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

NCT07492719 | Recruiting

• 1 other identifier: GUFTR-PSDysphagia-2026
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia After Stroke; Stroke; Dysphagia; Swallowing Disorders

Keywords

Post-Stroke Dysphagia; Swallowing Rehabilitation; Oropharyngeal Exercises; Neuromuscular Electrical Stimulation (NMES); Visual Biofeedback; Surface Electromyography (sEMG); Shear Wave Elastography

Outcome Measures

Primary Outcomes (2)

• Change in Suprahyoid Muscle Stiffness Measured by Shear Wave Elastography

  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

  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 Outcomes (7)

• Change in Suprahyoid Muscle Peak Amplitude (sEMG)

  Baseline, 2 weeks (interim assessment), and 4 weeks (end of treatment

• Change in Swallowing Function Measured by Gugging Swallowing Screen (GUSS)

  Baseline and 4 weeks

• Change in Functional Oral Intake Scale (FOIS)

  Baseline and 4 weeks

• Change in Eating Assessment Tool (EAT-10)

  Baseline and 4 weeks

• Change in Swallowing-Related Quality of Life (SWAL-QOL)

  Baseline and 4 weeks

Study Arms (2)

NMES + Visual Biofeedback (Game-Based Training)

EXPERIMENTAL

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); Behavioral: Visual Biofeedback Training

NMES + Conventional Oropharyngeal Exercise

ACTIVE COMPARATOR

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); Behavioral: Conventional Oropharyngeal Exercises

Interventions

Visual Biofeedback Training BEHAVIORAL

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.

NMES + Visual Biofeedback (Game-Based Training)

Suprahyoid Neuromuscular Electrical Stimulation (NMES) DEVICE

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.

Also known as: VitalStim, Neuromuscular Electrical Stimulation Therapy

NMES + Conventional Oropharyngeal Exercise; NMES + Visual Biofeedback (Game-Based Training)

Conventional Oropharyngeal Exercises BEHAVIORAL

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.

NMES + Conventional Oropharyngeal Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Hospital, Department of Physical Medicine and Rehabilitation Recruiting

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Alamer A, Melese H, Nigussie F. Effectiveness of Neuromuscular Electrical Stimulation on Post-Stroke Dysphagia: A Systematic Review of Randomized Controlled Trials. Clin Interv Aging. 2020 Sep 3;15:1521-1531. doi: 10.2147/CIA.S262596. eCollection 2020.

  PMID: 32943855 BACKGROUND

• Assoratgoon I, Shiraishi N, Tagaino R, Ogawa T, Sasaki K. Sensory neuromuscular electrical stimulation for dysphagia rehabilitation: A literature review. J Oral Rehabil. 2023 Feb;50(2):157-164. doi: 10.1111/joor.13391. Epub 2022 Nov 28.

  PMID: 36357332 BACKGROUND

• Fuma R, Ohkubo M, Miura K, Sugiyama T, Ishida R. Evaluation of the Effect of Training on the Anterior Belly of the Digastric Muscle Using Ultrasound Elastography. J Oral Rehabil. 2025 Oct;52(10):1715-1723. doi: 10.1111/joor.13988. Epub 2025 May 23.

  PMID: 40407129 BACKGROUND

• Park JS, Hwang NK, Kim HH, Lee G, Jung YJ. Effect of neuromuscular electrical stimulation combined with effortful swallowing using electromyographic biofeedback on oropharyngeal swallowing function in stroke patients with dysphagia: A pilot study. Medicine (Baltimore). 2019 Nov;98(44):e17702. doi: 10.1097/MD.0000000000017702.

  PMID: 31689798 BACKGROUND

• Kilinc HE, Arslan SS, Demir N, Karaduman A. The Effects of Different Exercise Trainings on Suprahyoid Muscle Activation, Tongue Pressure Force and Dysphagia Limit in Healthy Subjects. Dysphagia. 2020 Aug;35(4):717-724. doi: 10.1007/s00455-019-10079-w. Epub 2019 Nov 25.

  PMID: 31768618 BACKGROUND

• Gonzalez-Fernandez M, Ottenstein L, Atanelov L, Christian AB. Dysphagia after Stroke: an Overview. Curr Phys Med Rehabil Rep. 2013 Sep;1(3):187-196. doi: 10.1007/s40141-013-0017-y.

  PMID: 24977109 BACKGROUND

• Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.

  PMID: 16269630 BACKGROUND

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Ilgın N Manzak, MD

CONTACT

+905319335274; ilginmanzak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be performed by an assessor who is blinded to group allocation. Participants and therapists providing the intervention will not be blinded due to the nature of the exercise-based intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, MD

Model Details: Participants with post-stroke dysphagia will be randomly assigned to two parallel groups. The intervention group will receive visual biofeedback-assisted oropharyngeal exercises combined with neuromuscular electrical stimulation (NMES), while the control group will receive conventional oropharyngeal exercises combined with NMES. Both interventions will be administered five days per week for four weeks.

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 25, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)