Actively Recruiting
Gait Analysis Parameter and Upper Limb Evaluation in Adult Patients With Neurological or Metabolic Pathology
Led by Centre Hospitalier Universitaire de Liege · Updated on 2025-08-22
300
Participants Needed
1
Research Sites
52 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, to better understand how these conditions impact motor function over time. This observational study aims to collect detailed real-world data to develop reliable digital measures for future clinical trials. It is conducted at the Centre de Référence Liégeois des Maladies Neuromusculaires in Liège, Belgium, and involves 300 ambulant patients who can walk at least 10 meters without assistance. Participants will wear the Syde® device, a wearable sensor worn on the wrist or ankle, to continuously monitor their motor activity in daily life for up to two years. Clinical assessments, such as timed walking and stair-climbing tests, muscle strength measurements, and motor function evaluations, will be performed every six months. Patients with diseases affecting the neuromuscular junction will be followed for six months. The study also includes patient questionnaires to capture their impressions of change. Throughout the study, researchers will compare continuous data from the Syde® device with traditional clinical tests and questionnaires. They will monitor adherence to device use and evaluate various motor function scales. The main outcome measured every six months is the 95th centile of stride velocity. This approach aims to create meaningful digital endpoints that can enhance future therapeutic research. The total study duration varies by disease type but can last up to two years per participant.
CONDITIONS
Brief 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...
- Ambulant patients able to walk 10 meters without assistance
- Confirmed diagnosis by investigator using current gold standard methods
- Myotonic dystrophy type 1 and Charcot-Marie-Tooth patients must have sensory or motor signs on examination
- Myasthenic patients must be seropositive and classified as MGFA class II to IV
- Patients with morbid obesity with Body Mass Index ≥ 35 at inclusion
- Signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Non-ambulant patients
- Patients with severe cognitive disorders limiting understanding of study exercises
- Recent surgery or trauma affecting limbs within the last 6 months
- Presence of chronic or acute neurological, endocrine, infectious, allergic, or inflammatory conditions within 3 weeks prior to inclusion
- Participation in another interventional clinical trial
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years (6 months for neuromuscular junction diseases)
Participants undergo standardized clinical assessments including timed tests, motor function evaluations, strength measurements, and cognitive assessments at baseline and every six months. They also complete a patient-reported scale to assess changes over time.
Baseline visit and visits every 6 months
Duration - Up to 2 years (6 months for neuromuscular junction diseases)
Participants wear the Syde® device, a wearable magneto-inertial sensor, continuously during daily life to collect real-world motor activity data throughout the study period.
Continuous home-based monitoring
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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