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

January 20, 2024 updated by: Bulent Alyanak, Kocaeli University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41001
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMG-Biofeedback
Mendelsohn maneuver and effortful swallow exercise will be applied through game-based emg-biofeedback to patients with post-stroke dysphagia.
Behavioral: 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.
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.
Active Comparator: Classic Therapy
Mendelsohn maneuver and effortful swallow exercise with only verbal feedback will be applied to patients with post-stroke dysphagia.
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to the end of the treatment ( 3 week)
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.
From baseline to the end of the treatment ( 3 week)
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.
From baseline to the end of the treatment ( 3 week)
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.
From baseline to the end of the treatment ( 3 week)
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.
From baseline to the end of the treatment ( 3 week)
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.
From baseline to the end of the treatment ( 3 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2023

Primary Completion (Actual)

October 14, 2023

Study Completion (Actual)

October 14, 2023

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

April 16, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-68869993-000-1019202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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