Reinforced Feedback in Virtual Environment

Study Overview
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Brief Summary
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The aims of the study is to explore whether the rehabilitation of the upper extremity performed in interaction with a virtual environment could improve motor function in post-ischemic and post-haemorrhagic stroke subjects with hemiparesis, in comparison to the traditional neuromotor rehabilitation treatment.

Official Title
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The Role of Virtual Therapy by Means of Reinforced Feedback in Virtual Environment on Upper Limb Function in Post-stroke Patients.

Conditions
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Stroke

Intervention / Treatment
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* Device: Reinforced Feedback in Virtual Environment (RFVE)
* Other: Traditional Neuromotor Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients affected by a stroke occurring in the period no longer than 1 year before the enrolment both first ischemic and hemorrhagic stroke subjects who did not had RFVE treatment previously scoring higher than 24 points in the Mini-Mental State Examination test Exclusion Criteria: upper extremity complete hemiplegia upper limbs sensory disorders clinical evidence of cognitive impairment neglect apraxia comprehension difficulties post-traumatic injury of the upper limb

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reinforced Feedback in Virtual Environment<br>During the experiment, patients in the RFVE training group (Reinforced Feedback in Virtual Environment) will receive 1 hour of virtual reality-based therapy by means of RFVE and 1 hour of TNR treatment (Traditional Neuromotor Rehabilitation). Both treatments will last 1 hour a day, five days weekly for four weeks. The treatment is focused on motor function impairment of the upper extremity. | Device: Reinforced Feedback in Virtual Environment (RFVE)<br>* The patients allocated to RFVE group, will be treated using the Virtual Reality Rehabilitation System (VRRS). During the virtual therapy the subject will be seated in front of the wall screen grasping a sensorized real object with the affected hand. If the grasp is not possible the sensors will be fixed on a glove worn by the patient. The real object held by the subject, equipped with electromagnetic sensors, is matched to the virtual handling object. Thereafter, the patient moved the real object (e.g. ball) following the trajectory of the corresponding virtual object displayed on the computer screen in accordance with the requested virtual task.<br>* Other names: Virtual Reality Rehabilitation System (VRRS);|
| Other: Traditional Neromotor Rehabilitation<br>The TNR training group (Traditional Neuromotor Rehabilitation) patients will be treated totally for two hours daily by means of a TNR programme. The treatment will last 4 weeks. | Other: Traditional Neuromotor Rehabilitation<br>* The patients randomized to the Traditional Neuromotor Rehabilitation group will be asked to perform exercises for postural control, exercises for hand pre-configuration, exercises for the stimulation of manipulation and functional skills, exercises for proximal-distal coordination. All the exercises will be performed with or without the assistance of a physiotherapist. The upper limb motricity will be trained with progressive complexity. To achieve the requested goal (in a horizontal or vertical plane) patients will be asked to perform various movements, for example: shoulder flexion and extension, shoulder abduction and adduction, shoulder internal and external rotation and shoulder circumduction, elbow flexion and extension, forearm pronation and supination, hand grasping-release and clenching into a fist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl_Meyer Upper Extremity scale (F-M UE) | Applied at the beginning and at the end of treatment 4 weeks thereafter. | 20 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure scale (FIM) | Assessed at the beginning and at the end of treatment 4 weeks thereafter. | 20 min | 
| National Institutes of Health Stroke Scale (NIHSS) | Assessed at the beginning and at the end of treatment 4 weeks thereafter. | 5 min | 
| Kinematic assessment | The kinematic assessment include the execution of standardised upper limb movements, such as: forearm pronation and supination, elbow flexion and extension, shoulder abduction and adduction, shoulder internal and external rotation, shoulder flexion and extension and reaching movements. The mean linear velocity (Speed), the mean duration of movements (Time) and the mean number of submovements (Peak) will be measured, by means of the Virtual Reality Rehabilitation System (VRRS). The data will be registered at the beginning and at the end of treatment, 4 weeks thereafter. | 30 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Motor Learning, Rehabilitation, Upper Limb