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document
Home-based reach-to-grasp training for people after stroke : study protocol for a feasibility randomized controlled trial . 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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Intervention_Physical
Home-based reach-to-grasp training
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Intervention_Physical
home-based task-specific reach-to-grasp ( RTG )
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Intervention_Physical
training sessions
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Intervention_Control
arm therapy
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Outcome_Physical
arm function
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Outcome_Physical
Action Research Arm Test ( ARAT )
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Outcome_Physical
Wolf Motor Function Test ( WMFT )
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Outcome_Physical
Motor Activity Log
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Outcome_Physical
Stroke Impact Scale
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Outcome_Physical
Carer Strain Index
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Outcome_Other
health and social care resource use
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Outcome_Other
Recruitment
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Outcome_Mental
, adherence
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Outcome_Other
withdrawals
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Outcome_Adverse-effects
adverse events ( AEs )
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Outcome_Other
completeness of data
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Outcome_Other
acceptability
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Participant_Condition
after stroke
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Participant_Condition
stroke
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Participant_Sample-size
50
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Participant_Condition
upper-limb motor impairment
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Participant_Condition
stroke
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Participant_Condition
after discharge from hospital and up to 12 months post-stroke
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Participant_Condition
stroke