Quantifying Gait Alteration in Multiple Sclerosis Using a Wearable Device

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Wearable sensor

• Registration Number: NCT04969848
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-21
• Study Start: 2021-08-18
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
eMSGait	Wearable sensor	Record of IGP using IMU sensor (Metamotion R mbientlab) during T25FW.

Primary Outcome Measures

Name	Time	Method
Correlation with disability	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 Outcome Measures

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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France