Dysphagia Following Cerebrovascular AccidentNCT07810374
Evaluation of Effectiveness of an Interactive Dysphagia Education System for Patients With Stroke
A study testing Interactive dysphagia education in people with Dysphagia Following Cerebrovascular Accident, run by Mei-Yu Lin at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Dysphagia Following Cerebrovascular Accident
- What is being tested?
- Interactive dysphagia education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 22 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development and 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.
Read more
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
Read the 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.
- Being tested
- Interactive dysphagia education
- Keywords
- dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive dysphagia educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interactive dysphagia education group | Experimental | 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. Receives: Behavioral: Interactive dysphagia education |
| Routine education group | No intervention | Participants will receive routine inpatient education on dysphagia and printed educational materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Swallowing Status Assessed by the Eating Assessment Tool-10 (EAT-10)
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.
Measured: Baseline and 7 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion22 Jun 2027 (estimated)
- Study completion22 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia Following Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mei-Yu Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mei-Yu Lin, Mackay Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810374
- Sponsor's protocol ID
- 202605EM010
- Status last verified
- Jun 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because data sharing was not included in the approved study protocol and informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Effectiveness of an Interactive Dysphagia Education System for Patients With Stroke
- ClinicalTrials.gov ID
- NCT07810374
- Acronym / sponsor ID
- 202605EM010
- Keywords
- dysphagia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mei-Yu LinUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 22 Jun 2027 (estimated)
- Study completion
- 22 Jun 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interactive dysphagia education group | Experimental | Behavioral: Interactive dysphagia educationThe 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. |
| Routine education group | No intervention | –Participants will receive routine inpatient education on dysphagia and printed educational materials. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive dysphagia educationThe 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. | Behavioural | Interactive dysphagia education group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because data sharing was not included in the approved study protocol and informed consent.
Related trials for Dysphagia Following Cerebrovascular Accident
Not yet recruiting
Deep Brain Stimulation + Therapy for Stroke
Stroke, Dysarthria
Not yet recruiting
Combined Acupuncture-Based Therapy for Rehabilitation After Ischemic Stroke
Ischemic Stroke, Hemiplegia
Recruiting
K01 Impacts of Lingual Endurance Exercise
Dysphagia, Dysphagia, Oropharyngeal
Recruiting
Dysphagia Evaluation After Stroke- Effect Oral Neuromuscular Training on Swallowing Dysfunction
Dysphagia, Stroke
Recruiting
Effect of Visual Biofeedback-Assisted Oropharyngeal Exercises in Post-Stroke Dysphagia
Dysphagia After Stroke, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive dysphagia education in people with Dysphagia Following Cerebrovascular Accident, run by Mei-Yu Lin at 1 site in Taiwan.
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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 9 Sep 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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 Swallowing Status Assessed by the Eating Assessment Tool-10 (EAT-10) (time frame: Baseline and 7 days after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.