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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Motor Activity
• Intervention / Treatment: Behavioral: Horseback riding therapy

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon-si, Korea, Republic of
    • St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: hippotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of gross motor function (assessment of GMFM-88)	Assessment of GMFM-88 before and after the 16 sessions of horse riding program	Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
Change of Berg balance (assessment of pediatric berg balance scale)	Assessment of pediatric berg balance scale before and after the 16 sessions of horse riding	Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actigraph (to monitor activity)	wear an Actigraph to monitor activity of children	During the horse riding therapy/
Child Health Questionnaire (CHQ)	Caregivers answer the sheets	Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
Postural Assessment Scale for Hippotherapy (PASH)	Developed tool for assessment of ability for hippotherapy	From starting the therapy, every 2 weeks re-evaluated through study completion, in total 4 times

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Collaborators: Samsung Medical Center; Konkuk University
• Investigators: Principal Investigator: Bo Young Hong, MD, St.Vincent's Hospital, the Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2017
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: cerebral palsy; horseback riding
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: 316086-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 1 professor in Samsung Medical Center
• IPD Sharing Time Frame: When analysis is done after completion of the study
• IPD Sharing Access Criteria: Primary investigator of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No