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

Turton AJ, Cunningham P, Heron E, van Wijck F, Sackley C, Rogers C, Wheatley K, Jowett S, Wolf SL, van Vliet P - Trials (2013)

Bottom Line: Primary outcome measures for assessment of arm function are the Action Research Arm Test (ARAT) and Wolf Motor Function Test (WMFT).Recruitment, adherence, withdrawals, adverse events (AEs), and completeness of data will be recorded and reported.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Allied Health Professions, University of the West of England, Bristol BS351NS, UK. ailie.turton@uwe.ac.uk

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.

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Related in: MedlinePlus

Design of the feasibility randomized controlled trial.
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Figure 1: Design of the feasibility randomized controlled trial.

Mentions: This study is a two-arm, multicenter, assessor-blinded feasibility RCT of task-specific RTG treatment. The control group will receive arm therapy in accordance with usual care. The trial design is summarized in Figure‚ÄČ1.


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

Turton AJ, Cunningham P, Heron E, van Wijck F, Sackley C, Rogers C, Wheatley K, Jowett S, Wolf SL, van Vliet P - Trials (2013)

Design of the feasibility randomized controlled trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3675391&req=5

Figure 1: Design of the feasibility randomized controlled trial.
Mentions: This study is a two-arm, multicenter, assessor-blinded feasibility RCT of task-specific RTG treatment. The control group will receive arm therapy in accordance with usual care. The trial design is summarized in Figure‚ÄČ1.

Bottom Line: Primary outcome measures for assessment of arm function are the Action Research Arm Test (ARAT) and Wolf Motor Function Test (WMFT).Recruitment, adherence, withdrawals, adverse events (AEs), and completeness of data will be recorded and reported.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Allied Health Professions, University of the West of England, Bristol BS351NS, UK. ailie.turton@uwe.ac.uk

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.

Show MeSH
Related in: MedlinePlus