Wearable monitoring of walking and arm movement in adults with neuromuscular or metabolic movement disorders
Gait Analysis Parameter and Upper Limb Evaluation in Adult Patients With Neurological or Metabolic Pathology
This project uses a wrist/ankle wearable to continuously monitor walking and upper-limb movement in ambulant adults with neuromuscular diseases or obesity to see if digital measures like stride speed track real-life motor function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Liege Academic / other |
| Locations | 1 site (Liège) |
| Trial ID | NCT07136844 on ClinicalTrials.gov |
What this trial studies
This prospective, longitudinal observational project will enroll about 300 ambulant adults at specialist centers in Liège, Belgium and follow them for up to two years (six months for disorders of the neuromuscular junction). Participants will wear the Syde® magneto-inertial sensor on the wrist and/or ankle for continuous home monitoring, alongside standardized in-clinic tests such as the 6-minute walk test, 10-meter test, stair-climbing and muscle dynamometry. The primary focus is on digital mobility outcomes, notably the 95th centile of stride velocity (SV95C), to determine their reliability and practical use as objective endpoints across several diseases. Data collection includes regular clinic visits and remote wearable data to capture daily-life motor performance and change over time.
Who should consider this trial
Good fit: Ambulant adults who can walk 10 meters unaided with a confirmed diagnosis of a relevant neuromuscular disease (e.g., myotonic dystrophy type 1, Charcot-Marie-Tooth, seropositive myasthenia gravis) or morbid obesity (BMI ≥ 35) who can consent and comply with study procedures.
Not a fit: Non-ambulant patients, those with severe cognitive impairment, recent limb surgery or trauma, or individuals unable or unwilling to wear the monitoring device are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could provide objective, continuous measures of everyday motor function that improve clinical endpoints and help tailor future trials and care.
How similar studies have performed: Similar digital mobility measures, including SV95C, have been qualified and used successfully in Duchenne muscular dystrophy and the Syde device has prior validation in neuromuscular conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ambulant patients (i.e. able to walk 10 meters without assistance) * Confirmed diagnosis by the investigator based on current gold standard in his/her disease (genetic testing, clinical criteria, etc.) * Myotonic dystrophy type 1 (DM1) and Charcot-Marie-Tooth (CMT) patients should present sensitive of motor signs on physical examination. * Myasthenic patients should be seropositive, and Myasthenia Gravis Foundation of America (MGFA) class II to IV. * Patient with morbid obesity (Body Mass Index\> or = 35 at inclusion visit). * Signed informed consent form by patient him/herself and patient willing and able to comply with all study procedures. Exclusion Criteria: * Non-ambulant patients * Patients with extreme cognitive disorders that limit their understanding of the exercises to be performed * Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the upper or lower limbs * A concomitant chronic or acute neurological, endocrine, infectious, allergic, or inflammatory pathology within the 3-week period immediately prior to inclusion * Patients who are participating in an interventional clinical trial * Pregnant or breastfeeding women
Where this trial is running
Liège
- Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle — Liège, Belgium (Recruiting)
Study contacts
- Principal investigator: Laurent Servais, MD — Centre Hospitalier Universitaire de Liege
- Study coordinator: Nicolas Bovy
- Email: Nicolas.Bovy@citadelle.be
- Phone: +3243218095
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.