroke booklet. All authors have been involved in the drafting and revision of this manuscript, and have given approval of the final manuscript
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