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

NCT ID: NCT03471676

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-26

Study Completion Date

2019-05-28

Brief Summary

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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

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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

Conditions

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Neuromuscular Diseases in Infants Neuromuscular Diseases in Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Muscular oximetry

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

Muscular oximetry

Intervention Type OTHER

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

Interventions

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Muscular oximetry

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuelle LAGRUE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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University Hospital, Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2017-A02931-52

Identifier Type: OTHER

Identifier Source: secondary_id

17.11.07

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH3-RNI17/OXMNM

Identifier Type: -

Identifier Source: org_study_id