<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/NCT02184715</url>
  </required_header>
  <id_info>
    <org_study_id>HP-01</org_study_id>
    <nct_id>NCT02184715</nct_id>
  </id_info>
  <brief_title>Effects of Virtual Reality System in Children With Developmental Delays</brief_title>
  <official_title>The Additional Therapeutic Effects of Virtual Reality System in Children With Developmental Delays</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ru-Lan Hsieh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effects of virtual reality system on children&#xD;
      with developmental delays.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants attended eight 30-minute sessions of virtual reality system for 4 weeks in&#xD;
      addition to regular rehabilitation programs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">January 2011</primary_completion_date>
  <phase>Phase 4</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>health of children (Pediatric Quality of Life Inventory)</measure>
    <time_frame>changes from baseline at one and two months.</time_frame>
    <description>Following the recruitment and baseline assessment, outcome measures were assessed before treatment (Time 0), at the end of first intervention in the fourth week (Time 1), and at the end of second intervention in the eighth week (Time 2).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">157</enrollment>
  <condition>Developmental Delays</condition>
  <arm_group>
    <arm_group_label>Virtual reality video game</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received rehabilitation treatment and additional virtual reality system (30 minutes of interactive virtual reality system play, two times per week, in eight sessions over a 4-week span) for 1 month, followed by rehabilitation treatment for 1 month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual reality system</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>received rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system (30 minutes of interactive video game play, two times per week, in eight sessions over a 4-week span) during the one month of intervention period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>virtual reality system</intervention_name>
    <description>The participants were randomly assigned to either Group A or Group B. Group A received rehabilitation treatment and additional virtual reality system for 1 month, followed by rehabilitation treatment for 1 month; by contrast, the participants in Group B received rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system for 1 month.</description>
    <arm_group_label>Virtual reality system</arm_group_label>
    <arm_group_label>Virtual reality video game</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed to have developmental delays&#xD;
&#xD;
          -  provided informed consent&#xD;
&#xD;
          -  2 to 12 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  failed to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ru-Lan Hsieh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shin Kong Wu Ho-Su Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>111-01</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 8, 2014</last_update_submitted>
  <last_update_submitted_qc>July 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University</investigator_affiliation>
    <investigator_full_name>Ru-Lan Hsieh</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>virtual reality system, children, developmental delay</keyword>
  <!-- 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/NCT02184715
org study id: HP-01
nct id: NCT02184715
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the effects of virtual reality system on children
      with developmental delays.
Participants attended eight 30-minute sessions of virtual reality system for 4 weeks in
      addition to regular rehabilitation programs.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: health of children (Pediatric Quality of Life Inventory)
time frame: changes from baseline at one and two months.
description: Following the recruitment and baseline assessment, outcome measures were assessed before treatment (Time 0), at the end of first intervention in the fourth week (Time 1), and at the end of second intervention in the eighth week (Time 2).
arm group label: Virtual reality video game
arm group type: Active Comparator
description: Participants received rehabilitation treatment and additional virtual reality system (30 minutes of interactive virtual reality system play, two times per week, in eight sessions over a 4-week span) for 1 month, followed by rehabilitation treatment for 1 month
arm group label: Virtual reality system
arm group type: Placebo Comparator
description: received rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system (30 minutes of interactive video game play, two times per week, in eight sessions over a 4-week span) during the one month of intervention period.
intervention type: Other
intervention name: virtual reality system
description: The participants were randomly assigned to either Group A or Group B. Group A received rehabilitation treatment and additional virtual reality system for 1 month, followed by rehabilitation treatment for 1 month; by contrast, the participants in Group B received rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system for 1 month.
arm group label: Virtual reality system
arm group label: Virtual reality video game
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: Ru-Lan Hsieh, MD
role: Principal Investigator
affiliation: Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
facility: 
country: Taiwan
responsible party type: Sponsor-Investigator
investigator affiliation: Taipei Medical University
investigator full name: Ru-Lan Hsieh
investigator title: MD