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Digital Intelligent Tongue-Pressure Biofeedback Resistance Training for Post-Stroke Dysphagia: A Randomized Controlled Trial

RecruitingPhase 2Ages 18 Years - 80 YearsAllFirst People's Hospital of Foshan
NCT07798401 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 convent

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📋 Eligibility rules (as published)
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.
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What it tests

  • Digital Intelligent Tongue-Pressure Biofeedback Resistance Training
  • Conventional Tongue-Pressure Resistance Training
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Where

1 site
First People's Hospital of Foshan
Foshan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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