Collecting data on muscle disorders using wearable devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ActiLiège Next study aims to gather longitudinal data from patients with various neuromuscular disorders and control subjects through the use of a wearable magneto-inertial device. This innovative approach focuses on validating digital outcome measures to continuously assess motor function in real-life settings. The study includes patients with conditions such as Duchenne Muscular Dystrophy and Myotonic Dystrophy, ensuring a comprehensive understanding of these muscular pathologies. By monitoring motor function over time, the study seeks to enhance the management and treatment of these disorders.

Why it matters

Who can join: the full rules

Inclusion criteria

* For the patients:

  * Genetically confirmed diagnosis of DMD, FSHD, DM1, CMT or FKRP mutations or confirmed 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 physical examination.
  * Under the age of 20 years for patients with DMD, CNM or between the ages of 5 and 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 a wheelchair for at least one hour.
  * Patients with DMD treated with corticosteroids for at least 6 months or initiated 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 minor patients, signed informed consent form by patient's parents or legal guardians.

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.

Where it's running

• CHR de la Citadelle
  Liège, Belgium Recruiting
• Pediatric Neurology Clinic, Clinical Hospital of Psychiatry "Prof. Dr. Al. Obregia"
  Bucharest, Romania Recruiting
• Fakultni nemocnice v Motole
  Prague, Czechia Active not recruiting
• Galaa Military Medical Complex
  Cairo, Egypt Active not recruiting
• Semmelweis University 2nd Department of Paediatrics
  Budapest, Hungary Active not recruiting
• Warsaw Medical University Hospital, Department of Neurology
  Warsaw, Poland Active not recruiting

Study contacts

• Study coordinator: Charline DUBOIS
• Email: charline.dubois@citadelle.be
• Phone: 043215695

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VM100: a nutritional supplement to see if it improves quality of life for boys with Duchenne

  This Phase 2 study tests VM100, a nutritional drink, in boys aged 8 and up with Duchenne muscular dystrophy to see if it can improve quality of life and reduce fatigue.

  Recruiting Phase 2 University of Florida · Gainesville, Florida · NCT07766980

• KER-065 for Duchenne Muscular Dystrophy: safety and potential benefit in boys and men

  This study tests whether KER-065 is safe and can help with symptoms in males with Duchenne muscular dystrophy, including both ambulatory and nonambulatory participants who are on standard care.

  Recruiting at 2 sites Phase 2 Keros Therapeutics, Inc. · Tbilisi and 3 other locations · NCT07704099

• Understanding long-term progression in myotonic dystrophy type 1 (DM1)

  This study will follow adults with DM1 for at least four years to see how walking, hand function, muscle strength, heart rhythms, and lung function change over time.

  Recruiting Virginia Commonwealth University · Richmond, Virginia · NCT07700225

• GNR-097 gene therapy for Duchenne muscular dystrophy in boys

  This study tests a gene therapy (GNR-097) to see if it is safe, tolerable, and potentially beneficial for ambulatory boys with Duchenne muscular dystrophy.

  Recruiting at 6 sites Phase 1/2 Ao Generium · Minsk and 5 other locations · NCT07673809

• ELEVIDYS safety in Duchenne patients treated after market approval

  This study tests the safety of ELEVIDYS, with sirolimus as a protective treatment, in male children and young adults with Duchenne Muscular Dystrophy who have previously received ELEVIDYS or are eligible to receive it commercially.

  Recruiting Phase 4 Sarepta Therapeutics, Inc. · Houston, Texas · NCT07542314

• Nerve function and structure in CMT, anti‑MAG neuropathy, and CIDP

  This project will test nerve‑conduction, axonal‑excitability, skin biopsy, and ultrasound measures in adults with CMT, CIDP, or anti‑MAG neuropathy to see if they better describe nerve function and structure.

  Recruiting Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Milan · NCT07461896

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.