<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02234531</url>
  </required_header>
  <id_info>
    <org_study_id>Protocollo 2013.11</org_study_id>
    <nct_id>NCT02234531</nct_id>
  </id_info>
  <brief_title>Comparison Study of 'Virtual Teacher' Support for Rehabilitation After Stroke.</brief_title>
  <acronym>MAVASI</acronym>
  <official_title>Assessment of a Virtual Teacher Feedback for the Recovery of Upper Limb After Stroke.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS San Camillo, Venezia, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Società Italiana di Fisioterapia (SIF)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>IRCCS San Camillo, Venezia, Italy</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the project is to assess whether the continuous visualization of on-line teacher&#xD;
      in virtual reality (VR) is effective for the improvement of upper limb motor function, in&#xD;
      stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A single-blind randomized controlled trial (RCT) will be carried out to compare the effects&#xD;
      of reinforced feedback in virtual environment (RFVE) treatment with continuous displaying of&#xD;
      a virtual teacher (EVER TEACHER group) with RFVE without the presence of a virtual teacher&#xD;
      (NEVER TEACHER group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2013</start_date>
  <completion_date type="Actual">June 2021</completion_date>
  <primary_completion_date type="Actual">June 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Single blind randomized controlled trial (RCT)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Upper Extremity scale (FM UE)</measure>
    <time_frame>Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter)</time_frame>
    <description>Applied at the beginning and at the end of treatment (after 20 sessions).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment - Sensation</measure>
    <time_frame>Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)</time_frame>
    <description>Applied at the beginning and at the end of treatment (after 20 sessions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment - Pain and ROM</measure>
    <time_frame>Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)</time_frame>
    <description>Applied at the beginning and at the end of treatment (after 20 sessions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reaching Performance Scale</measure>
    <time_frame>Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)</time_frame>
    <description>Applied at the beginning and at the end of treatment (after 20 sessions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Scale</measure>
    <time_frame>Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter)</time_frame>
    <description>Applied at the beginning and at the end of treatment (after 20 sessions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure scale (FIM)</measure>
    <time_frame>Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)</time_frame>
    <description>Applied at the beginning and at the end of treatment (after 20 sessions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nine Hole Pegboard Test</measure>
    <time_frame>Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)</time_frame>
    <description>Applied at the beginning and at the end of treatment (after 20 sessions).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Kinematic Assessment</measure>
    <time_frame>Change from baseline of the following parameters; speed, time, peak at the end of Virtual therapy (four weeks thereafter)</time_frame>
    <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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>EVER TEACHER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In EVER TEACHER group a specific feedback called &quot;virtual teacher&quot; 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NEVER TEACHER</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EVER TEACHER</intervention_name>
    <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 &quot;virtual teacher&quot; 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.</description>
    <arm_group_label>EVER TEACHER</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NEVER TEACHER</intervention_name>
    <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.</description>
    <arm_group_label>NEVER TEACHER</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first single stroke,&#xD;
&#xD;
          -  absence of ideomotor apraxia, neglect, aphasia interfering with verbal comprehension,&#xD;
&#xD;
          -  0 &lt; NIHSS-IT &lt; 4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral or cerebellum stroke,&#xD;
&#xD;
          -  unstable medical conditions,&#xD;
&#xD;
          -  fracture,&#xD;
&#xD;
          -  major depressive disorders,&#xD;
&#xD;
          -  other neurological conditions,&#xD;
&#xD;
          -  epilepsy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Turolla, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Camillo IRCCS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Camillo IRCCS</name>
      <address>
        <city>Venezia</city>
        <state>VE</state>
        <zip>30126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda ULSS 3 Serenissima</name>
      <address>
        <city>Venice</city>
        <zip>30126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.sif-fisioterapia.it/</url>
    <description>Italian Society for Physiotherapy (Società Italiana di Fisioterapia)</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>23914733</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24745024</PMID>
  </reference>
  <reference>
    <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.</citation>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>June 7, 2022</last_update_submitted>
  <last_update_submitted_qc>June 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS San Camillo, Venezia, Italy</investigator_affiliation>
    <investigator_full_name>Andrea Turolla</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Virtual Reality,</keyword>
  <keyword>Enhanced Feedback,</keyword>
  <keyword>Stroke,</keyword>
  <keyword>Rehabilitation,</keyword>
  <keyword>Motor Learning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02234531
org study id: Protocollo 2013.11
nct id: NCT02234531
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single blind randomized controlled trial (RCT)
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fugl-Meyer Upper Extremity scale (FM UE)
time frame: Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter)
description: Applied at the beginning and at the end of treatment (after 20 sessions).
measure: Fugl-Meyer Assessment - Sensation
time frame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
description: Applied at the beginning and at the end of treatment (after 20 sessions).
measure: 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)
description: Applied at the beginning and at the end of treatment (after 20 sessions).
measure: Reaching Performance Scale
time frame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
description: Applied at the beginning and at the end of treatment (after 20 sessions).
measure: Modified Ashworth Scale
time frame: Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter)
description: Applied at the beginning and at the end of treatment (after 20 sessions).
measure: 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)
description: Applied at the beginning and at the end of treatment (after 20 sessions).
measure: Nine Hole Pegboard Test
time frame: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
description: Applied at the beginning and at the end of treatment (after 20 sessions).
measure: Kinematic Assessment
time frame: Change from baseline of the following parameters; speed, time, peak at the end of Virtual therapy (four weeks thereafter)
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.
arm group label: EVER TEACHER
arm group type: Experimental
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 group label: NEVER TEACHER
arm group type: Other
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: EVER TEACHER
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.
arm group label: EVER TEACHER
intervention type: Device
intervention name: NEVER TEACHER
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.
arm group label: NEVER TEACHER
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea Turolla, PhD
role: Principal Investigator
affiliation: San Camillo IRCCS
facility: 
facility: 
country: Italy
url: http://www.sif-fisioterapia.it/
description: Italian Society for Physiotherapy (Società Italiana di Fisioterapia)
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.
PMID: 23914733
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.
PMID: 24745024
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.
responsible party type: Principal Investigator
investigator affiliation: IRCCS San Camillo, Venezia, Italy
investigator full name: Andrea Turolla
investigator title: PhD
mesh term: Stroke