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Completed

NCT Number: NCT06634225

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint-Philibert Hospital, Lomme, Hauts-de-France, France

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About this study

Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system, and the leading cause of non-traumatic neurological disability in young adults. It affects around 100,000 people in France, and 5,000 are newly diagnosed each year. It generally begins between the ages of 20 and 40, and mainly affects women (sex ratio 3 women/1 man).

The clinical presentation of MS is highly polymorphic. Patients may present with motor deficits, sensory disorders, spasticity, gait disorders, balance disorders, visual disturbances, etc. The symptoms that have the greatest impact on patients' quality of life in the first 5 years following diagnosis are gait and balance disorders. However, these early disorders are barely visible on clinical examination, and are not highlighted by the balance and gait tests frequently used in routine practice. These sub-clinical locomotor disorders are also not taken into account by the Expanded Disability Status Scale (EDSS). However, the discomfort reported by patients is objectified using the Multiple Sclerosis Walking Scale-12 (MSWS-12) questionnaire.

The management of balance and gait disorders is essential to limit deconditioning during exercise and reduce their impact on patients' quality of life. Detecting these disorders is therefore a key factor in improving our understanding of them, and enabling us to provide appropriate rehabilitation.

In the early stages, gait and balance disorders can be detected by means of three-dimensional movement analysis.

Certain parameters, such as contribution and inefficiency indexes, have proved useful in detecting and quantifying gait and balance disorders in early-stage MS patients. These indexes are based on the calculation of linear moments. The contribution index reflects the contribution of each body segment to body forward motion, while the inefficiency index reflects the motor performance of a segment in carrying out a locomotor task. These indices could provide physical markers for quantifying balance and gait disorders and their progression, and thus help in disease monitoring.

However, 3D motion analysis is costly in both human and technical terms, and is restricted to a laboratory environment.

At present, in France, movement analysis laboratories are not widely available for clinical evaluation, which limits the screening of balance and gait disorders in the early stages of MS, and their follow-up in private practice. On the other hand, inertial measurement systems are inexpensive, easy-to-use tools that could help detect balance and gait disorders at an early stage in MS. In fact, inertial units comprise at least an accelerometer and a gyroscope, which can also be combined with a magnetometer. The kinematics of body segments could be used to calculate contribution and inefficiency indexes, in an ecological approach geared towards everyday practice, thus democratizing and facilitating the monitoring of these disorders.

In this study, the medical device used is Trigno® Avanti Sensor. This research evaluates a medical strategy that would enable to validate the transposition of a method for calculating contribution and inefficiency indexes from data obtained by the medical device.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patient:

  • 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

Inclusion criteria

for Volunteers:

  • 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

Exclusion criteria

for patient:

  • 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

Exclusion criteria

for Volunteers:

  • Neurological pathology
  • Rheumatological pathology
  • Antecedent of sprains (< 3 months), fractures (< 1 year) in the lower limbs
  • Pregnant women
  • Person under guardianship or trusteeship
  • Presence of implanted electronic devices of any kind, including pacemakers or similar assistive devices electronic infusion pumps and implanted pacemakers
  • Allergy to silver

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 1 month

    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..

Secondary outcomes

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

    Time frame: 1 month

    Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) will be calculated to evaluate the repeatability of measures of theTrigno® Avanti Sensor inertial units comparing at baseline and at one months.

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

    Time frame: Baseline, 1 month

    Evaluate the agreement between whole-body angular momentum during walking and tandem walking calculated with Trigno® Avanti Sensor inertial units and 3D motion analysis in MS patients and healthy controls.

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

    Time frame: 1 month

    Evaluate the correlation between the EDSS and the contribution and inefficiency indexes for each each method (Trigno® Avanti Sensor inertial units/3D analysis).

  4. 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

    Time frame: 1 month

    Assess the correlation between discomfort reported by MS patients and the contribution and inefficiency indexes, for each method method (Trigno® Avanti Sensor inertial units / 3D).

  5. 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).

    Time frame: 1 month

    Evaluate the correlation between discomfort reported by MS patients and whole-body angular momentum for each method (Trigno® Avanti Sensor inertial units/3D analysis).

  6. Differences in contribution and inefficiency indexes between groups

    Time frame: 1 month

    Evaluate the ability of Trigno® Avanti Sensor inertial sensors to detect the same differences between MS patients and healthy controls as 3D motion analysis.

    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..

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

IMUSEP : Use of Inertial Navigation Systems to Detect and Characterize Early Locomotor Disorders in Patients With Multiple Sclerosis.

Acronym: IMUSEP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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