Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-03-11 @ 6:59 AM
Study NCT ID:
NCT03852004
Status:
RECRUITING
Last Update Posted:
2023-05-06
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteopathic Treatment on Motor Development of Hypotonic Infants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009123', 'term': 'Muscle Hypotonia'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'simulated osteopathic treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-01-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-03', 'studyFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor development on the Denver II scale', 'timeFrame': 'at month 6', 'description': 'Comparison of the difference between chronological age (in corrected age) and motor development age on the Denver II motor scale in the 2 groups after 3 osteopathy consultations or simulation'}], 'secondaryOutcomes': [{'measure': 'Motor development on the Denver II scale', 'timeFrame': 'at month 2'}, {'measure': 'Motor development on the Denver II scale', 'timeFrame': 'at month 4'}, {'measure': 'Satisfaction visual scale (from 0 to 10)', 'timeFrame': 'at month 6', 'description': 'comparison of parents satisfaction with a visual analogic scale in the 2 groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteopathy', 'hypotonia', 'children'], 'conditions': ['Hypotonia']}, 'descriptionModule': {'briefSummary': 'Interventional study involving the human at risk and minimal constraint (RIPH2), randomized single-blind comparing the impact of osteopathic treatment on the axial tone of the hypotonic infant versus simulation', 'detailedDescription': 'Children referred to the "Center Broussais" clinic for hypotonia are evaluated in terms of psychomotor development by a pediatrician competent in neuro-pediatrics. It is a cabinet for the care of children from 0 to 16 years.\n\nOsteopaths and pediatricians work together in this office of which 50% are children with neurological disorders.\n\nIf osteopathic care is indicated, and for children with inclusion / non-inclusion criteria, the study will be offered to parents. In case of parental acceptance, children will be randomized in single blind to receive either an osteopathic treatment (osteo group) or a simulation (simulation group). Neither the parents nor the pediatrician will know the randomization group.\n\nThe osteopathic treatment or simulation will be performed in a standardized way according to a previously established protocol.\n\nIn both groups, a neurological evaluation of the axial tone will be performed by a pediatrician before randomization, at the end of the first consultation and at the end of the 3rd consultation, ie 3 consultations by a pediatrician.\n\nIf the child was drawn in the "simulation" group, three additional consultations will be offered at the end of the study to allow him to benefit from optimal osteopathic care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '8 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Age: 8 months-24 months corrected age Axial hypotonia in the neurological examination\n\n* Age (age corrected for prematurity) of motor development evaluated on the Denver II scale below chronological age\n* Proposal for osteopathic treatment by the pediatrician or treating physician\n\nExclusion Criteria:\n\n* • Fever, shock or recent fall (face, skull, spine) not medically investigated, persistent cyanosis, bulging or depressed fontanel, cervical stiffness, fever\n\n * Neuromuscular diseases without axial hypotonia\n * Not affiliated to a social security scheme\n * Refusal to participate in the study by parents'}, 'identificationModule': {'nctId': 'NCT03852004', 'acronym': 'HYPOSTEO', 'briefTitle': 'Osteopathic Treatment on Motor Development of Hypotonic Infants.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Comparison of Osteopathic Treatment Versus Simulation on Motor Development of Hypotonic Infants.', 'orgStudyIdInfo': {'id': 'HYPOSTEO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteopatic treatment', 'description': 'An osteopatic treatment will be realised by osteopath', 'interventionNames': ['Other: ostheopathy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'simulated osteopathic treatment', 'description': 'A simulated ostepathic treatment will be realised by osteopath', 'interventionNames': ['Other: simulated osteopathic treatment']}], 'interventions': [{'name': 'ostheopathy', 'type': 'OTHER', 'description': 'standardized osteopathic treatment', 'armGroupLabels': ['Osteopatic treatment']}, {'name': 'simulated osteopathic treatment', 'type': 'OTHER', 'description': 'standardized simulated osteopathic treatment', 'armGroupLabels': ['simulated osteopathic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Coraline GRISEL', 'role': 'CONTACT'}], 'facility': 'CHI Creteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yannick Aujard, MD PhD', 'role': 'CONTACT', 'email': 'yannick.aujard@aphp.fr', 'phone': '140032000', 'phoneExt': '+33'}], 'facility': 'Centre Broussais', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'camille JUNG, MDPhD', 'role': 'CONTACT', 'email': 'camille.jung@chicreteil.fr', 'phone': '157022268', 'phoneExt': '+33'}, {'name': 'Roselyne LALAUZE-POL', 'role': 'CONTACT', 'email': 'r.lalauze@wanadoo.fr', 'phone': '140540578', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Broussais', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}