Neuromuscular Electrical Stimulation Versus Electromyographic Biofeedback on Oropharyngeal Dysphagia in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional Oral Intake Scale (FOIS)
研究概览
简要总结
This study aims to investigate the effect of neuromuscular electrical stimulation versus electromyographic biofeedback on swallowing function and dysphagia severity in patients with stroke.
详细描述
Dysphagia is a common symptom seen in stroke patients, it is affected patients' nutrition supply, and may causes aspiration pneumonia. To solve the problem of nutritional support, nasogastric tubes are routinely indwelling to provide nutrition. This feeding method sometimes causes food reflux, aspiration, pneumonia, and discomfort and self-image acceptance.
Traditional exercise based on exercise like Shaker exercise, Chin resisted exercise and effortful training. Shaker exercise here is designed by professor Shaker has been regarded as popular rehabilitation training for dysphagia. Shaker exercise can strengthen upper esophageal sphincter, improving swallowing function.
Chin resisted exercise were developed to strengthen the suprahyoid muscles, whose contractions facilitate the opening of the upper esophageal sphincter, thereby improving bolus transfer.
Many studies reported that neuromuscular electrical stimulation can improve the swallowing function by enhancing swallowing coordination of post-stroke dysphagia patients. The improving of swallowing by surface electrical stimulation enhances raising and contraction of the hyoid bone of patients during swallowing. Neuromuscular electrical stimulation (VitalStim Plus), a method for stimulating muscles with short electrical pulses, is widely used in the therapy of stroke patients with pharyngeal dysphagia. It enhances the strength of the muscles associated with swallowing and facilitates reflex swallowing by sensory stimulation.
Using surface electromyography in post-stroke dysphagia cases increase ability of submental muscles activity and performance. Biofeedback or surface electromyography to ensure that target swallowing movements are being trained during rehabilitation, rather than maladaptive movements. Applying EMG-biofeedback add motivation to the therapy.
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
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient's age were range from 45 to 60 years old.
- •Presence of dysphagia from 3 weeks to 3 months, with preservation of cough reflex.
- •Patients with severe moderate dysphagia according to dysphagia outcome and severity scale.
- •Patients with sufficient cognitive abilities that enables them to understand and follow instructions.
排除标准
- •Patients with distributed conscious level.
- •Uncooperative patients.
- •Patients with psychiatric disorders.
- •Patients with syncope.
- •Patients with dementia.
- •Patients with history of dysphagia prior to onset of stroke.
- •Patients with previous operation or injury in the neck.
- •Patients with deficits in attention or cognition.
- •Patients with cardiac pacemaker or history of seizures.
研究组 & 干预措施
Neuromuscular electrical stimulation + Selected physical therapy program
It included 20 patients who received neuromuscular electrical stimulation using VitalStim Plus in addition to selected physical therapy program.
干预措施: Neuromuscular electrical stimulation (Device)
Neuromuscular electrical stimulation + Selected physical therapy program
It included 20 patients who received neuromuscular electrical stimulation using VitalStim Plus in addition to selected physical therapy program.
干预措施: Selected physical therapy program (Other)
Electromyographic Biofeedback + Selected physical therapy program
It included 20 patients who will receive electromyographic biofeedback in addition to selected physical therapy program.
干预措施: Electromyographic Biofeedback (Device)
Electromyographic Biofeedback + Selected physical therapy program
It included 20 patients who will receive electromyographic biofeedback in addition to selected physical therapy program.
干预措施: Selected physical therapy program (Other)
Selected physical therapy program
It included 20 patients who received selected physical therapy program only.
干预措施: Selected physical therapy program (Other)
结局指标
主要结局
Functional Oral Intake Scale (FOIS)
时间窗: 8 weeks
The Functional Oral Intake Scale (FOIS) is a validated, seven-point observer-rated scale used to assess and monitor functional oral intake without increasing patient burden. Originally developed for individuals with neurogenic dysphagia, it demonstrates high reliability, interrater validity, and sensitivity to change. The scale ranges from level 1 (nothing by mouth) to level 7 (total oral diet with no restrictions) and is applied by trained observers to track eating abilities over time.
Dysphagia Outcome and Severity Scale (DOSS)
时间窗: 8 weeks
The Dysphagia Outcome and Severity Scale (DOSS) is an easy-to-administer, seven-point clinician-rated scale used to assess dysphagia severity and guide dietary and nutritional recommendations. It demonstrates strong intra- and interrater reliability and is based on objective parameters such as oral bolus transfer, pharyngeal residue, and airway protection. The scale ranges from level 1 (severe dysphagia with no safe oral intake) to level 7 (normal swallowing with no restrictions).
次要结局
未报告次要终点
研究者
Hayaa yousri hussien khalifa
Principal Investigator
Cairo University