Clinical trial NCT03041818: Development of Horse-Riding Program Model for Children With Cerebral Palsy
Official title: Development of Horse-Riding Program Model for Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Motor Activity
Keywords: cerebral palsy
horseback riding
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Konkuk University
name: Samsung Medical Center
First posted: 2017-02-03
Enrollment: 12
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility 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

Primary outcomes:
measure: Change of gross motor function (assessment of GMFM-88)
timeFrame: Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
measure: Change of Berg balance (assessment of pediatric berg balance scale)
timeFrame: Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
Secondary outcomes:
measure: Actigraph (to monitor activity)
timeFrame: During the horse riding therapy/
measure: Child Health Questionnaire (CHQ)
timeFrame: Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
measure: Postural Assessment Scale for Hippotherapy (PASH)
timeFrame: From starting the therapy, every 2 weeks re-evaluated through study completion, in total 4 times
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: St. Vincent's hospital
Study officials:
affiliation: St.Vincent's hospital, The Catholic University of Korea
name: Bo Young Hong, MD
role: PRINCIPAL_INVESTIGATOR
References: