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Development of Horse-Riding Program Model for Children With Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041818
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
Konkuk University
Samsung Medical Center
Information provided by (Responsible Party):
Bo Young Hong, The Catholic University of Korea

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Motor Activity Behavioral: Horseback riding therapy Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development of Horse-Riding Program Model for Children With Cerebral Palsy
Actual Study Start Date : March 14, 2017
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: hippotherapy
16 sessions of horseback riding therapy
Behavioral: Horseback riding therapy
Apply 30 minutes/session, twice a week for 8 weeks of horseback riding therapy (provided with 1 horse rider, 2 side walkers)
Other Name: hippotherapy




Primary Outcome Measures :
  1. 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) ]
    Assessment of GMFM-88 before and after the 16 sessions of horse riding program

  2. 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) ]
    Assessment of pediatric berg balance scale before and after the 16 sessions of horse riding


Secondary Outcome Measures :
  1. Actigraph (to monitor activity) [ Time Frame: During the horse riding therapy/ ]
    wear an Actigraph to monitor activity of children

  2. Child Health Questionnaire (CHQ) [ Time Frame: Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks) ]
    Caregivers answer the sheets

  3. Postural Assessment Scale for Hippotherapy (PASH) [ Time Frame: From starting the therapy, every 2 weeks re-evaluated through study completion, in total 4 times ]
    Developed tool for assessment of ability for hippotherapy



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children or adolescent with cerebral palsy
  • GMFCS level I, II, III
  • Body weight less than 80 kg

Exclusion Criteria:

  • Medical condition who are not suitable for hippotherapy: severe osteoporosis, mental illness, not controlled seizure disorder etc.
  • Social condition who are not suitable for hippotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041818


Locations
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Korea, Republic of
St. Vincent's hospital
Suwon-si, Korea, Republic of
Sponsors and Collaborators
The Catholic University of Korea
Konkuk University
Samsung Medical Center
Investigators
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Principal Investigator: Bo Young Hong, MD St.Vincent's hospital, The Catholic University of Korea
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Responsible Party: Bo Young Hong, Assistant professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03041818    
Other Study ID Numbers: 316086-2
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 1 professor in Samsung Medical Center
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: When analysis is done after completion of the study
Access Criteria: Primary investigator of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bo Young Hong, The Catholic University of Korea:
cerebral palsy
horseback riding
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases