Efficacy of Game-Based EMG-Biofeedback Therapy in Post-Stroke Dysphagia

Kocaeli University

Status: Completed

Conditions: Surface Electromyography; Dysphagia; Stroke; Swallowing Disorder; Biofeedback

Treatments: Behavioral: Without EMG-Biofeedback; Behavioral: Usual Care; Device: With EMG-Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05832658

E-68869993-000-1019202

Details and patient eligibility

About

This study aims to determine the effectiveness of game-based biofeedback application via surface electromyography in patients with post-stroke dysphagia. The same treatment interventions will be applied with and without biofeedback, and thus the contribution of adding biofeedback to the treatment will be determined.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. History of hemorrhagic or ischemic stroke longer than 3 months
2. Being over the age of eighteen
3. Level ≤ 6 on the Functional Oral Intake Scale (FOIS)
4. Post-stroke onset of swallowing complaints
5. Ability to communicate with the patient and carry out the given commands
6. Mini mental test evaluation ≥ 24 points
7. Absence of concomitant serious systemic disease (unregulated hypertension, decompensated heart failure, malignancy, infection, pacemaker, epilepsy, etc.)
8. Detection of pathology in the oropharyngeal phase of swallowing in videofluoroscopic evaluation
9. Not taking any swallowing-related treatment in the last 3 months

Exclusion criteria

1. History of neoplastic disease and/or radiotherapy to the head and neck region
2. Having additional musculoskeletal disease or non-stroke neurologic disease that may cause swallowing disorders
3. Unable to communicate or carry out commands
4. Inability to maintain head-holding balance
5. Patients with severe pathology in bolus formation or delivery of the bolus to the pharynx during the oral swallowing phase

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups

EMG-Biofeedback

Experimental group

Description:

Mendelsohn maneuver and effortful swallow exercise will be applied through game-based emg-biofeedback to patients with post-stroke dysphagia.

Treatment:

Device: With EMG-Biofeedback

Behavioral: Usual Care

Classic Therapy

Active Comparator group

Description:

Mendelsohn maneuver and effortful swallow exercise with only verbal feedback will be applied to patients with post-stroke dysphagia.

Treatment:

Behavioral: Usual Care

Behavioral: Without EMG-Biofeedback