<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/NCT03041818</url>
  </required_header>
  <id_info>
    <org_study_id>316086-2</org_study_id>
    <nct_id>NCT03041818</nct_id>
  </id_info>
  <brief_title>Development of Horse-Riding Program Model for Children With Cerebral Palsy</brief_title>
  <official_title>Development of Horse-Riding Program Model for Children With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Konkuk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Catholic University of Korea</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to develop healing riding algorithm applicable in rural riding&#xD;
      centers and to apply this to children with cerebral palsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Horseback riding activities in Korea's riding centers have mostly centered on physical&#xD;
      rehabilitation for children with special needs, including those with cerebral palsy, mental&#xD;
      disabilities, and autism, with the program conducted by certified equine-assisted therapy&#xD;
      instructors. However, there is no definite way to assess the ability of children for&#xD;
      horseback riding and no standard riding program. Therefore, developing a assessment and&#xD;
      program algorithm for healing horseback riding is expected to contribute to providing more&#xD;
      activities for children with special needs and also for general people.&#xD;
&#xD;
      Children older than 4 years old or adolescent with cerebral palsy who voluntarily want to&#xD;
      enroll this study would be enrolled.&#xD;
&#xD;
      Participants have 2 times of 30-minute horse riding program for 8 weeks, total 16 times of&#xD;
      riding program in a local horse riding center.&#xD;
&#xD;
      Sample size assessment: Calculating for 20% of drop out, 16 patients were calculated to apply&#xD;
      the assessment and applicable program.&#xD;
&#xD;
      Drop out: missing more than 2 lessons of horse-riding&#xD;
&#xD;
      Plan for missing data: not included&#xD;
&#xD;
      Statistical analysis plan: paired t-test for the outcome measures&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2017</start_date>
  <completion_date type="Actual">October 31, 2017</completion_date>
  <primary_completion_date type="Actual">October 31, 2017</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of gross motor function (assessment of GMFM-88)</measure>
    <time_frame>Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)</time_frame>
    <description>Assessment of GMFM-88 before and after the 16 sessions of horse riding program</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Berg balance (assessment of pediatric berg balance scale)</measure>
    <time_frame>Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)</time_frame>
    <description>Assessment of pediatric berg balance scale before and after the 16 sessions of horse riding</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Actigraph (to monitor activity)</measure>
    <time_frame>During the horse riding therapy/</time_frame>
    <description>wear an Actigraph to monitor activity of children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Health Questionnaire (CHQ)</measure>
    <time_frame>Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)</time_frame>
    <description>Caregivers answer the sheets</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postural Assessment Scale for Hippotherapy (PASH)</measure>
    <time_frame>From starting the therapy, every 2 weeks re-evaluated through study completion, in total 4 times</time_frame>
    <description>Developed tool for assessment of ability for hippotherapy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Motor Activity</condition>
  <arm_group>
    <arm_group_label>hippotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>16 sessions of horseback riding therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Horseback riding therapy</intervention_name>
    <description>Apply 30 minutes/session, twice a week for 8 weeks of horseback riding therapy (provided with 1 horse rider, 2 side walkers)</description>
    <arm_group_label>hippotherapy</arm_group_label>
    <other_name>hippotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children or adolescent with cerebral palsy&#xD;
&#xD;
          -  GMFCS level I, II, III&#xD;
&#xD;
          -  Body weight less than 80 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical condition who are not suitable for hippotherapy: severe osteoporosis, mental&#xD;
             illness, not controlled seizure disorder etc.&#xD;
&#xD;
          -  Social condition who are not suitable for hippotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bo Young Hong, MD</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>May 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>May 16, 2018</last_update_submitted>
  <last_update_submitted_qc>May 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 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>horseback riding</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>1 professor in Samsung Medical Center</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>When analysis is done after completion of the study</ipd_time_frame>
    <ipd_access_criteria>Primary investigator of the study</ipd_access_criteria>
  </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/NCT03041818
org study id: 316086-2
nct id: NCT03041818
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to develop healing riding algorithm applicable in rural riding
      centers and to apply this to children with cerebral palsy.
Horseback riding activities in Korea's riding centers have mostly centered on physical
      rehabilitation for children with special needs, including those with cerebral palsy, mental
      disabilities, and autism, with the program conducted by certified equine-assisted therapy
      instructors. However, there is no definite way to assess the ability of children for
      horseback riding and no standard riding program. Therefore, developing a assessment and
      program algorithm for healing horseback riding is expected to contribute to providing more
      activities for children with special needs and also for general people.

      Children older than 4 years old or adolescent with cerebral palsy who voluntarily want to
      enroll this study would be enrolled.

      Participants have 2 times of 30-minute horse riding program for 8 weeks, total 16 times of
      riding program in a local horse riding center.

      Sample size assessment: Calculating for 20% of drop out, 16 patients were calculated to apply
      the assessment and applicable program.

      Drop out: missing more than 2 lessons of horse-riding

      Plan for missing data: not included

      Statistical analysis plan: paired t-test for the outcome measures
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change of gross motor function (assessment of GMFM-88)
time frame: Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
description: Assessment of GMFM-88 before and after the 16 sessions of horse riding program
measure: Change of Berg balance (assessment of pediatric berg balance scale)
time frame: Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
description: Assessment of pediatric berg balance scale before and after the 16 sessions of horse riding
measure: Actigraph (to monitor activity)
time frame: During the horse riding therapy/
description: wear an Actigraph to monitor activity of children
measure: Child Health Questionnaire (CHQ)
time frame: Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
description: Caregivers answer the sheets
measure: Postural Assessment Scale for Hippotherapy (PASH)
time frame: From starting the therapy, every 2 weeks re-evaluated through study completion, in total 4 times
description: Developed tool for assessment of ability for hippotherapy
arm group label: hippotherapy
arm group type: Experimental
description: 16 sessions of horseback riding therapy
intervention type: Behavioral
intervention name: Horseback riding therapy
description: Apply 30 minutes/session, twice a week for 8 weeks of horseback riding therapy (provided with 1 horse rider, 2 side walkers)
arm group label: hippotherapy
other name: hippotherapy
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Bo Young Hong, MD
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
sharing ipd: Yes
ipd description: 1 professor in Samsung Medical Center
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: When analysis is done after completion of the study
ipd access criteria: Primary investigator of the study