Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT03536403
Status:
COMPLETED
Last Update Posted:
2020-06-29
First Post:
2018-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007738', 'term': 'Kyphosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-26', 'studyFirstSubmitDate': '2018-04-26', 'studyFirstSubmitQcDate': '2018-05-14', 'lastUpdatePostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variations in spino-pelvic sagittal balance measured by EOS X-ray', 'timeFrame': '1 hour', 'description': 'Variations in spino-pelvic sagittal balances measured with et without a kyphosis induced corset measured by the GSC7 on EOS X-rays and by the C7-T10-Sacrum angle on optoelectronic Vicon system.'}], 'secondaryOutcomes': [{'measure': 'Position of the ground point projection of the center of mass', 'timeFrame': '1 hour', 'description': 'Position of the ground point projection of the center of mass with and without corset'}, {'measure': 'vertical deceleration of the center of mass during the second part of the oscillating phase', 'timeFrame': '1 hour', 'description': 'vertical deceleration of the center of mass during the second part of the oscillating phase with and without corset.'}, {'measure': 'Velocity of the center of mass during the second part of the oscillating phase', 'timeFrame': '1 hour', 'description': 'Velocity of the center of mass during the second part of the oscillating phase with and without corset.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kyphosis']}, 'descriptionModule': {'briefSummary': 'Spinal diseases often induce gait disorders with multifactorial origins such as lumbar pain, radicular pain, neurologic complications, or spinal deformities. However, radiography does not permit an analysis of spinal dynamics; therefore, sagittal balance dynamics during gait remain largely unexplored. This prospective and controlled study try to assess the Vicon system for detecting sagittal spinopelvic imbalance and to determine the modification induced by ant induced anterior sagittal imbalance on the kinetics walking parameters'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects\n* Aged between 20 to 40 years\n* Height between 165 to 190 centimeters\n* Asymptomatic subjects from spinal point of view\n* BMI \\< 30 kg/m²\n* Affiliated to French Social Security\n* Subjects having read the information note and signed informed consent\n\nExclusion Criteria:\n\n* Subjects with neurological, vestibular, rheumatological or orthopedic pathology which can influence walking and balance\n* Subjects with known spinal pathology\n* Subjects with visible morphologic spinal deformity\n* Subjects with significant visual impairment (visual acuity \\< 6/10) despite an optical correction port\n* Subjects unable to walk without help\n* Person placed under the safeguard of justice, guardianship or curatorship\n* Subjects involved in other biomedical research during this study\n* Subjects presenting an asymptomatic spinal pathology discovered at the inclusion on the spinal EOS images.'}, 'identificationModule': {'nctId': 'NCT03536403', 'acronym': 'VICON-SPINE', 'briefTitle': 'Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System - Model of Non-invasive Kyphosis', 'orgStudyIdInfo': {'id': '2016/066/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'healthy volunteers', 'description': 'EOS X-rays is done with et without a kyphosis induced corset and 8-meters walk test measured by optoelectronic Vicon system with et without a kyphosis induced corset', 'interventionNames': ['Radiation: EOS X-rays', 'Other: 8-meters walk test']}], 'interventions': [{'name': 'EOS X-rays', 'type': 'RADIATION', 'description': 'EOS X-rays is done with et without a kyphosis induced corset', 'armGroupLabels': ['healthy volunteers']}, {'name': '8-meters walk test', 'type': 'OTHER', 'description': '8-meters walk test measured by optoelectronic Vicon system with et without a kyphosis induced corset', 'armGroupLabels': ['healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rouen', 'country': 'France', 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Mourad OULD SLIMANE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}