Rhythmic-Based Training With Immersive Mirror Visual Feedback for Neuro-Rehabilitation

Study Overview
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Brief Summary
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In the proposed study, the investigators assumed that rhythmic-based training with immersive mirror visual feedback 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 rhythmic-based training with immersive mirror visual feedback, or mirror therapy on the upper extremity function and brain activity of the stroke patients.

Official Title
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Effects of Rhythmic-Based Training With Immersive Mirror Visual Feedback on Sensorimotor Function of Upper Extremity

Conditions
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Stroke, Rehabilitation, Virtual Reality, Mirror Movement Therapy

Intervention / Treatment
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* Device: Mirror therapy
* Device: Virtual reality-based mirror therapy with rhythmic skill training
* Other: Task-oriented training


Participation Criteria
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Eligibility Criteria
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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: Severe vision and hearing impairment; Major cognitive-perceptual deficit; Other brain disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mirror therapy using a mirror box<br>30 minutes' exercise of mirror therapy followed by 20 minutes' task-oriented training | Device: Mirror therapy<br>* 30 minutes' mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise of less-affected upper extremity using a mirror box<br>Other: Task-oriented training<br>* 20 minutes' motor training targeted to goals that are relevant to the functional needs of the patient<br>|
| Experimental: Virtual reality-based mirror therapy with rhythmic skill training<br>30 minutes' activity of virtual reality-based mirror therapy with rhythmic skill training followed by 20 minutes' task-oriented training | Device: Virtual reality-based mirror therapy with rhythmic skill training<br>* 30 minutes' virtual reality-based mirror therapy with rhythmic skill training included musical exercises involving virtual drums playing with less-affected upper extremity, and synchronized virtual drums playing and singing activity<br>Other: Task-oriented training<br>* 20 minutes' motor training targeted to goals that are relevant to the functional needs of the patient<br>|

What is the study measuring?
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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 | 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 motor performance score ranges from 0 to 66 for the upper extremity. | baseline, 9 weeks and 21 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the result of Box and block test | The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome. The minimum and maximum value is 0 and 150 respectively. | baseline, 9 weeks and 21 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 (ROM); 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, 9 weeks and 21 weeks | 
| Change in the result of Semmes-Weinstein monofilament (SWM) test | The Semmes-Weinstein monofilament test examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome | baseline, 9 weeks and 21 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 activities of daily living. Score range from 0-5. Higher values represent a better outcome | baseline, 9 weeks and 21 weeks |