Quantifying Gait Alteration in Multiple Sclerosis Using a Wearable Device (eMSGait)

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Wearable sensor

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 Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• France
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

MS patients cohort followed at Nantes university hospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
eMSGait; Record of IGP using IMU sensor (Metamotion R mbientlab) during T25FW.	Other: Wearable sensor; IMU sensor (as part of eMSGait device) worn at the hip during T25FW; Other Names: MetaMotionR Sensor, Mbientilab

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Gait; Wearable sensor
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: RC21_0070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No