Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 3:24 AM
Study NCT ID:
NCT07388992
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Specific Gait Patterns in Individuals Living With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'description of ambulation pattern in controlled environment in people living with multiple sclerosis (pwMS) with different disease severities', 'timeFrame': 'enrollment', 'description': 'Measurement of daily life-like activity movements by Optical Motion Capture, pressure sensitive walkway and wearable sensors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis', 'Healthy Adult']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate specific ambulation patterns characteristic of the quality of gait in people with MS (pwMS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with MS will be recruited from the CHU Lille. Patients will be informed of this study by the Investigator during routine follow-up visits.\n\nThe Investigator will also connect with local patient organizations and share a flyer. This flyer will also be displayed within the Neurology and Neurological Rehabilitation departments of the hospital and diffused to the hospital staff.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor people living with multiple sclerosis (pwMS):\n\n1. Age at inclusion between =18 and =65 years old\n2. Signed informed consent and ability to comply with study and follow-up.\n3. Confirmed MS diagnosis according to McDonald criteria (2017)\n4. Expanded Disability Status Scale EDSS = 6\n5. Stable treatment for 2 months before inclusion (for both disease modifying and symptomatic therapies)\n6. Ability and willingness to participate in and comply with all study procedures defined in the protocol\n7. Subject will be eligible for enrollment in this study only if either affiliated to, or a beneficiary of a social security category\n\nFor Healthy volunteers :\n\n1. Age at inclusion between =18 and =65 years old\n2. Signed informed consent and ability to comply with study and follow-up.\n3. Ability and willingness to participate in and comply with all study procedures defined in the protocol\n4. Subject will be eligible for enrollment in this study only if either affiliated to, or a beneficiary of a social security category\n\nExclusion Criteria:\n\nFor pwMS:\n\n1. Participants with a relapse within the past 3 months before the inclusion\n2. Participants with significant cognitive disorders, limiting the understanding of the exercises to be performed or presence of apparent communication difficulties hindering the correct collection of data, as assessed by the investigator\n3. Past or present pathology other than MS or surgery or trauma impacting gait, ambulatory function or upper limb function, as assessed by the investigator\n4. Vulnerable adults: individuals subject to a legal protection measure (guardianship, limited guardianship, or judicial protection) or unable to express their consent.\n\nFor healthy volunteers (HV):\n\n1. Participants with significant cognitive disorders, limiting the understanding of the exercises to be performed or presence of apparent communication difficulties hindering the correct collection of data, as assessed by the investigator\n2. Past or present pathology or surgery or trauma impacting gait, ambulatory function or upper limb function, as assessed by the investigator\n3. Vulnerable adults: individuals subject to a legal protection measure (guardianship, limited guardianship, or judicial protection) or unable to express their consent.'}, 'identificationModule': {'nctId': 'NCT07388992', 'acronym': 'GAIT-MS', 'briefTitle': 'Investigating Specific Gait Patterns in Individuals Living With Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'SYSNAV'}, 'officialTitle': 'Investigating Specific Gait Patterns in Individuals Living With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'PR5030-119'}, 'secondaryIdInfos': [{'id': '2025-A02511-48', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'people living with Multiple Sclerosis'}, {'label': 'Healthy Adult'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie Corbinau', 'role': 'CONTACT', 'email': 'sophie.corbinau@chu-lille.fr', 'phone': '+33 (0)3.20.44.59.62', 'phoneExt': '30768'}, {'name': 'Patrick Vermersch', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Ferial Toumi', 'role': 'CONTACT', 'email': 'ferial.toumi@sysnav.fr', 'phone': '+33 2 78 00 10 98'}], 'overallOfficials': [{'name': 'Patrick Vermersch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SYSNAV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}