Digital Tongue-Pressure Biofeedback Training for Post-Stroke Swallowing
Official title: Digital Intelligent Tongue-Pressure Biofeedback Resistance Training for Post-Stroke Dysphagia: A Randomized Controlled Trial
Run by First People's Hospital of Foshan · NCT07798401 · Data updated 2026-11-12
This study tests whether digital tongue-pressure biofeedback training helps people with swallowing difficulties after stroke.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | First People's Hospital of Foshan Academic / other |
| Locations | 1 site (Foshan, Guangdong) |
| Status | Recruiting |
| Started | June 5, 2026 |
| Main results expected | December 30, 2028 |
| Study ends | December 30, 2028 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT07798401 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with post-stroke dysphagia who can participate in tongue-pressure training and meet safety criteria.
✕Probably not a fit
Patients with severe cognitive impairment, oral disorders, or allergies to device materials may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, multicenter trial compares digital intelligent tongue-pressure biofeedback resistance training plus standard swallowing rehab versus standard rehab alone in adults with post-stroke dysphagia. The study hopes to see if real-time feedback improves tongue strength and swallowing function. It will enroll about 80 participants, randomly assigning them to intervention or control in a parallel design. The trial is open-label and assesses outcomes related to swallowing and safety during the treatment period.
Why it matters
Potential benefit: If successful, patients could experience improved swallowing function and reduced risk of pneumonia and malnutrition.
How similar studies have gone: Previous tongue-pressure training studies suggest potential benefits, but this digital biofeedback approach is a newer, more individualized method.
Who can join: the full rules
Show full inclusion / exclusion criteria
clusion Criteria: 1. Subarachnoid hemorrhage, transient ischemic attack, progressive stroke, reversible ischemic neurological deficit, or neurodegenerative disease. 2. Unable to complete tongue-pressure measurement or tongue-pressure resistance training, including participants with severe psychiatric disorders, severe cognitive impairment (Mini-Mental State Examination \[MMSE\] score \<18), oral structural abnormalities, or severe oral disease. 3. Known allergy or hypersensitivity to materials used in the study device. 4. Pregnant or breastfeeding, or planning pregnancy during the study period. 5. Participation in another medical device or drug clinical trial within the previous 1 month or current participation in another such trial. 6. Any other condition that, in the investigator's judgment, may result in poor compliance or make the participant unsuitable for the study.
Where it's running
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First People's Hospital of Foshan
Foshan, Guangdong, China Recruiting
Study contacts
- Study coordinator: Zhiming Tang
- Email: 104237506@qq.com
- Phone: +86-0757-83161805
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Effects of CTAR and a Swallowing Pressure Ball in Older Stroke Adults
This study tests whether home-based CTAR exercises plus a swallowing pressure ball can improve swallowing function and eating-related quality of life for older adults who had a stroke and have dysphagia.
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Visual biofeedback-assisted oropharyngeal exercises with NMES for post-stroke swallowing problems
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This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
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This study is testing if using kinesiology taping along with swallowing exercises can help stroke patients with swallowing difficulties improve their muscle strength and swallowing ability.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.