Effect of Visual Biofeedback-Assisted Oropharyngeal Exercises in Post-Stroke Dysphagia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGazi University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Suprahyoid Neuromuscular Electrical Stimulation (NMES)
DeviceSuprahyoid 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 Training
BehavioralVisual 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 Exercises
BehavioralParticipants 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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: NMES + Visual Biofeedback (Game-Based Training)Experimental treatment 2 interventions
Group B: NMES + Conventional Oropharyngeal ExerciseActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 4 weeks (end of treatment2
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.
Time frame
Baseline and 4 weeks (end of treatment)Secondary outcomes
1
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.
Time frame
Baseline, 2 weeks (interim assessment), and 4 weeks (end of treatment2
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.
Time frame
Baseline and 4 weeks3
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.
Time frame
Baseline and 4 weeks4
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.
Time frame
Baseline and 4 weeksSponsors and contacts
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Source ClinicalTrials.gov