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

Primary Purpose

Duchenne Dystrophy Muscular

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
No drug and no placebo were used in this study
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Duchenne Dystrophy Muscular focused on measuring DMD, morphological predictive factors, Mechanical

Eligibility Criteria

5 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CHRURecruiting
  • CHRU
  • CHRU
  • CH Le Mans
  • CHURecruiting
  • CHU de NantesRecruiting
  • CHU
  • CHU
  • CHRU
  • CHBA

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Duchenne muscular dystrophy children

Healthy children

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
June 10, 2015
Last Updated
March 15, 2018
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT02472990
Brief Title
Biomechanical and Morphological Changes in Dystrophic Muscle
Acronym
MARCHE-DMD
Official Title
Determining Biomechanical and Morphological Factors That Affect Children With Duchenne Muscular Dystrophy (DMD) Who Loss of the Ability to Walk
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Dystrophy Muscular
Keywords
DMD, morphological predictive factors, Mechanical

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Duchenne muscular dystrophy children
Arm Type
Other
Arm Description
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
Arm Title
Healthy children
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
No drug and no placebo were used in this study
Other Intervention Name(s)
Several parameters must be performed.
Intervention Description
measures of muscular strength of legs, motor function, walk testing and analysis (3D video recording), RMI
Primary Outcome Measure Information:
Title
Determine biomechanical and morphological predictive factors of the loss of the walk ability of the children with DMD
Description
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
Time Frame
24 years
Secondary Outcome Measure Information:
Title
Identify the muscles wasting and their implication in the loss of strength and the walking ability
Description
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
Time Frame
24 years
Title
Biomechanical evolutionary data collected during the last 2 years of walking
Description
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.
Time Frame
24 years
Title
Establish the relationship between the parameters of walking and the scrawny body morphological anomalies
Description
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
Time Frame
24 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvain BROCHARD, Dr
Phone
02 98 22 31 52
Email
sylvain.brochard@chu-brest.fr
Facility Information:
Facility Name
CHRU
City
Brest
State/Province
Brittanny
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Brochard, Dr
Phone
02 98 22 31 52
Email
sylvain.brochard@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Sylvain Brochard, Dr
First Name & Middle Initial & Last Name & Degree
Sylviane Peudenier, Dr
First Name & Middle Initial & Last Name & Degree
Juliette Ropars, Dr
Facility Name
CHRU
City
Lille
State/Province
North
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marie CUISSET, Dr
First Name & Middle Initial & Last Name & Degree
Jean-Marie CUISSET
Facility Name
CHRU
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien DURIGNEUX, Dr
First Name & Middle Initial & Last Name & Degree
Julien DURIGNEUX, Dr
Facility Name
CH Le Mans
City
Le Mans
ZIP/Postal Code
72650
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Colin, Dr
Phone
02 43 51 72 67
First Name & Middle Initial & Last Name & Degree
Denis Colin, Dr
Facility Name
CHU
City
Lyon
ZIP/Postal Code
63677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole Vuillerot, Dr
Phone
07 89 22 02 92
Email
carole.vuillerot@gmail.com
First Name & Middle Initial & Last Name & Degree
Carole Vuillerot, Dr
First Name & Middle Initial & Last Name & Degree
Stéphanie Fontaine, Dr
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann PEREON
Phone
02 40 08 36 17
First Name & Middle Initial & Last Name & Degree
Yann PEREON
First Name & Middle Initial & Last Name & Degree
Raphaël GROSS
Facility Name
CHU
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karoline LODE-KOLZ, Dr
Phone
05 49 44 44 44
First Name & Middle Initial & Last Name & Degree
Karoline LODE-KOLZ, Dr
Facility Name
CHU
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Rauscent, Dr
First Name & Middle Initial & Last Name & Degree
Hélène Rauscent, Dr
Facility Name
CHRU
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle Lagrue, Dr
First Name & Middle Initial & Last Name & Degree
Emmanuelle Lagrue, Dr
Facility Name
CHBA
City
Vannes
ZIP/Postal Code
56017
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hubert Journel, Dr
First Name & Middle Initial & Last Name & Degree
Hubert Journel, Dr

12. IPD Sharing Statement

Learn more about this trial

Biomechanical and Morphological Changes in Dystrophic Muscle

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