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Completed

NCT Number: NCT04969848

Quantifying Gait Alteration in Multiple Sclerosis Using a Wearable Device

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.

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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–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Wearable sensor

Other

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

Other names: MetaMotionR Sensor, Mbientilab

Primary outcomes

  1. 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

  1. Correlation with neurological function

    Time frame: One time point per patient (inclusion)

    Pyramidal, cerebellar and sensory functions are assessed with Kurtzke functional system scores which are based on neurological examination. Scores of the Pyramidal and sensory systems range from 0 (normal) to 6 . Cerebellar system scores range from 0 (normal) to 6. Cerebellar system scores range from 0 (normal) to 5

  2. Correlation with gait speed

    Time frame: One time point per patient (inclusion)

    Timed 25-Foot Walk (T25FW). T25FW measures the time needed to complete a 25-foot walk. Two trials are averaged

  3. Correlation with lateralization

    Time frame: One time point per patient (inclusion)

    Lower limb lateralization (right vs left)

  4. Correlation with disability location

    Time frame: One time point per patient (inclusion)

    Upper, lower limb, trunk MS symptoms location

  5. Correlation with MS symptoms severity

    Time frame: One time point per patient (inclusion)

    MS symptoms severity quote as none, mild moderate severe

  6. Reliability of sensor measures

    Time frame: At the inclusion

    Gait parameters record during a 25-foot walk repeated twice at 5 min apart.

  7. Developement of dedicated algorithm to improve signal processing from IMU.

    Time frame: Day 1

    Number of detected gait cycles during a foot walk.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: eMSGait

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2021
Registry last updated
Jun 3, 2022

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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