NCT06883357

Brief Summary

Graded repetitive arm supplementary program (GRASP) is a self administrated, home-based rehabilitation program and has been incorporated in Canadian Stroke Best Practice Recommendations. Past studies indicated that the home-based GRASP program could facilitate the motor function and motor recovery and prevent learned nonuse of affected upper limb of stroke patients. There is lacking of research and application of the home-based GRASP program in Taiwan. Therefore, this study aims to explore the effects of the home-based GRASP program, which is mainly executed in the form of group intervention, on the affected upper limb of stroke patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
8mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Mar 2025Dec 2026

First Submitted

Initial submission to the registry

March 12, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 17, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

March 12, 2025

Last Update Submit

May 15, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Fugl-Meyer Assessment for upper extremity (FMA-UE)

    The Fugl-Meyer Assessment for upper extremity (FMA-UE) includes 33 items for the motor recovery of upper limb. Each item is a 3 point ordinal scale. The total score ranges from 0 to 66, higher score means better motor recovery.

    From enrollment to the end of treatment at 6 weeks

  • Jamar Hydraulic Hand Dynamometer (Jamar Dynamometer)

    The Jamar Hydraulic Hand Dynamometer (Jamar Dynamometer) is a tool used for assessing the strength of grip, lateral pinch, and palmar pinch. The muscle strength is recorded in kilograms or pounds.

    From enrollment to the end of treatment at 6 weeks

  • Action Research Arm Test (ARAT)

    The Action Research Arm Test (ARAT) is developed for measuring the motor function of affected upper limb after stroke. ARAT includes subscales of grasp, grip, pinch, and gross movement. The total score ranges from 0 to 57, higher score means better motor function.

    From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (3)

  • Chedoke Arm and Hand Activity Inventory (CAHAI)

    From enrollment to the end of treatment at 6 weeks

  • Rating of Everyday Arm-use in the Community and Home Scale (REACH-Scale)

    From enrollment to the end of treatment at 6 weeks

  • Stroke Impact Scale Version 3.0 (SIS 3.0)

    From enrollment to the end of treatment at 6 weeks

Study Arms (2)

GRASP group

EXPERIMENTAL
Behavioral: Graded repetitive arm supplementary program (GRASP)

Control group

NO INTERVENTION

Interventions

Graded repetitive arm supplementary program (GRASP) is a self administrated, home-based rehabilitation program. home-based GRASP program could facilitate the motor function and motor recovery and prevent learned nonuse of affected upper limb of stroke patients. Participants in experimental group will receive Home GRASP program which will be executed 1hour at home per day. In addition, Participants will be requested to return hospital for follow-up and adjusting the training program in group discussion 3 times per week, lasting 4-6 weeks, and totally 12-18 sessions.

GRASP group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age is above 20 years old.
  • Onset of first stroke complicated with hemiplegia or hemiparesis.
  • The affected upper limb remains partially voluntary movements including lifting to chest level and holding for five seconds; slight flexion and extension of wrist and hand.
  • Understanding and complying with two-steps commands.
  • Understanding the content of trial and willing to sign informed consent.

You may not qualify if:

  • Complicating with other neurological disease.
  • Having Orthopedic diseases affecting the movements of upper limbs.
  • Having symptoms of pain to affect the movements of upper limbs.
  • Unstable vital sign or medical condition.
  • Participating another rehabilitative or drug research meanwhile.
  • Receiving botulinum toxin injection within three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, 300, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Chia-Yi Lin

    Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch

    STUDY DIRECTOR

Central Study Contacts

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
SPONSOR

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 19, 2025

Study Start

March 17, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations