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

NCT05832658 | Completed

• 1 other identifier: E-68869993-000-1019202
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Dysphagia; Surface Electromyography; Biofeedback; Swallowing Disorder

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

EMG-Biofeedback

EXPERIMENTAL

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

Device: With EMG-Biofeedback; Behavioral: Usual Care

Classic Therapy

ACTIVE COMPARATOR

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

Behavioral: Without EMG-Biofeedback; Behavioral: Usual Care

Interventions

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.

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.

Classic Therapy

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.

Classic Therapy; EMG-Biofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41001, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: April 27, 2023
• Study Start: May 7, 2023
• Primary Completion: October 14, 2023
• Study Completion: October 14, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)