Quantifying Gait Alteration in Multiple Sclerosis Using a Wearable Device
eMSGait
Uncontrolled, Single-center Study to Quantify Gait Disturbance in Patients With Multiple Sclerosis
1 other identifier
observational
44
1 country
1
Brief Summary
Gait alteration is frequent in MS and limitation in walking ability is a major concern in MS patients. The development of wearable device offers the opportunity to collect data during daily activity including walking.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2021
CompletedFirst Posted
Study publicly available on registry
July 21, 2021
CompletedStudy Start
First participant enrolled
August 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedJune 3, 2022
June 1, 2022
10 months
May 28, 2021
June 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation with disability
Correlation of gait measures (mean amplitude of walking cycles (m), mean duration of walking cycles (s), Stance swing phase ratio) obtained during a walk of 25 feet with Expanded Disability Status Scale (EDSS). EDSS is an ordinal scale measuring disability and ranging from 0 (normal examination) to 10 (death due to MS) in a 0,5-point increments from score 1.
One time point per patient (inclusion)
Secondary Outcomes (7)
Correlation with neurological function
One time point per patient (inclusion)
Correlation with gait speed
One time point per patient (inclusion)
Correlation with lateralization
One time point per patient (inclusion)
Correlation with disability location
One time point per patient (inclusion)
Correlation with MS symptoms severity
One time point per patient (inclusion)
- +2 more secondary outcomes
Study Arms (1)
eMSGait
Record of IGP using IMU sensor (Metamotion R mbientlab) during T25FW.
Interventions
IMU sensor (as part of eMSGait device) worn at the hip during T25FW
Eligibility Criteria
MS patients cohort followed at Nantes university hospital
You may qualify if:
- Age 18 - 64 years
- Diagnosis of MS based on McDonald criteria (including Relapsing-remitting and progressive MS)
- No relapse within the last 5 weeks before recruitment
- Able to walk with or without assistance/help/aid (one or 2 canes)
- EDSS \[0-6\]
You may not qualify if:
- Women who are pregnant
- Patient having expressed their opposition
- Patient under guardianship or security measure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nantes University Hospital
Nantes, Loire-Atlantique, 44093, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2021
First Posted
July 21, 2021
Study Start
August 18, 2021
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
June 3, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share