ClinicalTrials.gg
CompletedNCT03471676OXMNMUpdated Dec 9, 2021

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

An observational study in Neuromuscular Diseases in Infants and Neuromuscular Diseases in Children, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-12-09.

Sponsored by University Hospital, Tours · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
6 Years to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 84 studies in Neuromuscular Diseases with a site in France — 14 open to participants now, 17 under way, 2 of them phase 3. Neuromuscular Diseases · France.

Enrollment
24th of 36
40 · median 73
Started
2018
with 4 others
Observational
36 of 84
8 open now
Registered
42nd of 84
by date

Among the 84 studies in Neuromuscular Diseases with a site in France, this one is the 24th largest by enrollment of the 36 observational ones that give a count, is one of 5 that started in 2018, is one of 36 observational ones, and was the 42nd registered.

Neuromuscular Diseases

361 studies on the registry are indexed under Neuromuscular Diseases; 97 are open to participants now.

Browse Neuromuscular Diseases studies →

Open to participants now

14 of the 84 studies in Neuromuscular Diseases with a site in France are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 70 Neuromuscular Diseases studies recruiting now, 39 (56%) set no upper age limit and 23 (33%) stop at 75 or younger; 36 take children under 18; 16 take healthy volunteers.

This study: 6 Years to 17 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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
03

Conditions studied

  • Neuromuscular Diseases in Infants
  • Neuromuscular Diseases in Children
04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Hypoxia secondary to heart or lung disease
  • Visual impairment (\<5/10)
  • Parents refusal concerning data storage
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherMuscular oximetry

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

06

What researchers measure

Primary outcomes

  1. Muscular oxygenation

    Muscular oximetry

    Time frame: 6 minutes

Secondary outcomes

  1. 6 minutes walking distance

    6 minutes walking distance

    Time frame: 6 minutes

  2. Motor function

    Motor function measure (MFM scale)

    Time frame: 25 minutes

07

Study locations

1 site
  • University Hospital, Tours
    Tours, 37044, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in May 2019, 14 months.

Of 64 non-industry observational studies under Neuromuscular Diseases, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 114. This study's 14 months is below that.

Counting every sponsor, half of 70 studies reached it within 37 months; a quarter within 12 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2018
First posted
Mar 20, 2018
StartActual
Mar 26, 2018
Primary completionActual
May 28, 2019
CompletionActual
May 28, 2019
Last update
Dec 9, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03471676
Responsible party
Sponsor
First posted
Mar 20, 2018
Start date
Mar 26, 2018
Primary completion
May 28, 2019
Completion
May 28, 2019
Last update
Dec 9, 2021

Study contacts

Emmanuelle LAGRUE, MD, PhD
principal investigator · University Hospital, Tours

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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