Efficacy of Pharyngeal Balloon Muscle Resistance Treatment in Post-Stroke Dysphagia: A Randomized Controlled Trial
Abstract
BACKGROUND
Dysphagia affects a significant proportion of stroke survivors and leads to malnutrition and aspiration pneumonia. Conventional therapies often lack direct resistance targeting pharyngeal constrictor muscles. We aimed to evaluate the efficacy of Pharyngeal Balloon Muscle Resistance Treatment (PBMRT) on swallowing function in post-stroke patients.
METHODS
This randomized controlled trial included 60 patients with post-stroke dysphagia. Patients were randomized into a Control Group (CG, n=30) receiving standard rehabilitation and an Intervention Group receiving standard rehabilitation plus Pharyngeal Balloon Muscle Resistance Treatment (PBMRTG, n=30). The PBMRT involved swallowing against a water-filled balloon to generate resistance. The primary outcome was the Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS). Secondary outcomes included the Mann Assessment of Swallowing Ability (MASA), Functional Oral Intake Scale (FOIS), Functional Communication Measure (FCM), Penetration-Aspiration Scale (PAS), and surface Electromyography (sEMG) of submental muscles. Statistical analyses used Welch's two-sample t-test for continuous variables, Pearson's chi-squared test for categorical variables, and Wilcoxon rank-sum tests for ordinal outcomes. Subgroup analyses were performed using ANCOVA models adjusting for baseline values to assess interaction effects.
RESULTS
Sixty patients were enrolled and fifty-nine completed the study. At baseline, there were no significant…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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