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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05832658
• Other study ID #: E-68869993-000-1019202
• Status: Completed
• Phase: N/A
• Start date: May 7, 2023
• Est. completion date: October 14, 2023

Study information

• Verified date: January 2024
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 14, 2023
• Est. primary completion date: October 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biofeedback
• Deglutition Disorders
• Dysphagia
• Stroke
• Surface Electromyography
• Swallowing Disorder

Intervention

Device:
• With EMG-Biofeedback
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.

Behavioral:
• Without EMG-Biofeedback
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
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.

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gugging Swallowing Screen (GUSS)	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.	From baseline to the end of the treatment ( 3 week)
Primary	Functional Oral Intake Scale (FOIS)	7 point scale from 1-7. Higher number indicated increased amount and normality of oral intake.	From baseline to the end of the treatment ( 3 week)
Primary	Penetration Aspiration Scale (PAS)	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.	From baseline to the end of the treatment ( 3 week)
Primary	Functional Dysphagia Scale (FDS)	Videofluoroscopic evaluation is performed. It is a total of 100 points scale. A higher score indicates more severe dysphagia.	From baseline to the end of the treatment ( 3 week)
Primary	Dysphagia Outcome and Severity Scale (DOSS)	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.	From baseline to the end of the treatment ( 3 week)
Primary	Dysphagia Handicap Index (DHI)	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.	From baseline to the end of the treatment ( 3 week)