Status:
RECRUITING
Effectivity of TongueFit, A Novel Orofacial Manometer, as Tongue Strength and Endurance Therapy in Children With Dysphagia
Lead Sponsor:
Rizky Kusuma Wardhani
Conditions:
Dysphagia
Children
Eligibility:
All Genders
3-16 years
Phase:
NA
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 strengt...
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, participa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06921161
Start Date
March 1 2025
End Date
May 15 2025
Last Update
April 10 2025
Active Locations (1)
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1
Physical Medicine and Rehabilitation Polyclinic, Pediatric Division, Dr. Cipto Mangunkusumo Hospital
Jakarta, Jakarta Special Capital Region, Indonesia, 10430