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

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.

Conditions

• Oropharyngeal Dysphagia
• Geriatric Patients

Interventions

OTHER

Tongue-to-Palate Resistance 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.

COMBINATION_PRODUCT

Standard 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

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

61 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-19

Primary Completion

2024-11-25

Completion

2024-11-25

Countries

• Indonesia

Study Locations