Quantifying Gait Alteration in Multiple Sclerosis Using a Wearable Device

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Wearable sensor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| eMSGait<br>Record of IGP using IMU sensor (Metamotion R mbientlab) during T25FW. | Other: Wearable sensor<br>* IMU sensor (as part of eMSGait device) worn at the hip during T25FW<br>* Other names: MetaMotionR Sensor, Mbientilab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with disability | 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. | One time point per patient (inclusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with neurological function | 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 | One time point per patient (inclusion) | 
| Correlation with gait speed | Timed 25-Foot Walk (T25FW). T25FW measures the time needed to complete a 25-foot walk. Two trials are averaged | One time point per patient (inclusion) | 
| Correlation with lateralization | Lower limb lateralization (right vs left) | One time point per patient (inclusion) | 
| Correlation with disability location | Upper, lower limb, trunk MS symptoms location | One time point per patient (inclusion) | 
| Correlation with MS symptoms severity | MS symptoms severity quote as none, mild moderate severe | One time point per patient (inclusion) | 
| Reliability of sensor measures | Gait parameters record during a 25-foot walk repeated twice at 5 min apart. | At the inclusion | 
| Developement of dedicated algorithm to improve signal processing from IMU. | Number of detected gait cycles during a foot walk. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait, Wearable sensor