Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07492719

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

Led by Gazi University · Updated on 2026-03-25

34

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Post-stroke dysphagia is a common complication that can reduce quality of life and increase health risks such as aspiration pneumonia and malnutrition. Researchers are evaluating the effectiveness of visual biofeedback-assisted oropharyngeal exercises combined with neuromuscular electrical stimulation (NMES) compared to conventional oropharyngeal exercises with NMES in adult patients who have swallowing difficulties after a stroke. This study is a randomized controlled clinical trial designed to provide evidence on this new rehabilitation method. Participants are randomly assigned to one of two groups. One group receives NMES applied to the suprahyoid muscles plus game-based visual biofeedback training using surface electromyography, while the other group receives NMES plus conventional swallowing exercises such as effortful swallow and tongue strengthening. Both groups undergo treatments five days a week for four weeks, with each session lasting about 20 minutes. NMES is administered separately from the biofeedback training. During the study, researchers will measure changes in muscle stiffness using shear wave elastography and muscle activation with surface electromyography. Swallowing function and quality of life related to swallowing will be assessed using validated clinical scales at the start and end of treatment. The study involves regular monitoring of swallowing ability, muscle activity, and participant progress over the four-week period to evaluate the potential benefits of visual biofeedback-assisted rehabilitation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Clinical diagnosis of dysphagia defined by cough or throat clearing during a 90 mL water swallow test, reduced laryngeal elevation, 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
Not Eligible

You will not qualify if you...

  • Severe cognitive impairment (Mini-Mental State Examination score less than 20), dementia, or severe communication difficulties due to aphasia
  • Contraindications to electrical stimulation, including implantable cardioverter-defibrillator, impaired skin integrity or open wounds at electrode sites, or active epilepsy
  • History of cervical surgery or presence of respiratory distress
  • Diagnosis of malignancy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants receive neuromuscular electrical stimulation (NMES) combined with either visual biofeedback-assisted oropharyngeal exercises or conventional oropharyngeal swallowing exercises to improve swallowing function after stroke.

5 sessions per week for 4 weeks (20 sessions total)

Follow-up

Duration - Immediately after 4 weeks of treatment

Participants undergo assessments to evaluate changes in muscle stiffness, muscle activation, swallowing function, and quality of life after completing the treatment.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Gazi University Hospital, Department of Physical Medicine and Rehabilitation Recruiting

Ankara, Turkey (Türkiye), 06560

Actively Recruiting

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Research Team

I

Ilgın N Manzak, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effectiveness of Neuromuscular Electrical Stimulation on Post-Stroke Dysphagia: A Systematic Review of Randomized Controlled Trials.

Abayneh Alamer, Haimanot Melese, Fetene Nigussie

https://pubmed.ncbi.nlm.nih.gov/32943855

Effect of neuromuscular electrical stimulation combined with effortful swallowing using electromyographic biofeedback on oropharyngeal swallowing function in stroke patients with dysphagia: A pilot study.

Ji-Su Park, Na-Kyoung Hwang, Hwan-Hee Kim...

https://pubmed.ncbi.nlm.nih.gov/31689798

The Effects of Different Exercise Trainings on Suprahyoid Muscle Activation, Tongue Pressure Force and Dysphagia Limit in Healthy Subjects.

Hasan Erkan Kılınç, Selen Serel Arslan, Numan Demir...

https://pubmed.ncbi.nlm.nih.gov/31768618