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

• 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

Primary Outcome Measures

Name	Time	Method
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 height	through study completion (3 year)	Height of the strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
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