xml: <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/NCT06023563</url>
    </required_header>
    <id_info>
      <org_study_id>19116</org_study_id>
      <nct_id>NCT06023563</nct_id>
    </id_info>
    <brief_title>Effect of Virtual Reality-based Training on Balance and Walking in Youth With Autism Spectrum Disorder</brief_title>
    <official_title>Effect of Virtual Reality-based Training on Postural Control in Youth With Autism Spectrum Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indiana University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Indiana University</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>
        The goal of this clinical trial is to assess the effect of short-term (3 days/week for 2&#xD;
        weeks) Virtual Reality (VR) active video gaming intervention on static and dynamic balance,&#xD;
        versus traditional balance training exercises, in youth with ASD.&#xD;
  &#xD;
        The participants in the intervention group will engage in VR active video gaming using the&#xD;
        Nintendo Switch Sports under supervision via Zoom for 6 sessions occurring over 2 weeks, from&#xD;
        their home. While, the participants in the control group will engage in standard physical&#xD;
        therapy exercises for balance and walking under supervision via Zoom, for 6 sessions&#xD;
        occurring over 2 weeks, from their home.&#xD;
  &#xD;
        Their balance and walking will be assessed 3 times, 3-5 days before the intervention, 3-5&#xD;
        days after the intervention and 4-weeks after the intervention.&#xD;
  &#xD;
          -  Participants static balance will be assessed by standing on pressure mat, under 2&#xD;
             conditions, eyes open and eyes closed for 30 seconds each.&#xD;
  &#xD;
          -  The Pediatric Berg's balance Scale (PBS), a 14-point scale containing everyday&#xD;
             activities, will be used as a clinical measure for assessing the static and dynamic&#xD;
             balance.&#xD;
  &#xD;
          -  13-infra-red camera motion capture system, Qualisys, will be used for assessing the&#xD;
             walking.&#xD;
  &#xD;
        The difference in the balance and walking parameters will be assessed and compared.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postural control deficits, also referred to as balance deficits, are a noted example of&#xD;
        impaired motor-skills and are increasingly considered as one of the primary markers for&#xD;
        autism spectrum disorder (ASD)1-5. However, there are very few controlled clinical trials&#xD;
        examining effects of balance interventions in individuals with ASD. Moreover, to date there&#xD;
        exist few effective interventions based on well-designed research that address balance&#xD;
        deficits in youth with ASD and are home-implemented, cost-effective, generalizable, and&#xD;
        enjoyable and that promote adherence. Virtual reality (VR) active gaming is one such&#xD;
        intervention that incorporates scientific mechanisms for improving balance. But, there exist&#xD;
        few, evidence-based best practices that use this method to address balance in youth with ASD.&#xD;
        In addition to being based on principles of motor learning/control, commercially available VR&#xD;
        active gaming can be affordable, enjoyable, at-home intervention. Thus, the aim of this study&#xD;
        is to assess the effect of short-term (3 days/week for 2 weeks) Virtual Reality (VR) active&#xD;
        video gaming intervention on static and dynamic balance, versus traditional balance training&#xD;
        exercises, in youth with ASD.&#xD;
  &#xD;
        This study will take place at the Physical Activity and Biomechanics Labs at School of Public&#xD;
        Health, Indiana University, Bloomington, and participants home for total of 9 sessions&#xD;
        occurring over 7-8 weeks.&#xD;
  &#xD;
        Before participants come to the lab:&#xD;
  &#xD;
        Participants' parent/guardian will complete a couple of questionnaires that will ask&#xD;
        questions about any medications that participant takes and about participants' physical&#xD;
        health to make sure it is safe for the participant to participate in the study. They will&#xD;
        also answer questions that are used to determine if someone might have ASD.&#xD;
  &#xD;
        Participants will be shown a video which will give them information about the lab they will&#xD;
        be coming to do some of the study activities, and information about the people that will be&#xD;
        working with them during the study. Participants will then be randomly assigned (like&#xD;
        flipping a coin) to one of two groups: the Virtual Reality Group, or the Exercise Group. This&#xD;
        will determine what activities or exercise they will do for the upcoming sessions.&#xD;
  &#xD;
        Session #1, about 90 minutes:&#xD;
  &#xD;
        Researchers measure participants height, weight, and length of arm and leg. Researchers will&#xD;
        also measure which hand participants prefer to perform daily activities using Edinburgh&#xD;
        Handedness Inventory- short form (EHI-SF). Participants will also stand on a large mat&#xD;
        containing sensors that will measure how much their body moves back and forth while they are&#xD;
        standing. Participants will stand on the mat for 30 seconds with their eyes open, and then&#xD;
        for 30 seconds with their eyes closed.&#xD;
  &#xD;
        Then, researchers will measure how well participants are able to balance by having them do&#xD;
        some activities like sitting and standing without help, standing with their eyes closed,&#xD;
        reaching forward with their arms stretched in front, placing their right then left foot on a&#xD;
        stool, standing with alternating foot in front, and standing on one foot, alternating right&#xD;
        and left. The researcher will show the participants how to do each of these, and they can&#xD;
        practice a couple of times before the test begins.&#xD;
  &#xD;
        Participants will then do some walking in the lab with special sensors that are attached to&#xD;
        their lower back and feet. This will measure how participants walk. The sensors are attached&#xD;
        with special tape to the cloths and shoes, and are not painful. A special camera will take&#xD;
        pictures as the participants walk, and video recording will be done as well. Participants&#xD;
        will do this several times and will be reminded to walk at a normal pace.&#xD;
  &#xD;
        Lastly, if the participants are in the Virtual Reality Group, their parent/guardian will&#xD;
        receive the Nintendo switch™ console and the sports game to take home.&#xD;
  &#xD;
        At home, 3 times a week for two weeks for 30-40 minutes (Sessions 2-7):&#xD;
  &#xD;
          -  If participants are in the Virtual Reality Group, they will choose 2 video games on the&#xD;
             Nintendo Switch from golf, Frisbee, beach tennis, soccer, Volleyball, badminton,&#xD;
             bowling, and Chambara. Games will be played for 10 minutes each with a 5-minute break&#xD;
             in-between. The same 2 games will be played at each session in the same sequence.&#xD;
             Researchers will provide verbal prompts and encouragement during the games as they watch&#xD;
             participants via Zoom. Each session will take approximately 30-40 minutes. Ideally, each&#xD;
             session will occur with an off day in between, however this may not be realistic&#xD;
             depending on participants schedules and so sessions will occur at their convenience.&#xD;
  &#xD;
          -  If participants are in the Exercise Group, they will perform balance exercises for 15&#xD;
             minutes with 5 minutes of warm and cool down each. Some of the exercises are standing&#xD;
             with one foot in front of the other for 10 seconds, standing on 1 foot for 10 seconds,&#xD;
             standing with feet together etc. Breaks will be given, and they will be given&#xD;
             instructions and encouragement by the researcher who will be watching via Zoom.&#xD;
  &#xD;
        Sessions 8 and 9 (in the lab), about an hour:&#xD;
  &#xD;
        Session #8: 3-5 days after session 7, Participants will complete all the balance and walking&#xD;
        measurements that they did in session #1 excluding parameters such as EHI-SF, leg and arm&#xD;
        length, weight, height. It will take approximately 1 hour.&#xD;
  &#xD;
        On session #9: 4 weeks after session #7, participants will once again complete all the same&#xD;
        activities they completed during visit #8. It will take approximately 1 hour.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 15, 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>Two groups, intervention and the control, will be compared within and between longitudinally 3 times. Before-, after- and 4 weeks after the intervention.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in the center of pressure movement</measure>
      <time_frame>3-5 days before the intervention, 3-5 days after the intervention and 4 weeks after the intervention</time_frame>
      <description>High resolution pressure mat containing multiple integrated sensors is used to detect center of pressure movement of the person standing on it recorded at 100 Hz</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Pediatric Berg's Balance Scale score</measure>
      <time_frame>3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention</time_frame>
      <description>14-component battery that evaluates daily living tasks such as sitting to standing, transferring from one chair to another, and sitting and standing without support. This scale is reliable and valid clinical balance assessment tool for children and youth with motor impairments. Maximum total score is 56 points and minimum total score is 0 points. Higher score indicates better balance such that increase in total score by 3.7 points indicates minimal clinically important difference.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in step length (meters) of the gait</measure>
      <time_frame>3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention</time_frame>
      <description>13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: step length (meters).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in step width (meters) of the gait</measure>
      <time_frame>3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention</time_frame>
      <description>13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: step width (meters).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in stride length (meters) of the gait</measure>
      <time_frame>3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention</time_frame>
      <description>13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: stride length (meters).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in double support period (seconds) of the gait</measure>
      <time_frame>3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention</time_frame>
      <description>13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: double support period (seconds).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the cadence (steps/minute) of the gait</measure>
      <time_frame>3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention</time_frame>
      <description>13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: cadence (number of steps/minute).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in gait velocity (meters/second)</measure>
      <time_frame>3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention</time_frame>
      <description>13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: gait velocity (meters/second).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>Virtual reality active video gaming</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard balance exercises</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Virtual reality active video gaming using Nintendo switch sports</intervention_name>
      <description>Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.</description>
      <arm_group_label>Virtual reality active video gaming</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard physical therapy balance exercises</intervention_name>
      <description>Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.</description>
      <arm_group_label>Standard balance exercises</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age 7-22 years,&#xD;
  &#xD;
            -  existing ASD DSM-5 level 1 or 2 diagnosis confirmed by medical record/ educational&#xD;
               services categorized under ASD/ therapeutic services categorized under ASD/ any other&#xD;
               official document indicating the diagnosis of ASD,&#xD;
  &#xD;
            -  able to follow instructions and&#xD;
  &#xD;
            -  able to stand unsupported for at least 20 minutes.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  epilepsy or other medical conditions which can be exacerbated by looking at a screen,&#xD;
  &#xD;
            -  Uncorrected vision loss or any other eye condition prohibiting looking at the screen&#xD;
               for a prolong time,&#xD;
  &#xD;
            -  co-occurring musculoskeletal conditions such as joint or muscle pain or stiffness that&#xD;
               limits mobility, implanted plates, pins, or screws that limit mobility, fractures or&#xD;
               recent surgeries or any other physical condition that could interfere with the ability&#xD;
               to play an active video game&#xD;
  &#xD;
            -  co-occurring neurological conditions such as numbness or muscle weakness, temporary&#xD;
               loss of vision, speech or strength, loss of consciousness (black out), Dizziness or&#xD;
               lightheadedness, Impaired memory or confusion, any other cooccurring diagnosis that&#xD;
               could be negatively impacted by playing an active video game&#xD;
  &#xD;
            -  any other health conditions that are contraindicated to or may interfere with physical&#xD;
               activity such as impaired hearing (uncorrected), medically documented balance&#xD;
               disorder, Any heart condition prohibiting exercise, chronic pain or any pain at the&#xD;
               time of testing, need assistance to stand for 20 minutes or more,&#xD;
  &#xD;
            -  aggression or other severe behaviors that may limit the ability to safely participate&#xD;
               in the intervention.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>22 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Georgia Frey, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Indiana University, Bloomington</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Surabhi Date, M.P.T.</last_name>
      <phone>812-603-8031</phone>
      <email>dates@iu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Georgia Frey, Ph.D.</last_name>
      <phone>812-369-9800</phone>
      <email>gfrey@indiana.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Indiana University Bloomington</name>
        <address>
          <city>Bloomington</city>
          <state>Indiana</state>
          <zip>47405</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Surabhi Date, M.P.T.</last_name>
        <phone>812-603-8031</phone>
        <email>dates@iu.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Nobile M, Perego P, Piccinini L, Mani E, Rossi A, Bellina M, Molteni M. Further evidence of complex motor dysfunction in drug naive children with autism using automatic motion analysis of gait. Autism. 2011 May;15(3):263-83. doi: 10.1177/1362361309356929. Epub 2011 Apr 8.</citation>
      <PMID>21478224</PMID>
    </reference>
    <reference>
      <citation>Lim YH, Partridge K, Girdler S, Morris SL. Standing Postural Control in Individuals with Autism Spectrum Disorder: Systematic Review and Meta-analysis. J Autism Dev Disord. 2017 Jul;47(7):2238-2253. doi: 10.1007/s10803-017-3144-y.</citation>
      <PMID>28508177</PMID>
    </reference>
    <reference>
      <citation>Harris SR. Early motor delays as diagnostic clues in autism spectrum disorder. Eur J Pediatr. 2017 Sep;176(9):1259-1262. doi: 10.1007/s00431-017-2951-7. Epub 2017 Jun 28.</citation>
      <PMID>28660313</PMID>
    </reference>
    <reference>
      <citation>Li Y, Liu T, Venuti CE. Development of postural stability in children with autism spectrum disorder: a cross-sectional study. Int Biomech. 2021 Dec;8(1):54-62. doi: 10.1080/23335432.2021.1968316.</citation>
      <PMID>34414860</PMID>
    </reference>
    <reference>
      <citation>Minshew NJ, Sung K, Jones BL, Furman JM. Underdevelopment of the postural control system in autism. Neurology. 2004 Dec 14;63(11):2056-61. doi: 10.1212/01.wnl.0000145771.98657.62.</citation>
      <PMID>15596750</PMID>
    </reference>
    <reference>
      <citation>Mazurek MO, Shattuck PT, Wagner M, Cooper BP. Prevalence and correlates of screen-based media use among youths with autism spectrum disorders. J Autism Dev Disord. 2012 Aug;42(8):1757-67. doi: 10.1007/s10803-011-1413-8.</citation>
      <PMID>22160370</PMID>
    </reference>
    <reference>
      <citation>Ye S, Lee JE, Stodden DF, Gao Z. Impact of Exergaming on Children's Motor Skill Competence and Health-Related Fitness: A Quasi-Experimental Study. J Clin Med. 2018 Sep 7;7(9):261. doi: 10.3390/jcm7090261.</citation>
      <PMID>30205483</PMID>
    </reference>
    <reference>
      <citation>Bhat AN, Landa RJ, Galloway JC. Current perspectives on motor functioning in infants, children, and adults with autism spectrum disorders. Phys Ther. 2011 Jul;91(7):1116-29. doi: 10.2522/ptj.20100294. Epub 2011 May 5.</citation>
      <PMID>21546566</PMID>
    </reference>
    <reference>
      <citation>Ruggeri A, Dancel A, Johnson R, Sargent B. The effect of motor and physical activity intervention on motor outcomes of children with autism spectrum disorder: A systematic review. Autism. 2020 Apr;24(3):544-568. doi: 10.1177/1362361319885215. Epub 2019 Nov 29.</citation>
      <PMID>31782658</PMID>
    </reference>
    <reference>
      <citation>Zampella CJ, Wang LAL, Haley M, Hutchinson AG, de Marchena A. Motor Skill Differences in Autism Spectrum Disorder: a Clinically Focused Review. Curr Psychiatry Rep. 2021 Aug 13;23(10):64. doi: 10.1007/s11920-021-01280-6.</citation>
      <PMID>34387753</PMID>
    </reference>
    <reference>
      <citation>Jelsma D, Geuze RH, Mombarg R, Smits-Engelsman BC. The impact of Wii Fit intervention on dynamic balance control in children with probable Developmental Coordination Disorder and balance problems. Hum Mov Sci. 2014 Feb;33:404-18. doi: 10.1016/j.humov.2013.12.007. Epub 2014 Jan 18.</citation>
      <PMID>24444657</PMID>
    </reference>
    <reference>
      <citation>Rafiei Milajerdi H, Sheikh M, Najafabadi MG, Saghaei B, Naghdi N, Dewey D. The Effects of Physical Activity and Exergaming on Motor Skills and Executive Functions in Children with Autism Spectrum Disorder. Games Health J. 2021 Feb;10(1):33-42. doi: 10.1089/g4h.2019.0180. Epub 2020 Dec 23.</citation>
      <PMID>33370161</PMID>
    </reference>
    <reference>
      <citation>Travers BG, Mason AH, Mrotek LA, Ellertson A, Dean DC 3rd, Engel C, Gomez A, Dadalko OI, McLaughlin K. Biofeedback-Based, Videogame Balance Training in Autism. J Autism Dev Disord. 2018 Jan;48(1):163-175. doi: 10.1007/s10803-017-3310-2.</citation>
      <PMID>28921103</PMID>
    </reference>
    <reference>
      <citation>Caldani S, Atzori P, Peyre H, Delorme R, Bucci MP. Short rehabilitation training program may improve postural control in children with autism spectrum disorders: preliminary evidences. Sci Rep. 2020 May 13;10(1):7917. doi: 10.1038/s41598-020-64922-4.</citation>
      <PMID>32404919</PMID>
    </reference>
    <reference>
      <citation>Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.</citation>
      <PMID>17057441</PMID>
    </reference>
    <reference>
      <citation>Goetschius J, Feger MA, Hertel J, Hart JM. Validating Center-of-Pressure Balance Measurements Using the MatScan(R) Pressure Mat. J Sport Rehabil. 2018 Jan 1;27(1). doi: 10.1123/jsr.2017-0152. Epub 2018 Jan 24.</citation>
      <PMID>28714837</PMID>
    </reference>
    <reference>
      <citation>Chen CL, Shen IH, Chen CY, Wu CY, Liu WY, Chung CY. Validity, responsiveness, minimal detectable change, and minimal clinically important change of Pediatric Balance Scale in children with cerebral palsy. Res Dev Disabil. 2013 Mar;34(3):916-22. doi: 10.1016/j.ridd.2012.11.006. Epub 2013 Jan 3.</citation>
      <PMID>23291508</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indiana University</investigator_affiliation>
      <investigator_full_name>Georgia Frey</investigator_full_name>
      <investigator_title>Associate Professor, Public Health</investigator_title>
    </responsible_party>
    <keyword>Autism Spectrum Disorder</keyword>
    <keyword>Balance exercises</keyword>
    <keyword>Virtual reality</keyword>
    <keyword>Active video gaming</keyword>
    <keyword>Gait</keyword>
    <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>No</sharing_ipd>
      <ipd_description>Individual participant data will not be shared to maintain the confidentiality of the participants.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023563
  org study id: 19116
  nct id: NCT06023563
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to assess the effect of short-term (3 days/week for 2
        weeks) Virtual Reality (VR) active video gaming intervention on static and dynamic balance,
        versus traditional balance training exercises, in youth with ASD.
  
        The participants in the intervention group will engage in VR active video gaming using the
        Nintendo Switch Sports under supervision via Zoom for 6 sessions occurring over 2 weeks, from
        their home. While, the participants in the control group will engage in standard physical
        therapy exercises for balance and walking under supervision via Zoom, for 6 sessions
        occurring over 2 weeks, from their home.
  
        Their balance and walking will be assessed 3 times, 3-5 days before the intervention, 3-5
        days after the intervention and 4-weeks after the intervention.
  
          -  Participants static balance will be assessed by standing on pressure mat, under 2
             conditions, eyes open and eyes closed for 30 seconds each.
  
          -  The Pediatric Berg's balance Scale (PBS), a 14-point scale containing everyday
             activities, will be used as a clinical measure for assessing the static and dynamic
             balance.
  
          -  13-infra-red camera motion capture system, Qualisys, will be used for assessing the
             walking.
  
        The difference in the balance and walking parameters will be assessed and compared.
  Postural control deficits, also referred to as balance deficits, are a noted example of
        impaired motor-skills and are increasingly considered as one of the primary markers for
        autism spectrum disorder (ASD)1-5. However, there are very few controlled clinical trials
        examining effects of balance interventions in individuals with ASD. Moreover, to date there
        exist few effective interventions based on well-designed research that address balance
        deficits in youth with ASD and are home-implemented, cost-effective, generalizable, and
        enjoyable and that promote adherence. Virtual reality (VR) active gaming is one such
        intervention that incorporates scientific mechanisms for improving balance. But, there exist
        few, evidence-based best practices that use this method to address balance in youth with ASD.
        In addition to being based on principles of motor learning/control, commercially available VR
        active gaming can be affordable, enjoyable, at-home intervention. Thus, the aim of this study
        is to assess the effect of short-term (3 days/week for 2 weeks) Virtual Reality (VR) active
        video gaming intervention on static and dynamic balance, versus traditional balance training
        exercises, in youth with ASD.
  
        This study will take place at the Physical Activity and Biomechanics Labs at School of Public
        Health, Indiana University, Bloomington, and participants home for total of 9 sessions
        occurring over 7-8 weeks.
  
        Before participants come to the lab:
  
        Participants' parent/guardian will complete a couple of questionnaires that will ask
        questions about any medications that participant takes and about participants' physical
        health to make sure it is safe for the participant to participate in the study. They will
        also answer questions that are used to determine if someone might have ASD.
  
        Participants will be shown a video which will give them information about the lab they will
        be coming to do some of the study activities, and information about the people that will be
        working with them during the study. Participants will then be randomly assigned (like
        flipping a coin) to one of two groups: the Virtual Reality Group, or the Exercise Group. This
        will determine what activities or exercise they will do for the upcoming sessions.
  
        Session #1, about 90 minutes:
  
        Researchers measure participants height, weight, and length of arm and leg. Researchers will
        also measure which hand participants prefer to perform daily activities using Edinburgh
        Handedness Inventory- short form (EHI-SF). Participants will also stand on a large mat
        containing sensors that will measure how much their body moves back and forth while they are
        standing. Participants will stand on the mat for 30 seconds with their eyes open, and then
        for 30 seconds with their eyes closed.
  
        Then, researchers will measure how well participants are able to balance by having them do
        some activities like sitting and standing without help, standing with their eyes closed,
        reaching forward with their arms stretched in front, placing their right then left foot on a
        stool, standing with alternating foot in front, and standing on one foot, alternating right
        and left. The researcher will show the participants how to do each of these, and they can
        practice a couple of times before the test begins.
  
        Participants will then do some walking in the lab with special sensors that are attached to
        their lower back and feet. This will measure how participants walk. The sensors are attached
        with special tape to the cloths and shoes, and are not painful. A special camera will take
        pictures as the participants walk, and video recording will be done as well. Participants
        will do this several times and will be reminded to walk at a normal pace.
  
        Lastly, if the participants are in the Virtual Reality Group, their parent/guardian will
        receive the Nintendo switch™ console and the sports game to take home.
  
        At home, 3 times a week for two weeks for 30-40 minutes (Sessions 2-7):
  
          -  If participants are in the Virtual Reality Group, they will choose 2 video games on the
             Nintendo Switch from golf, Frisbee, beach tennis, soccer, Volleyball, badminton,
             bowling, and Chambara. Games will be played for 10 minutes each with a 5-minute break
             in-between. The same 2 games will be played at each session in the same sequence.
             Researchers will provide verbal prompts and encouragement during the games as they watch
             participants via Zoom. Each session will take approximately 30-40 minutes. Ideally, each
             session will occur with an off day in between, however this may not be realistic
             depending on participants schedules and so sessions will occur at their convenience.
  
          -  If participants are in the Exercise Group, they will perform balance exercises for 15
             minutes with 5 minutes of warm and cool down each. Some of the exercises are standing
             with one foot in front of the other for 10 seconds, standing on 1 foot for 10 seconds,
             standing with feet together etc. Breaks will be given, and they will be given
             instructions and encouragement by the researcher who will be watching via Zoom.
  
        Sessions 8 and 9 (in the lab), about an hour:
  
        Session #8: 3-5 days after session 7, Participants will complete all the balance and walking
        measurements that they did in session #1 excluding parameters such as EHI-SF, leg and arm
        length, weight, height. It will take approximately 1 hour.
  
        On session #9: 4 weeks after session #7, participants will once again complete all the same
        activities they completed during visit #8. It will take approximately 1 hour.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two groups, intervention and the control, will be compared within and between longitudinally 3 times. Before-, after- and 4 weeks after the intervention.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in the center of pressure movement
  time frame: 3-5 days before the intervention, 3-5 days after the intervention and 4 weeks after the intervention
  description: High resolution pressure mat containing multiple integrated sensors is used to detect center of pressure movement of the person standing on it recorded at 100 Hz
  measure: Change in Pediatric Berg's Balance Scale score
  time frame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
  description: 14-component battery that evaluates daily living tasks such as sitting to standing, transferring from one chair to another, and sitting and standing without support. This scale is reliable and valid clinical balance assessment tool for children and youth with motor impairments. Maximum total score is 56 points and minimum total score is 0 points. Higher score indicates better balance such that increase in total score by 3.7 points indicates minimal clinically important difference.
  measure: Change in step length (meters) of the gait
  time frame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
  description: 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: step length (meters).
  measure: Change in step width (meters) of the gait
  time frame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
  description: 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: step width (meters).
  measure: Change in stride length (meters) of the gait
  time frame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
  description: 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: stride length (meters).
  measure: Change in double support period (seconds) of the gait
  time frame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
  description: 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: double support period (seconds).
  measure: Change in the cadence (steps/minute) of the gait
  time frame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
  description: 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: cadence (number of steps/minute).
  measure: Change in gait velocity (meters/second)
  time frame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
  description: 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: gait velocity (meters/second).
  arm group label: Virtual reality active video gaming
  arm group type: Experimental
  description: The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks.
  arm group label: Standard balance exercises
  arm group type: Active Comparator
  description: The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks.
  intervention type: Behavioral
  intervention name: Virtual reality active video gaming using Nintendo switch sports
  description: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.
  arm group label: Virtual reality active video gaming
  intervention type: Behavioral
  intervention name: Standard physical therapy balance exercises
  description: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.
  arm group label: Standard balance exercises
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 22 Years
  healthy volunteers: No
  last name: Georgia Frey, Ph.D.
  role: Principal Investigator
  affiliation: Indiana University, Bloomington
  last name: Surabhi Date, M.P.T.
  phone: 812-603-8031
  email: dates@iu.edu
  last name: Georgia Frey, Ph.D.
  phone: 812-369-9800
  email: gfrey@indiana.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
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  PMID: 21478224
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  PMID: 28508177
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  PMID: 34414860
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  PMID: 15596750
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  PMID: 22160370
  citation: Ye S, Lee JE, Stodden DF, Gao Z. Impact of Exergaming on Children's Motor Skill Competence and Health-Related Fitness: A Quasi-Experimental Study. J Clin Med. 2018 Sep 7;7(9):261. doi: 10.3390/jcm7090261.
  PMID: 30205483
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  PMID: 34387753
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  PMID: 23291508
  responsible party type: Principal Investigator
  investigator affiliation: Indiana University
  investigator full name: Georgia Frey
  investigator title: Associate Professor, Public Health
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive
  sharing ipd: No
  ipd description: Individual participant data will not be shared to maintain the confidentiality of the participants.