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
- 1
- 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).
研究组 & 干预措施
Sensory level stimulation
ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.
干预措施: Neuromuscular electrical stimulation (Device)
Motor level stimulation
ten, 45-minute anterior neck sensory level electrical stimulation sessions in addition to traditional dysphagia therapy.
干预措施: Neuromuscular electrical stimulation (Device)
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