Use of Inertial Units in Patient With Multiple Sclerosis (IMUSEP) (NCT06634225) | Clinical Trial Compass
CompletedNot Applicable
Use of Inertial Units in Patient With Multiple Sclerosis (IMUSEP)
France70 participantsStarted 2024-11-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Intra-class correlation coefficients (ICC) and their 95% confidence intervals (IC95%) for validity of the Trigno® Avanti Sensor