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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

With EMG-Biofeedback

Without EMG-Biofeedback

Usual Care

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kocaeli University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EMG-Biofeedback

Classic Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Functional Oral Intake Scale (FOIS)

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

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.

Functional Dysphagia Scale (FDS)

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

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05832658

First Posted

April 16, 2023

Last Updated

October 14, 2023

Sponsor

Kirsehir Ahi Evran University

1. Study Identification

Unique Protocol Identification Number

NCT05832658

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

May 7, 2023 (Actual)

Primary Completion Date

October 14, 2023 (Actual)

Study Completion Date

October 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Dysphagia, Surface Electromyography, Biofeedback, Swallowing Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EMG-Biofeedback

Arm Type

Experimental

Arm Description

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

Arm Title

Classic Therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

With EMG-Biofeedback

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Without EMG-Biofeedback

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Usual Care

Intervention Description

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 Outcome Measure Information:

Title

Gugging Swallowing Screen (GUSS)

Description

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.

Time Frame