Actively Recruiting
Gait Analysis and Upper Limb Evaluation Using Syde Device in Adults with Neurological or Metabolic Movement Disorders
Led by Centre Hospitalier Universitaire de Liege · Updated on 2025-08-22
300
Participants Needed
1
Research Sites
348 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Liege
Lead Sponsor
C
Centre Hospitalier Régional de la Citadelle
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adult patients with neurological or metabolic diseases that affect movement, including neuromuscular disorders and obesity. This observational study at the Centre de Référence Liégeois des Maladies Neuromusculaires in Belgium plans to enroll 300 ambulant adults. The goal is to gather natural history data and evaluate digital mobility outcomes such as the 95th centile of stride velocity (SV95C) as objective markers for future clinical trials, building on previous findings in Duchenne muscular dystrophy. Participants will wear a Syde® device, a wearable magneto-inertial sensor worn on the wrist or ankle, to continuously monitor motor activity in daily life for up to two years (six months for diseases affecting the neuromuscular junction). Standardized clinical tests—including timed walking, stair climbing, rising from the floor, muscle strength measurements, and cognitive assessments—will be performed every six months. Patients will also complete a Patient Global Impression of Change questionnaire at these visits. Those who lose the ability to walk during the study will continue with adapted assessments. During the study, patients will be regularly evaluated through physical and motor function tests, strength measurements using MyoTools, and various clinical rating scales tailored to their conditions. Continuous data from the Syde® device will be compared to these clinical assessments to understand motor function better. The primary outcome measure is the 95th centile of stride velocity, recorded every six months for up to two years. This comprehensive monitoring aims to support the development of sensitive and meaningful digital endpoints for use in future therapeutic trials targeting movement disorders.
CONDITIONS
Official Title
Gait Analysis Parameter and Upper Limb Evaluation in Adult Patients With Neurological or Metabolic Pathology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to walk 10 meters without assistance
- Confirmed diagnosis based on standard methods for their disease
- Myotonic dystrophy type 1 and Charcot-Marie-Tooth patients must show sensitive or motor signs on exam
- Myasthenic patients must be seropositive and classified as MGFA class II to IV
- Patients with morbid obesity (BMI ≥ 35 at inclusion)
- Signed informed consent and willingness to follow study procedures
You will not qualify if you...
- Unable to walk
- Severe cognitive disorders limiting understanding of exercises
- Recent surgery or trauma to upper or lower limbs within 6 months
- Chronic or acute neurological, endocrine, infectious, allergic, or inflammatory disease within 3 weeks before inclusion
- Participation in an interventional clinical trial
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle
Liège, Belgium, 4000
Actively Recruiting
Research Team
N
Nicolas Bovy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
8
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