Duchenne Muscular Dystrophy Clinical Trial
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | March 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | CHR de la Citadelle | Liège |
Lead Sponsor | Collaborator |
---|---|
Laurent Servais | SYSNAV |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stride velocity | Stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second). | through study completion (3 year) | |
Primary | Stride length | Stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter). | through study completion (3 year) | |
Primary | Stairs number | Total number of strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life | through study completion (3 year) | |
Primary | Stairs speed | Vertical speed during strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life | through study completion (3 year) | |
Primary | Stairs height | Height of the strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life | through study completion (3 year) |
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