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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07810374
Enrollment
100
Registered
2026-09-09
Start date
2026-09-01
Completion date
2027-06-22
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia Following Cerebrovascular Accident

Keywords

dysphagia

Brief summary

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

Detailed description

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.

Interventions

BEHAVIORALInteractive dysphagia education

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.

Sponsors

Mei-Yu Lin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

No other parties are masked.

Intervention model description

Participants in the interactive dysphagia education group will receive routine inpatient dysphagia education plus the interactive dysphagia education system. The system will then 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Patients diagnosed with ischemic or hemorrhagic stroke and dysphagia. 2. Aged 20-75 years. 3. Clinically stable and within 48 hours of admission to the inpatient ward.

Exclusion criteria

1. Impaired consciousness or clinically unstable condition. 2. Moderate to severe aphasia that prevents completion of the study procedures. 3. Unable to understand the study information or complete the required assessments. 4. Unable to complete all scheduled assessment time points.

Design outcomes

Primary

MeasureTime frameDescription
Change in Swallowing Status Assessed by the Eating Assessment Tool-10 (EAT-10)Baseline and 7 days after the interventionSwallowing 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026