Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07136844

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Gait Analysis and Upper Limb Evaluation Using Syde Device in Adults with Neurological or Metabolic Movement Disorders | DecenTrialz