Validity of TongueFit: A Laboratory-Based Study

Area of Science:

• Pediatric Medicine
• Speech-Language Pathology
• Medical Device Technology

Background:

• Accurate assessment of tongue strength and endurance is crucial for managing pediatric dysphagia.
• TongueFit is a novel portable orofacial manometer designed for measuring tongue strength and endurance in children, incorporating a game-based training app.

Purpose of the Study:

• To evaluate the validity of the TongueFit device by comparing its air pressure measurements against a standard manometer, the current gold standard.

Main Methods:

• A laboratory study compared TongueFit with a standard manometer under three experimental conditions.
• Experiments involved using a Force Tester (MCT-2150) with MSatLite software for pressure control and varying bulb sizes (2 cm and 3 cm).
• Lin's concordance correlation coefficient was employed to assess the level of agreement between the two devices.

Main Results:

• TongueFit demonstrated a negligible mean absolute difference of 0.005 kPa compared to the standard manometer (n=35, ρC=1.00), indicating perfect agreement.
• With a 2 cm bulb, TongueFit showed perfect agreement (ρC = 1.000) with a mean difference of 0.007 kPa.
• Using a 3 cm bulb, TongueFit exhibited near-perfect agreement (ρC = 0.999) with a mean difference of 0.044 kPa.

Conclusions:

• The study confirms the high validity of TongueFit as an orofacial manometer, showing negligible differences and perfect or near-perfect agreement with the standard manometer.
• TongueFit is validated as an accurate and reliable tool for assessing tongue strength in pediatric patients.
• The device's portability and game-based app enhance its suitability for clinical use in pediatric dysphagia.