Neuromuscular Diseases in InfantsOXMNMNCT03471676
Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease.
An observational study of Neuromuscular Diseases in Infants and Neuromuscular Diseases in Children, run by University Hospital, Tours at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Neuromuscular Diseases in Infants, Neuromuscular Diseases in Children
- What is being tested?
- Muscular oximetry
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2018to 28 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 6-17 years old patients suffering from neuromuscular disorder and able to walk
Who may be able to join
- Children from 6 to 18 years-old suffering from a neuromuscular disorder
- Able to walk, with or without help
Who cannot join
- Hypoxia secondary to heart or lung disease
- Visual impairment (<5/10)
- Parents refusal concerning data storage
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Muscular oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscular oximetryOther
6 minutes walking test performed in the routine medical care with muscle oximetry recording
| Study group | Role | What they receive |
|---|---|---|
| Muscular oximetry | 6 minutes walking test performed in the routine medical care with muscle oximetry recording in children suffering from neuromuscular diseases Receives: Other: Muscular oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular oxygenation
Muscular oximetry
Measured: 6 minutes
Secondary outcomes (2)
6 minutes walking distance
6 minutes walking distance
Measured: 6 minutes
Motor function
Motor function measure (MFM scale)
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start26 Mar 2018
- Primary completion28 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Diseases in InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle LAGRUE, MD, PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471676
- Sponsor's protocol ID
- RIPH3-RNI17/OXMNM
- Other IDs
- 2017-A02931-52, 17.11.07
- Acronym
- OXMNM
- Status last verified
- Dec 2021
- First submitted
- 2 Mar 2018
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease.
- ClinicalTrials.gov ID
- NCT03471676
- Acronym / sponsor ID
- OXMNM / RIPH3-RNI17/OXMNM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscular oximetry | – | Other: Muscular oximetry6 minutes walking test performed in the routine medical care with muscle oximetry recording in children suffering from neuromuscular diseases |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 6-17 years old patients suffering from neuromuscular disorder and able to walk
Key inclusion criteria (2 listed)
- Children from 6 to 18 years-old suffering from a neuromuscular disorder
- Able to walk, with or without help
Key exclusion criteria (3 listed)
- Hypoxia secondary to heart or lung disease
- Visual impairment (<5/10)
- Parents refusal concerning data storage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscular oximetry6 minutes walking test performed in the routine medical care with muscle oximetry recording | Other | Muscular oximetry |
Primary outcome
Muscular oxygenation
Time frame: 6 minutes
Muscular oximetry
2 secondary outcomes
6 minutes walking distance
Time frame: 6 minutes
Motor function
Time frame: 25 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle LAGRUE, MD, PhD principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases in Infants and Neuromuscular Diseases in Children, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular oxygenation (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021; AzTrials last refreshed its copy on 29 Oct 2026.