Skip to content

Quantifying Gait Alteration in Multiple Sclerosis Using a Wearable Device

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04969848
Acronym
eMSGait
Enrollment
44
Registered
2021-07-21
Start date
2021-08-18
Completion date
2022-05-31
Last updated
2022-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Wearable sensor, Gait

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.

Interventions

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

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation with disabilityOne 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

MeasureTime frameDescription
Correlation with gait speedOne 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 lateralizationOne time point per patient (inclusion)Lower limb lateralization (right vs left)
Correlation with disability locationOne time point per patient (inclusion)Upper, lower limb, trunk MS symptoms location
Correlation with neurological functionOne 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
Reliability of sensor measuresAt the inclusionGait parameters record during a 25-foot walk repeated twice at 5 min apart.
Developement of dedicated algorithm to improve signal processing from IMU.Day 1Number of detected gait cycles during a foot walk.
Correlation with MS symptoms severityOne time point per patient (inclusion)MS symptoms severity quote as none, mild moderate severe

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026