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Biomechanical and Morphological Changes in Dystrophic Muscle (MARCHE-DMD)

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ClinicalTrials.gov Identifier: NCT02472990
Recruitment Status : Recruiting
First Posted : June 16, 2015
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.

Condition or disease Intervention/treatment Phase
Duchenne Dystrophy Muscular Other: No drug and no placebo were used in this study Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Determining Biomechanical and Morphological Factors That Affect Children With Duchenne Muscular Dystrophy (DMD) Who Loss of the Ability to Walk
Study Start Date : July 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Duchenne muscular dystrophy children

No drug and no placebo were used in this study. For 2h30 (time)

  • Measurement of leg strength using a dynamometer
  • Measurement of Motor Function
  • Walk test 6 minutes
  • Walk test 10 meters
  • Walk analysis: 3D recording of walking
  • Muscle MRI
Other: No drug and no placebo were used in this study
measures of muscular strength of legs, motor function, walk testing and analysis (3D video recording), RMI
Other Name: Several parameters must be performed.

Healthy children

No drug and no placebo were used in this study. For 2h30 (time)

  • Measurement of leg strength using a dynamometer
  • Measurement of Motor Function
  • Walk test 6 minutes
  • Walk test 10 meters
  • Walk analysis: 3D recording of walking
  • Muscle MRI
Other: No drug and no placebo were used in this study
measures of muscular strength of legs, motor function, walk testing and analysis (3D video recording), RMI
Other Name: Several parameters must be performed.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Identify the muscles wasting and their implication in the loss of strength and the walking ability [ Time Frame: 24 years ]
    Identify the muscles wasting and their implication in the loss of strength and walking. This will be made possible thanks to the predictive analysis and the evolutionary analysis of the MRI and strength before and after loss of walking ability

  2. Biomechanical evolutionary data collected during the last 2 years of walking [ Time Frame: 24 years ]
    Biomechanical evolutionary data collected during the last 2 years of walking by the repetition of the analysis of the walking until the loss of the walking ability.

  3. Establish the relationship between the parameters of walking and the scrawny body morphological anomalies [ Time Frame: 24 years ]
    Establish the relationship between the parameters of walking and the scrawny body morphological anomalies (muscular Atrophy, greasy infiltration, contractile muscular portion, three-dimensional morphological parameters) by doing correlations analysis



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472990


Contacts
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Contact: Sylvain BROCHARD, Dr 02 98 22 31 52 sylvain.brochard@chu-brest.fr

Locations
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France
CHRU Recruiting
Brest, Brittanny, France, 29609
Contact: Sylvain Brochard, Dr    02 98 22 31 52    sylvain.brochard@chu-brest.fr   
Principal Investigator: Sylvain Brochard, Dr         
Sub-Investigator: Sylviane Peudenier, Dr         
Principal Investigator: Juliette Ropars, Dr         
CHRU Not yet recruiting
Lille, North, France, 59037
Contact: Jean-Marie CUISSET, Dr         
Principal Investigator: Jean-Marie CUISSET         
CHRU Not yet recruiting
Angers, France, 49933
Contact: Julien DURIGNEUX, Dr         
Principal Investigator: Julien DURIGNEUX, Dr         
CH Le Mans Not yet recruiting
Le Mans, France, 72650
Contact: Denis Colin, Dr    02 43 51 72 67      
Principal Investigator: Denis Colin, Dr         
CHU Recruiting
Lyon, France, 63677
Contact: Carole Vuillerot, Dr    07 89 22 02 92    carole.vuillerot@gmail.com   
Principal Investigator: Carole Vuillerot, Dr         
Sub-Investigator: Stéphanie Fontaine, Dr         
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Yann PEREON    02 40 08 36 17      
Principal Investigator: Yann PEREON         
Sub-Investigator: Raphaël GROSS         
CHU Not yet recruiting
Poitiers, France, 86021
Contact: Karoline LODE-KOLZ, Dr    05 49 44 44 44      
Principal Investigator: Karoline LODE-KOLZ, Dr         
CHU Not yet recruiting
Rennes, France, 35033
Contact: Hélène Rauscent, Dr         
Principal Investigator: Hélène Rauscent, Dr         
CHRU Not yet recruiting
Tours, France, 37044
Contact: Emmanuelle Lagrue, Dr         
Principal Investigator: Emmanuelle Lagrue, Dr         
CHBA Not yet recruiting
Vannes, France, 56017
Contact: Hubert Journel, Dr         
Principal Investigator: Hubert Journel, Dr         
Sponsors and Collaborators
University Hospital, Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02472990     History of Changes
Other Study ID Numbers: MARCHE-DMD
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018

Keywords provided by University Hospital, Brest:
DMD
morphological predictive factors
Mechanical