NCT07136844 Gait Analysis Parameter and Upper Limb Evaluation in Adult Patients With Neurological or Metabolic Pathology
| NCT ID | NCT07136844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Liege |
| Condition | Neuromuscular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-03-29 |
| Primary Completion | 2029-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The ActiLiège-Adult study is a prospective, longitudinal, observational study designed to collect natural history data on adult patients with neurological or metabolic diseases affecting movement. Conducted at the Centre de Référence Liégeois des Maladies Neuromusculaires in Liège, Belgium, the study will enroll 300 ambulant patients, including individuals with neuromuscular disorders and obesity. Using the Syde® wearable device, the study aims to continuously monitor motor function in real-life settings over a period of up to two years. The primary objective is to evaluate the utility of digital mobility outcomes, such as the 95th centile of stride velocity (SV95C), as reliable and objective endpoints for future clinical trials.
Eligibility 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 chroni