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

NCT ID: NCT06204744

Last Updated: 2024-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-08

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Home-based GRASP program

Group Type EXPERIMENTAL

Home-based GRASP program

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Conventional occupational therapy home program

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chieh-ling Yang

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chieh-ling Yang

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

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Chiayi Chang Gung Memorial Hospital

Chiayi City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chieh-ling Yang

Role: CONTACT

03-2118800 ext. 3058

Facility Contacts

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Chieh-Ling Yang

Role: primary

03-2118800 ext. 3058

Other Identifiers

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202200321B0

Identifier Type: -

Identifier Source: org_study_id

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