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Trial record 8 of 5217 for:    neuromuscular disease

Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease. (OXMNM)

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ClinicalTrials.gov Identifier: NCT03471676
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:

Preliminary data underline the fact that muscular deoxygenation during training happens earlier in adult patients suffering from neuromuscular disorders in comparison to controls. Up to date, pediatric data are lacking.

The study aims at demonstrating if a correlation exists between the motor deficiency and the muscular deoxygenation in children suffering from neuromuscular disorders.


Condition or disease Intervention/treatment
Neuromuscular Diseases in Infants Neuromuscular Diseases in Children Other: Muscular oximetry

Detailed Description:

Preliminary data underline the fact that muscular deoxygenation during training happens earlier in adult patients suffering from neuromuscular disorders in comparison to controls, as it was demonstrated in Becker muscular dystrophy patients and fascioscapulo humeral muscular dystrophy. Moreover, the deoxygenation kinetics was positively correlated to the functional status and the muscular deficiency severity. However, no pediatric study has been conducted on this topic up to date.

The aim of the study is to determine if a correlation exists in children suffering from neuromuscular diseases:

  • between muscular oxygenation and the percentage of the 6 minutes walking test performed in the routine medical care
  • between muscular oxygenation and the total and D1 motor function measure value

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease.
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Muscular oximetry
6 minutes walking test performed in the routine medical care with muscle oximetry recording in children suffering from neuromuscular diseases
Other: Muscular oximetry
6 minutes walking test performed in the routine medical care with muscle oximetry recording




Primary Outcome Measures :
  1. Muscular oxygenation [ Time Frame: 6 minutes ]
    Muscular oximetry


Secondary Outcome Measures :
  1. 6 minutes walking distance [ Time Frame: 6 minutes ]
    6 minutes walking distance

  2. Motor function [ Time Frame: 25 minutes ]
    Motor function measure (MFM scale)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
6-17 years old patients suffering from neuromuscular disorder and able to walk
Criteria

Inclusion Criteria:

  • Children from 6 to 18 years-old suffering from a neuromuscular disorder
  • Able to walk, with or without help

Exclusion Criteria:

  • Hypoxia secondary to heart or lung disease
  • Visual impairment (<5/10)
  • Parents refusal concerning data storage

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): NCT03471676


Contacts
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Contact: Emmanuelle LAGRUE, MD, PhD +33 2 47 47 47 57 mnmenfant@chu-tours.fr

Locations
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France
University Hospital, Tours Recruiting
Tours, France, 37044
Contact: Emmanuelle LAGRUE, MD, PhD    +33 2 47 47 47 57    mnmenfant@chu-tours.fr   
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: Emmanuelle LAGRUE, MD, PhD University Hospital, Tours

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03471676     History of Changes
Other Study ID Numbers: RIPH3-RNI17/OXMNM
2017-A02931-52 ( Other Identifier: IdRCB )
17.11.07 ( Other Identifier: CPP )
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuromuscular Diseases
Nervous System Diseases