Health Trials

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

ConditionsNeuromuscular DiseasesObesity (Disorder)Myotonic Dystrophy 1Myasthenic SyndromeCharcot Marie Tooth Disease (CMT)Glycogen Storage Disease Type II Pompe DiseaseFacio-Scapulo-Humeral DystrophyMyasthenia GravisHuntington DiseaseProgressive Supranuclear Palsy (PSP)Hereditary Spastic ParaplegiaAtaxia, Spinocerebellar
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Liege

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Syde
  • Dynamometric measurements of muscle strength
  • The 6-minute walk test (6MWT)
  • The 10-meter test (10MWT)
  • The 4 stair-climbing test (4SC)
  • Test of rising from the floor (TRF)
  • The Timed up and go test (TUG)
  • The Progressive Supranuclear Palsy Rating Scale (PSP-RS)
  • The Montreal Cognitive Assessment (MOCA)
  • The Charcot-Marie-Tooth examination score (CMTES)
  • 9-Hole Peg Test (9-HPT)
  • The Unified Huntington's Disease Rating Scale (UHDRS)
  • Quantitative Myasthenia Gravis (QMG)
  • The Myasthenia Gravis Activities of Daily Living Scale (MG-ADL)
  • The Scale for the Assessment and Rating of Ataxia (SARA)
  • Patient's Global Impression of Change (PGIC)

Treatment groups

300 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators

Centre Hospitalier Universitaire de Liege

Lead sponsor

Centre Hospitalier Régional de la Citadelle

Collaborator

SYSNAV

Collaborator

Source ClinicalTrials.gov