<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/NCT03002298</url>
  </required_header>
  <id_info>
    <org_study_id>16796513.1.0000.0065</org_study_id>
    <nct_id>NCT03002298</nct_id>
  </id_info>
  <brief_title>Virtual Reality in Individuals With Duchenne Muscular Dystrophy</brief_title>
  <official_title>Motor Learning From Virtual to Natural Environments in Individuals With Duchenne Muscular Dystrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      With the growing accessibility of computer-assisted technology, one option for rehabilitation&#xD;
      programs for individuals with Duchenne muscular dystrophy (DMD) is the use of virtual reality&#xD;
      environments to enhance motor practice. Thus, it is important to examine whether performance&#xD;
      improvements in the virtual environment generalize to the natural environment. To examine&#xD;
      this issue, we had 64 individuals, 32 of which were individuals with DMD and 32 were&#xD;
      typically developing individuals. The groups practiced two coincidence timing tasks. In the&#xD;
      more tangible button-press task, the individuals were required to 'intercept' a falling&#xD;
      virtual object at the moment it reached the interception point by pressing a key on the&#xD;
      computer. In the more abstract task, they were instructed to 'intercept' the virtual object&#xD;
      by making a hand movement in a virtual environment using a webcam.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Department of Electronic System Engineering of the Polytechnic School of the University&#xD;
      of São Paulo (Brazil) developed the software that superimposes virtual objects over images of&#xD;
      real world, captured with a webcam.&#xD;
&#xD;
      The coincidence timing task could either have a virtual or a real interface. For the real&#xD;
      interface, a keyboard was used. For the virtual interface, a webcam recorded a marker on the&#xD;
      table alongside the keyboard of the computer. The images were fed into the computer and&#xD;
      analyzed online. Using the custom-made software, it was determined whether or not the&#xD;
      participant's hand occluded the marker, which was then fed back to the virtual environment.&#xD;
      The coincidence timing task was based on the Bassin Anticipation Timer. To this end, 10&#xD;
      3D-cubes were displayed simultaneously in a vertical column on a monitor. The cubes were&#xD;
      turned on (i.e., they changed from white to green) and off sequentially (from top to bottom)&#xD;
      until the target cube (i.e., the tenth cube) was reached. The task for the participant was to&#xD;
      either press the space bar on the keyboard (i.e., tangible button press task, by physical&#xD;
      contact, represented on figure 1A and 1B) or to make a sideward hand gesture as if hitting&#xD;
      the target object (i.e., the more abstract gesture task, with no physical contact,&#xD;
      represented on the figure 1C and 1D), i.e., occluding the marker at the exact moment the&#xD;
      target cube turned green.&#xD;
&#xD;
      Participants performed the task individually in a quiet room with only the examiner who gave&#xD;
      the instructions present. The computer was placed on a table. The participants were seated in&#xD;
      their wheelchair, which was adjusted according to the needs of the individual.&#xD;
&#xD;
      The examiner explained the task verbally and gave three demonstrations of how to perform the&#xD;
      coincidence timing tasks. The participants were instructed to place the preferred hand (i.e.,&#xD;
      the less affected hand) on a mark aside to the target (The location was individually adjusted&#xD;
      but ranged from 2 to 4 cm from the target). Once the first top cube turned on, the individual&#xD;
      had to move his hand to either touch the target key on the keyboard or to make a hitting&#xD;
      gesture in front of the webcam, exactly at the moment coinciding with the bottom target cube&#xD;
      turning on. Different sounds were provided as feedback for either a hit or miss during&#xD;
      acquisition, retention and transfer, the range of error being -200 to 200ms.&#xD;
&#xD;
      Participants with DMD and TD were divided into two subgroups randomly: (a) button-press task&#xD;
      group (BPT) - in this group during the acquisition phase the participants should press the&#xD;
      space button on keyboard to complete the coincidence timing task (more real interface) and&#xD;
      (b) gesture task group (GT) - in this group during the acquisition phase the participants&#xD;
      should cross a virtual target created by a webcam to complete the coincidence timing task&#xD;
      instead of press the computer button (more virtual interface).&#xD;
&#xD;
      For all tasks (button-press and gesture), during the acquisition phase, all groups started&#xD;
      performing 20 attempts of the coincidence timing task and, after five minutes with no contact&#xD;
      with the task, they performed five more repetitions for the retention phase (both phases in&#xD;
      slower speed - with the turning on and off of the lights in an interval of 400ms), finally&#xD;
      they performed five repetitions for two different transfers phases: the first transfer was&#xD;
      performed with a faster speed - 300ms of lights interval (transfer with speed increase -&#xD;
      TSI). The second transfer was performed with change task (transfer with exchange of en&#xD;
      vironment - TEE) between groups by doing 5 attempts transfer phase in another interface. It&#xD;
      means, the group that has done the acquisition phase in button-press task performed the&#xD;
      transfer on gesture task and vice versa.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">August 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motor Learning test by using a timing coincident task in virtual reality</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Duchenne Muscular Dystrophy</condition>
  <arm_group>
    <arm_group_label>DMD gesture task</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group that made the task using a gesture in front of a webcam</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DMD button-press task</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group that made the task pressing the button</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group gesture task</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group that made the task using a gesture in front of a webcam</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group button-press task</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group that made the task pressing the button</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DMD gesture task</intervention_name>
    <description>Timing coincident task in a virtual environment, using motor learning protocol in which a gesture in front of a webcam shoub be done to reach the task</description>
    <arm_group_label>DMD gesture task</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DMD button-press task</intervention_name>
    <description>Timing coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard</description>
    <arm_group_label>DMD button-press task</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group gesture task</intervention_name>
    <description>Timing coincident task in a virtual environment, using motor learning protocol in which a gesture in front of a webcam shoub be done to reach the task</description>
    <arm_group_label>Control group gesture task</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group button-press task</intervention_name>
    <description>Timing coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard</description>
    <arm_group_label>Control group button-press task</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medical diagnosis of Duchenne Muscular Dystrophy confirmed by molecular method and/or&#xD;
             protein expression in skeletal muscle;&#xD;
&#xD;
          -  signing of an informed consent form from the individual or person legally responsible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of associated comorbidities;&#xD;
&#xD;
          -  inability in comprehension of the task.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>32 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos BM Monteiro, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>April 8, 2017</last_update_submitted>
  <last_update_submitted_qc>April 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Carlos Bandeira de Mello Monteiro</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Dystrophies</mesh_term>
    <mesh_term>Muscular Dystrophy, Duchenne</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03002298
org study id: 16796513.1.0000.0065
nct id: NCT03002298
lead sponsor: 
has dmc: No
With the growing accessibility of computer-assisted technology, one option for rehabilitation
      programs for individuals with Duchenne muscular dystrophy (DMD) is the use of virtual reality
      environments to enhance motor practice. Thus, it is important to examine whether performance
      improvements in the virtual environment generalize to the natural environment. To examine
      this issue, we had 64 individuals, 32 of which were individuals with DMD and 32 were
      typically developing individuals. The groups practiced two coincidence timing tasks. In the
      more tangible button-press task, the individuals were required to 'intercept' a falling
      virtual object at the moment it reached the interception point by pressing a key on the
      computer. In the more abstract task, they were instructed to 'intercept' the virtual object
      by making a hand movement in a virtual environment using a webcam.
The Department of Electronic System Engineering of the Polytechnic School of the University
      of São Paulo (Brazil) developed the software that superimposes virtual objects over images of
      real world, captured with a webcam.

      The coincidence timing task could either have a virtual or a real interface. For the real
      interface, a keyboard was used. For the virtual interface, a webcam recorded a marker on the
      table alongside the keyboard of the computer. The images were fed into the computer and
      analyzed online. Using the custom-made software, it was determined whether or not the
      participant's hand occluded the marker, which was then fed back to the virtual environment.
      The coincidence timing task was based on the Bassin Anticipation Timer. To this end, 10
      3D-cubes were displayed simultaneously in a vertical column on a monitor. The cubes were
      turned on (i.e., they changed from white to green) and off sequentially (from top to bottom)
      until the target cube (i.e., the tenth cube) was reached. The task for the participant was to
      either press the space bar on the keyboard (i.e., tangible button press task, by physical
      contact, represented on figure 1A and 1B) or to make a sideward hand gesture as if hitting
      the target object (i.e., the more abstract gesture task, with no physical contact,
      represented on the figure 1C and 1D), i.e., occluding the marker at the exact moment the
      target cube turned green.

      Participants performed the task individually in a quiet room with only the examiner who gave
      the instructions present. The computer was placed on a table. The participants were seated in
      their wheelchair, which was adjusted according to the needs of the individual.

      The examiner explained the task verbally and gave three demonstrations of how to perform the
      coincidence timing tasks. The participants were instructed to place the preferred hand (i.e.,
      the less affected hand) on a mark aside to the target (The location was individually adjusted
      but ranged from 2 to 4 cm from the target). Once the first top cube turned on, the individual
      had to move his hand to either touch the target key on the keyboard or to make a hitting
      gesture in front of the webcam, exactly at the moment coinciding with the bottom target cube
      turning on. Different sounds were provided as feedback for either a hit or miss during
      acquisition, retention and transfer, the range of error being -200 to 200ms.

      Participants with DMD and TD were divided into two subgroups randomly: (a) button-press task
      group (BPT) - in this group during the acquisition phase the participants should press the
      space button on keyboard to complete the coincidence timing task (more real interface) and
      (b) gesture task group (GT) - in this group during the acquisition phase the participants
      should cross a virtual target created by a webcam to complete the coincidence timing task
      instead of press the computer button (more virtual interface).

      For all tasks (button-press and gesture), during the acquisition phase, all groups started
      performing 20 attempts of the coincidence timing task and, after five minutes with no contact
      with the task, they performed five more repetitions for the retention phase (both phases in
      slower speed - with the turning on and off of the lights in an interval of 400ms), finally
      they performed five repetitions for two different transfers phases: the first transfer was
      performed with a faster speed - 300ms of lights interval (transfer with speed increase -
      TSI). The second transfer was performed with change task (transfer with exchange of en
      vironment - TEE) between groups by doing 5 attempts transfer phase in another interface. It
      means, the group that has done the acquisition phase in button-press task performed the
      transfer on gesture task and vice versa.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Motor Learning test by using a timing coincident task in virtual reality
time frame: 1 day
arm group label: DMD gesture task
arm group type: Experimental
description: Experimental group that made the task using a gesture in front of a webcam
arm group label: DMD button-press task
arm group type: Experimental
description: Experimental group that made the task pressing the button
arm group label: Control group gesture task
arm group type: Active Comparator
description: Control group that made the task using a gesture in front of a webcam
arm group label: Control group button-press task
arm group type: Active Comparator
description: Control group that made the task pressing the button
intervention type: Behavioral
intervention name: DMD gesture task
description: Timing coincident task in a virtual environment, using motor learning protocol in which a gesture in front of a webcam shoub be done to reach the task
arm group label: DMD gesture task
intervention type: Behavioral
intervention name: DMD button-press task
description: Timing coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard
arm group label: DMD button-press task
intervention type: Behavioral
intervention name: Control group gesture task
description: Timing coincident task in a virtual environment, using motor learning protocol in which a gesture in front of a webcam shoub be done to reach the task
arm group label: Control group gesture task
intervention type: Behavioral
intervention name: Control group button-press task
description: Timing coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard
arm group label: Control group button-press task
criteria: 
gender: Male
minimum age: 12 Years
maximum age: 32 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carlos BM Monteiro, Ph.D.
role: Principal Investigator
affiliation: University of Sao Paulo
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Carlos Bandeira de Mello Monteiro
investigator title: Associate Professor
mesh term: Muscular Dystrophies
mesh term: Muscular Dystrophy, Duchenne
sharing ipd: Undecided