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

Gazi University

Status: Enrolling

Conditions: Dysphagia; Stroke; Swallowing Disorders; Dysphagia After Stroke

Treatments: Behavioral: Visual Biofeedback Training; Device: Suprahyoid Neuromuscular Electrical Stimulation (NMES); Behavioral: Conventional Oropharyngeal Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT07492719

GUFTR-PSDysphagia-2026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 years or older
• Clinical diagnosis of dysphagia, defined by at least one of the following: presence of cough or throat clearing during the 90 mL water swallow test, reduced laryngeal elevation on clinical examination, or at least one symptom related to dysphagia
• Ability to initiate reflex swallowing
• History of cerebrovascular event within the previous 6 months
• Stable vital signs
• Ability and willingness to provide written informed consent

Exclusion criteria

• Severe cognitive impairment (Mini-Mental State Examination [MMSE] score < 20), dementia, or severe communication difficulties due to aphasia
• Contraindications to electrical stimulation, including the presence of an
• implantable cardioverter-defibrillator (ICD), impaired skin integrity or open wounds at the electrode placement site, or active epilepsy
• History of cervical surgery or presence of respiratory distress
• Diagnosis of malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

NMES + Visual Biofeedback (Game-Based Training)

Experimental group

Description:

Participants in this group receive neuromuscular electrical stimulation (NMES) applied to the suprahyoid region using surface electrodes. In addition, participants perform game-based visual biofeedback training using surface electromyography (sEMG) targeting suprahyoid muscle activity (e.g., a flight simulation task). NMES is not delivered during the biofeedback tasks. Each session lasts approximately 20 minutes and is conducted 5 days per week for 4 weeks (total of 20 sessions).

Treatment:

Device: Suprahyoid Neuromuscular Electrical Stimulation (NMES)

Behavioral: Visual Biofeedback Training

NMES + Conventional Oropharyngeal Exercise

Active Comparator group

Description:

Participants in this group receive neuromuscular electrical stimulation (NMES) applied to the suprahyoid region using surface electrodes combined with conventional oropharyngeal swallowing exercises. The exercise program includes commonly used swallowing exercises such as effortful swallow, Mendelsohn maneuver, Shaker exercise, and tongue strengthening exercises. Each session lasts approximately 20 minutes and is conducted 5 days per week for 4 weeks (total of 20 sessions).

Treatment:

Behavioral: Conventional Oropharyngeal Exercises

Device: Suprahyoid Neuromuscular Electrical Stimulation (NMES)