Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT03072420
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2017-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of Fingertips Using MRI Images (FINGERS-COMPRESSION)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2015-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2017-03-01', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average fingertip deflection under compression', 'timeFrame': 'Day 1', 'description': 'The different stresses will be: compression of the fingertip by a static loading on the phalanx distal of the index of the subjects; Then also a shear stress in the transverse direction of the finger.'}], 'secondaryOutcomes': [{'measure': 'Average fingertip dimensions', 'timeFrame': 'Day 1', 'description': 'In order to develop realistic biomechanical models of the fingers allowing the simulation of the grip, an essential step will be the experimental mechanical characterization of the distal phalanges.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI, fingers compression'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29217092', 'type': 'BACKGROUND', 'citation': 'Dallard J, Merlhiot X, Petitjean N, Duprey S. MRI-based experimentations of fingertip flat compression: Geometrical measurements and finite element inverse simulations to investigate material property parameters. J Biomech. 2018 Jan 23;67:166-171. doi: 10.1016/j.jbiomech.2017.11.024. Epub 2017 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'The objectives was to obtain MRI images of the index finger of the subjects without loading and with loadings (normal and shear forces from 1 to 4N).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active voluntary healthy adult aged 18 to 65, affiliated to a social security scheme\n* Stature between 170 and 179cm\n* Body mass index (BMI) between 20 and 25\n* No previous hand musculoskeletal disorders\n* Cognitive level compatible with oral communication, adherence to instructions and understanding of gestures\n* Having signed the consent to participate in the study\n\nExclusion Criteria:\n\n* the subject presents a neurological or orthopedic disorder ;\n* the subject presents a pathology that could disturb the task ;\n* the subject has an Magnetic Resonance Imaging (MRI) contraindication (wears a pacemaker, insulin pump, prothesis, etc, has claustrophobia, …)'}, 'identificationModule': {'nctId': 'NCT03072420', 'briefTitle': 'Characterization of Fingertips Using MRI Images (FINGERS-COMPRESSION)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Characterization of Fingertips Using MRI Images : Development of Mechanically Faithful Models Dedicated to Manipulation.', 'orgStudyIdInfo': {'id': '69HCL16_0688'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group no manual work or activity', 'description': 'Subject with an office or student job.', 'interventionNames': ['Other: Compression of the fingertip under MRI.']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group manual work', 'description': 'Subject working in a manual or predominantly manual.', 'interventionNames': ['Other: Compression of the fingertip under MRI.']}], 'interventions': [{'name': 'Compression of the fingertip under MRI.', 'type': 'OTHER', 'description': 'Compression of the fingertip by a static loading on the phalanx distal of the index of the subjects; Then also a shear stress in the transverse direction of the finger. The data provided by the MRI images will be geometric information such as the thickness of the skin and its possible variation as a function of the area of the finger, the total thickness of soft tissues in compression as a function of the variation in l The angle between the axis of the phalanx and the plane of contact; Mechanical type information relating to the displacements and reaction forces, to the internal deformations of the different areas of the finger.', 'armGroupLabels': ['Group manual work', 'Group no manual work or activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69675', 'city': 'Bron', 'country': 'France', 'facility': 'IFSTTAR', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Georges BARATON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IFSTTAR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}