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Completed

NCT Number: NCT03471676

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

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.

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Key information

Conditions

Neuromuscular Diseases in Infants Neuromuscular Diseases in Children

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Tours

Tours, 37044, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscular oximetry

Other

6 minutes walking test performed in the routine medical care with muscle oximetry recording

Primary outcomes

  1. Muscular oxygenation

    Time frame: 6 minutes

    Muscular oximetry

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: OXMNM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2018
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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