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

April 24, 2024 updated by: Laurent Servais

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 ActiLiège Next Study is to collect natural history data in Duchenne muscular dystrophy (DMD) (ambulatory and non-ambulatory patients), and in affected patients with Facio-Scapulo-Humeral dystrophy (FSHD), a disease in which results are currently lacking. It consists of obtaining longitudinal data for the patients, as well as normative data for the control subjects, with a particular emphasis on pediatric subjects using the device on both ankles (for walking) in order to qualify the ascent rate of staircase.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

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 Contact Backup

Study Locations

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:

  • Genetically confirmed diagnosis of DMD or FSHD.
  • Between 5 and 20 years of age for patients with DMD, or between 5 and 80 years of age for patients with FSHD.
  • Ambulant (as defined by having the ability to walk without assistance for 10 meters) or non-ambulant DMD patients.
  • Ambulant FSHD patients
  • Non-ambulant DMD patients must be able to remain seated in an arm- or a wheel-chair for at least one hour.
  • Signed informed consent form by patient himself or, in case of minor patients, signed informed consent form by patient's parents or legal guardians.

Exclusion Criteria:

  • Patients with extreme cognitive disorders that limit their understanding of the exercises to be performed.
  • Patients treated with corticosteroids for less than 6 months.
  • 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.

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 or control subjects

Patients and control subjects will be included over a one-year 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, 6 and 12 months. Patients will be asked to wear the device during one year.

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
The two "watches" can be worn as wristwatch or placed near the ankle and on the wheelchair. Patients will wear the ActiMyo° during one year in order to collect natural history data in DMD and FSHD. Control subjects will wear the ActiMyo° during one month after inclusion and during one other month 11 months 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

Laurent Servais

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 (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

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

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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