Neurorehabilitation Using a Virtual Reality-based Mirror Therapy

March 20, 2024 updated by: National Cheng-Kung University Hospital

Effects of a Virtual Reality-Based Mirror NeuroRehabilitation System (VR-based MNRS) on Functional Performance of Upper Extremity for Unilateral Stroke Patients

In the proposed study, the investigators assumed that mirror therapy combined with virtual reality technology will provide a better treatment effects than traditional mirror therapy 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 virtual reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

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 Locations

  • Taiwan
      • Tainan, 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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Vision loss;
  2. Major cognitive-perceptual deficit;
  3. 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: Traditional occupational therapy
The program includes 30 minutes of traditional occupational therapy (sensorimotor facilitation techniques, such as: Rood, Bobath and propriocetive-neuromuscular-facilitation), followed by 20 minutes of motor task specific training in each treatment session.
Other: task-oriented training
Motor training targeted to goals that are relevant to the functional needs of the patient
Active Comparator: Mirror therapy using a mirror box
The program includes 30 minutes of mirror therapy, followed by 20 minutes of regular motor task specific training in each treatment session.
Other: task-oriented training
Motor training targeted to goals that are relevant to the functional needs of the patient
Experimental: Virtual reality based mirror therapy
The program includes 30 minutes treatment session of virtual reality mirror therapy, followed by 20 minutes of motor task specific training in each treatment session.
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, 6 weeks and 18 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, 6 weeks and 18 weeks
Change in the result of Modified Ashworth scale (MAS)
Time Frame: baseline, 6 weeks and 18 weeks
Muscle tone is defined by the resistance of a muscle being stretched without resistance. The MAS scores were distributed across the entire scale, ranging from 0 to 4, that is convenient for the clinician use. The grading of the scale is described as below: 0) no increase in muscle tone; 1) minimal resistance at the end of the range of motion; 1+) slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the reminder (less than half) of the ROM; 2) more marked increase in tone but only after part is easily flexed; 3) considerable increase in tone; and 4) passive movement is difficult and affected part is rigid in flexion or extension.
baseline, 6 weeks and 18 weeks
Change in the result of Box and blocks test
Time Frame: baseline, 6 weeks and 18 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, 6 weeks and 18 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test
Time Frame: baseline, 6 weeks and 18 weeks
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
baseline, 6 weeks and 18 weeks
Change in the result of Motor Activity Log
Time Frame: baseline, 6 weeks and 18 weeks
Semi-structured interview examine how much and how well the subject uses their more-affected arm for 30 ADLs. Score range from 0-180. Higher values represent a better outcome.
baseline, 6 weeks and 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Power Spectrum of the Electroencephalography (EEG)
Time Frame: baseline and 6 weeks
Power spectrum is computed for the alpha (8-13 Hz) and beta (14-24 Hz) frequency bands. Higher values represent a better outcome.
baseline and 6 weeks
Changes in Cortical Excitability Assessed by Transcranial Magnetic Stimulation
Time Frame: baseline and 6 weeks
Cortical silent period of to evaluate intercortical facilitation of brain. Lower values represent a better outcome.
baseline and 6 weeks

Collaborators and Investigators

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

Sponsor

National Cheng-Kung University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 13, 2017

Primary Completion (Actual)

March 20, 2024

Study Completion (Actual)

March 20, 2024

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-105-213

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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