Augmented-reality Based Mirror Therapy in Stroke Rehabilitation

Study Overview
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Brief Summary
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In the proposed study, the investigators assumed that mirror therapy combined with augmented 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 augmented reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.

Official Title
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Effects of Augmented-reality Based Mirror Therapy on Sensorimotor Function of Upper Extremity

Conditions
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Stroke, Rehabilitation, Technology, Mirror Movement Therapy

Intervention / Treatment
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* Other: Traditional occupational therapy
* Other: Mirror therapy using a mirror box
* Other: Augmented reality-based mirror therapy


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 impairment; Major cognitive-perceptual deficit; Other brain disease.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional occupational therapy<br>Traditional occupational therapy delivered skill training related to daily living tasks. | Other: Traditional occupational therapy<br>* Motor training targeted to goals that are relevant to the functional needs of the patient<br>|
| Active Comparator: Mirror therapy using a mirror box<br>Exercise of mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using a mirror box . | Other: Mirror therapy using a mirror box<br>* Mirror therapy using a mirror box<br>|
| Experimental: Augmented reality-based mirror therapy<br>Exercise of augmented reality-based mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using an augmented reality mirror therapy system . | Other: Augmented reality-based mirror therapy<br>* Augmented reality-based mirror therapy<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 maximum motor performance score is 66 points for the upper extremity. | baseline, 9 weeks and 21 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, 9 weeks and 21 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, 9 weeks and 21 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, 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 ADLs. Score range from 0-5. Higher values represent a better outcome. | baseline, 9 weeks and 21 weeks |