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NCT Number: NCT06921161

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

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.

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Key information

Conditions

Dysphagia Children Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Medicine and Rehabilitation Polyclinic, Pediatric Division, Dr. Cipto Mangunkusumo Hospital

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location status: Recruiting

About this study

This study was designed as a double-blinded and randomized controlled trial. Participants were selected through stratified random sampling. Upon meeting the inclusion and exclusion criteria, participants were randomly assigned to one of two groups (Intervention and Control Group). Each group consisted of 10 participants.

Participants in the control group received OSMS therapy, administered for 15 minutes per session, three times a week, over eight weeks. Participants in the intervention group received OSMS therapy combined with exercise therapy using the PMO "TongueFit." The exercise prescription followed the FITT principle (frequency, intensity, time, and type), incorporating both strengthening and endurance exercises. Strengthening exercises were performed at 60-80% intensity, while endurance exercises were performed at 40-60% intensity, with a frequency of 30 repetitions for each type. Each exercise session lasted 15 minutes and was conducted once per day, three times a week, for eight weeks.

Throughout the exercise therapy program, tongue strength and endurance measurements were taken every two weeks to adjust the target pressure needed for therapy. Evaluations for both groups were conducted at the 4th and 8th weeks, assessing tongue muscle strength and endurance. The mid- and final evaluation results were compared with baseline assessments to determine the effectiveness of each intervention method.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 3 to 16 years.
  • Diagnosed with oral phase dysphagia based on VFSS, with an MBSImP score greater than 0 and ≤12.
  • Ability to understand and follow instructions.
  • Adequate postural control, demonstrated by the ability to maintain a sitting position and support the head.
  • Good jaw stability (absence of open jaw posture, adequate lip seal).
  • Parental consent and/or patient willingness to participate, confirmed through signed informed consent.

Exclusion criteria

  • Children with multiple congenital craniomaxillofacial abnormalities.
  • Children using visual aids (glasses) or hearing aids.
  • Children with comorbid conditions that may deteriorate unpredictably.
  • Patients currently receiving inpatient treatment.
  • Children who are uncooperative during the training process.

Treatment and study plan

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.

Other names: Intervention, Orofacial manometer

OSMS

Other

Patients will receive OSMS therapy, conducted for 15 minutes per session, three times a week, over a duration of eight weeks.

Other names: Control

Primary outcomes

  1. Swallowing Function

    Time frame: Before enrollment of participants

    The examination was conducted using a Videofluoroscopic Swallowing Study (VFSS) to diagnose dysphagia by evaluating the Modified Barium Swallow Impairment Profile (MBSImP) score. The higher the score, the greater the disturbance.

  2. Baseline Tongue Strength

    Time frame: At enrollment, the first meeting

    The force generated by the anteromedial elevation movement of the tongue creates contact between the anteromedial tongue and the hard palate and is measured in kilopascals (kPa).

  3. Tongue Strength after 12 Sessions

    Time frame: 4th week (Middle of treatment)

    The force generated by the anteromedial elevation movement of the tongue creates contact between the anteromedial tongue and the hard palate and is measured in kilopascals (kPa).

  4. Tongue Strength after 24 Sessions

    Time frame: 8th week (End of treatment)

    The force generated by the anteromedial elevation movement of the tongue creates contact between the anteromedial tongue and the hard palate and is measured in kilopascals (kPa).

  5. Baseline Tongue Endurance

    Time frame: At enrollment, the first meeting

    The duration of the tongue ability to sustain submaximal pressure (50% of its maximum force)

  6. Tongue Endurance after 12 sessions

    Time frame: 4th week (Middle of treatment)

    The duration of the tongue ability to sustain submaximal pressure (50% of its maximum force)

  7. Tongue Endurance after 24 sessions

    Time frame: 8th week (End of treatment)

    The duration of the tongue ability to sustain submaximal pressure (50% of its maximum force)

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Rizky Kusuma Wardhani

Other

Registry information

Official study title

Effectivity of TongueFit as Tongue Strength and Endurance Therapy in Children With Dysphagia: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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