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NCT Number: NCT05982119

Assessments 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.

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Key information

Conditions

Duchenne Muscular Dystrophy Centronuclear Myopathy Charcot-Marie-Tooth Charcot-Marie-Tooth Disease Congenital Abnormalities Congenital Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fascioscapulohumeral Muscular Dystrophy Genetic Diseases, Inborn Genetic Diseases, X-Linked Hereditary Sensory and Motor Neuropathy Heredodegenerative Disorders, Nervous System Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Muscular Dystrophy, Facioscapulohumeral Musculoskeletal Diseases Myopathies, Structural, Congenital Myotonic Disorders Myotonic Dystrophy Myotonic Dystrophy 1 Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies

Age range

1 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR de la Citadelle, Liège, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Stride velocity

    Time frame: through study completion (3 year)

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

  2. Stride length

    Time frame: through study completion (3 year)

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

  3. Stairs number

    Time frame: through study completion (3 year)

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

  4. Stairs speed

    Time frame: through study completion (3 year)

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

  5. Stairs height

    Time frame: through study completion (3 year)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Charline DUBOIS

CONTACT

[email protected]

043215695 ext. +32

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Liege

Other

Collaborators

  • SYSNAV

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2023
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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