CompletedNot Applicable

Effect of Tongue-to-Palate Resistance Training in Geriatric Patients With Oropharyngeal Dysphagia

Indonesia17 participantsStarted 2022-12-19

Plain-language summary

The goal of this randomized controlled trial is to learn if a home-based Tongue-to-Palate Resistance Training (TPRT) program can improve swallowing muscle activity and swallowing safety in geriatric patients (aged \>60 years) with oropharyngeal dysphagia. The main questions it aims to answer are: 1. Does TPRT increase the electrical activity of the suprahyoid muscles (a key muscle group for swallowing) more than standard care? 2. Does TPRT reduce scores on the Penetration-Aspiration Scale (PAS), a measure of swallowing safety, more than standard care? 3. Researchers will compare the TPRT intervention group to the active control group to see if the simple, home-based TPRT exercise is as effective or more effective than standard hospital-based therapies. Participants in the intervention group will: Perform the TPRT exercise (pressing their tongue against the palate) for 30 repetitions, 5 times a week, for 8 weeks at home. Be supported by a caregiver and use a video guide and logbook. Participants in the control group will: Receive standard hospital-based therapy twice a week, which may include Neuromuscular Electrical Stimulation (NMES) or biofeedback. Perform unsupervised Chin Tuck Against Resistance (CTAR) exercises at home. All participants will also receive education on safe swallowing techniques.

Who can participate

Age range

61 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 60 years with a diagnosis of oropharyngeal dysphagia based on history, physical examination, and Videofluoroscopic Swallowing Study (VFSS) * Initial measurement of suprahyoid muscle electrical activity ≤ 37.1 µV RMS * Has not undergone any other swallowing exercises or is not currently participating in any swallowing exercise program within the past 2 weeks. * Cooperative and willing to participate in the study by signing the informed consent form after receiving an explanation * Has a caregiver who is willing to participate and is cooperative to ensure the patient follows the exercise protocol according to the study. Exclusion Criteria: * Cognitive impairment in the domains of memory, attention, or language based on the Montreal Cognitive Assessment - Indonesian version (MoCA-Ina), which would prevent the subject from following exercise instructions. * Presence of other conditions causing dysphagia, such as oral cavity malignancy, history of radical neck dissection, or history of chemoradiotherapy to the neck region less than 3 months after the last session. * Complete inability to move the tongue or initial suprahyoid muscle electrical activity measurement = 0 µV. * Allergy to barium, potato starch, corn starch, xanthan gum, dairy products, or latex. * Use of a pacemaker.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Penetration-Aspiration Scale (PAS) Score

Timeframe: Baseline and Week 8

Change in Suprahyoid Muscle Electrical Activity

Timeframe: Baseline, Week 4, and Week 8

Trial details

NCT IDNCT07203508

SponsorDr Cipto Mangunkusumo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-25

View on ClinicalTrials.gov More Oropharyngeal Dysphagia trials