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RECRUITING

NCT05982119

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

Sponsor: Centre Hospitalier Universitaire de Liege

View on ClinicalTrials.gov

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.

Official title: Gait Analysis Parameter, Stair Climbing and Upper Limb Evaluation in Patients With Muscular Pathology and in Control Subjects: The ActiLiège Next Study

Key Details

Gender

All

Age Range

1 Year - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2020-07-10

Completion Date

2026-03

Last Updated

2025-05-20

Healthy Volunteers

Yes

Conditions

Duchenne Muscular Dystrophy Fascioscapulohumeral Muscular Dystrophy Myotonic Dystrophy 1 Charcot-Marie-Tooth Centronuclear Myopathy Congenital Muscular Dystrophy

Interventions

DEVICE

ActiMyo/Syde

The two "watches" can be worn as wristwatch or placed near the ankle and on the wheelchair. * Patients with DMD or FKRP mutation will wear the ActiMyo°/Syde° during 3 months at baseline and then for one month every 3 months. * Patient with FSHD, DM1, CMT, CNM will wear the ActiMyo°/Syde° will wear the ActiMyo/Syde° during 3 months at baseline and then for one month every 6 months. * Control subjects \>4years will wear the ActiMyo°/Syde° during one month after inclusion and during one other month 11 months after inclusion. * Control subjects \<4years will wear the ActiMyo°/Syde° during one month after inclusion and during one other month every 6months after 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.

Locations (8)

CHR de la Citadelle

Liège, Belgium

Fakultni nemocnice v Motole

Prague, Czechia

Galaa Military Medical Complex

Cairo, Egypt

Semmelweis University 2nd Department of Paediatrics

Budapest, Hungary

Warsaw Medical University Hospital, Department of Neurology

Warsaw, Poland

Pediatric Neurology Clinic, Clinical Hospital of Psychiatry "Prof. Dr. Al. Obregia"

Bucharest, Romania

National Clinical Hospital for Children Neurohabilitation "Dr Nicolae Robanescu"