Enhanced Reality for Hemiparetic Arm in the Stroke Patients

Study Overview
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Brief Summary
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The researchers found that enhanced reality developed for the first time in the word by us had a synergistic or additive effect on brain plasticity in patients without central nervous system injury. The aim of this study is to determine the validity and feasibility of enhanced reality in hemiparetic arm in the stroke patients with central nervous system injury.

Detailed Description
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Pre-interventional evaluation; within 1 day of initiation of the intervention; 10 days after initiation of the intervention; 30 days after termination of treatment.

Official Title
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Enhanced Reality for Hemiparetic Arm in the Stroke Patients; Randomized Case-controlled Clinical Trial for Efficacy

Conditions
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Stroke, Paresis, Mirror Movement

Intervention / Treatment
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* Device: Enhanced reality
* Other: No Enhanced reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Arm motor Fugl-Mayer scale; wrist/hand subscales ≥ 2-20 9-hole pegboard ; ≥ 25% of contra-lateral hand Exclusion Criteria: Alexander apraxia scale ≤2 NIH stroke scale question Ia-c ≥1 Nottingham sensory scale; <75% of contra-lateral hand Ashworth scale ≥3 NIH stroke scale question IX ≥2 Beck depression inventory ≥21 Significant upper extremity disease causing hand or below elbow dysfunction Visual disturbance Refusal of participation

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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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced reality<br>Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes. ER therapy is provided 2 times a day for 10 minutes for 2 weeks (10 days of treatment week), except for time of installation, calibration, and 3 minute breaks. | Device: Enhanced reality<br>* This prototype is developed by investigators for the first time so that it have no trademark or manufacturer name yet. The patient sits facing the horizontal desk with the ER therapy device, and then raises the wrist joint to the fixed base. The hand, wrist, and distal forearm to be treated are positioned below the ER medical camera so that the wrist is visible on the screen. Fix the wrist and wrist joint using Velcro. When treating the distal forearm, detach the wrist fixing Velcro.<br>|
| Active Comparator: No Enhanced reality<br>Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes. | Other: No Enhanced reality<br>* Identical rehabilitation without enhanced reality<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Jebsen Taylor test | Jebsen-Taylor Hand Function Test | 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Arm motor Fugl-Mayer scale | Arm motor Fugl-Mayer scale; wrist & hand/proximal arm | 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment |