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Tongue Protrusion Assessment in Healthy Adult (FLEPI)

Assessment of Tongue Protrusion Motor Skills in Healthy Adult

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06169761
Enrollment
300
Registered
2023-12-13
Start date
2023-12-11
Completion date
2027-05-31
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Tongue, Motor skills, Protrusion, Strength, Fatigability

Brief summary

This study aims to evaluate tongue protrusion motor skills in healthy adults and to assess the reliability of these measurements as well as their validity in relation to other motor functions (handgrip and respiratory muscles).

Detailed description

The tongue is an organ involved in multiple essential daily functions (such as eating, speaking, and breathing). Normative values exist for the motor skills of tongue elevation in individuals. However, data regarding protrusion are lacking. Yet, the protrusive strength of the tongue is of particular interest. Indeed a weak protrusive tongue strength may contribute to sleep apnea and swallowing disorders. Therefore, this study aims to collect normative and clinimetric (validity and reliability) data of tongue protrusion strength and endurance among healthy adults.

Interventions

OTHERAssessment of motor skills of the tongue and others muscles, see below) and risk for sleep apnea

The following items will be assessed: 1. Risk for sleep apnea, through the STOP-BANG Questionnaire. 2. Anthropometric data: Height, weight, neck circumference, maximal mouth opening and maximal mouth opening with tongue to palate (with the Quick Tongue-Tie Assessment tool). 3. Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb in kPa) during 3 sec. of tongue protrusion and elevation. 4. Tongue endurance (i.e., the time to task failure in maintaining a pressure equal to a fixed percentage of Pmax against the IOPI bulb) during tongue protrusion and elevation 5. Tongue mobility restriction measured with the Quick Tongue-Tie Assessment Tool 6. Maximum inspiratory and expiratory pressures measured with MicroRPM in cmH2O 7. Handgrip strength (measured with a JAMAR dynamometer in kg) Tongue skills measurements will be repeated 2 to 4 weeks after baseline to assess the reliability of these measurements.

Sponsors

Université Catholique de Louvain
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Being 18 years of age or older

Exclusion criteria

* Eating disorder * Dysphagia * Cardiorespiratory disorder * Previous or ongoing obstructive sleep apnea-hypopnea syndrome * Neurological conditions (including neuromuscular disorders) * Previous or ongoing cancer of the head or neck * Pregnancy * Any physical or mental condition that may affect the ability to consent

Design outcomes

Primary

MeasureTime frameDescription
Tongue protrusion peak pressureMeasured two times: at baseline and after 2 to 4 weeksTongue peak pressure during protrusion movements will be measured via the IOPI device
Tongue protrusion enduranceMeasured two times: at baseline and after 2 to 4 weeksTongue endurance during protrusion movements will be measured via a timer (the time in seconds until the participant is not able to sustain tongue protrusion as controlled via the IOPI).

Secondary

MeasureTime frameDescription
Tongue elevation peak pressureMeasured two times: at baseline and after 2 to 4 weeksTongue peak pressure during elevation movements will be measured via the IOPI device
Tongue elevation enduranceMeasured two times: at baseline and after 2 to 4 weekswill be measured via a timer (the time in seconds until the participant is not able to sustain tongue protrusion as controlled via the IOPI).
Tongue mobility restrictionMeasured once at baselineAssessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate, measured with the Quick Tongue-Tie Assessment Tool
Maximum Inspiratory and Expiratory PressureMeasured once at baselineMaximum Inspiratory and Expiratory pressure will be measured via the MicroRPM device
Handgrip StrengthMeasured once at baselineHandgrip Strength will be measured with a JAMAR Hand Dynamometer

Countries

Belgium

Contacts

CONTACTWilliam Poncin, PT, PhD
william.poncin@uclouvain.be+3227641111
CONTACTJulien Da Purificaçao, PT
dapurificacaojulien.kine@uclouvain.be+33788734941

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026