Combined Neuromuscular Electrical Stimulation (NMES) With Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Functional Oral Intake Scale (FOIS)
研究概览
简要总结
The investigators aimed to evaluate effects of combined NMES, FEES and traditional swallowing rehabilitation in stroke patients with moderate-to-severe dysphagia.
详细描述
Neuromuscular electrical stimulation (NMES)and Fiberoptic endoscopic evaluation of swallowing (FEES) are both promising approaches to enhance swallowing recovery for dysphagic patients. However, there is no literature on the effectiveness of combined application of these modalities in the treatment of patients with poststroke dysphagia. The purpose of this study was to prospectively investigate whether combined NMES, FEES and traditional swallowing rehabilitation can improve swallowing functions in patients with moderate-to-severe dysphagia after stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 20-85 years old
- •first-time stroke confirmed by computed tomography or magnetic resonance image
- •dysphagia > 3 weeks, with preservation of the swallowing reflex
- •currently on a restricted diet, with a Functional Oral Intake Scale (FOIS) score of 5 or less
- •Mini-Mental State Examination (MMSE)> 21
- •no obvious mental depression, receptive aphasia or cognitive impairment
排除标准
- •progressive cerebrovascular disease or other neurologic diseases
- •unstable cardiopulmonary status, serious psychologic disorder or epilepsy;
- •tumors, extensive surgery or radiotherapy of the head and neck region
- •cardiac pacemakers
- •swallowing therapy within 2 months before participation
结局指标
主要结局
Functional Oral Intake Scale (FOIS)
时间窗: at 6-month follow-up
The FOIS is a 7-point ordinal scale reflecting the dietary intake of patients with dysphagia. It has adequate reliability and validity and has been used extensively in clinical studies of dysphagia to measure functional oral intake
次要结局
- The degree of dysphagia(at 6-month follow-up)
- swallowing VAS(at 6-month follow-up)
研究者
Shu-Fen Sun
MD,Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital, Taiwan
Kaohsiung Veterans General Hospital.