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

May 15, 2025 updated by: Laurent Servais, Centre Hospitalier Universitaire de Liege

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Liège, Belgium, 4000
  • Czechia
      • Prague, Czechia
        • Active, not recruiting
        • Fakultni nemocnice v Motole
  • Egypt
      • Cairo, Egypt
        • Active, not recruiting
        • Galaa Military Medical Complex
  • Hungary
      • Budapest, Hungary
        • Active, not recruiting
        • Semmelweis University 2nd Department of Paediatrics
  • Poland
      • Warsaw, Poland
        • Active, not recruiting
        • Warsaw Medical University Hospital, Department of Neurology
  • Romania
      • Bucarest, Romania
        • Active, not recruiting
        • National Clinical Hospital for Children Neurohabilitation "Dr Nicolae Robanescu"
      • Bucharest, Romania, 041914
        • Recruiting
        • Pediatric Neurology Clinic, Clinical Hospital of Psychiatry "Prof. Dr. Al. Obregia"
  • Slovenia
      • Ljubljana, Slovenia
        • Active, not recruiting
        • University Children's Hospital, Department for Pediatric Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stride velocity
Time Frame: through study completion (3 year)
Stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
through study completion (3 year)
Stride length
Time Frame: through study completion (3 year)
Stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
through study completion (3 year)
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
through study completion (3 year)
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
through study completion (3 year)
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
through study completion (3 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Liege

Collaborators

SYSNAV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2020

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ActiLiege Next

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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