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

Stroke Clinical Trial

Official title:

Implementation Science for Bridging the Gap Between Research and Practice: Implementation and Evaluation of the Graded Repetitive Arm Supplementary Program (GRASP) for People With Stroke in the Real-World Hospital Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106815
• Other study ID #: 202101830B0
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Chang Gung Memorial Hospital
• Contact: Chieh-ling Yang
• Phone: 03-2118800
• Email: chieh-ling.yang[@]cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Rehabilitation exercises
The Graded Repetitive Arm Supplementary Program (GRASP) is designed to improve upper extremity function in individuals with stroke. The GRASP program includes exercises for stretching, coordination, arm and hand strengthening, and fine motor skills.
• Usual Care
Usual Care

Locations

Country	Name	City	State
Taiwan	Chiayi Chang Gung Memorial Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Assessment (upper extremity)	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.	though study completion, an average of 4 months