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Completed

NCT Number: NCT03329417

Neurorehabilitation Using a Virtual Reality-based Mirror Therapy

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.

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Key information

Conditions

Rehabilitation, Mirror Neurons, Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Task-Oriented Training

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Nov 6, 2017
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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