Counteracting Learned Non-use Through Augmented Visuomotor Feedback in Virtual Reality (RGS)

Study Overview
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Brief Summary
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The purpose of this study is to determine if Reinforcement-Induced Movement Therapy (RIMT), a novel rehabilitation method that augments visuomotor feedback of movements of the patient in virtual reality, is effective in treating hemiparesis resp. learned non-use.

Official Title
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Desaprendiendo la parálisis Aprendida Con RGS en Pacientes Afectos de Ictus

Conditions
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Hemiparesis

Intervention / Treatment
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* Behavioral: Reinforcement-Induced Movement Therapy (RIMT)
* Behavioral: VR-based motor rehabilitation in RGS without augmented feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild-to-moderate upper-limbs hemiparesis (Proximal Medical Research Council Scale > 2) due to ischemic or hemorrhagic stroke Spasticity in the affected limb (Modified Ashworth Scale <3) First-ever ischemic or hemorrhagic stroke (>4 weeks post-stroke) Sufficient cognitive capacity for following the instruction of the intervention (Mini-Mental State Evaluation >24) Exclusion Criteria: Cognitive impairment that impede the correct execution or understanding of the intervention Severe impairments in vision or visual perception abilities (such as vision loss or spatial neglect), in spasticity, in communication abilities (such as aphasia or apraxia), severe pain as well as other neuromuscular or orthopedic changes that impede the correct execution of the intervention training Mental dysfunctioning during the acute or subacute phase after the stroke.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Virtual reality based therapy with augmented visuomotor feedback. | Behavioral: Reinforcement-Induced Movement Therapy (RIMT)<br>* 6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS) with augmented visuomotor feedback<br>* Other names: VR-based motor rehabilitation in RGS with amplified visuomotor feedback;|
| Active Comparator: Control Group<br>Virtual reality based therapy without augmentation. | Behavioral: VR-based motor rehabilitation in RGS without augmented feedback<br>* 6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The upper extremity Fugl-Meyer Assessment | change from baseline in motor function | at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chedoke Arm Hand Inventory | change from baseline in functional recovery | at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up | 
| Barthel Index | change from baseline in activities of daily living | at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up | 
| Hamilton Scale | change from baseline in measurement of depression | at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, learned non-use, Virtual Reality, Hemiparesis