Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-01-20 @ 3:37 PM
Study NCT ID:
NCT03041818
Status:
COMPLETED
Last Update Posted:
2018-05-18
First Post:
2017-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Horse-Riding Program Model for Children With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056147', 'term': 'Equine-Assisted Therapy'}], 'ancestors': [{'id': 'D056447', 'term': 'Animal Assisted Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2017-01-31', 'studyFirstSubmitQcDate': '2017-02-02', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': 'Assessment of GMFM-88 before and after the 16 sessions of horse riding program'}, {'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)', 'description': 'Assessment of pediatric berg balance scale before and after the 16 sessions of horse riding'}], 'secondaryOutcomes': [{'measure': 'Actigraph (to monitor activity)', 'timeFrame': 'During the horse riding therapy/', 'description': 'wear an Actigraph to monitor activity of children'}, {'measure': 'Child Health Questionnaire (CHQ)', 'timeFrame': 'Before the program starts (up to 2 weeks), After the program ends (up to 2 weeks)', 'description': 'Caregivers answer the sheets'}, {'measure': 'Postural Assessment Scale for Hippotherapy (PASH)', 'timeFrame': 'From starting the therapy, every 2 weeks re-evaluated through study completion, in total 4 times', 'description': 'Developed tool for assessment of ability for hippotherapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebral palsy', 'horseback riding'], 'conditions': ['Cerebral Palsy', 'Motor Activity']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nChildren older than 4 years old or adolescent with cerebral palsy who voluntarily want to enroll this study would be enrolled.\n\nParticipants have 2 times of 30-minute horse riding program for 8 weeks, total 16 times of riding program in a local horse riding center.\n\nSample size assessment: Calculating for 20% of drop out, 16 patients were calculated to apply the assessment and applicable program.\n\nDrop out: missing more than 2 lessons of horse-riding\n\nPlan for missing data: not included\n\nStatistical analysis plan: paired t-test for the outcome measures"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children or adolescent with cerebral palsy\n* GMFCS level I, II, III\n* Body weight less than 80 kg\n\nExclusion Criteria:\n\n* Medical condition who are not suitable for hippotherapy: severe osteoporosis, mental illness, not controlled seizure disorder etc.\n* Social condition who are not suitable for hippotherapy'}, 'identificationModule': {'nctId': 'NCT03041818', 'briefTitle': 'Development of Horse-Riding Program Model for Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Development of Horse-Riding Program Model for Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': '316086-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hippotherapy', 'description': '16 sessions of horseback riding therapy', 'interventionNames': ['Behavioral: Horseback riding therapy']}], 'interventions': [{'name': 'Horseback riding therapy', 'type': 'BEHAVIORAL', 'otherNames': ['hippotherapy'], 'description': 'Apply 30 minutes/session, twice a week for 8 weeks of horseback riding therapy (provided with 1 horse rider, 2 side walkers)', 'armGroupLabels': ['hippotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwon', 'country': 'South Korea', 'facility': "St. Vincent's hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Bo Young Hong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St.Vincent's hospital, The Catholic University of Korea"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When analysis is done after completion of the study', 'ipdSharing': 'YES', 'description': '1 professor in Samsung Medical Center', 'accessCriteria': 'Primary investigator of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'collaborators': [{'name': 'Konkuk University', 'class': 'OTHER'}, {'name': 'Samsung Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Bo Young Hong', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}