Effectivity of TongueFit, A Novel Orofacial Manometer, as Tongue Strength and Endurance Therapy in Children With Dysphagia

Sponsor
Rizky Kusuma Wardhani
Study ID
NCT06921161
Status
Recruiting
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Conditions

  • Children
  • Dysphagia

Eligibility Criteria

Sex
ALL
Age
3 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • TongueFit — DEVICE
    TongueFit is a newly orofacial manometer. This device is specifically developed for children to measure and improve tongue strength and endurance which includes a complementary application. Participants will do a series of tongue exercise therapy using "TongueFit". The exercise therapy will be performed once per day, three times a week, for eight weeks.
  • OSMS — OTHER
    Patients will receive OSMS therapy, conducted for 15 minutes per session, three times a week, over a duration of eight weeks.

Study Details

The tongue plays a crucial role in the swallowing process, and weakness in its muscles can lead to difficulties in bolus control, mastication, bolus transport, and oral residue. Reduced tongue strength is closely associated with dysphagia, a swallowing disorder that impairs the movement of food or liquids from the mouth, pharynx, or esophagus into the stomach. Measuring tongue strength is essential not only for diagnosing dysphagia but also for setting therapeutic goals and evaluating treatment effectiveness. However, Indonesia currently lacks accessible tools for assessing tongue strength and endurance or for providing tongue exercise therapy. Existing devices, such as the Tongueometer and Iowa Oral Performance Instrument (IOPI), are costly, difficult to access, and not well-suited for children. To address this gap, a prototype orofacial manometer (PMO) is needed-one that is affordable, child-friendly, and easy to use. TongueFit is an innovative orofacial manometer designed for both assessing and improving tongue strength and endurance. Similar to the IOPI, this prototype provides objective measurements while also incorporating a biofeedback feature in the form of a video game, enhancing engagement and participation in therapy, particularly for children. Additionally, TongueFit offers advantages in affordability, accessibility, and usability. It has been validated as a reliable and accurate tool for measuring tongue function. Given its potential, clinical trials are essential to evaluate the effectiveness of TongueFit in tongue strength and endurance therapy. These trials will support its broader clinical application and development, ensuring that it becomes a widely available tool for dysphagia management.

Key Dates

First listed
Apr 10, 2025
Start date
Mar 1, 2025
Status verified
Apr 2025
Primary completion
Apr 30, 2025
Completion
May 15, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    Oral Sensorimotor Stimulation Therapy
  • Experimental: Intervention group
    Combination Tongue Strength Exercise Therapy using TongueFit and OSMS Therapy

Primary Outcome Measure

Swallowing Function [ Time Frame: Before enrollment of participants ]

Central Contacts

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