- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06883357
The Effects of Home-based Graded Repetitive Arm Supplementary Program Group on Stroke.
May 15, 2026 updated by: National Taiwan University Hospital
The Effects of Home-based Graded Repetitive Arm Supplementary Program Group on Stroke: the Randomized Controlled Trial.
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chia-Yi Lin
- Phone Number: +886-3-5326151#523509
- Email: G04812@hch.gov.tw
Study Locations
-
-
-
Hsinchu, Taiwan, 300
- Recruiting
- National Taiwan University Hospital Hsin-Chu Branch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: GRASP group
|
Graded repetitive arm supplementary program (GRASP) is a self administrated, home-based rehabilitation program.
home-based GRASP program could facilitate the motor function and motor recovery and prevent learned nonuse of affected upper limb of stroke patients.
Participants in experimental group will receive Home GRASP program which will be executed 1hour at home per day.
In addition, Participants will be requested to return hospital for follow-up and adjusting the training program in group discussion 3 times per week, lasting 4-6 weeks, and totally 12-18 sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the end of treatment at 6 weeks
|
|
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.
|
From enrollment to the end of treatment at 6 weeks
|
|
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.
|
From enrollment to the end of treatment at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chedoke Arm and Hand Activity Inventory (CAHAI)
Time Frame: From enrollment to the end of treatment at 6 weeks
|
The Chedoke Arm and Hand Activity Inventory (CAHAI) is developed for measuring the level of function and involvement of the affected upper limb in bimanual tasks.
It contains 13 tasks and the total score is ranged from 13 to 91.
The higher score means better motor function and involvement.
|
From enrollment to the end of treatment at 6 weeks
|
|
Rating of Everyday Arm-use in the Community and Home Scale (REACH-Scale)
Time Frame: From enrollment to the end of treatment at 6 weeks
|
The Rating of Everyday Arm-use in the Community and Home Scale (REACH-Scale) is a self-evaluation scale designed for stroke patients to measure the involvement of the affected upper extremity in everyday life.
The score ranged from 0 to 5 and higher score indicate the more utilization of affected upper extremity.
|
From enrollment to the end of treatment at 6 weeks
|
|
Stroke Impact Scale Version 3.0 (SIS 3.0)
Time Frame: From enrollment to the end of treatment at 6 weeks
|
The Stroke Impact Scale Version 3.0 (SIS 3.0) is a self-evaluated assessment for measuring the quality of life of patients with stroke.
In our study, the strength domain(total score:4-20) and hand function domain(total score:5-25), and the an extra question on stroke recovery(total score:0-100)was used.
The higher score means better quality of life.
|
From enrollment to the end of treatment at 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Chia-Yi Lin, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 12, 2025
First Submitted That Met QC Criteria
March 12, 2025
First Posted (Actual)
March 19, 2025
Study Record Updates
Last Update Posted (Actual)
May 18, 2026
Last Update Submitted That Met QC Criteria
May 15, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202407010RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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