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

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06106815
Collaborator
(none)
55
1
2
25.9
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation exercises
  • Other: Usual Care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 5, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: The Graded Repetitive Arm Supplementary Program

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.

Active Comparator: Usual Care

Other: Usual Care
Usual Care

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chiayi Chang Gung Memorial Hospital Chiayi City Taiwan

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chieh-ling Yang, Chang Gung University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chieh-ling Yang, Assistant Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT06106815
Other Study ID Numbers:
  • 202101830B0
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 30, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 30, 2023