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

Last updated: May 15, 2025
Sponsor: Centre Hospitalier Universitaire de Liege
Overall Status: Active - Recruiting

Phase

N/A

Condition

Muscular Dystrophy

Neuropathy

Peripheral Neuropathy

Treatment

ActiMyo

ActiMyo/Syde

Clinical Study ID

NCT05982119
ActiLiege Next
  • Ages 1-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria

  • For the patients:

  • Genetically confirmed diagnosis of DMD, FSHD, DM1, CMT or FKRP mutations orconfirmed CNM based on muscle biopsy.

  • FSHD, DM1, CMT and CNM patients should be ambulant or in transition.

  • DM1 and CMT patients should present sensori-motor signs on physicalexamination.

  • Under the age of 20 years for patients with DMD, CNM or between the ages of 5and 80 years for patients with FSHD, CMT and DM1.

  • More than 2 years old for patients with FKRP mutations

  • Non-ambulant DMD patients must be able to remain seated in an arm- or awheelchair for at least one hour.

  • Patients with DMD treated with corticosteroids for at least 6 months orinitiated corticosteroid at V0 (except for patients under 4).

  • Signed informed consent form by patient himself or, in case of minor patients,signed informed consent form by patient's parents or legal guardians.

  • For the control subjects:

  • Ambulant boys and girls under 20 years old

  • Signed informed consent form by patient him/herself or, in case of minorpatients, signed informed consent form by patient's parents or legal guardians.

Exclusion

Exclusion Criteria:

  • For the patients:

  • Patients with extreme cognitive disorders that limit their understanding of theexercises to be performed.

  • Patients who have undergone a surgical procedure or who have experienced recenttrauma (within fewer than 6 months) affecting the upper or lower limbs (forambulant patients).

  • A concomitant chronic or acute neurological, endocrine, infectious, allergic,or inflammatory pathology within the 3-week period immediately prior toinclusion.

  • 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 recenttrauma (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 inflammatorypathology within the 3-week period immediately prior to inclusion.

  • An orthopedic, neuromuscular, or neurological pathology that affects thequality of the subject's walking gait.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: ActiMyo
Phase:
Study Start date:
July 10, 2020
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • CHR de la Citadelle

    Liège, 4000
    Belgium

    Active - Recruiting

  • Fakultni nemocnice v Motole

    Prague,
    Czech Republic

    Site Not Available

  • Fakultni nemocnice v Motole

    Prague,
    Czechia

    Site Not Available

  • Galaa Military Medical Complex

    Cairo,
    Egypt

    Site Not Available

  • Semmelweis University 2nd Department of Paediatrics

    Budapest,
    Hungary

    Site Not Available

  • Warsaw Medical University Hospital, Department of Neurology

    Warsaw,
    Poland

    Site Not Available

  • National Clinical Hospital for Children Neurohabilitation "Dr Nicolae Robanescu"

    Bucarest,
    Romania

    Site Not Available

  • Pediatric Neurology Clinic, Clinical Hospital of Psychiatry "Prof. Dr. Al. Obregia"

    Bucharest, 041914
    Romania

    Active - Recruiting

  • University Children's Hospital, Department for Pediatric Neurology

    Ljubljana,
    Slovenia

    Site Not Available

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