Biomechanical and Morphological Changes in Dystrophic Muscle

NCT ID: NCT02472990

Last Updated: 2018-03-16

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2021-01-31

Brief Summary

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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

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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.

Conditions

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Duchenne Dystrophy Muscular

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

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

Group Type OTHER

No drug and no placebo were used in this study

Intervention Type OTHER

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

Group Type OTHER

No drug and no placebo were used in this study

Intervention Type OTHER

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

Intervention Type OTHER

Other Intervention Names

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Several parameters must be performed.

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU

Brest, Brittanny, France

Site Status RECRUITING

CHRU

Lille, North, France

Site Status NOT_YET_RECRUITING

CHRU

Angers, , France

Site Status NOT_YET_RECRUITING

CH Le Mans

Le Mans, , France

Site Status NOT_YET_RECRUITING

CHU

Lyon, , France

Site Status RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

CHU

Poitiers, , France

Site Status NOT_YET_RECRUITING

CHU

Rennes, , France

Site Status NOT_YET_RECRUITING

CHRU

Tours, , France

Site Status NOT_YET_RECRUITING

CHBA

Vannes, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Sylvain BROCHARD, Dr

Role: CONTACT

02 98 22 31 52

Facility Contacts

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Sylvain Brochard, Dr

Role: primary

02 98 22 31 52

Jean-Marie CUISSET, Dr

Role: primary

Julien DURIGNEUX, Dr

Role: primary

Denis Colin, Dr

Role: primary

02 43 51 72 67

Carole Vuillerot, Dr

Role: primary

07 89 22 02 92

Yann PEREON

Role: primary

02 40 08 36 17

Karoline LODE-KOLZ, Dr

Role: primary

05 49 44 44 44

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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