Common and Specific Information From Neuroimaging and Smartphone

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT05482906
• 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. Umanit and LMJL (Nantes university) has developed a device call egait to assess walking ability in individuals (eg MS patients).

Detailed Description

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 previous works conducted on (IGP to assess) gait alteration in MS by adding (to IGP) new information from MRI.

Study Timeline

• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Status Verified: 2023-03
• Study Start: 2023-04-03
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clustering analyze based on IGP	At the inclusion	IGP consists of a curve, based on quaternion and representing the rotation recorded by the IMU during an average gait cycle (0-1).
Clustering analyze based on EDSS score	At the inclusion	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.
Clustering analyze based on MRI lesion load	At the inclusion	MRI characteristics are spinal and extraspinal lesion volumes.

Secondary Outcome Measures

Name	Time	Method
Correlation with disability	At the inclusion	Correlation of IGP 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. Here EDSS of 0 to 2 inclusive defined as mild, 2,5 to 4 inclusive as moderate and EFDSS of 4,5 to 6 inclusive defined as severe
Correlation with MRI lesion load	At the inclusion	Add lesion load (Spinal and extraspinal lesion volume) from MRI to previous correlation.
Building a predictive model for lesion load involving in walk ability from IGP	At the inclusion	Root mean square error between observed and lesion load predicted by the model, calculated by cross-validation.
Building a predictive model for group belonging from group established in main outcome based on IGP	At the inclusion	Multiclass accuracy between real and predict group, calculated by cross-validation

Trial Locations

Locations (1)

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