Using TongueFit to improve tongue strength and endurance in children with swallowing difficulties
Effectivity of TongueFit as Tongue Strength and Endurance Therapy in Children With Dysphagia: A Randomized Controlled Trial
This study is testing if using a new tool called TongueFit can help children with swallowing difficulties strengthen their tongues and improve their ability to swallow better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 3 Years to 16 Years |
| Sex | All |
| Sponsor | Indonesia University Academic / other |
| Locations | 1 site (Jakarta, Jakarta Special Capital Region) |
| Trial ID | NCT06921161 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of TongueFit, a novel orofacial manometer, in enhancing tongue strength and endurance in children diagnosed with dysphagia. The study employs a double-blinded, randomized controlled design, where participants are divided into intervention and control groups. The intervention group receives therapy using TongueFit alongside traditional OSMS therapy, while the control group only receives OSMS therapy. Measurements of tongue strength and endurance are taken bi-weekly to assess progress and adjust therapy as needed.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 16 years diagnosed with oral phase dysphagia.
Not a fit: Patients with multiple congenital craniomaxillofacial abnormalities or those currently receiving inpatient treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an accessible and effective therapy option for children with dysphagia, improving their swallowing abilities.
How similar studies have performed: While similar approaches have been explored, the use of TongueFit as a child-friendly tool for tongue strength therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jakarta, Jakarta Special Capital Region
- Physical Medicine and Rehabilitation Polyclinic, Pediatric Division, Dr. Cipto Mangunkusumo Hospital — Jakarta, Jakarta Special Capital Region, Indonesia (Recruiting)
Study contacts
- Study coordinator: Rizky Kusuma Wardhani, MD
- Email: rizkykusumawardhani@yahoo.co.id
- Phone: +628195174942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.