Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT06204744
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-08
• Study First Submitted: 2023-12-12
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-03
• Last Update Submitted: 2024-01-03
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 143

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl Meyer Assessment (upper extremity)	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.

Trial Locations

Locations (1)

Chiayi Chang Gung Memorial Hospital; 🇨🇳 Chiayi City, Taiwan