<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/NCT02971371</url>
  </required_header>
  <id_info>
    <org_study_id>43/2013</org_study_id>
    <nct_id>NCT02971371</nct_id>
  </id_info>
  <brief_title>The Role of MNS in Improving Motor Performance</brief_title>
  <official_title>The Role of Mirror Neuron System in Improving Motor Performance by Using Virtual Reality, as Revealed by EEG: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Centro Neurolesi &quot;Bonino-Pulejo&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Centro Neurolesi &quot;Bonino-Pulejo&quot;</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many studies have demonstrated the usefulness of repetitive task practice by using robotic&#xD;
      devices, including Lokomat, for the treatment of lower limb paresis. Virtual reality (VR) has&#xD;
      proved to be a valuable tool to improve neurorehabilitation training. Our pilot randomized&#xD;
      clinical trial aimed at evaluating the correlation between the modifications of brain&#xD;
      oscillations during a VR neurorehabilitative training of gait and the motor function recovery&#xD;
      in patients with chronic stroke.&#xD;
&#xD;
      Twenty-four patients suffering from a first unilateral ischemic stroke in the chronic phase&#xD;
      were randomized into two groups. One group performed 40 sessions of Lokomat with VR (RAGT+VR)&#xD;
      whereas the other group underwent Lokomat without VR (RAGT-VR). Outcomes (clinical,&#xD;
      kinematic, and event-related synchronization, ERS, and desynchronization, ERD, at the EEG)&#xD;
      were measured before and after the robotic intervention.&#xD;
&#xD;
      The robotic-based rehabilitation combined with VR could be associated with improvements in&#xD;
      several measurements of lower limb function, gait, and balance in patient with chronic&#xD;
      hemiparesis. Moreover, ERS/ERD analysis can be proposed as a tool to monitor motor&#xD;
      performance and to develop non-invasive brain-computer interfaces controlling robotic&#xD;
      devices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>gait evaluated by Rivermead Mobility Index (RMI)</measure>
    <time_frame>Six months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spasticity evaluated by Modified Ashworth Scale (MAS)</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Virtual Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group performed 40 45-min Lokomat sessions, five times a week, by using a visual feedback showing a Virtual Reality run game where the patient had to collect or avoid objects, to motivate him/her to walk actively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Only RAGT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This groups performed 40 Lokomat sessions (40-45min), five times a week, between 9am and 11am, in this case was not provided an avatar, and a smile indicating the goodness of each leg movement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lokomat</intervention_name>
    <description>Both the groups performed 40 45min Lokomat sessions, five times a week, between 9am and 11am. The &quot;RAGT&quot;and &quot;VR&quot; group received a visual feedback showing a VR run game where the patient had to collect or avoid objects, to motivate him/her to walk actively. Each avatar's leg movement corresponded to that performed by the patient. On the other hand, the &quot;RAGT&quot; without &quot;VR&quot; group was not provided an avatar, and a smile indicating the goodness of each leg movement. The biofeedback of the Lokomat gait orthosis is based on the interaction torques between the participant and the orthosis</description>
    <arm_group_label>Only RAGT</arm_group_label>
    <arm_group_label>Virtual Reality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥55 years&#xD;
&#xD;
          -  A first-ever ischemic supra-tentorial stroke (confirmed by MRI scan) at least 6 months&#xD;
             before their enrollment;&#xD;
&#xD;
          -  An unilateral hemiparesis, with a Muscle Research Council -MCR- score ≤3&#xD;
&#xD;
          -  Ability to follow verbal instructions, with a Mini-Mental State Examination (MMSE) &gt;24&#xD;
&#xD;
          -  A mild to moderate spasticity according to a Modified Ashworth Scale (MAS) ≤2&#xD;
&#xD;
          -  No severe bone or joint disease&#xD;
&#xD;
          -  No history of concomitant neurodegenerative diseases or brain surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive and behavioral impairments&#xD;
&#xD;
          -  Severe osteoporosis and previous bone fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>November 19, 2016</last_update_submitted>
  <last_update_submitted_qc>November 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Centro Neurolesi &quot;Bonino-Pulejo&quot;</investigator_affiliation>
    <investigator_full_name>Rocco Salvatore Calabrò</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <pending_results>
    <submitted>August 19, 2020</submitted>
    <returned>September 4, 2020</returned>
  </pending_results>
  <!-- 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/NCT02971371
org study id: 43/2013
nct id: NCT02971371
lead sponsor: 
has dmc: No
Many studies have demonstrated the usefulness of repetitive task practice by using robotic
      devices, including Lokomat, for the treatment of lower limb paresis. Virtual reality (VR) has
      proved to be a valuable tool to improve neurorehabilitation training. Our pilot randomized
      clinical trial aimed at evaluating the correlation between the modifications of brain
      oscillations during a VR neurorehabilitative training of gait and the motor function recovery
      in patients with chronic stroke.

      Twenty-four patients suffering from a first unilateral ischemic stroke in the chronic phase
      were randomized into two groups. One group performed 40 sessions of Lokomat with VR (RAGT+VR)
      whereas the other group underwent Lokomat without VR (RAGT-VR). Outcomes (clinical,
      kinematic, and event-related synchronization, ERS, and desynchronization, ERD, at the EEG)
      were measured before and after the robotic intervention.

      The robotic-based rehabilitation combined with VR could be associated with improvements in
      several measurements of lower limb function, gait, and balance in patient with chronic
      hemiparesis. Moreover, ERS/ERD analysis can be proposed as a tool to monitor motor
      performance and to develop non-invasive brain-computer interfaces controlling robotic
      devices.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: gait evaluated by Rivermead Mobility Index (RMI)
time frame: Six months
measure: Spasticity evaluated by Modified Ashworth Scale (MAS)
time frame: Six months
arm group label: Virtual Reality
arm group type: Experimental
description: This group performed 40 45-min Lokomat sessions, five times a week, by using a visual feedback showing a Virtual Reality run game where the patient had to collect or avoid objects, to motivate him/her to walk actively.
arm group label: Only RAGT
arm group type: Active Comparator
description: This groups performed 40 Lokomat sessions (40-45min), five times a week, between 9am and 11am, in this case was not provided an avatar, and a smile indicating the goodness of each leg movement.
intervention type: Device
intervention name: Lokomat
description: Both the groups performed 40 45min Lokomat sessions, five times a week, between 9am and 11am. The "RAGT"and "VR" group received a visual feedback showing a VR run game where the patient had to collect or avoid objects, to motivate him/her to walk actively. Each avatar's leg movement corresponded to that performed by the patient. On the other hand, the "RAGT" without "VR" group was not provided an avatar, and a smile indicating the goodness of each leg movement. The biofeedback of the Lokomat gait orthosis is based on the interaction torques between the participant and the orthosis
arm group label: Only RAGT
arm group label: Virtual Reality
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: IRCCS Centro Neurolesi "Bonino-Pulejo"
investigator full name: Rocco Salvatore Calabrò
investigator title: Principal investigator
submitted: August 19, 2020
returned: September 4, 2020