Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

This study aims to assess intra-rater and inter-rater reliability in measuring tongue motor skills in children.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Sleep quality assessment; Other: Anthropometry; Other: Tongue strength assessment; Other: Tongue endurance assessment; Other: Orofacial praxis assessment

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: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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 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

Outcome Measure	Measure Description	Time Frame
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 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 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 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 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

• Sponsor: Université Catholique de Louvain
• Investigators: Principal Investigator: William Poncin, Prof, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): June 15, 2025
• Study Completion (Actual): June 15, 2025

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: tongue; motor skills
• Additional Relevant MeSH Terms: Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Public Health; Environment and Public Health; Epidemiologic Measurements; Physical Examination; Biometry; Anthropometry
• Other Study ID 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