Collecting data on muscle disorders using wearable devices
Gait Analysis Parameter, Stair Climbing and Upper Limb Evaluation in Patients With Muscular Pathology and in Control Subjects: The ActiLiège Next Study
This study is testing a wearable device to track movement in people with muscle disorders like Duchenne Muscular Dystrophy and Myotonic Dystrophy to see how it can help improve their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 1 Year to 80 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Liege Academic / other |
| Locations | 8 sites (Liège and 7 other locations) |
| Trial ID | NCT05982119 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with genetically confirmed diagnoses of specific muscular dystrophies aged between 2 and 80 years.
Not a fit: Patients with muscular disorders who do not meet the age or diagnostic criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of muscular disorders, enhancing patient care.
How similar studies have performed: Other studies utilizing wearable technology for monitoring muscular disorders have shown promise, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Liège and 7 other locations
- CHR de la Citadelle — Liège, Belgium (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)
- Pediatric Neurology Clinic, Clinical Hospital of Psychiatry "Prof. Dr. Al. Obregia" — Bucharest, Romania (Recruiting)
- National Clinical Hospital for Children Neurohabilitation "Dr Nicolae Robanescu" — Bucharest, Romania (Active_not_recruiting)
- University Children's Hospital, Department for Pediatric Neurology — Ljubljana, Slovenia (Active_not_recruiting)
Study contacts
- Study coordinator: Charline DUBOIS
- Email: charline.dubois@citadelle.be
- Phone: 043215695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.