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

March 15, 2018 updated by: University Hospital, Brest

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Angers, France, 49933
        • Not yet recruiting
        • CHRU
        • Contact:
          • Julien DURIGNEUX, Dr
        • Principal Investigator:
          • Julien DURIGNEUX, Dr
      • Le Mans, France, 72650
        • Not yet recruiting
        • CH Le Mans
        • Contact:
          • Denis Colin, Dr
          • Phone Number: 02 43 51 72 67
        • Principal Investigator:
          • Denis Colin, Dr
      • Lyon, France, 63677
        • Recruiting
        • CHU
        • Contact:
        • Principal Investigator:
          • Carole Vuillerot, Dr
        • Sub-Investigator:
          • Stéphanie Fontaine, Dr
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes
        • Contact:
          • Yann PEREON
          • Phone Number: 02 40 08 36 17
        • Principal Investigator:
          • Yann Pereon
        • Sub-Investigator:
          • Raphaël GROSS
      • Poitiers, France, 86021
        • Not yet recruiting
        • CHU
        • Contact:
          • Karoline LODE-KOLZ, Dr
          • Phone Number: 05 49 44 44 44
        • Principal Investigator:
          • Karoline LODE-KOLZ, Dr
      • Rennes, France, 35033
        • Not yet recruiting
        • CHU
        • Contact:
          • Hélène Rauscent, Dr
        • Principal Investigator:
          • Hélène Rauscent, Dr
      • Tours, France, 37044
        • Not yet recruiting
        • CHRU
        • Contact:
          • Emmanuelle Lagrue, Dr
        • Principal Investigator:
          • Emmanuelle Lagrue, Dr
      • Vannes, France, 56017
        • Not yet recruiting
        • CHBA
        • Contact:
          • Hubert Journel, Dr
        • Principal Investigator:
          • Hubert Journel, Dr
    • Brittanny
      • Brest, Brittanny, France, 29609
        • Recruiting
        • CHRU
        • Contact:
        • Principal Investigator:
          • Sylvain Brochard, Dr
        • Sub-Investigator:
          • Sylviane Peudenier, Dr
        • Principal Investigator:
          • Juliette ROPARS, Dr
    • North
      • Lille, North, France, 59037
        • Not yet recruiting
        • CHRU
        • Contact:
          • Jean-Marie CUISSET, Dr
        • Principal Investigator:
          • Jean-Marie CUISSET

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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 Names:
  • Several parameters must be performed.
Other: 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 Names:
  • Several parameters must be performed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
24 years
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.
24 years
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
24 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MARCHE-DMD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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