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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis Parameter, Stair Climbing and Upper Limb Evaluation in Patients With Muscular Pathology and in Control Subjects: The ActiLiège Next Study
- ClinicalTrials.gov ID
- NCT05982119
- Acronym / sponsor ID
- ActiLiege Next
- Conditions
- Duchenne Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy, Myotonic Dystrophy 1, Charcot-Marie-Tooth, Centronuclear Myopathy, Congenital Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Collaborators
- SYSNAV
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with DMD/FSHD/CMT/DM1/CNM/FKRPmutation or control subjects | Other | Device: ActiMyo/SydePatients 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). |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- For the patients:
- For the control subjects:
Key exclusion criteria (11 listed)
- For the patients:
- For the control subjects:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiMyo/SydeThe 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. | Device | Patients with DMD/FSHD/CMT/DM1/CNM/FKRPmutation or control subjects |
Primary outcome
Stride velocity
Time frame: through study completion (3 year)
Stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
Stride length
Time frame: through study completion (3 year)
Stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
Stairs number
Time frame: through study completion (3 year)
Total number of strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Stairs speed
Time frame: through study completion (3 year)
Vertical speed during strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Stairs height
Time frame: through study completion (3 year)
Height of the strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Romania, Belgium, Czechia, Egypt, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charline DUBOIS (043215695 ext. +32, charline.dubois@citadelle.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride velocity (time frame: through study completion (3 year)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.