Immersive Virtual Reality for Stroke Motor Rehabilitation

Study Overview
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Brief Summary
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The present study aims at investigating (i) the feasibility in chronic stroke of using a dedicated virtual reality (VR) based system that embeds real-time 3D motion capture and embodied visual feedback to deliver functional exercises designed for training of impaired upper limb motor skills, (ii) whether chronic stroke survivors improve in functional outcomes in the upper limb when exposed to intensive VR-based therapy, and (iii) safety and tolerance to such a technology. The investigators hypothesize that intensive VR-based rehabilitation may lead to high rehabilitation doses and functional improvement in chronic stroke.

Official Title
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The Use of Immersive Virtual Reality for Upper Limb Neurorehabilitation in Stroke Survivors

Conditions
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Chronic Stroke, Motor Disorders

Intervention / Treatment
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* Device: MindMotion PRO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic or hemorrhagic minor-to-moderate (0<NIHSS<16) stroke with hemiparesis and experiencing arm motor difficulties At least 6 months after stroke incident Maximum 4 on the Medical Research Council Scale (MRCS) for shoulder elevation and elbow flexion/extension 18 years and older First ever stroke Exclusion Criteria: Participating in another movement treatment study at the time of the present study Severe cognitive impairment (Mini Mental Status Examination score < 18 points) Orthopedic impairment or visual disorders limiting the treatment Unable to give informed consent form Risk of epileptic seizures

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
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MindMotion PRO<br>The training sessions consist of virtual reality based rehabilitation exercises using the MindMotion PRO device. | Device: MindMotion PRO<br>* Patients will receive five weeks of therapy with 2 sessions (minimum) per week lasting for 45-60 minutes each minimum. The training sessions are based on the MindMotion PRO's virtual reality exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task) | Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task) | 5 weeks | 
| Training intensity: number of goal-directed movements per minute of effective training time. | Training intensity: number of goal-directed movements per minute of effective training time. | 5 weeks | 
| Change in Upper limb function assessed with Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | At baseline, 5 weeks (post intervention) and 9 weeks (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Independence Measure (FIM) |  | At baseline, 5 weeks (post intervention) and 9 weeks (follow-up) | 
| Change in kinematic metrics/goniometry (active range of motion). |  | At baseline, 5 weeks (post intervention) and 9 weeks (follow-up) | 
| Change in Modified Medical Research Council Scale (mMRCS) |  | At baseline, 5 weeks (post intervention) and 9 weeks (follow-up) | 
| Change in Visual Analog Scale (VAS) for Pain |  | At baseline, 5 weeks (post intervention) and 9 weeks (follow-up) | 
| Safety and Acceptance of Technology assessed with a questionnaire | Participants will answer a questionnaire to evaluate following aspects: Tolerance to VR intervention Adverse event monitoring Self-evaluation Acceptance of technology Motivation | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, neurorehabilitation, virtual reality, rehabilitation dose, motor rehabilitation