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Recruiting NCT05482906

Common and Specific Information From Neuroimaging and Smartphone

— Observational Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eGait.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other eGait
    IMU sensor (as part of eGait device) worn at the hip during T25FW

Primary outcome measures

  • Clustering analyze based on IGP [Time frame: At the inclusion]
  • Clustering analyze based on EDSS score [Time frame: At the inclusion]
  • Clustering analyze based on MRI lesion load [Time frame: At the inclusion]
Secondary outcome measures (4)
  • Correlation with disability [Time frame: At the inclusion]
  • Correlation with MRI lesion load [Time frame: At the inclusion]
  • Building a predictive model for lesion load involving in walk ability from IGP [Time frame: At the inclusion]
  • Building a predictive model for group belonging from group established in main outcome based on IGP [Time frame: At the inclusion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

France · 1 center
  • Nantes University Hospital — Nantes

Identifiers

NCT: NCT05482906 · RC20_0203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗