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

Condition(s) studied

Investigational drug(s) / intervention(s)

Digital Intelligent Tongue-Pressure Biofeedback Resistance Training: Digital intelligent tongue-pressure biofeedback resistance training is delivered using a tongue-pressure resistance training device equipped with real-time pressure sensing and visual biofeedback. Tongue pressure is measured at the anterior, middle, posterior, left, and right regions using a five-point pressure sensor. Training includes anterior tongue isometric strengthening, posterior tongue isometric strengthening, and precision biofeedback training. For strength training, the initial target is set at 80% of the participant's maximum tongue pressure, with 20 repetitions per site for 3 sets. For endurance training, the initial target is set at 50% of the maximum tongue pressure.

Conventional Tongue-Pressure Resistance Training: Conventional tongue-pressure resistance training is performed without digital pressure monitoring or real-time visual biofeedback. Participants perform conventional tongue-strengthening exercises by repeatedly pressing the tongue against the hard palate to strengthen the tongue musculature.

Study 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

Primary outcome measure(s)

• Functional Oral Intake Scale (FOIS) Score — Baseline and immediately after completion of the 2-week intervention
  The Functional Oral Intake Scale (FOIS) is a 7-point ordinal scale used to assess the functional level of oral food and liquid intake. Scores range from 1 (nothing by mouth) to 7 (total oral diet with no restrictions). Higher scores indicate better functional oral intake.

Trial sites (1)

More First People's Hospital of Foshan trials in China

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