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

NCT06921161 | Recruiting

• 1 other identifier: 24-02-0288
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysphagia; Children

Keywords

dysphagia; effectivity; orofacial manometer; tongue strength; tongue endurance; children

Outcome Measures

Primary Outcomes (7)

• Swallowing Function

  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.

  Before enrollment of participants

• Baseline Tongue Strength

  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).

  At enrollment, the first meeting

• Tongue Strength after 12 Sessions

  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).

  4th week (Middle of treatment)

• Tongue Strength after 24 Sessions

  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).

  8th week (End of treatment)

• Baseline Tongue Endurance

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

  At enrollment, the first meeting

• Tongue Endurance after 12 sessions

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

  4th week (Middle of treatment)

• Tongue Endurance after 24 sessions

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

  8th week (End of treatment)

Study Arms (2)

Control group

ACTIVE COMPARATOR

Oral Sensorimotor Stimulation Therapy

Other: OSMS

Intervention group

EXPERIMENTAL

Combination Tongue Strength Exercise Therapy using TongueFit and OSMS Therapy

Device: TongueFit; Other: OSMS

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.

Also known as: Intervention, Orofacial manometer

Intervention group

OSMS OTHER

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

Also known as: Control

Control group; Intervention group

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rizky Kusuma Wardhani: lead

Study Sites (1)

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

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Rizky Kusuma Wardhani, MD

CONTACT

+628195174942; rizkykusumawardhani@yahoo.co.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants (including parents of patients), physiatrists who conducted VFSS and physiatrists who examined the patients' tongue strength and endurance are all blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Rizky Kusuma Wardhani, M.D., Physiatrist

Model Details: Model Description

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 10, 2025
• Study Start: March 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 15, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)