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

Recruiting

Phase N/A Results N/A

Trial Description

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

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

Interventions

  • EVER TEACHER Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: EVER TEACHER
    Description: 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.
  • NEVER TEACHER Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: NEVER TEACHER
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Upper Extremity scale (FM UE) Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter) Yes
Secondary Reaching Performance Scale Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter) Yes
Secondary Modified Ashworth Scale Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter) Yes
Secondary Functional Independence Measure scale (FIM) Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter) Yes

Sponsors