HealthyNCT06464081
Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing
An observational study of Healthy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study aims to assess intra-rater and inter-rater reliability in measuring tongue motor skills in children. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sleep quality assessment, Anthropometry and Tongue strength assessment
- Type of treatment
- Pill or oral medicine
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Oct 2024to 15 Jun 2025
- 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 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children aged between 4 and 17 years old
Who may be able to join
- Aged between 4 and 17 years old
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, 1200
About this study
This study aims to assess intra-rater and inter-rater reliability in measuring tongue motor skills in children.
Read the 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.
- Conditions
- Healthy
- Being tested
- Sleep quality assessment, Anthropometry, Tongue strength assessment, Tongue endurance assessment, Orofacial praxis assessment
- Keywords
- tongue, motor skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep quality assessmentOther
- Pediatric Sleep Questionnaire.
AnthropometryOther
- 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
Tongue strength assessmentOther
- 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.
Tongue endurance assessmentOther
- 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.
Orofacial praxis assessmentOther
- Motricité Bucco-Linguo-Faciale (MBLF) test.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sleep quality assessment; Other: Anthropometry; Other: Tongue strength assessment; Other: Tongue endurance assessment; Other: Orofacial praxis assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reproducibility of tongue peak pressure
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: 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 outcomes (4)
Test-retest reproducibility of tongue endurance
Tongue endurance during elevation and protrusion movements will be measured. The inter-rater and intra-rater reliability of these measures will be computed.
Measured: 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
Tongue pressure during swallowing will be measured. The inter-rater and intra-rater reliability of these measures will be computed.
Measured: 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
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: 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
Orofacial praxis will be assessed. The inter-rater and intra-rater reliability of this measure will be computed.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start15 Oct 2024
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Poncin, Université Catholique de Louvain
- Investigators
- William Poncin, Prof, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464081
- Sponsor's protocol ID
- TMAC-reprod
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2024
- Last updated
- 29 Apr 2026
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing
- ClinicalTrials.gov ID
- NCT06464081
- Acronym / sponsor ID
- TMAC-reprod
- Conditions
- Healthy
- Keywords
- tongue, motor skills
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 18 Jun 2024 (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.
This study aims to assess intra-rater and inter-rater reliability in measuring tongue motor skills in children.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inter-rater reliability and intra-rater reliability | – | Other: Sleep quality assessment, Other: Anthropometry, Other: Tongue strength assessment, Other: Tongue endurance assessment, Other: Orofacial praxis assessmentTongue 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. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children aged between 4 and 17 years old
Key inclusion criteria (1 listed)
- Aged between 4 and 17 years old
Key exclusion criteria (10 listed)
- Eating disorder
- Dysphagia
- Cardiorespiratory disorder
- Neurological disorder (including neuromuscular disorders)
- Previous or ongoing obstructive sleep apnea-hypopnea syndrome
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 |
|---|---|---|
| Sleep quality assessment1. Pediatric Sleep Questionnaire. | Other | Inter-rater reliability and intra-rater reliability |
| Anthropometry2. 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 | Inter-rater reliability and intra-rater reliability |
| Tongue strength assessment3. 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 | Inter-rater reliability and intra-rater reliability |
| Tongue endurance assessment6. 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 | Inter-rater reliability and intra-rater reliability |
| Orofacial praxis assessment8. Motricité Bucco-Linguo-Faciale (MBLF) test. | Other | Inter-rater reliability and intra-rater reliability |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
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 29 Apr 2026.
- 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.
William Poncin, Prof principal investigator
Université Catholique de Louvain
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 Healthy, run by Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 10 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 29 Apr 2026. 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 Belgium. 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?
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). 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 29 Apr 2026.