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

Completed

• Conditions: Neuromuscular Diseases in Children; Neuromuscular Diseases in Infants
• Interventions: Other: Muscular oximetry

• Registration Number: NCT03471676
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-20
• Study Start: 2018-03-26
• Primary Completion: 2019-05-28
• Study Completion: 2019-05-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Muscular oximetry	Muscular oximetry	6 minutes walking test performed in the routine medical care with muscle oximetry recording in children suffering from neuromuscular diseases

Primary Outcome Measures

Name	Time	Method
Muscular oxygenation	6 minutes	Muscular oximetry

Secondary Outcome Measures

Name	Time	Method
Motor function	25 minutes	Motor function measure (MFM scale)
6 minutes walking distance	6 minutes	6 minutes walking distance

Trial Locations

Locations (1)

University Hospital, Tours; 🇫🇷 Tours, France