<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/NCT02223741</url>
  </required_header>
  <id_info>
    <org_study_id>CP_conjugated rehabilitation</org_study_id>
    <nct_id>NCT02223741</nct_id>
  </id_info>
  <brief_title>Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy</brief_title>
  <official_title>An Observational Study of the Conventional Rehabilitation and Traditional Korean Medicine Conjugated Rehabilitation on Children With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korean Medicine Hospital of Pusan National University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Korea Health Industry Development Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Korean Medicine Hospital of Pusan National University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to assess effectiveness, safety and cost-utility of conventional&#xD;
      rehabilitation and traditional Korean medicine conjugated rehabilitation on children with&#xD;
      cerebral palsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Survey&#xD;
&#xD;
             1. An interview survey on baseline&#xD;
&#xD;
                  -  Basic characteristics&#xD;
&#xD;
                  -  Cause of cerebral palsy&#xD;
&#xD;
                  -  Accompanied disorders&#xD;
&#xD;
                  -  Health problems&#xD;
&#xD;
                  -  Operation history&#xD;
&#xD;
                  -  Drug-taking&#xD;
&#xD;
                  -  Rehabilitation treatment&#xD;
&#xD;
                  -  Korean medicine treatment&#xD;
&#xD;
                  -  Health functional food&#xD;
&#xD;
                  -  Medical care cost&#xD;
&#xD;
             2. An interview survey on 26th and 52nd weeks&#xD;
&#xD;
                  -  Accompanied disorders&#xD;
&#xD;
                  -  Health problems&#xD;
&#xD;
             3. A weekly tracking survey&#xD;
&#xD;
                  -  Health problems&#xD;
&#xD;
                  -  Therapeutic change&#xD;
&#xD;
                  -  Medical care cost&#xD;
&#xD;
                  -  Quality of life&#xD;
&#xD;
        2. Assessment for function development on baseline, 26th and 52nd weeks&#xD;
&#xD;
             -  Gross Motor Function Classification System (GMFCS)&#xD;
&#xD;
             -  Gross Motor Function Measure-66 (GMFM-66)&#xD;
&#xD;
             -  Pediatric Evaluation of Disability Inventory (PEDI)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">May 11, 2017</completion_date>
  <primary_completion_date type="Actual">May 11, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Change from baseline on GMFM-66 scores at week 26 and 52</measure>
    <time_frame>Baseline, Week 26, Week 52</time_frame>
    <description>The GMFM-66 includes 66 items identified through Rasch analysis, which, together, best describe gross motor function in children with cerebral palsy of varying abilities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline on PEDI scores at week 26 and 52</measure>
    <time_frame>Baseline, Week 26, Week 52</time_frame>
    <description>The PEDI measures abilities in the three functional domains of self-care, mobility and social function with 217 questions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of severity from baseline on accompanied disorders and health problems at week 24 and 52</measure>
    <time_frame>Baseline, Week 26, Week 52</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Economy evaluation</measure>
    <time_frame>Baseline, Week 26, Week 52</time_frame>
    <description>Direct and indirect medical care cost, Labor productivity of family</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants with Serious and Non-Serious Adverse Events</measure>
    <time_frame>up to 52 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline on height and weight at week 24 and 52</measure>
    <time_frame>Baseline, Week 26, Week 52</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">207</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Korean medicine conjugate rehabilitation</arm_group_label>
    <description>those with more than 30 days of herbal drugs or more than 12 times of acupuncture (Korean medical treatment) within six months in addition to conventional rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional rehabilitation</arm_group_label>
    <description>those with one of the treatments; physical, occupational, speech-language or cognitive-behavioral therapies</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Korean medical treatment</intervention_name>
    <description>acupuncture and herbal drugs</description>
    <arm_group_label>Korean medicine conjugate rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Population will be selected from rehabilitation clinics for children&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with cerebral palsy&#xD;
&#xD;
          -  Age from 6 to 78 months&#xD;
&#xD;
          -  whose guardian consent to the present study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  who had an orthopedic operation due to cerebral palsy&#xD;
&#xD;
          -  who has congenital muscular disease, hereditary disease, or progressive central&#xD;
             nervous system diseases&#xD;
&#xD;
          -  who suffers from severe diseases (ie, cancer, severe heart disease, severe infectious&#xD;
             disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>78 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young-Ju Yun, MD, Ph D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Korean Medicine Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pusan national University Yangsan Hospital</name>
      <address>
        <city>Yangsan</city>
        <state>Gyeongnam</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>602-739</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seongmo-i Oriental Medical Clinic</name>
      <address>
        <city>Daegu</city>
        <zip>563-4</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haema Oriental Medical Clinic</name>
      <address>
        <city>Seoul</city>
        <zip>1605-5</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heoyoungjin Oriental Medical Clinic</name>
      <address>
        <city>Seoul</city>
        <zip>936-7</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-Eui University Korean Medical Hospital</name>
      <address>
        <city>Ulsan</city>
        <zip>479-7</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>February 23, 2020</last_update_submitted>
  <last_update_submitted_qc>February 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Korean Medicine Hospital of Pusan National University</investigator_affiliation>
    <investigator_full_name>Young Ju Yun</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Cerebral palsy</keyword>
  <keyword>GMFM-66</keyword>
  <keyword>PEDI</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>
  </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/NCT02223741
org study id: CP_conjugated rehabilitation
nct id: NCT02223741
lead sponsor: 
collaborator: 
has dmc: No
This study is designed to assess effectiveness, safety and cost-utility of conventional
      rehabilitation and traditional Korean medicine conjugated rehabilitation on children with
      cerebral palsy.
1. Survey

             1. An interview survey on baseline

                  -  Basic characteristics

                  -  Cause of cerebral palsy

                  -  Accompanied disorders

                  -  Health problems

                  -  Operation history

                  -  Drug-taking

                  -  Rehabilitation treatment

                  -  Korean medicine treatment

                  -  Health functional food

                  -  Medical care cost

             2. An interview survey on 26th and 52nd weeks

                  -  Accompanied disorders

                  -  Health problems

             3. A weekly tracking survey

                  -  Health problems

                  -  Therapeutic change

                  -  Medical care cost

                  -  Quality of life

        2. Assessment for function development on baseline, 26th and 52nd weeks

             -  Gross Motor Function Classification System (GMFCS)

             -  Gross Motor Function Measure-66 (GMFM-66)

             -  Pediatric Evaluation of Disability Inventory (PEDI)
observational model: Cohort
time perspective: Prospective
measure: Change from baseline on GMFM-66 scores at week 26 and 52
time frame: Baseline, Week 26, Week 52
description: The GMFM-66 includes 66 items identified through Rasch analysis, which, together, best describe gross motor function in children with cerebral palsy of varying abilities.
measure: Change from baseline on PEDI scores at week 26 and 52
time frame: Baseline, Week 26, Week 52
description: The PEDI measures abilities in the three functional domains of self-care, mobility and social function with 217 questions.
measure: Change of severity from baseline on accompanied disorders and health problems at week 24 and 52
time frame: Baseline, Week 26, Week 52
measure: Economy evaluation
time frame: Baseline, Week 26, Week 52
description: Direct and indirect medical care cost, Labor productivity of family
measure: Number of Participants with Serious and Non-Serious Adverse Events
time frame: up to 52 weeks
measure: Change from baseline on height and weight at week 24 and 52
time frame: Baseline, Week 26, Week 52
arm group label: Korean medicine conjugate rehabilitation
description: those with more than 30 days of herbal drugs or more than 12 times of acupuncture (Korean medical treatment) within six months in addition to conventional rehabilitation
arm group label: Conventional rehabilitation
description: those with one of the treatments; physical, occupational, speech-language or cognitive-behavioral therapies
intervention type: Other
intervention name: Korean medical treatment
description: acupuncture and herbal drugs
arm group label: Korean medicine conjugate rehabilitation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 78 Months
healthy volunteers: No
last name: Young-Ju Yun, MD, Ph D.
role: Principal Investigator
affiliation: Pusan National University Korean Medicine Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Korean Medicine Hospital of Pusan National University
investigator full name: Young Ju Yun
investigator title: Associate Professor
mesh term: Paralysis
mesh term: Cerebral Palsy