PMID- 23782653 OWN - NLM STAT- MEDLINE DCOM- 20131017 LR - 20240505 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 14 DP - 2013 Apr 25 TI - Home-based reach-to-grasp training for people after stroke: study protocol for a feasibility randomized controlled trial. PG - 109 LID - 10.1186/1745-6215-14-109 [doi] AB - 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. FAU - Turton, Ailie J AU - Turton AJ AD - Department of Allied Health Professions, University of the West of England, Bristol BS351NS, UK. ailie.turton@uwe.ac.uk FAU - Cunningham, Paul AU - Cunningham P FAU - Heron, Emma AU - Heron E FAU - van Wijck, Frederike AU - van Wijck F FAU - Sackley, Cath AU - Sackley C FAU - Rogers, Chris AU - Rogers C FAU - Wheatley, Keith AU - Wheatley K FAU - Jowett, Sue AU - Jowett S FAU - Wolf, Steven L AU - Wolf SL FAU - van Vliet, Paulette AU - van Vliet P LA - eng SI - ISRCTN/ISRCTN56716589 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130425 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Clinical Protocols MH - *Community Health Services MH - Disability Evaluation MH - England MH - Feasibility Studies MH - *Hand Strength MH - *Home Care Services, Hospital-Based MH - Humans MH - *Motor Activity MH - Patient Compliance MH - *Physical Therapy Modalities/adverse effects MH - Recovery of Function MH - *Research Design MH - Stroke/diagnosis/physiopathology MH - *Stroke Rehabilitation MH - Time Factors MH - Treatment Outcome PMC - PMC3675391 EDAT- 2013/06/21 06:00 MHDA- 2013/10/18 06:00 PMCR- 2013/04/25 CRDT- 2013/06/21 06:00 PHST- 2013/02/08 00:00 [received] PHST- 2013/03/22 00:00 [accepted] PHST- 2013/06/21 06:00 [entrez] PHST- 2013/06/21 06:00 [pubmed] PHST- 2013/10/18 06:00 [medline] PHST- 2013/04/25 00:00 [pmc-release] AID - 1745-6215-14-109 [pii] AID - 10.1186/1745-6215-14-109 [doi] PST - epublish SO - Trials. 2013 Apr 25;14:109. doi: 10.1186/1745-6215-14-109.