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Oropharyngeal DysphagiaNCT07203508

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

A study testing Tongue-to-Palate Resistance Training and Standard Dysphagia Therapy in people with Oropharyngeal Dysphagia and Geriatric Patients, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 61 years and older
Conditions the study is for
Oropharyngeal Dysphagia, Geriatric Patients
What is being tested?
Tongue-to-Palate Resistance Training and Standard Dysphagia Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteIndonesia
Study dates
19 Dec 2022to 25 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 61 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • RSUPN Dr. Cipto Mangunkusumo

    Jakarta Pusat, Jakarta Special Capital Region

Other trials in Indonesia

About this study

Official title: Effect of Tongue-to-Palate Resistance Training on Penetration-Aspiration Scale and Suprahyoid Muscle Electrical Activity in Geriatric Patients With Oropharyngeal Dysphagia

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.
Read more

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.

Read the detailed description

Title: Effect of Tongue-to-Palate Resistance Training on Penetration-Aspiration Scale and Suprahyoid Muscle Electrical Activity in Geriatric Patients with Oropharyngeal Dysphagia: A Randomized Control Trial

Journal \& Type: This is a manuscript for publication, presenting the results of a single-blind, randomized controlled trial (RCT).

Authors: The team is multi-disciplinary, consisting of experts in Internal Medicine, Physical Medicine and Rehabilitation (PM\&R), and Radiology from Cipto Mangunkusumo Hospital/University of Indonesia, and a collaborator from Germany.

Background \& Rationale:

Problem: Oropharyngeal dysphagia (difficulty swallowing) is a very common and serious problem in the elderly, leading to malnutrition, pneumonia from aspiration, and increased death rates.

Current Solutions: Existing therapies (like Shaker exercises or electrical stimulation) can be difficult for frail elderly patients to perform or require clinic visits.

Proposed Solution: Tongue-to-Palate Resistance Training (TPRT) is a simple, home-based exercise that could strengthen tongue and throat muscles, potentially improving swallowing. Preliminary studies showed it increases muscle activity, but robust evidence in geriatric patients was needed.

Objective: To determine if an 8-week home-based TPRT program is effective at improving swallowing muscle activity (measured by electromyography/sEMG) and swallowing safety (measured by the Penetration-Aspiration Scale on videofluoroscopy) in elderly dysphagia patients.

Methods:

Design: Single-blind Randomized Controlled Trial (RCT).

Participants: 20 elderly patients (>60 years) with confirmed oropharyngeal dysphagia. They had to have low baseline muscle activity and an available caregiver.

Intervention Group (n=9): Performed home-based TPRT (30 reps, 5x/week for 8 weeks) with video guidance and logbook monitoring.

Control Group (n=8): Received standard care, which included clinic-based Neuromuscular Electrical Stimulation (NMES) or biofeedback twice a week plus unsupervised home exercises (Chin Tuck Against Resistance).

Measurements:

Primary Outcome 1: Suprahyoid Muscle Activity. Measured using surface electromyography (sEMG) at baseline, 4 weeks, and 8 weeks.

Primary Outcome 2: Swallowing Safety. Measured using the Penetration-Aspiration Scale (PAS) via Videofluoroscopic Swallowing Study (VFSS) at baseline and 8 weeks.

Secondary Outcomes: Hyoid bone movement (crucial for swallowing) and Pharyngeal Transit Time (PTT) were also measured from the VFSS.

Analysis: Used advanced statistical tests (Repeated Measures ANOVA, Wilcoxon tests) to compare changes within and between groups over time.

Being tested
Tongue-to-Palate Resistance Training, Standard Dysphagia Therapy
Keywords
Rehabilitation, aspiration, dysphagia, swallowing, tongue
Medical subject headings
Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tongue-to-Palate Resistance TrainingOther

    Also called Tongue Press Exercise, Tongue Strength Training

    The Tongue-to-Palate Resistance Training (TPRT) is a home-based, device-free exercise program. Participants were instructed to press their tongue firmly against their hard palate and hold the contraction. The protocol consisted of 30 repetitions per session, performed five days a week for a duration of eight weeks. Adherence was supported through instructional videos, a caregiver, and a training logbook. The goal of the intervention is to strengthen the intrinsic and extrinsic tongue muscles and the suprahyoid muscle group to improve swallowing function.

  • Standard Dysphagia TherapyCombination product

    Also called Active Comparator, Conventional Dysphagia Therapy

    The active comparator consists of a conventional, multi-modal standard of care for oropharyngeal dysphagia. It includes in-clinic sessions twice a week featuring either Neuromuscular Electrical Stimulation (NMES), where electrodes are placed in the submental region to stimulate the swallowing muscles, or biofeedback swallowing therapy. Additionally, participants perform unsupervised Chin Tuck Against Resistance (CTAR) exercises at home. This arm represents the established clinical rehabilitation approach against which the experimental TPRT intervention is compared

Study groups in NCT07203508
Study groupRoleWhat they receive
Tongue-to-Palate Resistance Training (TPRT)ExperimentalParticipants in this arm performed a home-based Tongue-to-Palate Resistance Training (TPRT) program. The intervention consisted of pressing the tongue against the palate for 30 repetitions per session, five sessions per week, for a total of eight weeks. Participants were provided with video guidance and a logbook to record adherence, and were supported by a caregiver. This was a simple, device-free exercise regimen designed to strengthen the oropharyngeal and suprahyoid musculature.
Receives: Other: Tongue-to-Palate Resistance Training
Standard Dysphagia TherapyActive comparatorParticipants in this arm received the standard of care for oropharyngeal dysphagia. This included supervised, hospital-based sessions twice a week consisting of either Neuromuscular Electrical Stimulation (NMES) applied to the submental region or biofeedback swallowing therapy. Additionally, they were instructed to perform unsupervised Chin Tuck Against Resistance (CTAR) exercises at home. This arm represents the conventional, multi-modal rehabilitation approach against which the experimental TPRT intervention was compared.
Receives: Combination Product: Standard Dysphagia Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Penetration-Aspiration Scale (PAS) Score

    Change in swallowing safety as measured by the Penetration-Aspiration Scale (PAS). The PAS is an 8-point ordinal scale. The minimum score is 1 (no airway invasion) and the maximum score is 8 (aspiration of material into the airway with no reflexive response). A lower score on the PAS indicates a safer swallow and is a better outcome.

    Measured: Baseline and Week 8

  2. Change in Suprahyoid Muscle Electrical Activity

    The change in the electrical activity of the suprahyoid muscles (measured in microvolts root mean square, μV RMS) during a tongue press task and a dry swallow task. Measured using surface electromyography (sEMG).

    Measured: Baseline, Week 4, and Week 8

Secondary outcomes (3)

  1. Change in Anterior Hyoid Excursion

    The change in the distance of forward (anterior) movement of the hyoid bone during swallowing, expressed as a percentage of the C2-C4 vertebral distance. Measured from VFSS.

    Measured: Baseline and Week 8

  2. Change in Superior Hyoid Excursion

    The change in the distance of upward (superior) movement of the hyoid bone during swallowing, expressed as a percentage of the C2-C4 vertebral distance. Measured from VFSS.

    Measured: Baseline and Week 8

  3. Change in Pharyngeal Transit Time (PTT)

    The change in the time (in seconds) taken for the bolus to travel from the point where the bolus tail passes the ramus of the mandible to when it passes through the upper esophageal sphincter. Measured from VFSS.

    Measured: Baseline and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2025
  2. Study start19 Dec 2022
  3. Primary completion25 Nov 2024
  4. Study completion25 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study utilized a parallel-group design, which is the standard model for a two-arm randomized controlled trial (RCT). Participants were randomly allocated to one of two distinct intervention groups that proceeded concurrently throughout the trial duration. One group received the experimental Tongue-to-Palate Resistance Training (TPRT) intervention, while the parallel comparator group received an active control treatment consisting of standard dysphagia therapy. The outcomes for both groups were assessed and compared at identical time points (baseline, week 4, and week 8) to evaluate the relative efficacy of the TPRT intervention against the control condition.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07203508
Sponsor's protocol ID
KET-1415/UN2.F1/ETIK/PPM.00.02
Status last verified
Sep 2025
First submitted
17 Sep 2025
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared to protect participant confidentiality

Publications

  • Zhang Z, Perera S, Donohue C, Kurosu A, Mahoney AS, Coyle JL, Sejdic E. The Prediction of Risk of Penetration-Aspiration Via Hyoid Bone Displacement Features. Dysphagia. 2020 Feb;35(1):66-72. doi: 10.1007/s00455-019-10000-5. Epub 2019 Mar 27.

    PubMed 30919104

  • Bingjie L, Tong Z, Xinting S, Jianmin X, Guijun J. Quantitative videofluoroscopic analysis of penetration-aspiration in post-stroke patients. Neurol India. 2010 Jan-Feb;58(1):42-7. doi: 10.4103/0028-3886.60395.

    PubMed 20228462

  • Kim H, Kown Y, Choi H. Home Based Dysphagia Rehabilitation for Stroke Patients Using Information and Communication Technology. J Int Acad Phys Ther Res. 2021;12(1):2267-71

  • Pearson WG Jr, Hindson DF, Langmore SE, Zumwalt AC. Evaluating swallowing muscles essential for hyolaryngeal elevation by using muscle functional magnetic resonance imaging. Int J Radiat Oncol Biol Phys. 2013 Mar 1;85(3):735-40. doi: 10.1016/j.ijrobp.2012.07.2370. Epub 2012 Sep 18.

    PubMed 22995662

  • Han H, Shin G, Jun A, Park T, Ko D, Choi E, Kim Y. The Relation Between the Presence of Aspiration or Penetration and the Clinical Indicators of Dysphagia in Poststroke Survivors. Ann Rehabil Med. 2016 Feb;40(1):88-94. doi: 10.5535/arm.2016.40.1.88. Epub 2016 Feb 26.

    PubMed 26949674

  • Steele CM, Bailey GL, Chau T, Molfenter SM, Oshalla M, Waito AA, Zoratto DC. The relationship between hyoid and laryngeal displacement and swallowing impairment. Clin Otolaryngol. 2011 Feb;36(1):30-6. doi: 10.1111/j.1749-4486.2010.02219.x.

    PubMed 21414151

  • Hughes TD. The Effect of Two Rehabilitation Exercise on Submental Hyolaringeal Muscular Activity. Texas Christian University; 2015

  • Steele CM, Bayley MT, Peladeau-Pigeon M, Nagy A, Namasivayam AM, Stokely SL, Wolkin T. A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia. Dysphagia. 2016 Jun;31(3):452-61. doi: 10.1007/s00455-016-9699-5. Epub 2016 Mar 2.

    PubMed 26936446

  • Rogus-Pulia N, Rusche N, Hind JA, Zielinski J, Gangnon R, Safdar N, Robbins J. Effects of Device-Facilitated Isometric Progressive Resistance Oropharyngeal Therapy on Swallowing and Health-Related Outcomes in Older Adults with Dysphagia. J Am Geriatr Soc. 2016 Feb;64(2):417-24. doi: 10.1111/jgs.13933. Epub 2016 Jan 25.

    PubMed 26804715

  • Oommen ER. Effects of Three Lingual Conditions on Submental Muscle Activity in Healthy Young and Old Adults. Ohio University; 2013

  • Vaiman M, Eviatar E, Segal S. Surface electromyographic studies of swallowing in normal subjects: a review of 440 adults. Report 2. Quantitative data: amplitude measures. Otolaryngol Head Neck Surg. 2004 Nov;131(5):773-80. doi: 10.1016/j.otohns.2004.03.014.

    PubMed 15523465

  • Furlan R et al. Comparison of the electric activity of the suprahyoid muscles during different lingual exercises. Audiol Commun. 2015;20(3):203-9

  • Gutierrez DL. A Comparison of Two Devices for Isometric Lingual Strengthening in Healthy Adults A COMPARISON OF TWO DEVICES FOR ISOMETRIC. 2020

  • Palmer PM, Jaffe DM, McCulloch TM, Finnegan EM, Van Daele DJ, Luschei ES. Quantitative contributions of the muscles of the tongue, floor-of-mouth, jaw, and velum to tongue-to-palate pressure generation. J Speech Lang Hear Res. 2008 Aug;51(4):828-35. doi: 10.1044/1092-4388(2008/060).

    PubMed 18658054

  • Park JS, Kim HJ, Oh DH. Effect of tongue strength training using the Iowa Oral Performance Instrument in stroke patients with dysphagia. J Phys Ther Sci. 2015 Dec;27(12):3631-4. doi: 10.1589/jpts.27.3631. Epub 2015 Dec 28.

    PubMed 26834320

Questions about this trial

What is this clinical trial studying?

A study testing Tongue-to-Palate Resistance Training and Standard Dysphagia Therapy in people with Oropharyngeal Dysphagia and Geriatric Patients, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Penetration-Aspiration Scale (PAS) Score (time frame: Baseline and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07203508, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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