NCT07492719

Effect of Visual Biofeedback-Assisted Oropharyngeal Exercises in Post-Stroke Dysphagia

Effectiveness of Visual Biofeedback-Assisted Oropharyngeal Exercises Combined With Neuromuscular Electrical Stimulation in Patients With Post-Stroke Dysphagia: A Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Gazi University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Post-stroke dysphagia is a common complication that negatively affects nutritional status, quality of life, and morbidity. Conventional swallowing rehabilitation, including oropharyngeal exercises and neuromuscular electrical stimulation (NMES), is widely used to improve swallowing function. This randomized controlled clinical study aims to investigate the effectiveness of visual biofeedback-assisted oropharyngeal exercises combined with NMES in patients with post-stroke dysphagia. Participants will be randomly assigned to either a visual biofeedback-assisted exercise group or a conventional exercise group, with both groups receiving NMES. Treatment will be administered five days per week for four weeks. Changes in swallowing function, suprahyoid muscle activity assessed by surface electromyography, and muscle stiffness evaluated by shear wave elastography will be analyzed to determine the effectiveness of the intervention.

Detailed description

Post-stroke dysphagia is a frequent complication following cerebrovascular events and is associated with increased risk of aspiration pneumonia, malnutrition, prolonged hospitalization, and reduced quality of life. Rehabilitation strategies aiming to improve swallowing function commonly include oropharyngeal exercises and neuromuscular electrical stimulation (NMES). These approaches are intended to enhance suprahyoid muscle activation, improve hyolaryngeal elevation, and facilitate safer swallowing.Visual biofeedback has recently emerged as a potential method to enhance motor learning and patient engagement during rehabilitation. Providing real-time feedback about muscle activity may improve exercise performance, increase patient motivation, and potentially enhance therapeutic outcomes. However, the clinical effectiveness of visual biofeedback-assisted swallowing exercises in patients with post-stroke dysphagia has not been sufficiently investigated.The aim of this randomized controlled clinical trial is to evaluate the effectiveness of visual biofeedback-assisted oropharyngeal exercises combined with neuromuscular electrical stimulation in patients with post-stroke dysphagia. Adult patients diagnosed with post-stroke dysphagia will be recruited and randomly assigned to one of two groups. The visual biofeedback group will perform conventional oropharyngeal swallowing exercises with visual feedback provided through the NMES device interface, while the control group will perform conventional oropharyngeal exercises without visual feedback. Both groups will receive suprahyoid NMES as part of the rehabilitation protocol.The intervention will be administered five days per week for four weeks. The primary outcome of the study is the change in suprahyoid muscle stiffness measured by shear wave elastography. Secondary outcomes include changes in muscle activation assessed by surface electromyography and improvements in swallowing function and swallowing-related quality of life measured using validated clinical scales.This study is designed as a single-center, randomized, controlled, double-blind academic clinical study conducted at the Department of Physical Medicine and Rehabilitation, Gazi University Faculty of Medicine. The findings of this study may provide evidence regarding the potential benefits of visual biofeedback-assisted swallowing rehabilitation in patients with post-stroke dysphagia.

Conditions

• Dysphagia After Stroke
• Stroke
• Dysphagia
• Swallowing Disorders

Interventions

Type	Name	Description
DEVICE	Suprahyoid Neuromuscular Electrical Stimulation (NMES)	Suprahyoid neuromuscular electrical stimulation will be applied using a clinically approved NMES device as part of the swallowing rehabilitation protocol. Stimulation parameters and electrode placement will follow standard therapeutic guidelines. NMES will be administered five days per week for four weeks.
BEHAVIORAL	Visual Biofeedback Training	Visual biofeedback will be provided through the NMES device interface using an interactive visual feedback task designed to activate swallowing-related muscles. During the intervention, participants will perform muscle activation tasks guided by real-time visual feedback. The task is designed to engage muscle groups similar to those targeted during conventional oropharyngeal swallowing exercises. The visual biofeedback training will be performed for approximately 20 minutes per session, five days per week for four weeks.
BEHAVIORAL	Conventional Oropharyngeal Exercises	Participants will perform conventional oropharyngeal swallowing exercises targeting swallowing-related muscle groups. The exercise program will consist of four exercises per session, including tongue resistance exercise, Shaker exercise, Mendelsohn maneuver, and effortful swallow. Each exercise will be performed for approximately five minutes per session, five days per week for four weeks. The exercises were selected to activate muscle groups similar to those engaged during the visual biofeedback training.

Timeline

• Start date: 2026-02-16
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: Turkey (Türkiye)