<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/NCT03254992</url>
  </required_header>
  <id_info>
    <org_study_id>55498016.1.0000.5390</org_study_id>
    <nct_id>NCT03254992</nct_id>
  </id_info>
  <brief_title>Real and Virtual Environments in Autism Spectrum Disorder</brief_title>
  <official_title>Motor Learning Transfer Between Real and Virtual Environments in Autism Spectrum Disorder.</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Individuals with Autism Spectrum Disorder (ASD) are known to have difficulty with&#xD;
      socio-communicative functioning and restricted or repetitive behaviors or interests, and&#xD;
      there is considerable evidence that the majority also struggle with associated emotional&#xD;
      problems. Speech is typically delayed or may regress, comprehension is impaired, if not at&#xD;
      the word level, then at the level of sentences, nonverbal and verbal language are affected,&#xD;
      and pretend play is delayed or absent, some children are nonverbal or have sparse,&#xD;
      impoverished, poorly articulated, and grammatical speech. Objective: To assess in which&#xD;
      interface has ASD best performance or functionality. Method: Will be evaluated 100&#xD;
      individuals divided into two groups: 50 individuals with diagnosis of Autistic Spectrum&#xD;
      Disorder (ASD-group), aged 7 to 15 years old, males and females; and 50 individuals with&#xD;
      typical development (TD-group) matched by age and sex to the ASD-group. Individuals with&#xD;
      comorbidities and functional disabilities that would impede the completion of the task were&#xD;
      excluded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Will be evaluated 100 individuals divided into two groups: 50 individuals with diagnosis of&#xD;
      Autistic Spectrum Disorder (ASD-group), aged 7 to 15 years old, males and females; and 50&#xD;
      individuals with typical development (TD-group) matched by age and sex to the ASD-group. The&#xD;
      ASD-group will be recruited from GAPI - Special Education in São Bernardo do Campo, São&#xD;
      Paulo, Brazil, which is a school for children and adolescents with pervasive developmental&#xD;
      disorders.&#xD;
&#xD;
      For a diagnosis of ASD, apart from qualitative alterations in social communication and&#xD;
      interaction (criterion A) in addition to stereotyped, repetitive, restricted behavior&#xD;
      patterns (criterion B), that present in the early developmental period (criterion C), it is&#xD;
      also required that these &quot;symptoms cause clinically significant impairment in social,&#xD;
      occupational and other important areas of current functioning&quot; (criterion D), and that they&#xD;
      are not better explained otherwise (criterion E). Given this information these items will be&#xD;
      taken into consideration and the group was well evaluated.&#xD;
&#xD;
      With the purpose to homogenize the sample, will be only included ASD with the 1st level to&#xD;
      5th education to grade elementary.&#xD;
&#xD;
      Instrument For data collection will be used a gaming software created in partnership with the&#xD;
      Information Systems group of School of Arts, Sciences and Humanities, EACH-USP.&#xD;
&#xD;
      The game offers task of &quot;Timing&quot; Coincident, which when executed are displayed on the&#xD;
      computer screen 10 balls accessing (red light) in sequence until the last ball, which is&#xD;
      considered the target (green light). The participant can have immediate feedback of hit or&#xD;
      task error by different sounds (Auditory Interaction) and through visual images (Visual&#xD;
      Interaction) that change colors, that will be previously shown to him.&#xD;
&#xD;
      Task Coincident Timing In the more tangible button-press task, the individuals will be&#xD;
      required to 'intercept' a falling virtual object at the moment it reached the interception&#xD;
      point by pressing a button on the computer's keyboard. In the more abstract, less tangible&#xD;
      task, they were instructed to 'intercept' the virtual object by making a hand movement (i.e.,&#xD;
      a waving gesture) in a virtual environment.&#xD;
&#xD;
      The magnitude and direction of each participant's error in anticipating the light's &quot;arrival&quot;&#xD;
      at the end of the runway, in milliseconds, is recorded by the game.&#xD;
&#xD;
      Objective the game is to evaluate the difference in time between the participant's execution&#xD;
      of the response and the arrival of the object at the target location, overall temporal&#xD;
      accuracy, and hence coincidence-anticipation timing skill.&#xD;
&#xD;
      The software provides a &quot;user login&quot; for each research participant, where the following data&#xD;
      are stored: Participant name; Date of birth; sex; Pathology type; Researcher name.&#xD;
&#xD;
      Procedures The participants will be positioned comfortably in a chair adjusted according to&#xD;
      size and needs along with a footrest so that they will be positioned properly to enable task&#xD;
      execution. Before starting the task, the operation of the game will be verbally explained and&#xD;
      a demonstration will be offered by the examiner. Runtime will be noted in each experimental&#xD;
      stage, as explained below: acquisition (A), retention (R), and transfer (T).&#xD;
&#xD;
      All participants made 20 trial acquisitions, 5 retention trials after 5 minutes with no&#xD;
      contact with the task and 5 transfer trials immediately after retention trials. Thus, each&#xD;
      participant will have 30 trials. During acquisition and retention trials, the bubbles&#xD;
      simulate a dropped light movement with 0.5 seconds between each bubble and 5 seconds between&#xD;
      the first and last bubble.&#xD;
&#xD;
      The subjects will perform alternating interfaces for the same task, Kinect for Windows&#xD;
      (gesture task with virtual environments), Keyboard (button press with tangible environments),&#xD;
      and both groups will carry out the transfer phase on Touch Screen interface. The subjects of&#xD;
      each group (ASD and TD) will be divided into 2 groups, group A and group B, according to the&#xD;
      order of interfaces to carry out the task; Group A will perform the abstract task (kinect&#xD;
      with more virtual activity) and then the tangible task (keyboard with more real activity),&#xD;
      and the group B, will perform the reverse process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2016</start_date>
  <completion_date type="Actual">November 20, 2017</completion_date>
  <primary_completion_date type="Actual">October 20, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in performance, measured by coincident timing task</measure>
    <time_frame>1 day</time_frame>
    <description>The participants who will perform the abstract task first, will present decrease on performance, measured by the coincident timing task.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>ASD - Abstract task</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group using Kinect with more virtual activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ASD - Tangible task</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group using Keyboard with more real activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TD - Abstract task</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group using Kinect with more virtual activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TD - Tangible task</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group using Keyboard with more real activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ASD - Abstract task</intervention_name>
    <description>Experimental group using Kinect with more virtual activity.</description>
    <arm_group_label>ASD - Abstract task</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ASD - Tangible task</intervention_name>
    <description>Experimental group using Keyboard with more real activity.</description>
    <arm_group_label>ASD - Tangible task</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TD - Abstract task</intervention_name>
    <description>Control group using Kinect with more virtual activity.</description>
    <arm_group_label>TD - Abstract task</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TD - Tangible task</intervention_name>
    <description>Control group using Keyboard with more real activity.</description>
    <arm_group_label>TD - Tangible task</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  need to understand the task, assessed by the ability to properly perform three&#xD;
             attempts explanatory statement by the evaluator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  of incomprehension.&#xD;
&#xD;
          -  no completion of the task.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>15 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>
  <location>
    <facility>
      <name>Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>03828-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>June 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>November 22, 2017</last_update_submitted>
  <last_update_submitted_qc>November 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 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>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</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/NCT03254992
org study id: 55498016.1.0000.5390
nct id: NCT03254992
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Individuals with Autism Spectrum Disorder (ASD) are known to have difficulty with
      socio-communicative functioning and restricted or repetitive behaviors or interests, and
      there is considerable evidence that the majority also struggle with associated emotional
      problems. Speech is typically delayed or may regress, comprehension is impaired, if not at
      the word level, then at the level of sentences, nonverbal and verbal language are affected,
      and pretend play is delayed or absent, some children are nonverbal or have sparse,
      impoverished, poorly articulated, and grammatical speech. Objective: To assess in which
      interface has ASD best performance or functionality. Method: Will be evaluated 100
      individuals divided into two groups: 50 individuals with diagnosis of Autistic Spectrum
      Disorder (ASD-group), aged 7 to 15 years old, males and females; and 50 individuals with
      typical development (TD-group) matched by age and sex to the ASD-group. Individuals with
      comorbidities and functional disabilities that would impede the completion of the task were
      excluded.
Will be evaluated 100 individuals divided into two groups: 50 individuals with diagnosis of
      Autistic Spectrum Disorder (ASD-group), aged 7 to 15 years old, males and females; and 50
      individuals with typical development (TD-group) matched by age and sex to the ASD-group. The
      ASD-group will be recruited from GAPI - Special Education in São Bernardo do Campo, São
      Paulo, Brazil, which is a school for children and adolescents with pervasive developmental
      disorders.

      For a diagnosis of ASD, apart from qualitative alterations in social communication and
      interaction (criterion A) in addition to stereotyped, repetitive, restricted behavior
      patterns (criterion B), that present in the early developmental period (criterion C), it is
      also required that these "symptoms cause clinically significant impairment in social,
      occupational and other important areas of current functioning" (criterion D), and that they
      are not better explained otherwise (criterion E). Given this information these items will be
      taken into consideration and the group was well evaluated.

      With the purpose to homogenize the sample, will be only included ASD with the 1st level to
      5th education to grade elementary.

      Instrument For data collection will be used a gaming software created in partnership with the
      Information Systems group of School of Arts, Sciences and Humanities, EACH-USP.

      The game offers task of "Timing" Coincident, which when executed are displayed on the
      computer screen 10 balls accessing (red light) in sequence until the last ball, which is
      considered the target (green light). The participant can have immediate feedback of hit or
      task error by different sounds (Auditory Interaction) and through visual images (Visual
      Interaction) that change colors, that will be previously shown to him.

      Task Coincident Timing In the more tangible button-press task, the individuals will be
      required to 'intercept' a falling virtual object at the moment it reached the interception
      point by pressing a button on the computer's keyboard. In the more abstract, less tangible
      task, they were instructed to 'intercept' the virtual object by making a hand movement (i.e.,
      a waving gesture) in a virtual environment.

      The magnitude and direction of each participant's error in anticipating the light's "arrival"
      at the end of the runway, in milliseconds, is recorded by the game.

      Objective the game is to evaluate the difference in time between the participant's execution
      of the response and the arrival of the object at the target location, overall temporal
      accuracy, and hence coincidence-anticipation timing skill.

      The software provides a "user login" for each research participant, where the following data
      are stored: Participant name; Date of birth; sex; Pathology type; Researcher name.

      Procedures The participants will be positioned comfortably in a chair adjusted according to
      size and needs along with a footrest so that they will be positioned properly to enable task
      execution. Before starting the task, the operation of the game will be verbally explained and
      a demonstration will be offered by the examiner. Runtime will be noted in each experimental
      stage, as explained below: acquisition (A), retention (R), and transfer (T).

      All participants made 20 trial acquisitions, 5 retention trials after 5 minutes with no
      contact with the task and 5 transfer trials immediately after retention trials. Thus, each
      participant will have 30 trials. During acquisition and retention trials, the bubbles
      simulate a dropped light movement with 0.5 seconds between each bubble and 5 seconds between
      the first and last bubble.

      The subjects will perform alternating interfaces for the same task, Kinect for Windows
      (gesture task with virtual environments), Keyboard (button press with tangible environments),
      and both groups will carry out the transfer phase on Touch Screen interface. The subjects of
      each group (ASD and TD) will be divided into 2 groups, group A and group B, according to the
      order of interfaces to carry out the task; Group A will perform the abstract task (kinect
      with more virtual activity) and then the tangible task (keyboard with more real activity),
      and the group B, will perform the reverse process.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in performance, measured by coincident timing task
time frame: 1 day
description: The participants who will perform the abstract task first, will present decrease on performance, measured by the coincident timing task.
arm group label: ASD - Abstract task
arm group type: Experimental
description: Experimental group using Kinect with more virtual activity.
arm group label: ASD - Tangible task
arm group type: Experimental
description: Experimental group using Keyboard with more real activity.
arm group label: TD - Abstract task
arm group type: Active Comparator
description: Control group using Kinect with more virtual activity.
arm group label: TD - Tangible task
arm group type: Active Comparator
description: Control group using Keyboard with more real activity.
intervention type: Device
intervention name: ASD - Abstract task
description: Experimental group using Kinect with more virtual activity.
arm group label: ASD - Abstract task
intervention type: Device
intervention name: ASD - Tangible task
description: Experimental group using Keyboard with more real activity.
arm group label: ASD - Tangible task
intervention type: Device
intervention name: TD - Abstract task
description: Control group using Kinect with more virtual activity.
arm group label: TD - Abstract task
intervention type: Device
intervention name: TD - Tangible task
description: Control group using Keyboard with more real activity.
arm group label: TD - Tangible task
criteria: 
gender: All
minimum age: 7 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carlos BM Monteiro, Ph.D.
role: Principal Investigator
affiliation: University of Sao Paulo
facility: 
country: Brazil
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: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: Undecided