Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Multicentric Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating whether biofeedback treatment is more effective than standard verbal feedback training in helping people recover from dysphagia after a stroke. This multicenter randomized controlled study will enroll 100 patients who have had a stroke and experience swallowing difficulties. The goal is to compare the recovery of swallowing function between those receiving biofeedback and those receiving conventional therapy without visual feedback. Participants will undergo 20 sessions over 4 weeks, attending five one-hour sessions each week. In the biofeedback group, sensors will be placed on the mylohyoid muscle to provide real-time visual feedback on muscle activity during swallowing exercises. The control group will perform the same swallowing maneuvers but will receive only verbal feedback from a speech therapist. Both groups will use effortful swallow techniques, timing and coordination tasks, and the Masako maneuver during training. Before starting treatment, and at two follow-up points—after 4 weeks of therapy and again two months later—patients will have clinical and instrumental evaluations including fibroendoscopy and several swallowing function scales. Researchers will measure swallowing efficacy, penetration/aspiration, pharyngeal residues, and quality of life related to swallowing. Data will be analyzed statistically to assess treatment effects and safety throughout the study duration.

Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia