<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/NCT04489498</url>
  </required_header>
  <id_info>
    <org_study_id>B-1909/562-302</org_study_id>
    <nct_id>NCT04489498</nct_id>
  </id_info>
  <brief_title>Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study</brief_title>
  <official_title>Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to: 1) secure basic data of patients with cerebral palsy, 2)&#xD;
      seek ways to simplify the data for clinical application, 3) progress of hip dislocation,&#xD;
      presence or absence of hip surgery, and The purpose of this study is to compare differences&#xD;
      in body development according to severity and nutritional methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2019</start_date>
  <completion_date type="Actual">September 6, 2021</completion_date>
  <primary_completion_date type="Actual">September 6, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anthropometric data (body length)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Measure the body length using a tape measure.(cm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anthropometric data (BMI)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>weight and height will be combined to report BMI in kg/m^2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anthropometric data (body circumference )</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Measure the body circumference using a tape measure.(cm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression of hip dislocation</measure>
    <time_frame>Use simple x-ray within 1 year prior to participation</time_frame>
    <description>It is measured by migration index, which measures the proportion of femoral heads not covered by acetabulum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression of scoliosis</measure>
    <time_frame>Use simple x-ray within 1 year prior to participation</time_frame>
    <description>The degree of scoliosis is measured by Cobbs angle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Have hip dislocation surgery</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Confirmation of hip dislocation surgery</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">196</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Children with stiff cerebral palsy</arm_group_label>
    <description>Children with stiff cerebral palsy, aged 1 to 13 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal children</arm_group_label>
    <description>Normal children, aged 1 to 13 years</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        It is difficult to find the basis for calculation because there are no papers that measure&#xD;
        the body size of children with cerebral palsy and papers that compare with normal children.&#xD;
        In particular, children with cerebral palsy are rare diseases, and it is difficult to&#xD;
        recruit a large number of subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 1 to 13&#xD;
&#xD;
          -  Experiment group: Children with cerebral palsy, Control group: Normal children&#xD;
&#xD;
          -  Patients who agreed to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  do not agree with the study&#xD;
&#xD;
          -  Those who find it difficult to participate under the judgment of the research director&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul national university bundang hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Bundang-gu</state>
        <zip>13354</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>November 5, 2021</last_update_submitted>
  <last_update_submitted_qc>November 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Ju Seok Ryu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <!-- 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/NCT04489498
org study id: B-1909/562-302
nct id: NCT04489498
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to: 1) secure basic data of patients with cerebral palsy, 2)
      seek ways to simplify the data for clinical application, 3) progress of hip dislocation,
      presence or absence of hip surgery, and The purpose of this study is to compare differences
      in body development according to severity and nutritional methods.
observational model: Case-Control
time perspective: Other
measure: Anthropometric data (body length)
time frame: through study completion, an average of 1 year
description: Measure the body length using a tape measure.(cm)
measure: Anthropometric data (BMI)
time frame: through study completion, an average of 1 year
description: weight and height will be combined to report BMI in kg/m^2
measure: Anthropometric data (body circumference )
time frame: through study completion, an average of 1 year
description: Measure the body circumference using a tape measure.(cm)
measure: Progression of hip dislocation
time frame: Use simple x-ray within 1 year prior to participation
description: It is measured by migration index, which measures the proportion of femoral heads not covered by acetabulum
measure: Progression of scoliosis
time frame: Use simple x-ray within 1 year prior to participation
description: The degree of scoliosis is measured by Cobbs angle
measure: Have hip dislocation surgery
time frame: through study completion, an average of 1 year
description: Confirmation of hip dislocation surgery
arm group label: Children with stiff cerebral palsy
description: Children with stiff cerebral palsy, aged 1 to 13 years
arm group label: Normal children
description: Normal children, aged 1 to 13 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Ju Seok Ryu
investigator title: Professor
mesh term: Cerebral Palsy