Scale-out of a Home-based Arm and Hand Exercise Program for Stroke: A Multisite Implementation-efficacy Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- Fugl Meyer Assessment (upper extremity)
Study Overview
Brief Summary
The goal of this multisite clinal trial is to evaluate the implementation of the home-based Graded Repetitive Arm Supplementary Program (GRASP) at rehabilitation clinics across several hospitals. The main questions it aims to answer is:
• the efficacy of the home-based GRASP program relative to the conventional occupational therapy intervention on improving health outcomes, including UE motor function, daily function, quality of life, and motor control strategies.
Stroke participants will be randomly assigned to either the Home-based GRASP group or the conventional occupational therapy home program group. Each group will undergo an 4 to 6-week intervention (3 sessions/week) with evaluations conducted before, immediately after, and 3 months post-trial, assessing clinical and kinematic measures. Interviews and surveys will be conducted to gain insights into the perspectives of patients regarding the implementation of the home-based GRASP program.
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
- •are aged 20 years or older
- •have upper extremity hemiparesis due to the first-ever stroke
- •have some voluntary movement in the affected UE
- •are able to follow 2-step instructions
Exclusion Criteria
- •orthopedic conditions affecting the arm/hand or other neurological conditions
- •severe pain that prevents movement in the affected arm and hand
- •unstable medical status
Outcomes
Primary Outcomes
Fugl Meyer Assessment (upper extremity)
Time Frame: Baseline, post-test (1 month after baseline), 3-month followup
The FMA-UE is one of the most widely used assessments to quantify UE sensorimotor impairment of the shoulder, elbow, forearm, wrist, and hand. It is based on a 3-point scale (0 cannot perform; 1 can perform partially; 2 can perform fully). The total scores range between 0 and 66, with a higher FMA-UE score indicating less motor impairment.
Secondary Outcomes
No secondary outcomes reported
Investigators
Chieh-ling Yang
Assistant Professor
Chang Gung Memorial Hospital