Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

April 28, 2026 updated by: William Poncin, Université Catholique de Louvain
This study aims to assess intra-rater and inter-rater reliability in measuring tongue motor skills in children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Several motor skills of the tongue can be described: tongue elevation, swallowing, and protrusion. They are all relevant for a wide array of disorders, including neurological, musculoskeletal, and respiratory conditions. An ongoing study by our team is attempting to collect normative data on these motor skills in a pediatric cohort (NCT06166680). From this ongoing study, 56 subjects will be selected to assess the intra-rater and inter-rater reliability in measuring these motor skills.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
    • Brussels Capital
      • Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
        • Cliniques universitaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy children aged between 4 and 17 years old

Description

Inclusion Criteria:

  • Aged between 4 and 17 years old

Exclusion Criteria:

  • Eating disorder
  • Dysphagia
  • Cardiorespiratory disorder
  • Neurological disorder (including neuromuscular disorders)
  • Previous or ongoing obstructive sleep apnea-hypopnea syndrome
  • Previous or ongoing cancer of the head or neck
  • Previous oral or pharyngeal surgery (except for the surgical removal of wisdom teeth)
  • Cranial, oral or upper airway malformation (ex.: nasal cavities, pharynx)
  • Previous or ongoing orthodontic treatment (e.g. braces)
  • More than 33% of positive answers to the Pediatric Sleep Questionnaire (≥ 8/22)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Inter-rater reliability and intra-rater reliability

Tongue protrusion, elevation and swallowing measurements will be assessed at three time points, each interspersed by a one-week to one-month interval.

Assessments will be conducted by the same rater during two of these time points, whereas another independent rater will conduct the assessments of the third time point.
Other: Sleep quality assessment
1. Pediatric Sleep Questionnaire.
Other: Anthropometry
2. Anthropometric data : 2.1 Height; 2.2 Weight; 2.3 Maximal mouth opening; 2.4 Maximal mouth opening with tongue to palate The measures 2.3 and 2.4 will be realized via the Quick Tongue-Tie assessment tool
Other: Tongue strength assessment
3. Tongue pressure while swallowing. 4. Tongue peak pressure during tongue elevation. 5. Tongue peak pressure during tongue protrusion. These measures will be realized via the IOPI (Iowa Oral Performance Instrument) device.
Other: Tongue endurance assessment
6. The tongue endurance during tongue elevation. 7. The tongue endurance during tongue protrusion. These measures will be realized via the IOPI (Iowa Oral Performance Instrument) device and a timer.
Other: Orofacial praxis assessment
8. Motricité Bucco-Linguo-Faciale (MBLF) test.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Test-retest reproducibility of tongue peak pressure
Time Frame: Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval
Tongue peak pressure during elevation and protrusion movements will be measured. The inter-rater and intra-rater reliability of these measures will be computed.
Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Test-retest reproducibility of tongue endurance
Time Frame: Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval
Tongue endurance during elevation and protrusion movements will be measured. The inter-rater and intra-rater reliability of these measures will be computed.
Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval
Test-retest reproducibility of tongue pressure during swallowing
Time Frame: Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval
Tongue pressure during swallowing will be measured. The inter-rater and intra-rater reliability of these measures will be computed.
Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval
Test-retest reproducibility of tongue mobility restriction
Time Frame: Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval
Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate. The inter-rater and intra-rater reliability of these measures will be computed.
Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval
Test-retest reproducibility of orofacial praxis
Time Frame: Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval
Orofacial praxis will be assessed. The inter-rater and intra-rater reliability of this measure will be computed.
Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université Catholique de Louvain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William Poncin, Prof, Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMAC-reprod

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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