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

Not Applicable

Recruiting

• Conditions: Myotonic Dystrophy 1; Centronuclear Myopathy; Duchenne Muscular Dystrophy; Charcot-Marie-Tooth; Fascioscapulohumeral Muscular Dystrophy; Congenital Muscular Dystrophy
• Interventions: Device: ActiMyo/Syde

• Registration Number: NCT05982119
• Lead Sponsor: Centre Hospitalier Universitaire de Liege

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-10
• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with DMD/FSHD/CMT/DM1/CNM/FKRPmutation or control subjects	ActiMyo/Syde	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 Measures

Name	Time	Method
Stairs height	through study completion (3 year)	Height of the strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Stride velocity	through study completion (3 year)	Stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
Stride length	through study completion (3 year)	Stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
Stairs speed	through study completion (3 year)	Vertical speed during strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Stairs number	through study completion (3 year)	Total number of strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life

Trial Locations

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

National Clinical Hospital for Children Neurohabilitation "Dr Nicolae Robanescu"; 🇷🇴 Bucarest, Romania

Pediatric Neurology Clinic, Clinical Hospital of Psychiatry "Prof. Dr. Al. Obregia"; 🇷🇴 Bucharest, Romania

University Children's Hospital, Department for Pediatric Neurology; 🇸🇮 Ljubljana, Slovenia