Development of Horse-Riding Program Model for Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Motor Activity
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Horseback riding therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Cerebral Palsy focused on measuring cerebral palsy, horseback riding
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
Sites / Locations
- St. Vincent's hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hippotherapy
Arm Description
16 sessions of horseback riding therapy
Outcomes
Primary Outcome Measures
Change of gross motor function (assessment of GMFM-88)
Assessment of GMFM-88 before and after the 16 sessions of horse riding program
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
Secondary Outcome Measures
Actigraph (to monitor activity)
wear an Actigraph to monitor activity of children
Child Health Questionnaire (CHQ)
Caregivers answer the sheets
Postural Assessment Scale for Hippotherapy (PASH)
Developed tool for assessment of ability for hippotherapy
Full Information
NCT ID
NCT03041818
First Posted
January 31, 2017
Last Updated
May 16, 2018
Sponsor
The Catholic University of Korea
Collaborators
Konkuk University, Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03041818
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 14, 2017 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
Collaborators
Konkuk University, Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Motor Activity
Keywords
cerebral palsy, horseback riding
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hippotherapy
Arm Type
Experimental
Arm Description
16 sessions of horseback riding therapy
Intervention Type
Behavioral
Intervention Name(s)
Horseback riding therapy
Other Intervention Name(s)
hippotherapy
Intervention Description
Apply 30 minutes/session, twice a week for 8 weeks of horseback riding therapy (provided with 1 horse rider, 2 side walkers)
Primary Outcome Measure Information:
Title
Change of gross motor function (assessment of GMFM-88)
Description
Assessment of GMFM-88 before and after the 16 sessions of horse riding program
Time Frame
Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
Title
Change of Berg balance (assessment of pediatric berg balance scale)
Description
Assessment of pediatric berg balance scale before and after the 16 sessions of horse riding
Time Frame
Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
Secondary Outcome Measure Information:
Title
Actigraph (to monitor activity)
Description
wear an Actigraph to monitor activity of children
Time Frame
During the horse riding therapy/
Title
Child Health Questionnaire (CHQ)
Description
Caregivers answer the sheets
Time Frame
Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
Title
Postural Assessment Scale for Hippotherapy (PASH)
Description
Developed tool for assessment of ability for hippotherapy
Time Frame
From starting the therapy, every 2 weeks re-evaluated through study completion, in total 4 times
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Young Hong, MD
Organizational Affiliation
St.Vincent's hospital, The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's hospital
City
Suwon-si
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Development of Horse-Riding Program Model for Children With Cerebral Palsy
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