Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and Disorders
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Normalized Task-related sEMG Amplitude (Signal Quality Parameter)
研究概览
简要总结
Wearable tele-rehabilitation technology allows for the efficient provision of rehabilitation services from a distance, facilitating tele-management of many disorders. The proposed research will develop and validate a set of mechanically compliant, easy-to-use, and inexpensive wearable tele-monitoring systems, for future use in the rehabilitation of swallowing disorders (dysphagia). The hypothesis is that the newly developed wearable sensors will have equal or better performance than traditional wired sensors used today in clinical practice. Factors related to signal quality and patient reported outcomes (e.g., satisfaction/comfort level, adverse effects etc.) will be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for healthy adults:
- •Age 18-30 OR 50-90 years of age
- •No history of dysphagia
- •No history of a neurological disorder
- •A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA):
- •A score of <3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia).
- •Inclusion criteria for patients with dysphagia:
- •Age 18-90 years of age
- •Diagnoses of dysphagia as a result of a neurological disorder (e.g., stroke, Parkinson's disease).
- •A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA).
- •A score of ≥3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia).
排除标准
- •Significant cognitive impairment (a score in the moderate-severe range on MoCA):
结局指标
主要结局
Normalized Task-related sEMG Amplitude (Signal Quality Parameter)
时间窗: Post each experiment (i.e., 1 hour after the sensors have been placed)
Normalized sEMG amplitude values during standardized swallow tasks and maneuvers will be recorded and compared between the two sEMG devices. Normalized amplitude is used as a signal quality parameter and is not a health related outcome.
Signal to Noise Ratio (Signal Quality Parameter)
时间窗: Post each experiment (i.e., 1 hour after the sensors have been placed)
Signal to Noise ratio will be calculated and compared between sensor types tested. Signal to noise ration is a signal quality parameter and not a health related outcome.
次要结局
- Ease of Use/Comfort(Post each experiment (i.e., 1 hour after the sensors have been placed))
- Adverse Effects and Safety(Pre and Post each experiment (i.e., right before the placement of sensors on the subject and 1 hour after the sensors have been placed and 5 minutes after their removal))
研究者
Georgia A. Malandraki
Associate Professor, Department of Speech, Language and Hearing Sciences
Purdue University