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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EVER TEACHER
NEVER TEACHER
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Virtual Reality,, Enhanced Feedback,, Stroke,, Rehabilitation,, Motor Learning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Camillo IRCCS
  • Azienda ULSS 3 Serenissima

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

EVER TEACHER

NEVER TEACHER

Arm 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.

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.

Outcomes

Primary Outcome Measures

Fugl-Meyer Upper Extremity scale (FM UE)
Applied at the beginning and at the end of treatment (after 20 sessions).

Secondary Outcome Measures

Fugl-Meyer Assessment - Sensation
Applied at the beginning and at the end of treatment (after 20 sessions).
Fugl-Meyer Assessment - Pain and ROM
Applied at the beginning and at the end of treatment (after 20 sessions).
Reaching Performance Scale
Applied at the beginning and at the end of treatment (after 20 sessions).
Modified Ashworth Scale
Applied at the beginning and at the end of treatment (after 20 sessions).
Functional Independence Measure scale (FIM)
Applied at the beginning and at the end of treatment (after 20 sessions).
Nine Hole Pegboard Test
Applied at the beginning and at the end of treatment (after 20 sessions).

Full Information

First Posted
August 29, 2014
Last Updated
June 7, 2022
Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
Società Italiana di Fisioterapia (SIF), Ministry of Health, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT02234531
Brief Title
Comparison Study of 'Virtual Teacher' Support for Rehabilitation After Stroke.
Acronym
MAVASI
Official Title
Assessment of a Virtual Teacher Feedback for the Recovery of Upper Limb After Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
Società Italiana di Fisioterapia (SIF), Ministry of Health, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Virtual Reality,, Enhanced Feedback,, Stroke,, Rehabilitation,, Motor Learning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind randomized controlled trial (RCT)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVER TEACHER
Arm Type
Experimental
Arm 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.
Arm Title
NEVER TEACHER
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
EVER TEACHER
Intervention Description
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
Intervention Name(s)
NEVER TEACHER
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity scale (FM UE)
Description
Applied at the beginning and at the end of treatment (after 20 sessions).
Time Frame
Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter)
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment - Sensation
Description
Applied at the beginning and at the end of treatment (after 20 sessions).
Time Frame
Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Title
Fugl-Meyer Assessment - Pain and ROM
Description
Applied at the beginning and at the end of treatment (after 20 sessions).
Time Frame
Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Title
Reaching Performance Scale
Description
Applied at the beginning and at the end of treatment (after 20 sessions).
Time Frame
Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Title
Modified Ashworth Scale
Description
Applied at the beginning and at the end of treatment (after 20 sessions).
Time Frame
Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter)
Title
Functional Independence Measure scale (FIM)
Description
Applied at the beginning and at the end of treatment (after 20 sessions).
Time Frame
Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
Title
Nine Hole Pegboard Test
Description
Applied at the beginning and at the end of treatment (after 20 sessions).
Time Frame
Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
Other Pre-specified Outcome Measures:
Title
Kinematic Assessment
Description
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.
Time Frame
Change from baseline of the following parameters; speed, time, peak at the end of Virtual therapy (four weeks thereafter)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Turolla, PhD
Organizational Affiliation
San Camillo IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Camillo IRCCS
City
Venezia
State/Province
VE
ZIP/Postal Code
30126
Country
Italy
Facility Name
Azienda ULSS 3 Serenissima
City
Venice
ZIP/Postal Code
30126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23914733
Citation
Turolla A, Dam M, Ventura L, Tonin P, Agostini M, Zucconi C, Kiper P, Cagnin A, Piron L. Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial. J Neuroeng Rehabil. 2013 Aug 1;10:85. doi: 10.1186/1743-0003-10-85.
Results Reference
background
PubMed Identifier
24745024
Citation
Kiper P, Agostini M, Luque-Moreno C, Tonin P, Turolla A. Reinforced feedback in virtual environment for rehabilitation of upper extremity dysfunction after stroke: preliminary data from a randomized controlled trial. Biomed Res Int. 2014;2014:752128. doi: 10.1155/2014/752128. Epub 2014 Mar 13.
Results Reference
background
Citation
Zucconi C, Valt V, Agostini M, Turolla A, Tonin P, Piron L. Assessment of a virtual teacher feedback for the recovery of the upper limb after stroke. Italian Journal of Physiotherapy 2011;1(4):101-6.
Results Reference
background
Links:
URL
http://www.sif-fisioterapia.it/
Description
Italian Society for Physiotherapy (Società Italiana di Fisioterapia)

Learn more about this trial

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

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