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Clinical Trials/NCT05482906
NCT05482906
Recruiting
N/A

Individual Gait Pattern and MRI Lesion Load to Quantify Gait Impairment in MS: A Cross Sectional Study.

Nantes University Hospital1 site in 1 country100 target enrollmentApril 3, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Nantes University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Clustering analyze based on IGP
Status
Recruiting
Last Updated
last month

Overview

Brief Summary

Gait alteration is frequent in MS and limitation in walking ability is a major concern in MS patients. Umanit and LMJL (Nantes university) has developed a device call egait to assess walking ability in individuals (eg MS patients).

Detailed Description

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 previous works conducted on (IGP to assess) gait alteration in MS by adding (to IGP) new information from MRI.

Registry
clinicaltrials.gov
Start Date
April 3, 2023
End Date
June 30, 2026
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of MS based on McDonald criteria (including Relapsing-remitting and progressive MS)
  • Over 18 years old /age greater than 18 years
  • Patients followed at Nantes university hospital or Rennes university hospital
  • Last known EDSS before inclusion ranging from 0 to 6 inclusive/EDSS of 0 to 6 inclusive, prior inclusion
  • No relapse within 3 months
  • With a Medullar MRI planed as part as usual care
  • MRI scan can be performed within a maximum of 4 months after or before the walking test.
  • Affiliated person or beneficiary of a social security scheme

Exclusion Criteria

  • Bilateral aid needed to walk
  • Women who are pregnant
  • Patient having expressed their opposition
  • Patient under guardianship or security measure

Outcomes

Primary Outcomes

Clustering analyze based on IGP

Time Frame: At the inclusion

IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle (0-1).

Clustering analyze based on EDSS score

Time Frame: At the inclusion

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.

Clustering analyze based on MRI lesion load

Time Frame: At the inclusion

MRI characteristics are spinal and extraspinal lesion volumes.

Secondary Outcomes

  • Correlation with disability(At the inclusion)
  • Correlation with MRI lesion load(At the inclusion)
  • Building a predictive model for lesion load involving in walk ability from IGP(At the inclusion)
  • Building a predictive model for group belonging from group established in main outcome based on IGP(At the inclusion)

Study Sites (1)

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