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

Neuromuscular Diseases in Children Clinical Trial

— OXMNM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471676
• Other study ID #: RIPH3-RNI17/OXMNM
• Secondary ID: 2017-A02931-5217
• Status: Completed
• Start date: March 26, 2018
• Est. completion date: May 28, 2019

Study information

• Verified date: December 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 28, 2019
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Diseases
• Neuromuscular Diseases in Children
• Neuromuscular Diseases in Infants

Intervention

Other:
• Muscular oximetry
6 minutes walking test performed in the routine medical care with muscle oximetry recording

Locations

Country	Name	City	State
France	University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscular oxygenation	Muscular oximetry	6 minutes
Secondary	6 minutes walking distance	6 minutes walking distance	6 minutes
Secondary	Motor function	Motor function measure (MFM scale)	25 minutes