Efficacy of Neuromuscular Electrical Stimulation Plus Conventional Dysphagia Therapy in Acute and Subacute Stroke Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional Oral Intake
研究概览
简要总结
Aim: The aim of this study is to investigate the effect of neuromuscular electrical stimulation (NMES) combined with traditional dysphagia therapy (TDT) in acute/subacute stroke patients with dysphagia.
Methods: We design a randomized controlled trial to conduct this study. A total of 100 participants with stroke-induced dysphagia are included and randomly assigned to two groups: NMES+TDT and sham NMES+TDT. Participants receive a two-week training protocol, 5 times a week, with each session lasting 30 minutes. Clinical outcomes are recorded at baseline and at 1-, 2-, and 4-week follow-up visits. These outcomes include the Function Oral Intake Scale (FOIS), Eating Assessment Tool (EAT-10), and Swallowing-Related Quality of Life (Taiwan version).
Expected results: We hope that the effectiveness of NMES in treating stroke-induced dysphagia can be clarified. This information can be provided when treating patients with stroke-induced 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute or subacute stroke;
- •Presence of dysphagia;
- •Receiving tube feeding;
- •Age between 20 and 80 years;
- •Able to understand and follow simple instructions with prompts, and able to respond to questions either verbally or through gestures.
排除标准
- •Pre-existing dysphagia prior to the current stroke;
- •Other neurological diseases (e.g., dementia);
- •Unstable cardiopulmonary function;
- •Severe psychiatric disorders;
- •Head and neck cancer, history of surgical tissue removal, or radiation therapy;
- •Prior participation in swallowing training before this study;
- •Presence of implanted electronic devices (e.g., pacemakers, cochlear implants);
- •Impaired consciousness.
研究组 & 干预措施
Sham neuromuscular electrical stimulation combined with traditional dysphagia therapy
Traditional dysphagia therapy combined with sham neuromuscular electrical stimulation electrical, in which stimulation intensity was set at the minimum level (1 mA), with a frequency of 80 Hz and a pulse duration of 700 μs.
干预措施: traditional dysphagia therapy (Other)
neuromuscular electrical stimulation combined with traditional dysphagia therapy
干预措施: neuromuscular electrical stimulation (Other)
结局指标
主要结局
Functional Oral Intake
时间窗: The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up.
Swallowing function was assessed using the Functional Oral Intake Scale (FOIS), an ordinal scale that reflects the functional level of oral intake in patients with dysphagia.
Swallowing function assessment
时间窗: The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up.
Swallowing function was assessed using the self-administered Eating Assessment Tool (EAT-10, Chinese version).
次要结局
- Swallowing quality of life(The time frame included four assessment points: at baseline, after 1 week of treatment, after 2 weeks of treatment, and at a 2-week follow-up.)