The Effect of Sensory Level Versus Motor Level Electrical Stimulation of Pharyngeal Muscles in Acute Stroke Patients With Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Dysphagia outcome Severity Scale
研究概览
简要总结
Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support these different modes of stimulation is lacking. This study compared the effectiveness of sensory and motor level stimulation on post-stroke dysphagia.
详细描述
Objective: Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support sensory versus motor stimulation is lacking. This study compares the effect of sensory and motor stimulation on post-stroke dysphagia.
Design: Randomized controlled trial
Setting: Inpatient rehabilitation facility.
Participants: Participants (50-75 years of age) who had dysphagia caused by a stroke within 6 months prior to enrollment were included. Participants were excluded if they had a contraindication for electrical stimulation, previous stroke, psychiatric disorder, contraindications for MBS, or pre-stroke swallowing disorders.
Interventions: Each patient received ten, 45-minute anterior neck sensory or motor level electrical stimulation sessions in addition to standard speech therapy. Motor stimulation was administered as a stimulus intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin (approximately 4-5mA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute ischemic CVA within the first month and confirmed by MRI.
- •Diagnosis of dysphagia will be obtained by bedside swallowing exam and MBS/FEES studies.
排除标准
- •patients who have contraindications for electrical stimulation (malignancy, DVT/thrombophlebitis, hemorrhagic conditions, pregnancy, pacemaker or other electrical hardware)
- •known premorbid swallowing disorders
- •dementia or psychiatric disorder
- •bilateral cerebral involvement
- •contraindications for FEES/MBS (infectious disease such as HIV, HCV, HBV, nasal obstruction, decompensated heart disease, risk of bleeding such as active ulcers, allergy to contrast).
结局指标
主要结局
Change in Dysphagia outcome Severity Scale
时间窗: up to 2 months
seven-point functional outcome scale designed to assess dysphagia severity on the MBSS, lowest score = 1; highest = 7.
Change in Swallow Functional Assessment Measure
时间窗: up to 2 months
7 point swallow scale the Functional oral intake scale (FOIS) lowest score = 1; highest = 7.
次要结局
- Change in Swal-Qol(up to 3 months)
- Change in PenAsp(up to 2 months)
研究者
Emily Rosario
Director of Research
Casa Colina Hospital and Centers for Healthcare