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Completed

NCT Number: NCT05832658

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

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.

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Key information

Conditions

Stroke Biofeedback Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Surface Electromyography Swallowing Disorder Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, 41001, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

With EMG-Biofeedback

Device

Once a day for a total of 15 sessions, the Mendelsohn maneuver will be performed for 15 minutes and the effortful swallow maneuver will be performed for 15 minutes with game-based emg-biofeedback.

Without EMG-Biofeedback

Behavioral

Once a day for a total of 15 sessions, the Mendelsohn maneuver will be performed for 15 minutes and the effortful swallow maneuver will be performed for 15 minutes with only verbal feedback.

Usual Care

Behavioral

Patient and family education will be provided by the investigator. In addition, each patient will be evaluated and oral motor exercises and thermal tactile stimulation will be given to each patient when necessary.

Primary outcomes

  1. Gugging Swallowing Screen (GUSS)

    Time frame: From baseline to the end of the treatment ( 3 week)

    It is used to determine the severity of dysphagia and the risk of aspiration in patients with acute stroke. It is evaluated out of 20 points. It recommends videofluoroscopy as an advanced examination for patients with a score of less than 20.

  2. Functional Oral Intake Scale (FOIS)

    Time frame: From baseline to the end of the treatment ( 3 week)

    7 point scale from 1-7. Higher number indicated increased amount and normality of oral intake.

  3. Penetration Aspiration Scale (PAS)

    Time frame: From baseline to the end of the treatment ( 3 week)

    Videofluoroscopic evaluation is performed. It is an 8-point scale. The higher the number, the greater the increase in penetration/aspiration. 1 means no penetration and no aspiration. 8 means there is aspiration and there is no patient response.

  4. Functional Dysphagia Scale (FDS)

    Time frame: From baseline to the end of the treatment ( 3 week)

    Videofluoroscopic evaluation is performed. It is a total of 100 points scale. A higher score indicates more severe dysphagia.

  5. Dysphagia Outcome and Severity Scale (DOSS)

    Time frame: From baseline to the end of the treatment ( 3 week)

    Videofluoroscopic evaluation is performed. It is a 7-point scale. A score of 6 and 7 represents normal swallowing, a score of 5 represents mild dysphagia, a score of 2 to 4 represents moderate dysphagia, and a score of 1 represents severe dysphagia.

  6. Dysphagia Handicap Index (DHI)

    Time frame: From baseline to the end of the treatment ( 3 week)

    Dysphagia Handicap Index (DHI) is a self-assessment questionnaire which consists of 25 statements to examine three aspects of dysphagia patients' quality of life (QoL): functional, physical, and emotional. The patient can get a maximum score of 100 points.A higher score indicates a more severe swallowing disorder.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2023
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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