ActiMyo/Syde: The two "watches" can be worn as wristwatch or placed near the ankle and on the wheelchair.
* Patients with DMD or FKRP mutation will wear the ActiMyo°/Syde° during 3 months at baseline and then for one month every 3 months.
* Patient with FSHD, DM1, CMT, CNM will wear the ActiMyo°/Syde° will wear the ActiMyo/Syde° during 3 months at baseline and then for one month every 6 months.
* Control subjects \>4years will wear the ActiMyo°/Syde° during one month after inclusion and during one other month 11 months after inclusion.
* Control subjects \<4years will wear the ActiMyo°/Syde° during one month after inclusion and during one other month every 6months after inclusion.
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
Sex
ALL
Min age
1 Year
Max age
80 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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 number — through study completion (3 year) Total number of 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 height — through study completion (3 year) Height of the strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Trial sites (8)
Facility
City
Region
Status
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.