Gait Analysis Parameter, Stair Climbing and Upper Limb Evaluation in Patients with Muscular Pathology and in Control Subjects: the ActiLiège Next Study

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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, Charcot-Marie-Tooth, Centronuclear Myopathy, Congenital Muscular Dystrophy), we aim to validate digital outcome measures to continuously assess motor function in real-life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Belgium
CHR de la Citadelle
RECRUITING
Liège
Czech Republic
Fakultni nemocnice v Motole
ACTIVE_NOT_RECRUITING
Prague
Egypt
Galaa Military Medical Complex
ACTIVE_NOT_RECRUITING
Cairo
Hungary
Semmelweis University 2nd Department of Paediatrics
ACTIVE_NOT_RECRUITING
Budapest
Poland
Warsaw Medical University Hospital, Department of Neurology
ACTIVE_NOT_RECRUITING
Warsaw
Romania
National Clinical Hospital for Children Neurohabilitation Dr Nicolae Robanescu
ACTIVE_NOT_RECRUITING
Bucarest
Pediatric Neurology Clinic, Clinical Hospital of Psychiatry Prof. Dr. Al. Obregia
RECRUITING
Bucharest
Slovenia
University Children's Hospital, Department for Pediatric Neurology
ACTIVE_NOT_RECRUITING
Ljubljana
Contact Information
Primary
Charline DUBOIS
charline.dubois@citadelle.be
043215695
Time Frame
Start Date: 2020-07-10
Estimated Completion Date: 2026-03
Participants
Target number of participants: 300
Treatments
Other: Patients with DMD/FSHD/CMT/DM1/CNM/FKRPmutation or control subjects
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).
Sponsors
Collaborators: SYSNAV
Leads: Laurent Servais

This content was sourced from clinicaltrials.gov