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Clinical Trials/NCT04969848
NCT04969848
Completed
N/A

Uncontrolled, Single-center Study to Quantify Gait Disturbance in Patients With Multiple Sclerosis

Nantes University Hospital1 site in 1 country44 target enrollmentAugust 18, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Nantes University Hospital
Enrollment
44
Locations
1
Primary Endpoint
Correlation with disability
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

Umanit and LMJ (Nantes university) has developed a device call eMSgait to assess walking ability in MS patients individuals (eg MS patients). This device consists in a commercialized IMU sensor (MetaMotionR Sensor, Mbientilab) worn at the right hip, a smartphone app and dedicated algorithm/mathematical model to extract raw sensor data and calculate individual gait pattern (IGP). This IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle. Pursue first pilot work assessing information from IGP on gait alteration in MS.

Registry
clinicaltrials.gov
Start Date
August 18, 2021
End Date
May 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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 \[0-6\]

Exclusion Criteria

  • Women who are pregnant
  • Patient having expressed their opposition
  • Patient under guardianship or security measure

Outcomes

Primary Outcomes

Correlation with disability

Time Frame: One time point per patient (inclusion)

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.

Secondary Outcomes

  • 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))
  • Reliability of sensor measures(At the inclusion)
  • Developement of dedicated algorithm to improve signal processing from IMU.(Day 1)

Study Sites (1)

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