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

March 19, 2026 updated by: İlgin Nilhan MANZAK, Gazi University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06560
        • Recruiting
        • Gazi University Hospital, Department of Physical Medicine and Rehabilitation Recruiting
        • Principal Investigator:
          • Levent Karatas, MD
        • Principal Investigator:
          • Gulcin Kaymak Karatas, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ilgin N Manzak, MD
        • Sub-Investigator:
          • Halit N Sendur, MD
        • Sub-Investigator:
          • Aysim Sivri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NMES + Visual Biofeedback (Game-Based Training)
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).
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.
Other Names:
  • VitalStim
  • Neuromuscular Electrical Stimulation Therapy
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.
Active Comparator: NMES + Conventional Oropharyngeal Exercise
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).
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.
Other Names:
  • VitalStim
  • Neuromuscular Electrical Stimulation Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Suprahyoid Muscle Stiffness Measured by Shear Wave Elastography
Time Frame: Baseline and 4 weeks (end of treatment
Change in stiffness of the suprahyoid muscles (geniohyoid and anterior digastric) measured using shear wave elastography (SWE). Muscle stiffness will be quantified in kilopascals (kPa), and the difference between baseline and post-treatment measurements will be compared between groups.
Baseline and 4 weeks (end of treatment
Change in Geniohyoid Muscle Thickness
Time Frame: Baseline and 4 weeks (end of treatment)
Change in geniohyoid muscle thickness measured using ultrasound imaging during shear wave elastography assessment. The difference between baseline and post-treatment measurements will be evaluated.
Baseline and 4 weeks (end of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Suprahyoid Muscle Peak Amplitude (sEMG)
Time Frame: Baseline, 2 weeks (interim assessment), and 4 weeks (end of treatment
Change in peak amplitude of suprahyoid muscle activity measured using surface electromyography during effortful swallowing. Measurements will be obtained during three repetitions of effortful swallowing with 5 cc water, with rest periods between repetitions.
Baseline, 2 weeks (interim assessment), and 4 weeks (end of treatment
Change in Swallowing Function Measured by Gugging Swallowing Screen (GUSS)
Time Frame: Baseline and 4 weeks
Swallowing function will be assessed using the Gugging Swallowing Screen (GUSS). Total scores range from 0 to 20, with higher scores indicating better swallowing function and lower aspiration risk. Changes in total scores will be evaluated over time.
Baseline and 4 weeks
Change in Functional Oral Intake Scale (FOIS)
Time Frame: Baseline and 4 weeks
Functional oral intake will be assessed using the Functional Oral Intake Scale (FOIS). Scores range from 1 to 7, with higher scores indicating better oral intake and functional feeding ability.
Baseline and 4 weeks
Change in Eating Assessment Tool (EAT-10)
Time Frame: Baseline and 4 weeks
Patient-reported swallowing difficulty will be evaluated using the Eating Assessment Tool-10 (EAT-10). Total scores range from 0 to 40, with higher scores indicating greater dysphagia severity.
Baseline and 4 weeks
Change in Swallowing-Related Quality of Life (SWAL-QOL)
Time Frame: Baseline and 4 weeks
Swallowing-related quality of life will be assessed using the Swallowing Quality of Life Questionnaire (SWAL-QOL). Scores range from 0 to 100, with higher scores indicating better swallowing-related quality of life.
Baseline and 4 weeks
Change in Suprahyoid Muscle RMS Activity (sEMG)
Time Frame: Baseline, 2 weeks, 4 weeks
Change in average root mean square (RMS) of suprahyoid muscle activity measured using surface electromyography during effortful swallowing under standardized conditions.
Baseline, 2 weeks, 4 weeks
Change in Suprahyoid Muscle Activity (%MVC)
Time Frame: Baseline, 2 weeks, 4 weeks
Change in normalized suprahyoid muscle activity expressed as percentage of maximum voluntary contraction (%MVC) measured using surface electromyography.
Baseline, 2 weeks, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUFTR-PSDysphagia-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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