The Effects of Home-based Graded Repetitive Arm Supplementary Program Group on Stroke: the Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Jamar Hydraulic Hand Dynamometer (Jamar Dynamometer)
Study Overview
Brief Summary
Graded repetitive arm supplementary program (GRASP) is a self administrated, home-based rehabilitation program and has been incorporated in Canadian Stroke Best Practice Recommendations. Past studies indicated that the home-based GRASP program could facilitate the motor function and motor recovery and prevent learned nonuse of affected upper limb of stroke patients. There is lacking of research and application of the home-based GRASP program in Taiwan. Therefore, this study aims to explore the effects of the home-based GRASP program, which is mainly executed in the form of group intervention, on the affected upper limb of stroke patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age is above 20 years old.
- •Onset of first stroke complicated with hemiplegia or hemiparesis.
- •The affected upper limb remains partially voluntary movements including lifting to chest level and holding for five seconds; slight flexion and extension of wrist and hand.
- •Understanding and complying with two-steps commands.
- •Understanding the content of trial and willing to sign informed consent.
Exclusion Criteria
- •Complicating with other neurological disease.
- •Having Orthopedic diseases affecting the movements of upper limbs.
- •Having symptoms of pain to affect the movements of upper limbs.
- •Unstable vital sign or medical condition.
- •Participating another rehabilitative or drug research meanwhile.
- •Receiving botulinum toxin injection within three months.
Arms & Interventions
Control group
GRASP group
Intervention: Graded repetitive arm supplementary program (GRASP) (Behavioral)
Outcomes
Primary Outcomes
Jamar Hydraulic Hand Dynamometer (Jamar Dynamometer)
Time Frame: From enrollment to the end of treatment at 6 weeks
The Jamar Hydraulic Hand Dynamometer (Jamar Dynamometer) is a tool used for assessing the strength of grip, lateral pinch, and palmar pinch. The muscle strength is recorded in kilograms or pounds.
Fugl-Meyer Assessment for upper extremity (FMA-UE)
Time Frame: From enrollment to the end of treatment at 6 weeks
The Fugl-Meyer Assessment for upper extremity (FMA-UE) includes 33 items for the motor recovery of upper limb. Each item is a 3 point ordinal scale. The total score ranges from 0 to 66, higher score means better motor recovery.
Action Research Arm Test (ARAT)
Time Frame: From enrollment to the end of treatment at 6 weeks
The Action Research Arm Test (ARAT) is developed for measuring the motor function of affected upper limb after stroke. ARAT includes subscales of grasp, grip, pinch, and gross movement. The total score ranges from 0 to 57, higher score means better motor function.
Secondary Outcomes
- Chedoke Arm and Hand Activity Inventory (CAHAI)(From enrollment to the end of treatment at 6 weeks)
- Rating of Everyday Arm-use in the Community and Home Scale (REACH-Scale)(From enrollment to the end of treatment at 6 weeks)
- Stroke Impact Scale Version 3.0 (SIS 3.0)(From enrollment to the end of treatment at 6 weeks)