NCT07525713

Brief Summary

In this study, we hypothesized that Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA) would yield superior therapeutic effects compared to conventional Virtual Reality Mirror Therapy (VRMT) in individuals with unilateral stroke. The aim of this study is to compare the immediate effects of a single session of VRMT, VRMTFOA, and VRMTFOA with auditory feedback on upper extremity function and brain activity in stroke patients.

Trial Health

63
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Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
19mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress9%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 6, 2026

Last Update Submit

April 6, 2026

Conditions

StrokeRehabilitationVirtual RealityMirror Movement TherapyAttentionTask 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 (6)

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

    baseline, 9 weeks and 21 weeks

  • 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

  • Surface electromyography (sEMG)

    baseline, 9 weeks

  • +1 more secondary outcomes

Study Arms (3)

Virtual Reality Mirror Therapy Group

ACTIVE COMPARATOR

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

Other: task-oriented training

Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA)

EXPERIMENTAL

30 minutes of Virtual Reality Mirror Therapy with Focused Object-Directed Attention combined with 20 minutes of conventional task-oriented therapy.

Other: task-oriented training

VRMTFOA with auditory feedback

ACTIVE COMPARATOR

30 minutes of VRMTFOA with auditory feedback combined with 20 minutes of conventional task-oriented therapy.

Other: task-oriented training

Interventions

task-oriented trainingOTHER

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

VRMTFOA with auditory feedbackVirtual Reality Mirror Therapy GroupVirtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA)

Eligibility Criteria

Age20 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

Location

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

April 6, 2026

First Posted

April 13, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

TW(1)