Duchenne Muscular DystrophyNCT05982119
Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study
A study testing ActiMyo/Syde in people with Duchenne Muscular Dystrophy and Fascioscapulohumeral Muscular Dystrophy, run by Centre Hospitalier Universitaire de Liege at 8 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy, Myotonic Dystrophy 1
- What is being tested?
- ActiMyo/Syde
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 10 Jul 2020to Mar 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 7 countries
Romania2 sites, 1 recruiting
- Recruiting
Pediatric Neurology Clinic, Clinical Hospital of Psychiatry "Prof. Dr. Al. Obregia"
Bucharest, 041914
- Active, not recruiting
National Clinical Hospital for Children Neurohabilitation "Dr Nicolae Robanescu"
Bucharest
Belgium1 site, 1 recruiting
- Recruiting
CHR de la Citadelle
Liège, 4000
Noor Benmhammed, 43217726 ext. +32, Noor.Benmhammed@citadelle.be
Laurie Medard, 43218222 ext. +32, Laurie.Medard@citadelle.be
Hungary1 site
- Active, not recruiting
Semmelweis University 2nd Department of Paediatrics
Budapest
Poland1 site
- Active, not recruiting
Warsaw Medical University Hospital, Department of Neurology
Warsaw
Slovenia1 site
- Active, not recruiting
University Children's Hospital, Department for Pediatric Neurology
Ljubljana
About this study
Official title: Gait Analysis Parameter, Stair Climbing and Upper Limb Evaluation in Patients With Muscular Pathology and in Control Subjects: The ActiLiège Next Study
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
- Duchenne Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy, Myotonic Dystrophy 1, Charcot-Marie-Tooth, Centronuclear Myopathy, Congenital Muscular Dystrophy
- Being tested
- ActiMyo/Syde
- Medical subject headings
- Muscular Dystrophy, Duchenne, Muscular Dystrophy, Facioscapulohumeral, Myotonic Dystrophy, Charcot-Marie-Tooth Disease, Myopathies, Structural, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiMyo/SydeDevice
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 group | Role | What they receive |
|---|---|---|
| Patients with DMD/FSHD/CMT/DM1/CNM/FKRPmutation or control subjects | Other | Patients and control subjects will be included over a 3-years study period. Patients will be examined by a neuropaediatrician or neurologist and perform standardized assessments (timed tests, motor function tests, and strength tests) at baseline and then every 6 to 12 months (depending on age).
From February 2024, controls subjects can be remotely recruited and enrolled. They won't be evaluated on site, but data, such as age, sex, weight, and height, will be collected by phone or visio-conference at inclusion and every 6 months for 3 years.
Patients will be asked to wear the device during 1 to 3 months at baseline (depending on disease group) and then for 1 month every 3-12months (depending on age and disease group).
Control subjects will be examined by a physician and perform the same tests than those for ambulant patients at baseline and 12 months. Control subjects will be asked to wear the device for two months (one month at inclusion, one month 11 months after inclusion). Receives: Device: ActiMyo/Syde |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride velocity
Stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
Measured: through study completion (3 year)
Stride length
Stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
Measured: through study completion (3 year)
Stairs number
Total number of strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Measured: through study completion (3 year)
Stairs speed
Vertical speed during strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Measured: through study completion (3 year)
Stairs height
Height of the strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Measured: through study completion (3 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start10 Jul 2020
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Collaborators
- SYSNAV
- Responsible party
- Principal investigator, Laurent Servais, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982119
- Sponsor's protocol ID
- ActiLiege Next
- Status last verified
- May 2025
- First submitted
- 20 Jul 2021
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No