Oral Care Strategies for Stroke Patients with Dysphagia (NCT06692101) | Clinical Trial Compass
CompletedNot Applicable
Oral Care Strategies for Stroke Patients with Dysphagia
Taiwan35 participantsStarted 2021-12-09
Plain-language summary
This study aims to evaluate whether combining neuromuscular electrical stimulation (NMES) with oral care can improve swallowing function in patients who have experienced an acute stroke and are dealing with dysphagia (difficulty swallowing). The researchers are exploring two main questions: Is this combined approach practical and manageable for patients and caregivers to use during the early stages of stroke recovery? And does this combination lead to better swallowing function and fewer stroke-related complications compared to using only oral care or traditional routine care? The goal is to identify effective strategies to support safer and faster recovery in stroke patients with swallowing difficulties.
Who can participate
Age range
20 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 20 years.
. First diagnosis of acute ischemic stroke (AIS) and hospitalization.
. Stroke onset within 48 hours.
. NIHSS score ≥ 5 upon admission, with at least one of the following NIHSS items: facial palsy, language, or dysarthria.
. Difficulty swallowing upon admission, indicated by a Gugging Swallowing Screen-Indirect Test score \< 5.
. Ability to communicate verbally or in writing and provide informed consent.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in stroke severity and swallowing function (GUSS) at three-time points-baseline (T0), the fourth-day post-stroke (T1), and the eighth-day post-stroke (T2)
Timeframe: From enrollment to the end of treatment at day 8 post-stroke. Outcome measures were assessed at baseline (day 0), day 4, and day 8 post-stroke.
2
Changes in stroke severity and swallowing function (ROAG) at three-time points-baseline (T0), the fourth-day post-stroke (T1), and the eighth-day post-stroke (T2)
Timeframe: From enrollment to the end of treatment at day 8 post-stroke. Outcome measures were assessed at baseline (day 0), day 4, and day 8 post-stroke.
3
Changes in stroke severity and swallowing function (NIHSS) at three-time points-baseline (T0), the fourth-day post-stroke (T1), and the eighth-day post-stroke (T2)
Timeframe: From enrollment to the end of treatment at day 8 post-stroke. Outcome measures were assessed at baseline (day 0), day 4, and day 8 post-stroke.
4
Reducing stroke-associated pneumonia (SAP) incidence in acute stroke patients
Timeframe: Comparison of SAP occurrence within seven days after stroke.
Trial details
NCT IDNCT06692101
SponsorTaipei Medical University Shuang Ho Hospital