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

NCT07203508 | Completed

• 1 other identifier: KET-1415/UN2.F1/ETIK/PPM.00.02
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does TPRT increase the electrical activity of the suprahyoid muscles (a key muscle group for swallowing) more than standard care?
2. 2.Does TPRT reduce scores on the Penetration-Aspiration Scale (PAS), a measure of swallowing safety, more than standard care?
3. 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.

Conditions

Oropharyngeal Dysphagia; Geriatric Patients

Keywords

Rehabilitation; aspiration; dysphagia; swallowing; tongue

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and Week 8

• 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).

  Baseline, Week 4, and Week 8

Secondary Outcomes (3)

• Change in Anterior Hyoid Excursion

  Baseline and Week 8

• Change in Superior Hyoid Excursion

  Baseline and Week 8

• Change in Pharyngeal Transit Time (PTT)

  Baseline and Week 8

Study Arms (2)

Tongue-to-Palate Resistance Training (TPRT)

EXPERIMENTAL

Participants 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.

Other: Tongue-to-Palate Resistance Training

Standard Dysphagia Therapy

ACTIVE COMPARATOR

Participants 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.

Combination Product: Standard Dysphagia Therapy

Interventions

Tongue-to-Palate Resistance Training OTHER

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.

Also known as: Tongue Press Exercise, Tongue Strength Training

Tongue-to-Palate Resistance Training (TPRT)

Standard Dysphagia Therapy COMBINATION_PRODUCT

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

Also known as: Active Comparator, Conventional Dysphagia Therapy

Standard Dysphagia Therapy

Eligibility Criteria

• Age: 61 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Location

Related Publications (40)

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MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: While the participants, care providers, and investigators involved in delivering the interventions were not masked due to the nature of the exercise-based interventions, the study maintained a single-blind design. The key masked party was the outcomes assessor. Specifically, the rehabilitation medicine physician who performed the surface electromyography (sEMG) measurements and the radiologist and rehabilitation medicine specialist who analyzed the videofluoroscopic swallowing study (VFSS) recordings were blinded to group allocation. This was implemented to ensure objective and unbiased assessment of the primary outcome measures (suprahyoid muscle electrical activity and Penetration-Aspiration Scale scores)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. dr. Melinda Harini, Sp.K.F.R., Ger. (K)

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 2, 2025
• Study Start: December 19, 2022
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)