NCT07139379

Brief Summary

In the proposed study, the investigators assumed that Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Therapy (VRMCTOMT) will provide a better treatment effects than traditional virtual reality mirror therapy (VRMT) for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either VRMCTOMT, or VRMT on the upper extremity function and brain activity of the stroke patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
8mo left

Started Jun 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 Progress57%
Jun 2025Dec 2026

Study Start

First participant enrolled

June 24, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
1.4 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

April 15, 2026

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

August 15, 2025

Last Update Submit

April 12, 2026

Conditions

StrokeRehabilitationVirtual RealityMirror Movement TherapyTask Performance

Outcome Measures

Primary Outcomes (1)

  • Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test

    Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.

    baseline, 9 weeks and 21 weeks

Secondary Outcomes (1)

  • Change in the result of Modified Ashworth scale (MAS)

    baseline, 9 weeks and 21 weeks

Other Outcomes (4)

  • Change in the result of Box and blocks test

    baseline, 9 weeks and 21 weeks

  • Change in the result of Semmes-Weinstein monofilament (SWM) test

    baseline, 9 weeks and 21 weeks

  • Change in the result of Motor Activity Log

    baseline, 9 weeks and 21 weeks

  • +1 more other outcomes

Study Arms (2)

Virtual Reality Mirror Therapy Group

ACTIVE COMPARATOR

30 minutes of task-based Virtual Reality Mirror Therapy combined with 20 minutes of conventional task-oriented therapy.

Other: task-oriented trainingOther: Virtual Reality Mirror Therapy

Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy Group

EXPERIMENTAL

30 minutes of Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy combined with 20 minutes of conventional task-oriented therapy.

Other: task-oriented trainingOther: Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy

Interventions

task-oriented trainingOTHER

Motor training targeted to goals that are relevant to the functional needs of the patient

Virtual Reality Mirror Therapy GroupVirtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy Group
Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror TherapyOTHER

Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy using goggle

Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy Group
Virtual Reality Mirror TherapyOTHER

Virtual Reality Mirror Therapy using goggle

Virtual Reality Mirror Therapy Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of stroke with unilateral side involved;
  • A score of Mini-mental state examination greater than 24 for proving higher mental function
  • Time of onset \> 6 months before treatment begins; and
  • Premorbid right-handedness.

You may not qualify if:

  • Severe vision impairment;
  • Major cognitive-perceptual deficit;
  • Other brain disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, Taiwan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Hsiu-Yun Hsu, Ph.D

CONTACT

886-6-2353535hyhsu@mail.ncku.edu.tw

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

August 15, 2025

First Posted

August 24, 2025

Study Start

June 24, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 15, 2026

Record last verified: 2025-05

Locations

TW(1)