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Clinical Trials/NCT05982119
NCT05982119
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire de Liege8 sites in 7 countries300 target enrollmentJuly 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Duchenne Muscular Dystrophy
Sponsor
Centre Hospitalier Universitaire de Liege
Enrollment
300
Locations
8
Primary Endpoint
Stride velocity
Status
Recruiting
Last Updated
11 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 10, 2020
End Date
March 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laurent Servais

Professor Laurent Servais

Centre Hospitalier Universitaire de Liege

Eligibility Criteria

Inclusion Criteria

  • Not provided

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.

Outcomes

Primary Outcomes

Stride velocity

Time Frame: through study completion (3 year)

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

Stride length

Time Frame: through study completion (3 year)

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

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

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

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

Study Sites (8)

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