Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-01-07 @ 10:06 PM
Study NCT ID:
NCT03125434
Status:
TERMINATED
Last Update Posted:
2021-02-01
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normative Dynamic & Magnetic Spine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D000077107', 'term': 'Gait Analysis'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005684', 'term': 'Gait'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000076604', 'term': 'Physical Functional Performance'}, {'id': 'D010809', 'term': 'Physical Fitness'}, {'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'funding problems', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-04-19', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normal dynamic stability margin (DSM) in children and adults', 'timeFrame': '2 hours', 'description': 'DSM= xCoM (extrapolated center of mass)- BoS (Base of Support). Unit = meters Normalized on body height (m)'}], 'secondaryOutcomes': [{'measure': 'number of rotatores muscles', 'timeFrame': '2 hours', 'description': 'counting every rotatore muscle (from MRI data), no unit'}, {'measure': 'volume of back muscles', 'timeFrame': '2 hours', 'description': 'from segmentation of each muscle group, unit = voxel'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'Dynamic Stability Margin', 'Gait', 'Paraspinal Muscles']}, 'descriptionModule': {'briefSummary': 'This study aims to describe normal spinal musculoskeletal patterns in healthy adolescents and young adults by using static and dynamic measures. Static informations are obtained from full-spine stereoradiography for skeletal measures and from high-resolution spine muscle MRI for muscular data. Dynamics stability is calculated from 3D gait analysis.', 'detailedDescription': 'Spinal diseases and deformities in adults (degenerative or traumatic) and children (scoliosis and kyphosis) are major public health issues.\n\nPostural imbalance due to spinal deformity is usually measured on static radiographs, using standard X-rays. However, bipedal walk is characteristic from human being and the trunk is the main stabilizer.\n\nPathogenesis of spinal deformities remains undefined. To understand the different mechanisms involved in the pathological field, normal musculoskeletal performances of the spine, in static and dynamic conditions must be identified.\n\nUltra-low doses stereoradiography using the EOS system allows the acquisition of full-spine images in standing position. Furthermore, 3D reconstruction can also be create from both anteroom-posterior and lateral side view. Stereoradiography is used in clinical routine especially in children spinal deformities.\n\nHigh resolution muscular MRI is the only device that can provide a detailed muscular analysis, with detection of abnormalities at an early stage. No mapping of normal paraspinal muscles has been yet realized, particularly regarding to rotatores muscles.\n\nMotion analysis is the reference exam to analyse dynamic stability during gait. Several parameters reflecting stability during gait can be collected in different conditions. Recently, the "Dynamic Stability Margin" has been developed but no standard values especially in healthy children has been published.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent signed by adult or by the holders of parental authority for the children and adolescents\n* Child or teenager, male or female, aged from 8 years to 17 years inclusive\n* Adult, male or female, aged from 18 years to 40 years inclusive\n* Realization of a preliminary medical examination\n\nExclusion Criteria:\n\n* Refuse to participate to the study\n* Patient under guardianship or curatorship\n* Inability to cooperate\n* Pregnant woman\n* Non affiliation to social security\n* Subject with spinal and/or lower limbs affection\n* Subject with antecedent of spinal and/or lower limbs surgery\n* Subject with contraindication to MRI\n* Refusal of the parent or the subject to be informed about a fortuitous discovery during the examinations of the exams'}, 'identificationModule': {'nctId': 'NCT03125434', 'acronym': 'NDMS', 'briefTitle': 'Normative Dynamic & Magnetic Spine', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Normative Dynamic & Magnetic Spine. Musculoskeletal Characteristics Static and Dynamic of Spine in Healthy Subject', 'orgStudyIdInfo': {'id': '2016-A01825-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'healthy volunteers', 'description': 'EOS full-spine, MRI, gait analysis', 'interventionNames': ['Other: EOS full-spine, MRI, gait analysis']}], 'interventions': [{'name': 'EOS full-spine, MRI, gait analysis', 'type': 'OTHER', 'description': 'full-spine stereoradiography, high-resolution spine muscle MRI and 3D gait analysis will be performed', 'armGroupLabels': ['healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'APHP Hopital raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}