Tongue Muscular Assessment in Healthy Children

Healthy Clinical Trial

— TMAC  

Official title:

Assessment of Tongue Motor Functions in Healthy Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166680
• Other study ID #: TMAC
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: December 2023
• Source: Université Catholique de Louvain
• Contact: William Poncin, PT, PhD, Prof
• Phone: +32470592032
• Email: william.poncin[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to obtain normative values for tongue motor functions in healthy children.

Description:

Since the tongue is a complex structure consisting of a continuous array of muscle fibers with varying orientation, tongue motor functions (strength, endurance) are likely to differ according to a protrusion (pulling out the tongue), elevation (lifting the tongue to the roof of the mouth) or swallowing movement. There are currently no normative data for the motor functions of the tongue in children. After their parents fulfilled the Pediatric Sleep Questionnaire, each included children will undergo an anthropometric and a tongue motor functions assessment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• Being between the ages of 4 and 17

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Sleep quality assessment
The following item will be assessed in all subjects (n=420): 1. Sleep, through the Pediatric Sleep Questionnaire.
• Anthropometry
The following items will be assessed in all subjects (n=420): 2. Anthropometric data : 2.1 Height; 2.2 Weight; 2.3 Maximal mouth opening; 2.4 Maximal mouth opening with tongue to palate (with the Quick Tongue-Tie assessment tool)
• Tongue strength assessment
The following items will be assessed in all subjects (n=420): 3. Tongue pressure (in kPa) exerted against the IOPI (Iowa Oral Performance Instrument) bulb while swallowing. 4. Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb) during 3 sec. of tongue elevation. 5. Tongue peak pressure during 3 sec. of tongue protrusion.
• Tongue endurance assessment
The following items will be assessed in all subjects (n=420): 6. The tongue endurance (i.e., the time to task failure in maintaining a pressure equal to 50%Pmax against the IOPI bulb) during tongue elevation. 7. The tongue endurance during tongue protrusion.
• Orofacial praxis assessment
- The following item will be assessed in a subset of subjects (n=31): 8. Orofacial praxis through the Motricité Bucco-Linguo-Faciale (MBLF) test.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Woluwe-Saint-Lambert

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tongue peak pressure during elevation and protrusion movements	Tongue peak pressure during elevation and protrusion movements will be measured via the IOPI (Iowa Oral Performance Instrument) device	At baseline
Secondary	Tongue mobility restriction	Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate, measured with the Quick Tongue-Tie Assessment tool	At baseline
Secondary	Orofacial praxis	In a subset of subjects (n=31), orofacial praxis will be assessed through the Motricité Bucco-Linguo-Faciale (MBLF) test	At baseline
Secondary	Tongue endurance during elevation and protrusion movements	Tongue endurance during elevation and protrusion movements will be measured via the IOPI device and a timer	At baseline
Secondary	Tongue pressure during swallowing	Tongue pressure during swallowing will be measured via the IOPI device	At baseline