Neurorehabilitation Using a Virtual Reality-based Mirror Therapy

NCT03329417 | Completed

• 1 other identifier: A-ER-105-213
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation, Mirror Neurons, Stroke

Outcome Measures

Primary Outcomes (5)

• 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.

  baseline, 6 weeks and 18 weeks

• 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.

  baseline, 6 weeks and 18 weeks

• 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.

  baseline, 6 weeks and 18 weeks

• 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.

  baseline, 6 weeks and 18 weeks

• 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.

  baseline, 6 weeks and 18 weeks

Secondary Outcomes (2)

• Change in Power Spectrum of the Electroencephalography (EEG)

  baseline and 6 weeks

• Changes in Cortical Excitability Assessed by Transcranial Magnetic Stimulation

  baseline and 6 weeks

Study Arms (3)

Traditional occupational therapy

ACTIVE COMPARATOR

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

Mirror therapy using a mirror box

ACTIVE COMPARATOR

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

Virtual reality based mirror therapy

EXPERIMENTAL

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

Interventions

task-oriented training OTHER

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

Mirror therapy using a mirror box; Traditional occupational therapy; Virtual reality based mirror therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Location

Related Publications (1)

• Hsu HY, Kuo LC, Lin YC, Su FC, Yang TH, Lin CW. Effects of a Virtual Reality-Based Mirror Therapy Program on Improving Sensorimotor Function of Hands in Chronic Stroke Patients: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Jun;36(6):335-345. doi: 10.1177/15459683221081430. Epub 2022 Mar 28.

  PMID: 35341360 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: November 13, 2017
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: March 21, 2024

Record last verified: 2023-03

Locations

TW (1)