Quantifying Gait Alteration in Multiple Sclerosis Using a Wearable Device

Multiple Sclerosis Clinical Trial

— eMSGait  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04969848
• Other study ID #: RC21_0070
• Status: Completed
• Start date: August 18, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Wearable sensor
IMU sensor (as part of eMSGait device) worn at the hip during T25FW

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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