Dysphagia After StrokeNCT07492719
Effect of Visual Biofeedback-Assisted Oropharyngeal Exercises in Post-Stroke Dysphagia
A study testing Suprahyoid Neuromuscular Electrical Stimulation (NMES), Visual Biofeedback Training and Conventional Oropharyngeal Exercises in people with Dysphagia After Stroke and Stroke, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia After Stroke, Stroke, Dysphagia
- What is being tested?
- Suprahyoid Neuromuscular Electrical Stimulation (NMES), Visual Biofeedback Training and Conventional Oropharyngeal Exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Hospital, Department of Physical Medicine and Rehabilitation Recruiting
Ankara, 06560
Ilgin N Manzak, MD, +905319335274, ilginnilhanmanzak@gazi.edu.tr
ilginmanzak@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Suprahyoid Neuromuscular Electrical Stimulation (NMES), Visual Biofeedback Training, Conventional Oropharyngeal Exercises
- Keywords
- Post-Stroke Dysphagia, Swallowing Rehabilitation, Oropharyngeal Exercises, Neuromuscular Electrical Stimulation (NMES), Visual Biofeedback, Surface Electromyography (sEMG), Shear Wave Elastography
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprahyoid Neuromuscular Electrical Stimulation (NMES)Device
Also called VitalStim, Neuromuscular Electrical Stimulation Therapy
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.
Visual Biofeedback TrainingBehavioural
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.
Conventional Oropharyngeal ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Suprahyoid Neuromuscular Electrical Stimulation (NMES); Behavioral: Conventional Oropharyngeal Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 4 weeks (end of treatment)
Secondary outcomes (7)
Change in Suprahyoid Muscle Peak Amplitude (sEMG)
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.
Measured: Baseline, 2 weeks (interim assessment), and 4 weeks (end of treatment
Change in Swallowing Function Measured by Gugging Swallowing Screen (GUSS)
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.
Measured: Baseline and 4 weeks
Change in Functional Oral Intake Scale (FOIS)
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.
Measured: Baseline and 4 weeks
Change in Eating Assessment Tool (EAT-10)
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.
Measured: Baseline and 4 weeks
Change in Swallowing-Related Quality of Life (SWAL-QOL)
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.
Measured: Baseline and 4 weeks
Change in Suprahyoid Muscle RMS Activity (sEMG)
Change in average root mean square (RMS) of suprahyoid muscle activity measured using surface electromyography during effortful swallowing under standardized conditions.
Measured: Baseline, 2 weeks, 4 weeks
Change in Suprahyoid Muscle Activity (%MVC)
Change in normalized suprahyoid muscle activity expressed as percentage of maximum voluntary contraction (%MVC) measured using surface electromyography.
Measured: Baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start16 Feb 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dysphagia After StrokeStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlgin Nilhan MANZAK, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492719
- Sponsor's protocol ID
- GUFTR-PSDysphagia-2026
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32943855Assoratgoon 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.
PubMed 36357332Fuma 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.
PubMed 40407129Park 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.
PubMed 31689798Kilinc 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.
PubMed 31768618Gonzalez-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.
PubMed 24977109Martino 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.
PubMed 16269630
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Visual Biofeedback-Assisted Oropharyngeal Exercises Combined With Neuromuscular Electrical Stimulation in Patients With Post-Stroke Dysphagia: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07492719
- Acronym / sponsor ID
- GUFTR-PSDysphagia-2026
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| NMES + Visual Biofeedback (Game-Based Training) | Experimental | Device: Suprahyoid Neuromuscular Electrical Stimulation (NMES), Behavioral: Visual Biofeedback TrainingParticipants 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). |
| NMES + Conventional Oropharyngeal Exercise | Active comparator | Device: Suprahyoid Neuromuscular Electrical Stimulation (NMES), Behavioral: Conventional Oropharyngeal ExercisesParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprahyoid Neuromuscular Electrical Stimulation (NMES)Also: VitalStim, Neuromuscular Electrical Stimulation TherapySuprahyoid 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. | Device | NMES + Conventional Oropharyngeal Exercise, NMES + Visual Biofeedback (Game-Based Training) |
| Visual Biofeedback TrainingVisual 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. | Behavioural | NMES + Visual Biofeedback (Game-Based Training) |
| Conventional Oropharyngeal ExercisesParticipants 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. | Behavioural | NMES + Conventional Oropharyngeal Exercise |
Primary outcome
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.
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.
7 secondary outcomes
Change in Suprahyoid Muscle Peak Amplitude (sEMG)
Time frame: 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
Change in Functional Oral Intake Scale (FOIS)
Time frame: Baseline and 4 weeks
Change in Eating Assessment Tool (EAT-10)
Time frame: Baseline and 4 weeks
Change in Swallowing-Related Quality of Life (SWAL-QOL)
Time frame: Baseline and 4 weeks
Change in Suprahyoid Muscle RMS Activity (sEMG)
Time frame: Baseline, 2 weeks, 4 weeks
Change in Suprahyoid Muscle Activity (%MVC)
Time frame: Baseline, 2 weeks, 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 32943855Alamer 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.
- Background: PubMed 36357332Assoratgoon 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.
- Background: PubMed 40407129Fuma 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.
- Background: PubMed 31689798Park 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.
- Background: PubMed 31768618Kilinc 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.
- Background: PubMed 24977109Gonzalez-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.
- Background: PubMed 16269630Martino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprahyoid Neuromuscular Electrical Stimulation (NMES), Visual Biofeedback Training and Conventional Oropharyngeal Exercises in people with Dysphagia After Stroke and Stroke, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilgın N Manzak, MD (+905319335274, ilginmanzak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Suprahyoid Muscle Stiffness Measured by Shear Wave Elastography (time frame: Baseline and 4 weeks (end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07492719, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.