Actively Recruiting
Gait Analysis, Stair Climbing, and Upper Limb Evaluation in Patients With Muscular Disorders and Control Subjects: The ActiLiège Next Study
Led by Centre Hospitalier Universitaire de Liege · Updated on 2025-05-20
300
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Liege
Lead Sponsor
S
SYSNAV
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting long-term data from patients with various neuromuscular disorders such as Duchenne Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy, Myotonic Dystrophy 1, Charcot-Marie-Tooth, Centronuclear Myopathy, and Congenital Muscular Dystrophy, along with healthy control subjects. The goal is to validate digital tools that measure motor function continuously in everyday life using a wearable device. This observational study aims to better understand the natural progression of these conditions through real-life movement data. Participants will wear the ActiMyo/Syde device, which can be worn on the wrist or ankle, or placed on a wheelchair, for varying periods depending on their condition and age. Patients with different muscular disorders wear the device for 1 to 3 months at the start and then periodically for one month every 3 to 12 months. Control subjects also wear the device for one month at inclusion and for another month either 6 or 11 months later. Patients undergo standard clinical assessments every 6 to 12 months, while control subjects have evaluations at baseline and after 12 months. During the study, participants will be evaluated through timed motor tests, strength tests, and gait analysis conducted by neurologists or neuropaediatricians. Control subjects may be recruited remotely and provide data such as age and weight by phone or video calls. The primary measurements include stride velocity, stride length, stair climbing details such as number, speed, and height of stairs climbed, tracked over a three-year period. This study includes regular follow-ups to monitor motor function changes and device adherence.
CONDITIONS
Brief Title
Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Genetically confirmed diagnosis of DMD, FSHD, DM1, CMT, FKRP mutations, or confirmed CNM by muscle biopsy
- Ambulatory or transitioning patients for FSHD, DM1, CMT, and CNM
- DM1 and CMT patients must show sensori-motor signs on exam
- Age under 20 years for DMD or CNM patients
- Age 5 to 80 years for FSHD, CMT, and DM1 patients
- Age over 2 years for FKRP mutation patients
- Non-ambulant DMD patients must be able to sit in a wheelchair or armchair for at least one hour
- DMD patients must have at least 6 months of corticosteroid treatment or start at baseline (except under 4 years old)
- Signed informed consent by patient or guardian
- Ambulant boys and girls under 20 years old for control subjects
- Signed informed consent for control subjects
You will not qualify if you...
- Severe cognitive disorders limiting exercise understanding
- Surgery or recent trauma within 6 months affecting limbs (for ambulant patients or controls)
- Chronic or acute neurological, endocrine, infectious, allergic, or inflammatory disease within 3 weeks before inclusion
- Participation in another interventional clinical trial
- DMD patients in transition not on corticosteroids
- Elite athletes at national level (controls)
- Orthopedic, neuromuscular, or neurological condition affecting walking gait (controls)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to assess eligibility
Duration - Up to 3 years
Participants will wear the ActiMyo/Syde device for periods ranging from one to three months at baseline depending on disease group or control status, followed by additional wearing periods every 3 to 12 months depending on age and disease group.
Device wearing periods include 1 to 3 months at baseline and 1 month every 3 to 12 months; assessments occur at baseline and every 6 to 12 months for patients, and at inclusion and 12 months for control subjects
Duration - Up to 3 years
Participants undergo standardized assessments including timed tests, motor function tests, and strength tests at baseline and follow-up visits occurring every 6 to 12 months depending on age and disease group. Control subjects have remote data collection by phone or video conference every 6 months for 3 years.
Assessments every 6 to 12 months for patients; remote data collection every 6 months for controls
Trial Site Locations
Total: 8 locations
1
CHR de la Citadelle
Liège, Belgium, 4000
Actively Recruiting
2
Fakultni nemocnice v Motole
Prague, Czechia
Active, Not Recruiting
3
Galaa Military Medical Complex
Cairo, Egypt
Active, Not Recruiting
4
Semmelweis University 2nd Department of Paediatrics
Budapest, Hungary
Active, Not Recruiting
5
Warsaw Medical University Hospital, Department of Neurology
Warsaw, Poland
Active, Not Recruiting
6
Pediatric Neurology Clinic, Clinical Hospital of Psychiatry "Prof. Dr. Al. Obregia"
Bucharest, Romania, 041914
Actively Recruiting
7
National Clinical Hospital for Children Neurohabilitation "Dr Nicolae Robanescu"
Bucharest, Romania
Active, Not Recruiting
8
University Children's Hospital, Department for Pediatric Neurology
Ljubljana, Slovenia
Active, Not Recruiting
Research Team
C
Charline DUBOIS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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