Domiciliary VR Rehabilitation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.

Conditions
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Hemiparesis, Functional Independence, Movement Disorder, Stroke

Intervention / Treatment
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* Behavioral: Domiciliary VR-based motor rehabilitation
* Behavioral: Domiciliary occupational therapy for motor rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Hemorrhagic or ischemic stroke Subject had the stroke more than 12 months ago. Subject presents mild-to-moderate upper-limbs hemiparesis (Proximal Medial Research Council Scale>2) secondary to a first-ever stroke. Age between 45 and 85 years old. Subject has previous experience using the RGS system in the clinic. Exclusion Criteria: Subject presents a major cognitive impairment (Mini-Mental State Evaluation> 22).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR-based therapy<br>3 weeks of home-based treatment for motor training using a virtual reality rehabilitation setup. | Behavioral: Domiciliary VR-based motor rehabilitation<br>* 3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.<br>|
| Active Comparator: Control<br>3 weeks of home-based occupational therapy for motor training. | Behavioral: Domiciliary occupational therapy for motor rehabilitation<br>* 3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical |  | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression as measured by the Hamilton scale |  | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | 
| Change in motor function as measured by the Medical Research Council scale |  | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | 
| Change in spasticity for the upper arms as measured by the Ashworth scale |  | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | 
| Change in cognitive function as measured by the Mini-mental State Evaluation test |  | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | 
| Change in Grip Force as measured by a grip dynamometer |  | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | 
| Change in shoulder pain as measured by the Visual Analog Assessment scale |  | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. | 
| Change in motor function as measured by the upper extremity Fugl-Meyer Assessment |  | At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. |