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

June 7, 2022 updated by: Andrea Turolla, IRCCS San Camillo, Venezia, Italy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Venice, Italy, 30126
        • Azienda Ulss 3 Serenissima
    • VE
      • Venezia, VE, Italy, 30126
        • San Camillo IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Upper Extremity scale (FM UE)
Time Frame: Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter)
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
Time Frame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
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
Time Frame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
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
Time Frame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
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
Time Frame: Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter)
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)
Time Frame: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
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
Time Frame: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinematic Assessment
Time Frame: Change from baseline of the following parameters; speed, time, peak at the end of Virtual therapy (four weeks thereafter)
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®. Khymeia Group, Noventa Padovana. Italy). The data will be registered at the beginning and at the end of treatment, 4 weeks thereafter.
Change from baseline of the following parameters; speed, time, peak at the end of Virtual therapy (four weeks thereafter)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Camillo, Venezia, Italy

Collaborators

Ministry of Health, Italy
Società Italiana di Fisioterapia (SIF)

Investigators

  • Principal Investigator: Andrea Turolla, PhD, San Camillo IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Actual)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocollo 2013.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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