Randomized Study of the Influence of Functional Electrical Stimulation in Patients With Dysphagia After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Safe food Intake assessed by Functional Scale Oral Ingestion - FOIS
研究概览
简要总结
This study will evaluate the effectiveness of conventional speech therapy associated with functional electrical stimulation in patients with dysphagia after ischemic stroke. Included patients will be divided into two groups, where in the intervention group the speech therapy is associated to functional electrical stimulation, and in the control group, the patients will receive the conventional speech therapy with electrical stimulation Placebo with intensity 0hz.
详细描述
Since the 1980's, electrical stimulation has been used for therapeutic purposes in Brazil, and, since 1990's, it has been used as a relevant therapeutic tool in the cases of oropharyngeal dysphagia in addition to speech therapy. Positive results have been observed in the treatment of swallowing disorders, including in patients that carry neurological diseases. However, there is no substantial evidences for this interventions.
In this study, the electrotherapy will be used as a complement to conventional speech therapy and performed the application of electrical stimulation protocol in dysphagia, through the apparatus Neurodyn Portable TENS/FES (transcutaneous electrical neurostimulation/ functional electrical stimulation), which is a transcutaneous neuromuscular stimulator flow TENS/FES from two channels with independent intensity adjustment. It is about a non-invasive technique with no systemic effect, causing no dependence or undesirable side effects, and consists by gentle application in electrical stimulation, through electrodes placed in body areas affected by pain or to activate skeletal muscles and produce movements. A channel of electrodes will be placed in the submental region and the other channel on the thyroid cartilage., in formation of a T. The explication of the procedure in the patient treatment, is describing the sensations that he should expect that happened during the stimulation. The intensity of necessary flow to apply in the treatment, will depend in the sensation of the patient, therefore, it is applicable until the tolerance level or desirable muscular contraction. Thus, the treatment should be initiated with minimal levels of intensity, by being carefully raised if appropriate effects are achieved on the procedure and according to the patient report.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke - ischemic type;
- •Dysphagia following stroke;
- •40 to 70 years old;
- •Exclusive enteral Feeding;
- •Glasgow > 11.
排除标准
- •Pregnants;
- •Febrile Condition;
- •Neoplasia;
- •Pacemaker;
- •Cochlear Implant;
- •Anxious Patient;
- •Degenerative Neurological Diseases.
结局指标
主要结局
Safe food Intake assessed by Functional Scale Oral Ingestion - FOIS
时间窗: 5 days (before and immediately after intervention)
Measured by the Functional Oral Ingestion Scale (FOIS). FOIS results are rated on a scale of 1 to 7 levels. The levels will increase according to the safe amount of oral diet ingested by the patient safely. Level1 - nothing by mouth; Level 2 - tube dependent with minimal attempts of Food or liquid; Level 3 - tube dependent with consistence oral Intake of Food or liquid; Level 4 - total oral diet of a single consistency; Level 5 - total oral diet with multiple consistencies but requiring special preparation or compensations; Level 6 - total oral diet with multiplex consistencies without special preparation, but with specific Food limitations; Level 7 - total oral diet with no restrictions.
Level of dysphagia assessed by videoendoscopy of swallowing
时间窗: 5 days ( before and immediately after intervention)
Anatomical Evaluation:Tongue, palate, pharynx, larynx - normal or specify changes Functional Evaluation: * Mobility (lips/tongue), tongue's sensitivity, palatine veil's closure - adequate or inadequate * Pharynx - salivary/alimentary stasis * Larynx - normal, decreased mobility, unilateral or bilateral immobility Deglutition assessment (liquid, thick, pasty and solid foods): -Delay of swallowing, anterior/posterior escape, stasis in vallecula/pyriform sinuses, laryngeal penetration, laryngotracheal aspiration - present or absent Functional swallowing: alteration in anatomical or functional evaluation with absence of salivary/alimentary stasis Mild dysphagia: there is also salivary or food stasis in only one consistency with efficient maneuvers such as lowered head, Masako or effortless swallowing Moderate dysphagia: there is also laryngeal penetration to one or more consistencies Severe dysphagia: there is also laryngotracheal aspiration or absence of swallowing reflex
次要结局
- Clinical evaluation of swallowing through the risk assessment protocol for dysphagia - PARD(5 days (before and immediately after intervention))
研究者
Klayne Cunha Matos
Principal Investigator
Hospital Geral de Fortaleza