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Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study

ConditionsDuchenne Muscular DystrophyFascioscapulohumeral Muscular DystrophyMyotonic Dystrophy 1Charcot-Marie-ToothCentronuclear MyopathyCongenital Muscular Dystrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-80
SponsorCentre Hospitalier Universitaire de Liege

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • ActiMyo/Syde

    Device

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Patients with DMD/FSHD/CMT/DM1/CNM/FKRPmutation or control subjectsOther 1 intervention

Trial outcomes

Primary outcomes

1

Stride velocity

Stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

Time frame
through study completion (3 year)
2

Stride length

Stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).

Time frame
through study completion (3 year)
3

Stairs number

Total number of strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life

Time frame
through study completion (3 year)
4

Stairs speed

Vertical speed during strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life

Time frame
through study completion (3 year)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Liege

Lead sponsor

SYSNAV

Collaborator

Source ClinicalTrials.gov
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