NCT05982119 Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study
| NCT ID | NCT05982119 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Liege |
| Condition | Duchenne Muscular Dystrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-07-10 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2020-07-10 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion criteria * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05982119 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 80 Years, studying Duchenne Muscular Dystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05982119 currently recruiting?
Yes, NCT05982119 is actively recruiting participants. Contact the research team at charline.dubois@citadelle.be for enrollment information.
Where is the NCT05982119 trial being conducted?
This trial is being conducted at Liège, Belgium, Prague, Czechia, Cairo, Egypt, Budapest, Hungary and 4 additional locations.
Who is sponsoring the NCT05982119 clinical trial?
NCT05982119 is sponsored by Centre Hospitalier Universitaire de Liege. The trial plans to enroll 300 participants.