<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/NCT03277027</url>
  </required_header>
  <id_info>
    <org_study_id>VC17OESI0046</org_study_id>
    <nct_id>NCT03277027</nct_id>
  </id_info>
  <brief_title>Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy</brief_title>
  <official_title>Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Catholic University of Korea</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 primary aim of this study is assessing physical activity, the quality of sleep and health&#xD;
      related quality of life in children with cerebral palsy, and parenting stress of caregivers&#xD;
      of the children with cerebral palsy in Korea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Monitor the physical activity, health related quality of life, parenting stress according to&#xD;
      GMFCS level in children with cerebral palsy in Korea.&#xD;
&#xD;
        1. Physical activity and quality of sleep are monitored by wearing Actigraph for a week.&#xD;
&#xD;
        2. Health related quality of life is checked by parents withChild Health Questionnaire&#xD;
           Parent Form 50 (CHQ-PF50).&#xD;
&#xD;
        3. Parenting stress is monitored with Korean Parenting Stress Index-Short Form (K-PSI-SF)&#xD;
           by parents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2017</start_date>
  <completion_date type="Actual">May 10, 2018</completion_date>
  <primary_completion_date type="Actual">May 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Non-randomized single group Accelerometer was weared for a week to check physical activity and sleep in children with cerebral palsy.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Monitored for a week</time_frame>
    <description>vector magnitude, steps, percentage of sedentary time monitored with Actigraph</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>health related quality of life</measure>
    <time_frame>Once (cross sectional)</time_frame>
    <description>Checked with Child Health Questionnaire Parent Form 50 (CHQ-PF50) by parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting stress</measure>
    <time_frame>Once (cross sectional)</time_frame>
    <description>Checked with Korean Parenting Stress Index-Short Form (K-PSI-SF) by parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of sleep</measure>
    <time_frame>Monitored for a week</time_frame>
    <description>Sleep efficiency, number of awakening monitored with Actigraph</description>
  </secondary_outcome>
  <enrollment type="Actual">62</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Quality of Life</condition>
  <condition>Physical Activity</condition>
  <condition>Physical Disability</condition>
  <condition>Parenting</condition>
  <condition>Sleep Disorder</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>interventional study</intervention_name>
    <description>The participants wear a monitoring equipment (Actigraph) for a week. And parents do Child Health Questionnaire Parent Form 50 (CHQ-PF50), and Korean Parenting Stress Index-Short Form (K-PSI-SF)</description>
    <other_name>Wear a monitoring equipment (Actigraph) for a week</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with cerebral palsy, 4-19 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with progressive brain lesions, tumors, leukodystrophies, etc.&#xD;
&#xD;
          -  Children with mitochondrial myopathy&#xD;
&#xD;
          -  Some diseases that are known to progress, Rett syndrome, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Vincent's hospital, The Catholic University of Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Vincent's hospital</name>
      <address>
        <city>Suwon-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>July 22, 2018</last_update_submitted>
  <last_update_submitted_qc>July 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Bo Young Hong</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>cerebral palsy</keyword>
  <keyword>Health-Related Quality Of Life</keyword>
  <keyword>Physical Activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD is only available to main reserchers</ipd_description>
  </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/NCT03277027
org study id: VC17OESI0046
nct id: NCT03277027
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is assessing physical activity, the quality of sleep and health
      related quality of life in children with cerebral palsy, and parenting stress of caregivers
      of the children with cerebral palsy in Korea.
Monitor the physical activity, health related quality of life, parenting stress according to
      GMFCS level in children with cerebral palsy in Korea.

        1. Physical activity and quality of sleep are monitored by wearing Actigraph for a week.

        2. Health related quality of life is checked by parents withChild Health Questionnaire
           Parent Form 50 (CHQ-PF50).

        3. Parenting stress is monitored with Korean Parenting Stress Index-Short Form (K-PSI-SF)
           by parents.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Non-randomized single group Accelerometer was weared for a week to check physical activity and sleep in children with cerebral palsy.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Physical activity
time frame: Monitored for a week
description: vector magnitude, steps, percentage of sedentary time monitored with Actigraph
measure: health related quality of life
time frame: Once (cross sectional)
description: Checked with Child Health Questionnaire Parent Form 50 (CHQ-PF50) by parents
measure: Parenting stress
time frame: Once (cross sectional)
description: Checked with Korean Parenting Stress Index-Short Form (K-PSI-SF) by parents
measure: Quality of sleep
time frame: Monitored for a week
description: Sleep efficiency, number of awakening monitored with Actigraph
intervention type: Other
intervention name: interventional study
description: The participants wear a monitoring equipment (Actigraph) for a week. And parents do Child Health Questionnaire Parent Form 50 (CHQ-PF50), and Korean Parenting Stress Index-Short Form (K-PSI-SF)
other name: Wear a monitoring equipment (Actigraph) for a week
criteria: 
gender: All
minimum age: 4 Years
maximum age: 19 Years
healthy volunteers: No
last name: Hong
role: Principal Investigator
affiliation: St. Vincent's hospital, The Catholic University of Korea
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Bo Young Hong
investigator title: Assistant professor
mesh term: Paralysis
mesh term: Cerebral Palsy
mesh term: Sleep Wake Disorders
sharing ipd: No
ipd description: IPD is only available to main reserchers