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New treatment option for Duchenne Muscular Dystrophy
Official title Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study
ClinicalTrials.gov ID: NCT05982119
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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...
- A concomitant chronic or acute neurological, endocrine, infectious, allergic, or inflammatory pathology within the 3-week period immediately prior to...
- Patients who are participating in an treatment clinical trial.
- DMD patients in transition who are not on corticosteroids.
See the full eligibility 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 people:
- 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.
- 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 treatment clinical trial.
- DMD patients in transition who are not on corticosteroids.
- For the control people:
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Liège, Belgium
- Prague, Czechia
- Cairo, Egypt
- Budapest, Hungary
- Warsaw, Poland
- Bucharest, Romania
- Ljubljana, Slovenia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Liège, Belgium; Prague, Czechia; Cairo, Egypt; Budapest, Hungary; Warsaw, Poland; Bucharest, Romania and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.