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Enrolling by invitation

NCT Number: NCT07810374

Evaluation of Effectiveness of an Interactive Dysphagia Education System for Patients With Stroke

The goal of this clinical trial is to learn if an interactive dysphagia education system can improve swallowing outcomes and quality of life in patients with post-stroke dysphagia. The main questions it aims to answer are:

Does the interactive dysphagia education system improve swallowing outcomes? Does the interactive dysphagia education system improve quality of life? Researchers will compare the interactive dysphagia education system plus routine dysphagia education with routine dysphagia education alone to see if the interactive system provides additional benefits.

Participants will:

Receive either interactive dysphagia education plus routine education or routine education alone Use the interactive dysphagia education system at the bedside for 48 hours if assigned to the interactive education group Complete assessments of swallowing outcomes and quality of life

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital

Yuli, Yilan County, 265, Taiwan

About this study

Stroke is a common cause of dysphagia, which may affect swallowing function, nutritional intake, and quality of life. Patient education and swallowing training are important components of dysphagia care. However, routine inpatient education may be limited by patients' physical condition, learning pace, and opportunities to review educational content.

This study will evaluate an interactive dysphagia education system designed for patients with post-stroke dysphagia. The system provides interactive educational content related to dysphagia and swallowing training and allows patients to review the content according to their individual needs.

A total of 100 participants will be assigned to either an interactive dysphagia education group (n = 50) or a routine education group (n = 50).

Participants in the interactive dysphagia education group will receive routine inpatient dysphagia education plus the interactive dysphagia education system. Research staff will provide approximately 15-20 minutes of instruction on how to use the system. The system will then be placed at the participant's bedside and made available for 48 hours. The educational program takes approximately 25 minutes to complete. Participants may use the system according to their physical condition and preferred schedule and may review the educational content multiple times during the intervention period.

Participants in the routine education group will receive routine inpatient dysphagia education and printed educational materials.

The study will compare changes between the two groups to determine whether adding the interactive dysphagia education system to routine education improves swallowing-related outcomes and quality of life in patients with post-stroke dysphagia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with ischemic or hemorrhagic stroke and dysphagia.
  • Aged 20-75 years.
  • Clinically stable and within 48 hours of admission to the inpatient ward.

Exclusion criteria

  • Impaired consciousness or clinically unstable condition.
  • Moderate to severe aphasia that prevents completion of the study procedures.
  • Unable to understand the study information or complete the required assessments.
  • Unable to complete all scheduled assessment time points.

Treatment and study plan

Interactive dysphagia education

Behavioral

The system will be placed at the participant's bedside and made available for 48 hours. Participants may use the system according to their physical condition and preferred schedule and may review the educational content multiple times during the intervention period.

Primary outcomes

  1. Change in Swallowing Status Assessed by the Eating Assessment Tool-10 (EAT-10)

    Time frame: Baseline and 7 days after the intervention

    Swallowing status will be assessed using the Eating Assessment Tool-10 (EAT-10), a 10-item patient-reported questionnaire designed to assess swallowing difficulties. Each item is rated from 0 (no problem) to 4 (severe problem), resulting in a total score ranging from 0 to 40. Higher total scores indicate greater perceived swallowing difficulties.

Sponsors and collaborators

Lead sponsor

Mei-Yu Lin

Other

Registry information

Official study title

Development and Evaluation of Effectiveness of an Interactive Dysphagia Education System for Patients With Stroke

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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