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临床试验/NCT01363973
NCT01363973已完成不适用

Pilot Study to Evaluate the Efficacy and Safety of Transcutaneous Electrical Stimulation on Swallowing in Patients With Oropharyngeal Dysphagia After Stroke

Hospital de Mataró2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Safety of swallow

研究概览

简要总结

Oropharyngeal dysphagia (OD, swallowing dysfunction) is a major complaint following stroke. Despite its enormous impact on functional capacity, quality of life, and survival, OD is both underestimated and underdiagnosed as a cause of major nutritional and respiratory complications in stroke patients. A recent systematic review on the effects of rehabilitation therapy on OD concluded that although some positive effects were found, the number of studies was small, many of them had methodological problems and there was a need for further research using randomized controlled trials. Transcutaneous electrical stimulation was approved by the FDA as a treatment of dysphagia in June 2001 and is traditionally used to activate pharyngeal muscles through stimulation of peripheral motor nerves (neuromuscular electrical estimulation, NMES). However, their real effectiveness and safety in the treatment of dysphagia is still matter of discussion (Logemann Dysphagia 2007, Ludlow dysphagia 2007) and studies evaluating NMES therapy, present discordant results. On the other hand, in recent years, transcutaneous electrical stimulation is beginning to use as a sensory strategy (Gallas 2010), avoiding muscle contraction during the treatment.Our research strategy includes the assessment of the therapeutic effect of these two main strategies using transcutaneous electrical stimulation on swallow physiology and clinical outcomes of post-stroke dysphagic patients.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18
  • Background of swallowing difficulties associated with stroke, more than 3 months of evolution
  • Study explained and signed informed consent

排除标准

  • Patients who are suspected or can not meet the protocol. patients who are participating or have participated in a trial last 4 weeks. Patients with active cancer Patients with active infectious process. patients with severe dementia or inability to communicate. patients with neurodegenerative diseases. patients with pacemakers. patients with implanted electrodes. patients with epilepsy or seizure disorders. patients with gastroesophageal reflux.

结局指标

主要结局

Safety of swallow

时间窗: 5 days

Prevalence of penetrations or aspirations after the treatment

次要结局

  • Efficacy of swallow(5 days)

研究者

发起方
Hospital de Mataró
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pere Clave

MD, PhD

Hospital de Mataró

研究点 (2)

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