Neurorehabilitation Using a Virtual Reality-based Mirror Therapy

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

task-oriented training

About this trial

This is an interventional treatment trial for Rehabilitation, Mirror Neurons, Stroke

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Vision loss;
Major cognitive-perceptual deficit;
Other brain disease.

Sites / Locations

National Cheng-Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Traditional occupational therapy

Mirror therapy using a mirror box

Virtual reality based mirror therapy

Arm Description

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.

The program includes 30 minutes of mirror therapy, followed by 20 minutes of regular motor task specific training in each treatment session.

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.

Outcomes

Primary Outcome Measures

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.

Change in the result of Modified Ashworth scale (MAS)

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.

Change in the result of Box and blocks test

The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.

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

The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.

Change in the result of Motor Activity Log

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.

Secondary Outcome Measures

Change in Power Spectrum of the Electroencephalography (EEG)

Power spectrum is computed for the alpha (8-13 Hz) and beta (14-24 Hz) frequency bands. Higher values represent a better outcome.

Changes in Cortical Excitability Assessed by Transcranial Magnetic Stimulation

Cortical silent period of to evaluate intercortical facilitation of brain. Lower values represent a better outcome.

Full Information

NCT ID

NCT03329417

First Posted

October 30, 2017

Last Updated

March 22, 2023

Sponsor

National Cheng-Kung University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03329417

Brief Title

Neurorehabilitation Using a Virtual Reality-based Mirror Therapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 13, 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rehabilitation, Mirror Neurons, Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Traditional occupational therapy

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Mirror therapy using a mirror box

Arm Type

Active Comparator

Arm Description

The program includes 30 minutes of mirror therapy, followed by 20 minutes of regular motor task specific training in each treatment session.

Arm Title

Virtual reality based mirror therapy

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

task-oriented training

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame