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Clinical Trials/NCT02472990
NCT02472990
Unknown
Not Applicable

Determining Biomechanical and Morphological Factors That Affect Children With Duchenne Muscular Dystrophy (DMD) Who Loss of the Ability to Walk

University Hospital, Brest5 sites in 1 country50 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Duchenne Dystrophy Muscular
Sponsor
University Hospital, Brest
Enrollment
50
Locations
5
Primary Endpoint
Determine biomechanical and morphological predictive factors of the loss of the walk ability of the children with DMD
Last Updated
8 years ago

Overview

Brief Summary

The loss of ability to walk in many children with DMD (Duchenne muscular Dystrophy) is a pejorative event. Biomechanical and morphological unknowledge about the loss of the walk ability in children with DMD is an obstacle in reeducative, pharmacological or surgical therapeutic targets.

Detailed Description

The loss of ability to walk in many children with DMD (Duchenne muscular Dystrophy) is a pejorative event. Biomechanical and morphological unknowledge about the loss of the walk ability in children with DMD is an obstacle in reeducative, pharmacological or surgical therapeutic targets. We suppose that there are muscular characteristics and predictive parameters of the loss of walk ability. The identification of these potential therapeutic targets would improve the surveillance and the clinical care but would also guide future clinical and fundamental trials too.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
January 2021
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Young man ou woman (5 to 17 years old) with Duchenne Muscular Dystrophy (confirmed by immunohistochimy on the muscular biopsy and/or mutation in the dystrophin confirmed by molecular biology)
  • Time more than 7 secondes to test of 10 m and/or distance less than 330 m to walk test of 6 minutes. These values are recent markers to include children with a strong risk of loss of walking ability in 2 years.
  • Parental inform sign consent and / or child inform consent

Exclusion Criteria

  • Recent orthopaedic surgery of lower limbs (6 months)
  • Other chronic disease associated, which have an impact on the walking
  • Cognitive Deficiency or behavior disorders limiting the understanding of the study
  • Children who can benefit ATU (translarna ® or other) during the study
  • All MRI contradications : pacemaker or neurosensory stimulator or implantable defibrillator, neurosurgical valves, cochlear implant or ferromagnetic implants near nervous structures, brace, metallic prostheses, not cooperative or agitated patients, patient claustrophobic, pregnant woman.

Outcomes

Primary Outcomes

Determine biomechanical and morphological predictive factors of the loss of the walk ability of the children with DMD

Time Frame: 24 years

Determine the biomechanical factors (muscular atrophy, muscular strength, muscular shrinkage) and morphological (greasy infiltration, contractile portion, muscular geometry) predictive of the loss of the walk ability of the children with DMD

Secondary Outcomes

  • Identify the muscles wasting and their implication in the loss of strength and the walking ability(24 years)
  • Biomechanical evolutionary data collected during the last 2 years of walking(24 years)
  • Establish the relationship between the parameters of walking and the scrawny body morphological anomalies(24 years)

Study Sites (5)

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