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

NCT06106815 | Unknown

• 1 other identifier: 202101830B0
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

The Graded Repetitive Arm Supplementary Program

EXPERIMENTAL

Other: Rehabilitation exercises

Usual Care

ACTIVE COMPARATOR

Other: Usual Care

Interventions

Rehabilitation exercises OTHER

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.

The Graded Repetitive Arm Supplementary Program

Usual Care OTHER

Usual Care

Usual Care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chiayi Chang Gung Memorial Hospital

Chiayi City, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Chieh-ling Yang

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chieh-ling Yang

CONTACT

03-2118800; chieh-ling.yang@cgu.edu.tw

Chieh-ling Yang

CONTACT

03-2118800

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: October 5, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

TW (1)