- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07388992
Investigating Specific Gait Patterns in Individuals Living With Multiple Sclerosis (GAIT-MS)
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ferial Toumi
- Phone Number: +33 2 78 00 10 98
- Email: ferial.toumi@sysnav.fr
Study Locations
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Lille, France
- Recruiting
- CHU Lille
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Principal Investigator:
- Patrick Vermersch
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Contact:
- Sophie Corbinau
- Phone Number: 30768 +33 (0)3.20.44.59.62
- Email: sophie.corbinau@chu-lille.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
The 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.
Description
Inclusion Criteria:
For people living with multiple sclerosis (pwMS):
- Age at inclusion between =18 and =65 years old
- Signed informed consent and ability to comply with study and follow-up.
- Confirmed MS diagnosis according to McDonald criteria (2017)
- Expanded Disability Status Scale EDSS = 6
- Stable treatment for 2 months before inclusion (for both disease modifying and symptomatic therapies)
- Ability and willingness to participate in and comply with all study procedures defined in the protocol
- Subject will be eligible for enrollment in this study only if either affiliated to, or a beneficiary of a social security category
For Healthy volunteers :
- Age at inclusion between =18 and =65 years old
- Signed informed consent and ability to comply with study and follow-up.
- Ability and willingness to participate in and comply with all study procedures defined in the protocol
- Subject will be eligible for enrollment in this study only if either affiliated to, or a beneficiary of a social security category
Exclusion Criteria:
For pwMS:
- Participants with a relapse within the past 3 months before the inclusion
- 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
- Past or present pathology other than MS or surgery or trauma impacting gait, ambulatory function or upper limb function, as assessed by the investigator
- Vulnerable adults: individuals subject to a legal protection measure (guardianship, limited guardianship, or judicial protection) or unable to express their consent.
For healthy volunteers (HV):
- 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
- Past or present pathology or surgery or trauma impacting gait, ambulatory function or upper limb function, as assessed by the investigator
- Vulnerable adults: individuals subject to a legal protection measure (guardianship, limited guardianship, or judicial protection) or unable to express their consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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people living with Multiple Sclerosis
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Healthy Adult
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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description of ambulation pattern in controlled environment in people living with multiple sclerosis (pwMS) with different disease severities
Time Frame: enrollment
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Measurement of daily life-like activity movements by Optical Motion Capture, pressure sensitive walkway and wearable sensors
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enrollment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick Vermersch, CHU Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR5030-119
- 2025-A02511-48 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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