Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
Scale-out of a Home-based Arm and Hand Exercise Program for Stroke: A Multisite Implementation-efficacy Trial
1 other identifier
interventional
143
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Sep 2023
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2023
CompletedFirst Submitted
Initial submission to the registry
December 12, 2023
CompletedFirst Posted
Study publicly available on registry
January 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 12, 2024
January 1, 2024
3.2 years
December 12, 2023
January 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Home-based GRASP program
EXPERIMENTALConventional occupational therapy home program
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- orthopedic conditions affecting the arm/hand or other neurological conditions
- severe pain that prevents movement in the affected arm and hand
- unstable medical status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chiayi Chang Gung Memorial Hospital
Chiayi City, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chieh-ling Yang
Chang Gung University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 12, 2023
First Posted
January 12, 2024
Study Start
September 8, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 12, 2024
Record last verified: 2024-01