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

December 8, 2021 updated by: University Hospital, Tours

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

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

Study Locations

  • France
      • Tours, France, 37044
        • University Hospital, Tours

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

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

6-17 years old patients suffering from neuromuscular disorder and able to walk

Description

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

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular oxygenation
Time Frame: 6 minutes
Muscular oximetry
6 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minutes walking distance
Time Frame: 6 minutes
6 minutes walking distance
6 minutes
Motor function
Time Frame: 25 minutes
Motor function measure (MFM scale)
25 minutes

Collaborators and Investigators

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

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Emmanuelle LAGRUE, MD, PhD, University Hospital, Tours

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 (Actual)

March 26, 2018

Primary Completion (Actual)

May 28, 2019

Study Completion (Actual)

May 28, 2019

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 19, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

December 8, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPH3-RNI17/OXMNM
  • 2017-A02931-52 (Other Identifier: IdRCB)
  • 17.11.07 (Other Identifier: CPP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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