Linking a hip-worn smartphone gait sensor with spinal MRI in people with multiple sclerosis
Individual Gait Pattern and MRI Lesion Load to Quantify Gait Impairment in MS: A Cross Sectional Study.
Nantes University Hospital · NCT05482906
This project will try whether combining a hip-worn IMU smartphone app and routine spinal MRI can better describe walking changes in adults with multiple sclerosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Locations | 1 site (Nantes, Loire-Atlantique) |
| Trial ID | NCT05482906 on ClinicalTrials.gov |
What this trial studies
This observational project uses a commercial IMU sensor worn at the right hip (MetaMotionR), a smartphone app, and an algorithm to extract an individual gait pattern (IGP) represented as a quaternion-based rotation curve. Adults with MS (EDSS 0–6) who are followed at Nantes or Rennes University Hospitals and have a spinal MRI planned as part of routine care will perform a walking test while wearing the device. Investigators will compare the smartphone-derived gait curves with routine spinal MRI findings obtained within four months of the walking test to look for common and specific signatures. The goal is to refine noninvasive, easy-to-collect digital markers of gait that can be linked to neuroimaging changes.
Who should consider this trial
Good fit: Adults over 18 with a diagnosis of multiple sclerosis (EDSS 0–6), followed at Nantes or Rennes University Hospitals, free of relapse for at least 3 months, and scheduled for a spinal MRI are ideal candidates.
Not a fit: Patients who require bilateral walking aids, are pregnant, under guardianship, or who decline participation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide clinicians with objective, easy-to-collect gait measures that relate to spinal MRI findings and help personalize monitoring and care.
How similar studies have performed: Previous work using IMU-derived individual gait patterns has shown promise for detecting gait changes in MS, but combining those patterns with MRI information is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : * Diagnosis of MS based on McDonald criteria (including Relapsing-remitting and progressive MS) * Over 18 years old /age greater than 18 years * Patients followed at Nantes university hospital or Rennes university hospital * Last known EDSS before inclusion ranging from 0 to 6 inclusive/EDSS of 0 to 6 inclusive, prior inclusion * No relapse within 3 months * With a Medullar MRI planed as part as usual care * MRI scan can be performed within a maximum of 4 months after or before the walking test. * Affiliated person or beneficiary of a social security scheme Exclusion Criteria : * Bilateral aid needed to walk * Women who are pregnant * Patient having expressed their opposition * Patient under guardianship or security measure
Where this trial is running
Nantes, Loire-Atlantique
- Nantes University Hospital — Nantes, Loire-Atlantique, France (RECRUITING)
Study contacts
- Study coordinator: David LAPLAUD, PHD
- Email: david.laplaud@chu-nantes.fr
- Phone: 33 2 40 16 52 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, Wearable sensor, Gait, MRI