Visual biofeedback-assisted oropharyngeal exercises with NMES for post-stroke swallowing problems
Effectiveness of Visual Biofeedback-Assisted Oropharyngeal Exercises Combined With Neuromuscular Electrical Stimulation in Patients With Post-Stroke Dysphagia: A Randomized Controlled Clinical Trial
This test will try adding real-time visual feedback to swallowing exercises plus NMES in adults with post-stroke dysphagia to see if it improves swallowing function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gazi University Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT07492719 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial assigns adults with post-stroke dysphagia to either visual biofeedback-assisted oropharyngeal exercises plus suprahyoid NMES or to conventional oropharyngeal exercises plus NMES. Treatment is delivered five days per week for four weeks at a single center. Outcomes include changes in clinical swallowing function, suprahyoid muscle activity measured by surface electromyography, and muscle stiffness measured by shear wave elastography. The trial enrolls patients within six months of a cerebrovascular event who can initiate reflex swallowing and provide informed consent.
Who should consider this trial
Good fit: Adults aged 18 or older with dysphagia after a stroke within the past six months who can initiate reflex swallowing, have stable vital signs, and can provide informed consent are ideal candidates.
Not a fit: Patients with severe cognitive impairment or aphasia, implanted cardiac devices, open skin wounds at electrode sites, active epilepsy, recent cervical surgery, respiratory distress, malignancy, or those outside the 6-month post-stroke window are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding visual biofeedback could improve swallowing safety and muscle function, reducing aspiration risk and improving nutrition and quality of life.
How similar studies have performed: Prior work shows mixed but promising results for NMES combined with swallowing exercises, while visual biofeedback is a newer adjunct with limited clinical evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ankara
- Gazi University Hospital, Department of Physical Medicine and Rehabilitation Recruiting — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ilgın N Manzak, MD
- Email: ilginmanzak@gmail.com
- Phone: +905319335274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.