Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-01-01 @ 5:03 PM
Study NCT ID:
NCT05755295
Status:
RECRUITING
Last Update Posted:
2023-07-13
First Post:
2023-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Horse Therapy for Children, Adolescents and Young Adults in Remission From Medulloblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009447', 'term': 'Neuroblastoma'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-11', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-02-22', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of sessions performed', 'timeFrame': '16 weeks', 'description': 'number of sessions equitherapy and hippotherapy performed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hippotherapy', 'equitherapy'], 'conditions': ['Neuroblastoma']}, 'descriptionModule': {'briefSummary': 'On average, each year in the former region, 60 new patients under the age of 18 are treated for a brain tumor, with an active post-treatment follow-up file of 350 patients. Because of the significant sequelae induced by the disease or the treatments, these patients will very often require rehabilitative care.\n\nThe interest of involving the horse in the population of patients cured of a medulloblastoma but with important physical and psychological after-effects is to be able to combine a therapy using animal mediation (equitherapy) and a rehabilitation therapy based on the three-dimensional movement of the horse (hippotherapy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '26 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* complete remission of medulloblastoma and after 5 years of the end of treatment\n* living within 30 km away the riding center and/or less than 1 hour of transport\n* informed consent\n\nExclusion Criteria:\n\n* Landsky score below 50% for minors until 16 years old and Karnofsky score below 50% for patients over 16 years\n* major under juridical protection'}, 'identificationModule': {'nctId': 'NCT05755295', 'acronym': 'EQUI-HIPPO', 'briefTitle': 'Horse Therapy for Children, Adolescents and Young Adults in Remission From Medulloblastoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Pilot Study Evaluating Feasibility and Acceptability of Horse Therapy for Children, Adolescents and Young Adults in Remission From Medulloblastoma and Describing the Evolution of Their Physical and Psychological Characteristics', 'orgStudyIdInfo': {'id': 'RC31/22/0218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'horse therapy', 'interventionNames': ['Other: horse therapy']}], 'interventions': [{'name': 'horse therapy', 'type': 'OTHER', 'description': 'equitherapy and hippotherapy once a week during 16 weeks', 'armGroupLabels': ['horse therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Isabelle BERTOZZI, MD', 'role': 'CONTACT', 'email': 'bertozzi.ai@chu-toulouse.fr', 'phone': '0561772233'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Anne-Isabelle BERTOZZI, MD', 'role': 'CONTACT', 'email': 'bertozzi.ai@chu-toulouse.fr', 'phone': '05 34 55 86 83', 'phoneExt': '33'}, {'name': 'Françoise AURIOL, MD', 'role': 'CONTACT', 'email': 'auriol.f@chu-toulouse.fr'}], 'overallOfficials': [{'name': 'Anne-Isabelle BERTOZZI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}