Virtual Reality Mirror Therapy With Focused Object-Directed Attention System

April 6, 2026 updated by: National Cheng-Kung University Hospital

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taiwan
      • Tainan, Taiwan, Taiwan, 704
        • National Cheng-Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Virtual Reality Mirror Therapy Group
30 minutes of Virtual Reality Mirror Therapy combined with 20 minutes of conventional task-oriented therapy.
Other: task-oriented training
Motor training targeted to goals that are relevant to the functional needs of the patient
Experimental: Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA)
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
Motor training targeted to goals that are relevant to the functional needs of the patient
Active Comparator: VRMTFOA with auditory feedback
30 minutes of VRMTFOA with auditory feedback combined with 20 minutes of conventional task-oriented therapy.
Other: task-oriented training
Motor training targeted to goals that are relevant to the functional needs of the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 9 weeks and 21 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the result of Box and blocks test
Time Frame: baseline, 9 weeks and 21 weeks
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
baseline, 9 weeks and 21 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test
Time Frame: baseline, 9 weeks and 21 weeks
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
baseline, 9 weeks and 21 weeks
Change in the result of Motor Activity Log
Time Frame: baseline, 9 weeks and 21 weeks
Semi-structured interview examine how much and how well the subject uses their more-affected arm for 30 ADLs. Score range from 0-5. Higher values represent a better outcome.
baseline, 9 weeks and 21 weeks
Change in the result of Modified Ashworth scale (MAS)
Time Frame: baseline, 9 weeks and 21 weeks
Muscle tone is defined by assess muscle tone by evaluating resistance to passive stretch, reflecting the level of spasticity, with scores ranging from 0 (no increase in tone) to 4 (rigidity in flexion or extension).
baseline, 9 weeks and 21 weeks
Surface electromyography (sEMG)
Time Frame: baseline, 9 weeks
Change in the root mean square (RMS) of the EMG signal was computed to quantify the change of muscle activation.
baseline, 9 weeks
Clinical Global Impression (CGI) scale
Time Frame: 9 weeks
Assess overall clinical change, rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-114-469

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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