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 range61 Years

SexALL

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.

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