Multiple SclerosisIMUSEPNCT06634225
Use of Inertial Units in Patient With Multiple Sclerosis (IMUSEP)
An observational study of Multiple Sclerosis and Medical Device, run by Lille Catholic University at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Medical Device, Coordination and Balance Disturbances
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Nov 2024to 19 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Multiple sclerosis patients and volunteers
Who may be able to join
- 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)
Show all 9Show fewer
- Proficient in French
- Agreeing to participate in the study and having signed the informed consent form
- Affiliated with a social security plan
Who cannot join
- 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
Show all 18Show fewer
- 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
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Saint-Philibert Hospital
Lomme, Hauts-de-France, 59462
Saint-Amand-Les-Eaux Hospital
Saint-Amand-les-Eaux, Hauts-de-France, 59230
About this study
Official title: IMUSEP : Use of Inertial Navigation Systems to Detect and Characterize Early Locomotor Disorders in Patients With Multiple Sclerosis.
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.
Read the detailed description
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.
- Being tested
- Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device test
- Keywords
- Multiple Sclerosis, Trigno Avanti Sensor, Coordination and Balance Disturbances
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device testDiagnostic 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).
Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device testDiagnostic test
They will be asked to perform two gait analysis tests on a three-dimensional platform, equipped with sensors (medical device).
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Volunteers without pathology Receives: 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 Receives: Diagnostic Test: Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: 1 month
Secondary outcomes (6)
Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) for repeatability
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.
Measured: 1 month
Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95% )for the whole-body angular momentum
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.
Measured: 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
Evaluate the correlation between the EDSS and the contribution and inefficiency indexes for each each method (Trigno® Avanti Sensor inertial units/3D analysis).
Measured: 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
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).
Measured: 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).
Evaluate the correlation between discomfort reported by MS patients and whole-body angular momentum for each method (Trigno® Avanti Sensor inertial units/3D analysis).
Measured: 1 month
Differences in contribution and inefficiency indexes between groups
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..
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start8 Nov 2024
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Caroline MASSOT, PhD, Principal investigator, Hôpital Saint-Philibert
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634225
- Sponsor's protocol ID
- RC-P00121
- Acronym
- IMUSEP
- Status last verified
- Mar 2026
- First submitted
- 7 Oct 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMUSEP : Use of Inertial Navigation Systems to Detect and Characterize Early Locomotor Disorders in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT06634225
- Acronym / sponsor ID
- IMUSEP / RC-P00121
- Keywords
- Multiple Sclerosis, Trigno Avanti Sensor, Coordination and Balance Disturbances
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | Diagnostic Test: Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device testVolunteers without pathology |
| Patient with multiple sclerosis | – | Diagnostic Test: Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device testPatient with multiple sclerosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple sclerosis patients and volunteers
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device testPatients 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). | Diagnostic test | Patient with multiple sclerosis |
| Usual care (as recommended by the Haute Authorité de Santé (HAS)) and medical device testThey will be asked to perform two gait analysis tests on a three-dimensional platform, equipped with sensors (medical device). | Diagnostic test | Volunteers |
Primary outcome
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..
6 secondary outcomes
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% )for the whole-body angular momentum
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 1 month
Differences in contribution and inefficiency indexes between groups
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline MASSOT, PhD principal investigator
Hôpital Saint-Philibert
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Medical Device, run by Lille Catholic University at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) for validity of the Trigno® Avanti Sensor (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.