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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2021-06-30

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.

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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).

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blind randomized controlled trial (RCT)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EVER TEACHER

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.

Group Type EXPERIMENTAL

EVER TEACHER

Intervention Type DEVICE

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.

NEVER TEACHER

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.

Group Type OTHER

NEVER TEACHER

Intervention Type DEVICE

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.

Interventions

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EVER TEACHER

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.

Intervention Type DEVICE

NEVER TEACHER

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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No