Using TongueFit to improve tongue strength and endurance in children with swallowing difficulties

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How surgery for obstructive sleep apnea affects swallowing and oral function

  This study compares swallowing and oral function before and after surgical treatment for OSA versus non-surgical care in adults with moderate-to-severe OSA.

  Recruiting National Sun Yat-sen University · Kaohsiung City · NCT07880067

• taVNS added to oral motor training for babies with severe swallowing trouble

  This trial tests whether pairing a noninvasive taVNS treatment with oral sensorimotor training helps infants in NICUs swallow better and feed more safely.

  Recruiting Medical University of South Carolina · Charleston, South Carolina · NCT07802301

• Digital Tongue-Pressure Biofeedback Training for Post-Stroke Swallowing

  This study tests whether digital tongue-pressure biofeedback training helps people with swallowing difficulties after stroke.

  Recruiting Phase 2 First People's Hospital of Foshan · Foshan, Guangdong · NCT07798401

• Masseter and Thigh Muscle Ultrasound to Predict Dysphagia and Sarcopenia in Critically Ill Adults

  This study tests whether measuring the masseter muscle with ultrasound can help identify dysphagia in adults after critical illness and extubation, alongside evaluation of sarcopenia.

  Recruiting Hospital General Universitario Gregorio Marañon · Madrid, Madrid · NCT07787312

• Impact of Patient Position on EndoFLIP Measurements in Kids and Young Adults

  This study tests whether EndoFLIP measurements differ when patients are in the supine versus left-side position during the procedure.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT07780981

• Effects of CTAR and a Swallowing Pressure Ball in Older Stroke Adults

  This study tests whether home-based CTAR exercises plus a swallowing pressure ball can improve swallowing function and eating-related quality of life for older adults who had a stroke and have dysphagia.

  Recruiting Chimei Medical Center · Tainan, Tainan City · NCT07620210

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.