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

RecruitingNAAges 3 Years - 16 YearsAllRizky Kusuma Wardhani
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Children aged 3 to 16 years. * Diagnosed with oral phase dysphagia based on VFSS, with an MBSImP score greater than 0 and โ‰ค12. * 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.
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What it tests

  • TongueFit
  • OSMS
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Where

1 site
Physical Medicine and Rehabilitation Polyclinic, Pediatric Division, Dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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