Efficacy of Game-Based EMG-Biofeedback Therapy in Post-Stroke Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Penetration Aspiration Scale (PAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Penetration Aspiration Scale (PAS)
时间窗: 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.
Dysphagia Outcome and Severity Scale (DOSS)
时间窗: 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.
Dysphagia Handicap Index (DHI)
时间窗: 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.
Gugging Swallowing Screen (GUSS)
时间窗: 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.
Functional Dysphagia Scale (FDS)
时间窗: 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.
Functional Oral Intake Scale (FOIS)
时间窗: 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.
次要结局
未报告次要终点
研究者
Bulent Alyanak
Research assistant
Kocaeli University