Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-05 @ 6:12 AM
Study NCT ID:
NCT02896933
Status:
COMPLETED
Last Update Posted:
2016-09-12
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrophysiological Study of Spatiotemporal Gait Parameters in Patients in Early Stage of Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-07', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-09-07', 'lastUpdatePostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation coefficient of gait cadence', 'timeFrame': 'baseline'}]}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': "35 patients with multiple sclerosis have been enrolled in a previous study to record and analyze gait parameters.\n\nThis study aims to enroll gender and and matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '54 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "35 patients with multiple sclerosis progressing for less than 5 years, age 18 to 54 years old, and handicap score (EDSS) \\< 2 in all the subscores concerning gait, have been enrolled in a previous observational study recording and analyzing gait parameters.\n\nThis study aims to enroll gender and aed matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'.\n\nThe 35 patients have given their consent for this new data analysis.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects without any gait trouble\n* age ≥ 18 and \\< 55 years old\n* gender and age (+/- 5 years) matched\n\nExclusion Criteria:\n\n* pathology with potential gait impairment\n* pregnant or breast feeding patient\n* patient under legal protection\n* no health insurance coverage\n* absence of written informed consent'}, 'identificationModule': {'nctId': 'NCT02896933', 'acronym': 'MARCHE', 'briefTitle': 'Electrophysiological Study of Spatiotemporal Gait Parameters in Patients in Early Stage of Multiple Sclerosis', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'orgStudyIdInfo': {'id': 'RDZ_2014_17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with multiple sclerosis', 'description': 'recruited in a former study'}, {'label': 'healthy control subjects'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Raphaël DEPAZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation OPH A de Rothschild'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}