Implementation and Evaluation of the Graded Repetitive Arm Supplementary Program (GRASP) for People With Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Usual Care; Other: Rehabilitation exercises

• Registration Number: NCT06106815
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The goal of this clinical trial is to compare the effect of the Graded Repetitive Arm Supplementary Program (GRASP) with the usual care on upper extremity function in individuals with stroke.

The main questions it aims to answer are:

* Compare the effectiveness of the GRASP program delivered by train occupational therapists

* Explore the patients' and therapists' experiences of the GRASP program using interviews and surveys

Stroke participants will receive either the GRASP program or Usual Care for four weeks (3 sessions/week). Stroke participants will be evaluated before, immediately after, and 3 months after the intervention. Therapist participants will be trained for the delivery of the GRASP program. Interviews and surveys/questionnaires will be administered to understand patients' and therapists' perspectives on the implementation of the GRASP program.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-05
• Status Verified: 2023-10
• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-10-26
• Last Update Submitted: 2023-10-26
• Study First Posted: 2023-10-30
• Last Update Posted: 2023-10-30
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• 1. are aged 20 years or older, 2) stroke onset > 3 months, 3) have upper extremity hemiparesis due to the first-ever stroke, (4) have some voluntary movement in the affected UE, including the ability to lift the affected arm to chest level and hold for 5 seconds, some ability to extend the affected wrist, and some ability to grasp and release an object such as a cup handle, and 5) are able to follow 2-step instructions.

Exclusion Criteria

• 1. orthopedic conditions affecting the arm/hand or other neurological conditions, 2) severe pain that prevents movement in the affected arm and hand, and 3) unstable medical status.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	-
The Graded Repetitive Arm Supplementary Program	Rehabilitation exercises	-

Primary Outcome Measures

Name	Time	Method
Fugl Meyer Assessment (upper extremity)	though study completion, an average of 4 months	The Fugl-Meyer Assessment of Upper Extremity (FMA-UE) is one of the most widely used assessment to quantify upper extremity sensorimotor impairment. It includes items related to movements of the shoulder, elbow, forearm, wrist, and hand and 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.

Trial Locations

Locations (1)

Chiayi Chang Gung Memorial Hospital; 🇨🇳 Chiayi City, Taiwan