Comparison Study of 'Virtual Teacher' Support for Rehabilitation After Stroke.

Study Overview
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Brief Summary
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The aim of the project is to assess whether the continuous visualization of on-line teacher in virtual reality (VR) is effective for the improvement of upper limb motor function, in stroke patients.

Detailed Description
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A single-blind randomized controlled trial (RCT) will be carried out to compare the effects of reinforced feedback in virtual environment (RFVE) treatment with continuous displaying of a virtual teacher (EVER TEACHER group) with RFVE without the presence of a virtual teacher (NEVER TEACHER group).

Official Title
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Assessment of a Virtual Teacher Feedback for the Recovery of Upper Limb After Stroke.

Conditions
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Stroke

Intervention / Treatment
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* Device: EVER TEACHER
* Device: NEVER TEACHER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first single stroke, absence of ideomotor apraxia, neglect, aphasia interfering with verbal comprehension, 0 < NIHSS-IT < 4 Exclusion Criteria: bilateral or cerebellum stroke, unstable medical conditions, fracture, major depressive disorders, other neurological conditions, epilepsy.

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
Interventional Model Description: Single blind randomized controlled trial (RCT)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVER TEACHER<br>In EVER TEACHER group a specific feedback called virtual teacher will be displayed. The virtual teacher perform the correct movement to emulate, that is supposed to stimulate the motor adaptation exploiting a supervised learning mechanism. This feedback will give an on-line information on motor performance quality, allowing a real time visual comparison between patient's own execution and teacher one. During the experiment, patients will receive 1 hour of virtual reality-based therapy and the treatment will last 1 hour a day, five days weekly for four weeks. | Device: EVER TEACHER<br>* The treatment will be performed in a darkened room, to avoid distraction provided by environmental stimuli. The patients will be seat on a standard chair in front of a wall screen handling a sensorized object with plegic hand. In case of grasping deficits the hand's surface will be used as end effector (i.e. sensorized glove worn by the patient). During the treatment a specific feedback called virtual teacher will be displayed. The Reinforced Feedback in Virtual Environment (RFVE) approach consists of performing different motor tasks moving the end effector simultaneously displayed in the virtual scenario. The Virtual Reality Rehabilitation System (VRRS®. Khymeia Group, Noventa Padovana. Italy) will be used as device to provide the artificial environment.<br>|
| Other: NEVER TEACHER<br>In NEVER TEACHER group the subjects will be asked to perform the same exercises with the upper limb without the virtual teacher assistance. The treatment will last four weeks with daily sessions of 60 minutes, five times per week. | Device: NEVER TEACHER<br>* The patients allocated to NEVER TEACHER group, will be treated using the VRRS and the proceedings will be the same as described for experimental group. In this group, the patient will move the real object (e.g. ball) following the trajectory of the corresponding virtual object displayed on the wall screen in accordance with the requested virtual task and without the 'virtual teacher' support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Upper Extremity scale (FM UE) | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment - Sensation | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter) | 
| Fugl-Meyer Assessment - Pain and ROM | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter) | 
| Reaching Performance Scale | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter) | 
| Modified Ashworth Scale | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter) | 
| Functional Independence Measure scale (FIM) | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter) | 
| Nine Hole Pegboard Test | Applied at the beginning and at the end of treatment (after 20 sessions). | Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality,, Enhanced Feedback,, Stroke,, Rehabilitation,, Motor Learning