NCT03041818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

January 31, 2017

Last Update Submit

May 16, 2018

Conditions

Keywords

cerebral palsyhorseback riding

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Actigraph (to monitor activity)

    During the horse riding therapy/

  • Child Health Questionnaire (CHQ)

    Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)

  • Postural Assessment Scale for Hippotherapy (PASH)

    From starting the therapy, every 2 weeks re-evaluated through study completion, in total 4 times

Study Arms (1)

hippotherapy

EXPERIMENTAL

16 sessions of horseback riding therapy

Behavioral: Horseback riding therapy

Interventions

Apply 30 minutes/session, twice a week for 8 weeks of horseback riding therapy (provided with 1 horse rider, 2 side walkers)

Also known as: hippotherapy
hippotherapy

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children or adolescent with cerebral palsy
  • GMFCS level I, II, III
  • Body weight less than 80 kg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Animal Assisted TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Bo Young Hong, MD

    St.Vincent's hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 3, 2017

Study Start

March 14, 2017

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

May 18, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

1 professor in Samsung Medical Center

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
When analysis is done after completion of the study
Access Criteria
Primary investigator of the study

Locations