DysphagiaNCT06921161
Effectivity of TongueFit, A Novel Orofacial Manometer, as Tongue Strength and Endurance Therapy in Children With Dysphagia
A study testing TongueFit and OSMS in people with Dysphagia and Children, run by Rizky Kusuma Wardhani at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 16 years
- What is being tested?
- TongueFit and OSMS
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2025to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Physical Medicine and Rehabilitation Polyclinic, Pediatric Division, Dr. Cipto Mangunkusumo Hospital
Jakarta, Jakarta Special Capital Region, 10430
Rizky Kusuma Wardhani, MD, +628195174942, rizkykusumawardhani@yahoo.co.id
Rizky Kusuma Wardhani, MD
About this study
Official title: Effectivity of TongueFit as Tongue Strength and Endurance Therapy in Children With Dysphagia: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Being tested
- TongueFit, OSMS
- Keywords
- dysphagia, effectivity, orofacial manometer, tongue strength, tongue endurance, children
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TongueFitDevice
Also called Intervention, Orofacial manometer
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.
OSMSOther
Also called Control
Patients will receive OSMS therapy, conducted for 15 minutes per session, three times a week, over a duration of eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Oral Sensorimotor Stimulation Therapy Receives: Other: OSMS |
| Intervention group | Experimental | Combination Tongue Strength Exercise Therapy using TongueFit and OSMS Therapy Receives: Device: TongueFit; Other: OSMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 8th week (End of treatment)
Baseline Tongue Endurance
The duration of the tongue ability to sustain submaximal pressure (50% of its maximum force)
Measured: 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)
Measured: 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)
Measured: 8th week (End of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Mar 2025
- Primary completion30 Apr 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rizky Kusuma Wardhani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rizky Kusuma Wardhani, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921161
- Sponsor's protocol ID
- 24-02-0288
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of TongueFit as Tongue Strength and Endurance Therapy in Children With Dysphagia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06921161
- Acronym / sponsor ID
- 24-02-0288
- Keywords
- dysphagia, effectivity, orofacial manometer, tongue strength, tongue endurance, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rizky Kusuma WardhaniUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: OSMSOral Sensorimotor Stimulation Therapy |
| Intervention group | Experimental | Device: TongueFit, Other: OSMSCombination Tongue Strength Exercise Therapy using TongueFit and OSMS Therapy |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TongueFitAlso: Intervention, Orofacial manometerTongueFit 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. | Device | Intervention group |
| OSMSAlso: ControlPatients will receive OSMS therapy, conducted for 15 minutes per session, three times a week, over a duration of eight weeks. | Other | Control group, Intervention group |
Primary outcome
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.
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).
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).
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).
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TongueFit and OSMS in people with Dysphagia and Children, run by Rizky Kusuma Wardhani at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rizky Kusuma Wardhani, MD (+628195174942, rizkykusumawardhani@yahoo.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing Function (time frame: Before enrollment of participants). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.