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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041818
• Other study ID #: 316086-2
• Status: Completed
• Phase: N/A
• Start date: March 14, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: May 2018
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Motor Activity
• Paralysis

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's hospital	Suwon-si

Sponsors (3)

Lead Sponsor	Collaborator
The Catholic University of Korea	Konkuk University, Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Actigraph (to monitor activity)	wear an Actigraph to monitor activity of children	During the horse riding therapy/
Secondary	Child Health Questionnaire (CHQ)	Caregivers answer the sheets	Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
Secondary	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