Actively Recruiting

Phase Not Applicable
Age: 1Year - 80Years
All Genders
Healthy Volunteers
NCT05982119

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

Led by Centre Hospitalier Universitaire de Liege · Updated on 2025-05-20

300

Participants Needed

8

Research Sites

294 weeks

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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Year - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Genetically confirmed diagnosis of DMD, FSHD, DM1, CMT, FKRP mutations, or confirmed CNM by muscle biopsy
  • FSHD, DM1, CMT, and CNM patients must be ambulant or in transition
  • DM1 and CMT patients must have sensori-motor signs on physical exam
  • Patients with DMD, CNM under 20 years old
  • Patients with FSHD, CMT, and DM1 between 5 and 80 years old
  • Patients with FKRP mutations older than 2 years
  • Non-ambulant DMD patients able to remain seated in an armchair or wheelchair for at least one hour
  • DMD patients treated with corticosteroids for at least 6 months or started corticosteroids at baseline (except patients under 4)
  • Signed informed consent by patient or guardian
  • Control subjects ambulant boys and girls under 20 years old
  • Signed informed consent by control subject or guardian
Not Eligible

You will not qualify if you...

  • Patients with severe cognitive disorders limiting understanding of exercises
  • Patients with surgery or trauma to upper or lower limbs within 6 months (ambulant patients)
  • Chronic or acute neurological, endocrine, infectious, allergic, or inflammatory disease within 3 weeks before inclusion
  • Patients enrolled in another interventional clinical trial
  • DMD patients in transition not receiving corticosteroids
  • Control subjects with surgery or trauma to limbs within 6 months
  • Elite athletes at the national level
  • Control subjects with chronic or acute muscular, neurological, infectious, or inflammatory disease within 3 weeks before inclusion
  • Control subjects with orthopedic, neuromuscular, or neurological conditions affecting walking quality

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

C

Charline DUBOIS

CONTACT

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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