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

Post‐stroke dysphagia is a common complication of stroke and may lead to impaired oralintake, malnutrition, aspiration, and pneumonia. Reduced tongue strength and tonguepressure are important contributors to impaired swallowing after stroke. Conventionaltongue‐pressure resistance training may improve tongue strength, but traditional trainingprovides limited real‐time feedback and may be difficult to individualize.Thisprospective, multicenter, randomized, open‐label, parallel‐controlled trial will evaluatethe effectiveness of digital intelligent tongue‐pressure biofeedback resistance trainingin patients with post‐stroke dysphagia. A total of 80 participants will be randomlyassigned in a 1:1 ratio to an intervention group or a control group. Participants in theintervention group will receive digital intelligent tongue‐pressure biofeedbackresistance training in addition to conventional swallowing rehabilitation, whileparticipants in the control group will receive conventional rehabilitation without thedigital biofeedback intervention. The intervention period will last 2 weeks.Swallowingfunction will be assessed at baseline and after completion of the intervention. Theprimary outcome is the change in Functional Oral Intake Scale (FOIS) score. Secondaryassessments include maximum tongue pressure and quantitative videofluoroscopic swallowingstudy (VFSS) measures, including oral transit time, Penetration‐Aspiration Scale score,and pharyngeal residue. The study aims to determine whether digital intelligenttongue‐pressure biofeedback resistance training provides additional benefits forswallowing function, tongue strength, and swallowing safety in patients with post‐strokedysphagia.