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

Sponsor
Centre Hospitalier Universitaire de Liege
Study ID
NCT05982119
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
1 Year - 80 Years
Healthy Volunteers
Accepted

Interventions

  • ActiMyo/Syde — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 8, 2023
Start date
Jul 10, 2020
Status verified
May 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Patients with DMD/FSHD/CMT/DM1/CNM/FKRPmutation or control subjects
    Patients and control subjects will be included over a 3-years study period. Patients will be examined by a neuropaediatrician or neurologist and perform standardized assessments (timed tests, motor function tests, and strength tests) at baseline and then every 6 to 12 months (depending on age). From February 2024, controls subjects can be remotely recruited and enrolled. They won't be evaluated on site, but data, such as age, sex, weight, and height, will be collected by phone or visio-conference at inclusion and every 6 months for 3 years. Patients will be asked to wear the device during 1 to 3 months at baseline (depending on disease group) and then for 1 month every 3-12months (depending on age and disease group). Control subjects will be examined by a physician and perform the same tests than those for ambulant patients at baseline and 12 months. Control subjects will be asked to wear the device for two months (one month at inclusion, one month 11 months after inclusion).

Primary Outcome Measure

Stride velocity [ Time Frame: through study completion (3 year) ]

Central Contacts

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