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NCT Number: NCT05482906

Common and Specific Information From Neuroimaging and Smartphone

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location status: Recruiting

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eGait

Other

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

Other names: Wearable sensor

Primary outcomes

  1. 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).

  2. 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.

  3. Clustering analyze based on MRI lesion load

    Time frame: At the inclusion

    MRI characteristics are spinal and extraspinal lesion volumes.

Secondary outcomes

  1. Correlation with disability

    Time frame: At the inclusion

    Correlation of IGP 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. Here EDSS of 0 to 2 inclusive defined as mild, 2,5 to 4 inclusive as moderate and EFDSS of 4,5 to 6 inclusive defined as severe

  2. Correlation with MRI lesion load

    Time frame: At the inclusion

    Add lesion load (Spinal and extraspinal lesion volume) from MRI to previous correlation.

  3. Building a predictive model for lesion load involving in walk ability from IGP

    Time frame: At the inclusion

    Root mean square error between observed and lesion load predicted by the model, calculated by cross-validation.

  4. Building a predictive model for group belonging from group established in main outcome based on IGP

    Time frame: At the inclusion

    Multiclass accuracy between real and predict group, calculated by cross-validation

Study contacts

Contact information is provided by the study sponsor or research team.

David LAPLAUD, PHD

CONTACT

[email protected]

33 2 40 16 52 00

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Rennes University Hospital

Registry information

Official study title

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

Acronym: MS-CSI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2022
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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