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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982119
• Other study ID #: ActiLiege Next
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2020
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Liege
• Contact: Manon Duclos
• Phone: 003243215586
• Email: manon.duclos[@]chrcitadelle.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, Charcot-Marie-Tooth, Centronuclear Myopathy, Congenital Muscular Dystrophy), we aim to validate digital outcome measures to continuously assess motor function in real-life.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Centronuclear Myopathy
• Charcot-Marie-Tooth
• Charcot-Marie-Tooth Disease
• Congenital Muscular Dystrophy
• Duchenne Muscular Dystrophy
• Hereditary Sensory and Motor Neuropathy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Muscular Dystrophy, Facioscapulohumeral
• Myotonic Dystrophy
• Myotonic Dystrophy 1
• Nerve Compression Syndromes

Intervention

Device:
• ActiMyo/Syde
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.

Locations

Country	Name	City	State
Belgium	CHR de la Citadelle	Liège

Sponsors (2)

Lead Sponsor	Collaborator
Laurent Servais	SYSNAV

Country where clinical trial is conducted

Belgium, 

Outcome

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)