NCT03471676

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2019

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

March 2, 2018

Last Update Submit

December 8, 2021

Conditions

Neuromuscular Diseases in InfantsNeuromuscular Diseases in Children

Outcome Measures

Primary Outcomes (1)

  • Muscular oxygenation

    Muscular oximetry

    6 minutes

Secondary Outcomes (2)

  • 6 minutes walking distance

    6 minutes

  • Motor function

    25 minutes

Study Arms (1)

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

Interventions

Muscular oximetryOTHER

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

Muscular oximetry

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Children from 6 to 18 years-old suffering from a neuromuscular disorder
  • Able to walk, with or without help

You may not qualify if:

  • Hypoxia secondary to heart or lung disease
  • Visual impairment (\<5/10)
  • Parents refusal concerning data storage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Tours

Tours, 37044, France

Location

Study Officials

  • Emmanuelle LAGRUE, MD, PhD

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 20, 2018

Study Start

March 26, 2018

Primary Completion

May 28, 2019

Study Completion

May 28, 2019

Last Updated

December 9, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)