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Clinical Trials/NCT07525713
NCT07525713
Not yet recruiting
Not Applicable

Virtual Reality Mirror Therapy With Focused Object-Directed Attention for Neuro-Rehabilitation

National Cheng-Kung University Hospital1 site in 1 country54 target enrollmentStarted: April 20, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
54
Locations
1
Primary Endpoint
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: task-oriented training (Other)

Virtual Reality Mirror Therapy Group

Active Comparator

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

Intervention: task-oriented training (Other)

VRMTFOA with auditory feedback

Active Comparator

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

Intervention: task-oriented training (Other)

Outcomes

Primary Outcomes

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

Time Frame: baseline, 9 weeks and 21 weeks

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.

Secondary Outcomes

  • 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)
  • Clinical Global Impression (CGI) scale(9 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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