The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in Functional Oral Intake Scale (FOIS)
研究概览
简要总结
In our study, our aim is to evaluate the effect of neuromuscular electrical stimulation added to traditional dysphagia therapy in stroke patients with dysphagia, on functional oral intake status, dysphagia-related symptoms, quality of life, and complications related to dysphagia.
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
- Single (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
- •After the first week after a stroke, detecting dysphagia by using bedside water assessment test
- •Lesion location is shown by MRI or CT
- •Unsupported sitting balance
- •The score of Mini-mental state examination test (MMSE) 20 and above
- •Over 18 years old
排除标准
- •Global aphasia or cognitive disorders that may affect the understanding of the instructions
- •Patients with major medical problems that may affect participation
- •Tracheostomy presence
- •Previous neck surgery
- •To have received radiotherapy in the head or neck area
- •Presence of a cardiac pacemaker or a history of epilepsy
结局指标
主要结局
Change in Functional Oral Intake Scale (FOIS)
时间窗: before intervention, immediately after intervention, 3 months after the intervention
Functional Oral Intake Scale (FOIS) is a scale that shows the functional oral intake of patients with dysphagia. FOIS used for evaluation is a two part scale consisting of 7 levels. It is used to show whether the individual is dependent on the feeding tube and the level of oral intake. On this scale, 7 shows the best and 1 shows the worst functional oral intake. The change in FOIS will be our primary outcome measure in our research. It has been evaluated as an appropriate tool to demonstrate the change in functional oral intake in stroke patients. It is suitable as an independent measure of functional oral intake in prospective studies of stroke-related dysphagia.
次要结局
- Change in Eating Assessment Tool-10 (EAT-10) Score(before intervention, immediately after intervention, 3 months after the intervention)
- Change in Swallowing-related Quality of Life (SWAL-QOL) Score(before intervention, immediately after intervention, 3 months after the intervention)
- Change in Voice-Related Quality of Life (V-RQOL) Score(before intervention, immediately after intervention, 3 months after the intervention)
- Change in Visual Analog Scale (VAS)(before intervention, immediately after intervention, 3 months after the intervention)
- Change in Laryngostroboscopy Examination(before intervention, immediately after intervention)
- Change in Fiberoptic Endoscopic Evaluation of Swallowing (FEES)(before intervention, immediately after intervention)
研究者
Elif Tarihçi
Principal Investigator
Istanbul University