NCT07798401 Digital Intelligent Tongue-Pressure Biofeedback Resistance Training for Post-Stroke Dysphagia: A Randomized Controlled Trial
| NCT ID | NCT07798401 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | First People's Hospital of Foshan |
| Condition | Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-06-05 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2026-06-05 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Post-stroke dysphagia is a common complication of stroke and may lead to impaired oral intake, malnutrition, aspiration, and pneumonia. Reduced tongue strength and tongue pressure are important contributors to impaired swallowing after stroke. Conventional tongue-pressure resistance training may improve tongue strength, but traditional training provides limited real-time feedback and may be difficult to individualize.This prospective, multicenter, randomized, open-label, parallel-controlled trial will evaluate the effectiveness of digital intelligent tongue-pressure biofeedback resistance training in patients with post-stroke dysphagia. A total of 80 participants will be randomly assigned in a 1:1 ratio to an intervention group or a control group. Participants in the intervention group will receive digital intelligent tongue-pressure biofeedback resistance training in addition to conventional swallowing rehabilitation, while participants in the control group will receive conventional rehabilitation without the digital biofeedback intervention. The intervention period will last 2 weeks.Swallowing function will be assessed at baseline and after completion of the intervention. The primary outcome is the change in Functional Oral Intake Scale (FOIS) score. Secondary assessments include maximum tongue pressure and quantitative videofluoroscopic swallowing study (VFSS) measures, including oral transit time, Penetration-Aspiration Scale score, and pharyngeal residue. The study aims to determine whether digital intelligent tongue-pressure biofeedback resistance training provides additional benefits for swallowing function, tongue strength, and swallowing safety in patients with post-stroke dysphagia.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07798401 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07798401 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07798401 currently recruiting?
Yes, NCT07798401 is actively recruiting participants. Contact the research team at 104237506@qq.com for enrollment information.
Where is the NCT07798401 trial being conducted?
This trial is being conducted at Foshan, China.
Who is sponsoring the NCT07798401 clinical trial?
NCT07798401 is sponsored by First People's Hospital of Foshan. The trial plans to enroll 80 participants.