Status:
RECRUITING
Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study
Lead Sponsor:
Centre Hospitalier Universitaire de Liege
Collaborating Sponsors:
SYSNAV
Conditions:
Duchenne Muscular Dystrophy
Fascioscapulohumeral Muscular Dystrophy
Eligibility:
All Genders
1-80 years
Phase:
NA
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 neu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05982119
Start Date
July 10 2020
End Date
March 1 2026
Last Update
May 20 2025
Active Locations (8)
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1
CHR de la Citadelle
Liège, Belgium, 4000
2
Fakultni nemocnice v Motole
Prague, Czechia
3
Galaa Military Medical Complex
Cairo, Egypt
4
Semmelweis University 2nd Department of Paediatrics
Budapest, Hungary