<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/NCT03033797</url>
  </required_header>
  <id_info>
    <org_study_id>54172416.6.0000.0082</org_study_id>
    <nct_id>NCT03033797</nct_id>
  </id_info>
  <brief_title>Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities</brief_title>
  <official_title>Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faculdade de Medicina do ABC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faculdade de Medicina do ABC</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>
      Background: Games using motion capture from webcam have become increasingly popular. A&#xD;
      population that lacks much stimulus in the teaching-learning process has under-explored the&#xD;
      benefits of this kind of games: The Intellectually Disabled. The aim of this study is to&#xD;
      analyse the effectiveness of games with virtual reality in the total reaction time. Method: A&#xD;
      convenience sample of 165 Intellectually Disabled participants will have their performance&#xD;
      measured using a virtual reality game. The intervention is to play two different games twice,&#xD;
      in two sessions with an interval of, at least, seven days between the sessions. Participants&#xD;
      will be randomized between two raters, both master students.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 8, 2016</start_date>
  <completion_date type="Anticipated">March 24, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 10, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>total reaction time</measure>
    <time_frame>6 minutes</time_frame>
    <description>decrease in time indicates a better performance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time MoviLetrando</measure>
    <time_frame>up to 15 days</time_frame>
    <description>less time to hit the targets indicates a better performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>acerts MoviLetrando</measure>
    <time_frame>up to 15 days</time_frame>
    <description>more hits indicates a better performance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">165</enrollment>
  <condition>Intellectual Disability</condition>
  <arm_group>
    <arm_group_label>MoviLetrando-MoveHero</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Half of the children will play first two different levels of the game MoviLetrando (2 minutes each) and, after the game MoveHero, more 2 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MoveHero-MoviLetrando</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The other half of the children will play first 2 minutes of the game MoveHero and after, two different levels of the Game MoviLetrando, two minutes each.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MoviLetrando</intervention_name>
    <description>Half of the participants will play two different levels of the Game MoviLetrando, two minutes each.</description>
    <arm_group_label>MoveHero-MoviLetrando</arm_group_label>
    <arm_group_label>MoviLetrando-MoveHero</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MoveHero</intervention_name>
    <description>Half of the participants will play 2 minutes of the game MoveHero.</description>
    <arm_group_label>MoveHero-MoviLetrando</arm_group_label>
    <arm_group_label>MoviLetrando-MoveHero</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All the children that uses to go the institution where the data collection will be&#xD;
             realised (APAE).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who decline to participate&#xD;
&#xD;
          -  Those who are not present in the two days of evaluation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Regiani Guarnieri</last_name>
    <phone>4899344597</phone>
    <email>regianig1@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Associação de Pais e Amigos dos Excepcionais</name>
      <address>
        <city>São Paulo</city>
        <zip>04040-033</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Viviane AM Perico</last_name>
      <phone>+551150807009</phone>
      <phone_ext>345</phone_ext>
      <email>vivianeperico@apaesp.org.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Faculdade de Medicina do ABC</investigator_affiliation>
    <investigator_full_name>Regiani Guarnieri</investigator_full_name>
    <investigator_title>Graphic Computer Specialist</investigator_title>
  </responsible_party>
  <keyword>assitive technology</keyword>
  <keyword>virtual reality games</keyword>
  <keyword>intellectual disability</keyword>
  <keyword>augmentative and alternative communication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intellectual Disability</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03033797
org study id: 54172416.6.0000.0082
nct id: NCT03033797
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Games using motion capture from webcam have become increasingly popular. A
      population that lacks much stimulus in the teaching-learning process has under-explored the
      benefits of this kind of games: The Intellectually Disabled. The aim of this study is to
      analyse the effectiveness of games with virtual reality in the total reaction time. Method: A
      convenience sample of 165 Intellectually Disabled participants will have their performance
      measured using a virtual reality game. The intervention is to play two different games twice,
      in two sessions with an interval of, at least, seven days between the sessions. Participants
      will be randomized between two raters, both master students.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: total reaction time
time frame: 6 minutes
description: decrease in time indicates a better performance
measure: time MoviLetrando
time frame: up to 15 days
description: less time to hit the targets indicates a better performance
measure: acerts MoviLetrando
time frame: up to 15 days
description: more hits indicates a better performance
arm group label: MoviLetrando-MoveHero
arm group type: Experimental
description: Half of the children will play first two different levels of the game MoviLetrando (2 minutes each) and, after the game MoveHero, more 2 minutes
arm group label: MoveHero-MoviLetrando
arm group type: Experimental
description: The other half of the children will play first 2 minutes of the game MoveHero and after, two different levels of the Game MoviLetrando, two minutes each.
intervention type: Device
intervention name: MoviLetrando
description: Half of the participants will play two different levels of the Game MoviLetrando, two minutes each.
arm group label: MoveHero-MoviLetrando
arm group label: MoviLetrando-MoveHero
intervention type: Device
intervention name: MoveHero
description: Half of the participants will play 2 minutes of the game MoveHero.
arm group label: MoveHero-MoviLetrando
arm group label: MoviLetrando-MoveHero
criteria: 
gender: All
minimum age: 7 Years
maximum age: 14 Years
healthy volunteers: No
last name: Regiani Guarnieri
phone: 4899344597
email: regianig1@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Faculdade de Medicina do ABC
investigator full name: Regiani Guarnieri
investigator title: Graphic Computer Specialist
mesh term: Intellectual Disability
sharing ipd: No