NCT05982119Recruiting
Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study
Gait Analysis Parameter, Stair Climbing and Upper Limb Evaluation in Patients With Muscular Pathology and in Control Subjects: The ActiLiège Next Study
Source: ClinicalTrials.gov · Last updated 20 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 20 Jul 2021
- Start date
- 10 Jul 2020
- Primary completion date
- Mar 2026
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Diseases
- Duchenne muscular dystrophy
- NCT number
- NCT05982119
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 10 Jul 2020 to the primary completion date, Mar 2026
- 8 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 1 year to 80 years · Sex: All · Accepts healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHR de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Galaa Military Medical Complex Coordinator of this site? Confirm its status | Cairo | Egypt | Active, not recruiting |
| Semmelweis University 2nd Department of Paediatrics Coordinator of this site? Confirm its status | Budapest | Hungary | Active, not recruiting |
| Warsaw Medical University Hospital, Department of Neurology Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| National Clinical Hospital for Children Neurohabilitation "Dr Nicolae Robanescu" Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Pediatric Neurology Clinic, Clinical Hospital of Psychiatry "Prof. Dr. Al. Obregia" Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| University Children's Hospital, Department for Pediatric Neurology Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.