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Gait Analysis Parameter and Upper Limb Evaluation in Adult Patients With Neurological or Metabolic Pathology

RECRUITINGN/ASponsored by Centre Hospitalier Universitaire de Liege
Actively Recruiting
PhaseN/A
SponsorCentre Hospitalier Universitaire de Liege
Started2024-03-29
Est. completion2029-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07136844

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions13

Ataxia, SpinocerebellarCancerCharcot Marie Tooth Disease (CMT)Facio-Scapulo-Humeral DystrophyGlycogen Storage Disease Type II Pompe DiseaseHereditary Spastic ParaplegiaHuntington DiseaseMyasthenia GravisMyasthenic SyndromeMyotonic Dystrophy 1

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