Use of Inertial Units in Patient With Multiple Sclerosis (IMUSEP)

NCT06634225 | Completed

• 1 other identifier: RC-P00121
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this case control study is to evaluate the use of inertial navigation systems to detect and characterize early locomotor disorders in patients with multiple sclerosis (MS). The study aims to: • Validate the contribution and inefficiency indexes obtained by the Trigno® Avanti Sensor inertial units, in comparison with indexes calculated with 3D motion analysis during walking and tandem in early-stage MS patients. Researchers will compare MS patients, to healthy controls.

Conditions

Medical Device; Coordination and Balance Disturbances; Multiple Sclerosis

Keywords

Multiple Sclerosis; Trigno Avanti Sensor; Coordination and Balance Disturbances

Outcome Measures

Primary Outcomes (1)

• Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) for validity of the Trigno® Avanti Sensor

  Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) will be calculated to validate the contribution and inefficiency indexes obtained by the Trigno® Avanti Sensor inertial units, in comparison with indexes calculated with 3D motion analysis during walking and tandem in early-stage MS patients, and in healthy controls. The coefficient are interpreted as follows: (\>0.8) very high correlation, (0.61-0.79) good correlation, moderate correlation, (0.41-0.60) low correlation if less bad correlation. These quantified indexes could be used as physical markers to quantify both the balance deterioration and the efficiency of rehabilitation program during the follow up of MS from the early stage of their disease..

  1 month

Secondary Outcomes (6)

• Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) for repeatability

  1 month

• Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95% )for the whole-body angular momentum

  Baseline, 1 month

• Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) between the Expanded Disability Status Scale (EDSS) and the contribution and inefficiency indexes

  1 month

• Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) between the MSWS-12 (multiple sclerosis walking scale-two weeks) and the contribution and inefficiency indexes

  1 month

• Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) between the MSWS-12 and whole-body angular momentum method (Trigno® Avanti Sensor inertial units / 3D 3D).

  1 month

Study Arms (2)

Volunteers

Volunteers without pathology

Diagnostic Test: Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device test

Patient with multiple sclerosis

Patient with multiple sclerosis

Diagnostic Test: Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device test

Interventions

Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device test DIAGNOSTIC_TEST

Patients will receive the care they need, in line with HAS recommendations. They will be asked to perform two gait analysis tests on a three-dimensional platform, equipped with sensors (medical device).

Patient with multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple sclerosis patients and volunteers

You may qualify if:

• Age 18 to 65 (inclusive)
• Expanded Disability Status Scale (EDSS) ≤ 4
• Proficient in French
• Agreeing to participate in the study and having signed the informed consent form
• Affiliated with a social security scheme
• Age 18 to 65 (inclusive)
• Proficient in French
• Agreeing to participate in the study and having signed the informed consent form
• Affiliated with a social security plan

You may not qualify if:

• MS crisis within the last 6 weeks
• Botulinum toxin injection in the last 3 months
• Neurological pathology other than MS
• Disabling musculoskeletal pathology
• Unstable cardiac and respiratory pathology
• Pregnant women
• Patients with comprehension or cognitive disorders
• Recent change in background treatment (\< 3 months)
• Patients under guardianship or curatorship
• Presence of implanted electronic devices of any kind, including pacemakers or similar assistive devices, electronic infusion pumps and implanted pacemakers
• Allergy to silver
• Neurological pathology
• Rheumatological pathology
• Antecedent of sprains (\< 3 months), fractures (\< 1 year) in the lower limbs
• Pregnant women

Sponsors & Collaborators

• Lille Catholic University: lead
• Roche Pharma AG: collaborator

Study Sites (2)

Saint-Philibert Hospital

Lomme, Hauts-de-France, 59462, France

Location

Saint-Amand-Les-Eaux Hospital

Saint-Amand-les-Eaux, Hauts-de-France, 59230, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Caroline MASSOT, PhD

  Hôpital Saint-Philibert

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: November 8, 2024
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (2)