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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMG-Biofeedback | Experimental | Mendelsohn maneuver and effortful swallow exercise will be applied through game-based emg-biofeedback to patients with post-stroke dysphagia. |
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| Classic Therapy | Active Comparator | Mendelsohn maneuver and effortful swallow exercise with only verbal feedback will be applied to patients with post-stroke dysphagia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli University | Kocaeli | 41001 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
|
| From baseline to the end of the treatment ( 3 week) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |