Effects of a Virtual Reality-Based Mirror NeuroRehabilitation System (VR-based MNRS) on Functional Performance of Upper Extremity for Unilateral Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 134
- Locations
- 2
- Primary Endpoint
- Change in the result of Box and blocks test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
Secondary Outcomes
- Changes in Cortical Excitability Assessed by Transcranial Magnetic Stimulation(baseline and 6 weeks)
- Change in Power Spectrum of the Electroencephalography (EEG)(baseline and 6 weeks)