Biomechanical and Morphological Changes in Dystrophic Muscle
NCT ID: NCT02472990
Last Updated: 2018-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2015-07-31
2021-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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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
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
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
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
5 Years
17 Years
ALL
Yes
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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CHRU
Brest, Brittanny, France
CHRU
Lille, North, France
CHRU
Angers, , France
CH Le Mans
Le Mans, , France
CHU
Lyon, , France
CHU de Nantes
Nantes, , France
CHU
Poitiers, , France
CHU
Rennes, , France
CHRU
Tours, , France
CHBA
Vannes, , France
Countries
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Central Contacts
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Facility Contacts
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Jean-Marie CUISSET, Dr
Role: primary
Julien DURIGNEUX, Dr
Role: primary
Denis Colin, Dr
Role: primary
Yann PEREON
Role: primary
Karoline LODE-KOLZ, Dr
Role: primary
Hélène Rauscent, Dr
Role: primary
Emmanuelle Lagrue, Dr
Role: primary
Hubert Journel, Dr
Role: primary
Other Identifiers
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MARCHE-DMD
Identifier Type: -
Identifier Source: org_study_id
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