<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/NCT04483050</url>
  </required_header>
  <id_info>
    <org_study_id>B-2002/594-305</org_study_id>
    <nct_id>NCT04483050</nct_id>
  </id_info>
  <brief_title>The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Pilot Study</brief_title>
  <official_title>The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Open Label, Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Korea Health Industry Development Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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 Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in&#xD;
      Patients With Severe Neuromuscular Disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2020</start_date>
  <completion_date type="Actual">March 11, 2021</completion_date>
  <primary_completion_date type="Actual">March 11, 2021</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Migration index</measure>
    <time_frame>6 months</time_frame>
    <description>Hip AP radiography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cobb's angle (')</measure>
    <time_frame>6 months</time_frame>
    <description>using radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion of hip joint (')</measure>
    <time_frame>6 months</time_frame>
    <description>Using goniometer, measure the hip and knee abduction and flexion angle expressed by degree from 0' to 180'. The closer to 180', the better the value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analog scale</measure>
    <time_frame>6 months</time_frame>
    <description>measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Likert scale (score)</measure>
    <time_frame>immediately after wearing orthosis</time_frame>
    <description>measure the satisfaction about hip protection orthosis expressed by score from 0 to 5. The closer to 5, the higher the satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Health Index of Life with Disabilities (CPCHILD)</measure>
    <time_frame>6 months</time_frame>
    <description>measure the quality of life expressed by score from 0 to 100. The higher the quality of life.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hip protection orthosis</intervention_name>
    <description>Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age from 1 to 15&#xD;
&#xD;
          -  Patients with severe neuromuscular disease&#xD;
&#xD;
          -  Patients who agreed to participate in the study&#xD;
&#xD;
          -  Hip dislocation more than 10% (migration index)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If do not agree with the study&#xD;
&#xD;
          -  Those who are determined to be difficult to participate under the judgment of the&#xD;
             research director&#xD;
&#xD;
          -  History of hip joint surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juseok Ryu, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <state>Seongnam-si, Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>November 22, 2022</last_update_submitted>
  <last_update_submitted_qc>November 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2022</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>Hip Dislocation</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Neuromuscular Diseases</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/NCT04483050
org study id: B-2002/594-305
nct id: NCT04483050
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in
      Patients With Severe Neuromuscular Disease
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Migration index
time frame: 6 months
description: Hip AP radiography
measure: Cobb's angle (')
time frame: 6 months
description: using radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value.
measure: Range of motion of hip joint (')
time frame: 6 months
description: Using goniometer, measure the hip and knee abduction and flexion angle expressed by degree from 0' to 180'. The closer to 180', the better the value.
measure: Visual analog scale
time frame: 6 months
description: measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.
measure: Likert scale (score)
time frame: immediately after wearing orthosis
description: measure the satisfaction about hip protection orthosis expressed by score from 0 to 5. The closer to 5, the higher the satisfaction.
measure: Child Health Index of Life with Disabilities (CPCHILD)
time frame: 6 months
description: measure the quality of life expressed by score from 0 to 100. The higher the quality of life.
arm group label: experimental group
arm group type: Experimental
intervention type: Device
intervention name: Hip protection orthosis
description: Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.
arm group label: experimental group
criteria: 
gender: All
minimum age: 1 Year
maximum age: 15 Years
healthy volunteers: No
last name: Juseok Ryu, PhD
role: Study Director
affiliation: Seoul National University Bundang Hospital
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: Hip Dislocation
mesh term: Cerebral Palsy
mesh term: Neuromuscular Diseases