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NCT Number: NCT06204744

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

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chiayi Chang Gung Memorial Hospital

Chiayi City, Taiwan

Location status: Recruiting

Location contact

Chieh-Ling Yang

CONTACT

[email protected]

03-2118800 ext. 3058

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based GRASP program

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

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.

Primary outcomes

  1. Fugl Meyer Assessment (upper extremity)

    Time frame: Baseline, post-test (1 month after baseline), 3-month followup

    The FMA-UE is one of the most widely used assessments to quantify UE sensorimotor impairment of the shoulder, elbow, forearm, wrist, and hand. It 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chieh-ling Yang

CONTACT

[email protected]

03-2118800 ext. 3058

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Scale-out of a Home-based Arm and Hand Exercise Program for Stroke: A Multisite Implementation-efficacy Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2024
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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