Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study

Recruiting now · Not applicable

Conditions studied: Duchenne Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy, Myotonic Dystrophy 1, Charcot-Marie-Tooth, Centronuclear Myopathy, Congenital Muscular Dystrophy

In brief

The objective of the ActiLiège Next study is to collect longitudinal data from patients and control subjects using a wearable magneto-inertial device. By collecting natural history data in various neuromuscular disorders (Duchenne Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy, Myotonic Dystrophy 1, Charcot-Marie-Tooth, Centronuclear Myopathy, Congenital Muscular Dystrophy), we aim to validate digital outcome measures to continuously assess motor function in real-life.

Key facts

Study ID: NCT05982119
Run by: Centre Hospitalier Universitaire de Liege
People needed: 300
Starts: 2020-07-10
Expected to finish: 2026-03-01
Last updated by the study team: 2025-05-20

Who can join

Age: 1 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

For the patients:
Genetically confirmed diagnosis of DMD, FSHD, DM1, CMT or FKRP mutations or confirmed CNM based on muscle biopsy.
FSHD, DM1, CMT and CNM patients should be ambulant or in transition.
DM1 and CMT patients should present sensori-motor signs on physical examination.
Under the age of 20 years for patients with DMD, CNM or between the ages of 5 and 80 years for patients with FSHD, CMT and DM1.
More than 2 years old for patients with FKRP mutations
Non-ambulant DMD patients must be able to remain seated in an arm- or a wheelchair for at least one hour.
Patients with DMD treated with corticosteroids for at least 6 months or initiated corticosteroid at V0 (except for patients under 4).
Signed informed consent form by patient himself or, in case of minor patients, signed informed consent form by patient's parents or legal guardians.
For the control subjects:
Ambulant boys and girls under 20 years old
Signed informed consent form by patient him/herself or, in case of minor patients, signed informed consent form by patient's parents or legal guardians.

You may not qualify if…

For the 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 (for ambulant patients).
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.
DMD patients in transition who are not on corticosteroids.
For the control subjects:
Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the upper or lower limbs.
Elite athletes (at the national level).
A chronic or acute muscular, neurological, infectious, or inflammatory pathology within the 3-week period immediately prior to inclusion.
An orthopedic, neuromuscular, or neurological pathology that affects the quality of the subject's walking gait.

Where it is running

Pediatric Neurology Clinic, Clinical Hospital of Psychiatry "Prof. Dr. Al. Obregia" — Bucharest, Romania (enrolling)
CHR de la Citadelle — Liège, Belgium (enrolling)
Galaa Military Medical Complex — Cairo, Egypt
Semmelweis University 2nd Department of Paediatrics — Budapest, Hungary
Warsaw Medical University Hospital, Department of Neurology — Warsaw, Poland
National Clinical Hospital for Children Neurohabilitation "Dr Nicolae Robanescu" — Bucharest, Romania
University Children's Hospital, Department for Pediatric Neurology — Ljubljana, Slovenia
Fakultni nemocnice v Motole — Prague, Czechia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.