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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age is above 20 years old.
  2. Onset of first stroke complicated with hemiplegia or hemiparesis.
  3. 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.
  4. Understanding and complying with two-steps commands.
  5. Understanding the content of trial and willing to sign informed consent.

Exclusion Criteria:

  1. Complicating with other neurological disease.
  2. Having Orthopedic diseases affecting the movements of upper limbs.
  3. Having symptoms of pain to affect the movements of upper limbs.
  4. Unstable vital sign or medical condition.
  5. Participating another rehabilitative or drug research meanwhile.
  6. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: GRASP group
Behavioral: Graded repetitive arm supplementary program (GRASP)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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