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

Stroke Clinical Trial

Official title:

Scale-out of a Home-based Arm and Hand Exercise Program for Stroke: A Multisite Implementation-efficacy Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204744
• Other study ID #: 202200321B0
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Chang Gung Memorial Hospital
• Contact: Chieh-ling Yang
• Phone: 03-2118800
• Email: chieh-ling.yang[@]cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 143
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Home-based GRASP program
The home-based Graded Repetitive Arm Supplementary Program (GRASP) is designed to improve the upper extremity function for people with stroke, including exercises for stretching, coordination, arm and hand strengthening, and fine motor skills.
• Conventional occupational therapy home program
The conventional OT home program will be prescribed by the occupational therapists, customizing stroke rehabilitation exercises to individual patient goals, with a primary focus on improving upper extremity function.

Locations

Country	Name	City	State
Taiwan	Chiayi Chang Gung Memorial Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Assessment (upper extremity)	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.	Baseline, post-test (1 month after baseline), 3-month followup