Cerebral PalsyNCT03041818
Development of Horse-Riding Program Model for Children With Cerebral Palsy
A study testing Horseback riding therapy in people with Cerebral Palsy and Motor Activity, run by The Catholic University of Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy, Motor Activity
- What is being tested?
- Horseback riding therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Mar 2017to 31 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children or adolescent with cerebral palsy
- GMFCS level I, II, III
- Body weight less than 80 kg
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Cerebral Palsy, Motor Activity
- Being tested
- Horseback riding therapy
- Keywords
- cerebral palsy, horseback riding
- Medical subject headings
- Cerebral Palsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horseback riding therapyBehavioural
Also called hippotherapy
Apply 30 minutes/session, twice a week for 8 weeks of horseback riding therapy (provided with 1 horse rider, 2 side walkers)
| Study group | Role | What they receive |
|---|---|---|
| hippotherapy | Experimental | 16 sessions of horseback riding therapy Receives: Behavioral: Horseback riding therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gross motor function (assessment of GMFM-88)
Assessment of GMFM-88 before and after the 16 sessions of horse riding program
Measured: 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
Measured: Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
Secondary outcomes (3)
Actigraph (to monitor activity)
wear an Actigraph to monitor activity of children
Measured: During the horse riding therapy/
Child Health Questionnaire (CHQ)
Caregivers answer the sheets
Measured: 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
Measured: From starting the therapy, every 2 weeks re-evaluated through study completion, in total 4 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start14 Mar 2017
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Konkuk University, Samsung Medical Center
- Responsible party
- Principal investigator, Bo Young Hong, The Catholic University of Korea
- Investigators
- Bo Young Hong, MD, Principal investigator, St.Vincent's hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041818
- Sponsor's protocol ID
- 316086-2
- Status last verified
- May 2018
- First submitted
- 31 Jan 2017
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1 professor in Samsung Medical Center
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Horse-Riding Program Model for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03041818
- Acronym / sponsor ID
- 316086-2
- Conditions
- Cerebral Palsy, Motor Activity
- Keywords
- cerebral palsy, horseback riding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Konkuk University, Samsung Medical Center
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hippotherapy | Experimental | Behavioral: Horseback riding therapy16 sessions of horseback riding therapy |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children or adolescent with cerebral palsy
- GMFCS level I, II, III
- Body weight less than 80 kg
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Horseback riding therapyAlso: hippotherapyApply 30 minutes/session, twice a week for 8 weeks of horseback riding therapy (provided with 1 horse rider, 2 side walkers) | Behavioural | hippotherapy |
Primary outcome
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
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
3 secondary outcomes
Actigraph (to monitor activity)
Time frame: During the horse riding therapy/
Child Health Questionnaire (CHQ)
Time frame: Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)
Postural Assessment Scale for Hippotherapy (PASH)
Time frame: From starting the therapy, every 2 weeks re-evaluated through study completion, in total 4 times
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Individual participant dataSharing planned: Yes. 1 professor in Samsung Medical Center
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Young Hong, MD principal investigator
St.Vincent's hospital, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horseback riding therapy in people with Cerebral Palsy and Motor Activity, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.