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临床试验/NCT01765673
NCT01765673已完成不适用

Passy-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke

James Madison University1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2013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
入组人数
13
试验地点
1
主要终点
Change in Swallowing Frequency 70 & 110 Hz

研究概览

简要总结

This is a device evaluation study to determine the optimal stimulation characteristics for using vibrotactile stimulation as a sensory triggering device for self retraining in patients with chronic moderate to severe dysphagia. Stimulation characteristics to be tested are frequency of vibration, pressure between the device and the skin, mode of vibration (pulsed or continuous).

详细描述

Participants were recruited who had chronic moderate to severe dysphagia following stroke or radiation treatment for head and neck cancer. Their frequency of swallowing was transduced with an accelerometer placed on the skin over the thyroid cartilage and inductive plethysmography bands placed over the rib cage and abdomen. When laryngeal elevation coincided with respiratory apnea a swallow was marked. Five different motor frequencies were evaluated to determine their effect on participants frequency of swallowing (swallows per minute). Frequencies were 30, 70, 110, and 150 Hz and a combination of 70 and 110 Hz. For each vibratory frequency the number of swallows per minute occurring during stimulation was compared with sham when the participant was wearing the device but the motor was not turned on. The frequency fo swallowing during stimulation was compared with the frequency of swallowing between stimulations. Visual analogue ratings of the urge to swallow and discomfort were also measured after each condition. Other parameters were the pressure between the motor and the skin (0, 2, 4, and 6 kPa) and swallow initiation time when stimulation was on and when it was not. Swallowing frequency with continuous versus pulsed stimulation was also compared.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Stroke or post radiation for the treatment of head and neck cancer
  • Dysphagia with a score of 2 or greater on the Penetration/Aspiration Scale OR a Mann Assessment of Swallowing Ability ordinal risk rating of "probable" or "definite"

排除标准

  • Neck injury
  • Neurological disorder other than stroke
  • Psychiatric illness other than depression
  • Uncontrolled gastroesophageal reflux disease
  • Inability to communicate secondary to significant speech or language problems
  • Inability to maintain alertness for 1 hour
  • Significant health concerns that would put the participant at risk

结局指标

主要结局

Change in Swallowing Frequency 70 & 110 Hz

时间窗: During one session within 1 hour

Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)

Change in Swallow Frequency 30 Hz

时间窗: During one session within 1 hour

Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)

Change in Swallow Frequency 150 Hz

时间窗: During one session within 1 hour

Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)

Change in Swallow Frequency 110 Hz

时间窗: During one session within 1 hour

Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)

Change in Swallow Frequency 70 Hz

时间窗: During one session within 1 hour

Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)

次要结局

  • Change in VAS Urge to Swallow 110 Hz(During one session within 1 hour)
  • Percent Change in Swallow Frequency Pulse vs Continuous(During one session within one hour)
  • Change in Swallow Frequency 4 kPa(During one session within 1 hour)
  • Change in Swallow Frequency 6 kPa(During one session within 1 hour)
  • Change in Discomfort 150 Hz(During one session within 1 hour)
  • Change in Discomfort 70 & 110 Hz(During one session within 1 hour)
  • Change in Swallowing Frequency 2 kPa(During one session within 1 hour)
  • Change in Urge to Swallow 70 Hz(During one session within 1 hour)
  • Change in VAS Urge to Swallow 150 Hz(During one session within 1 hour)
  • Change in VAS Urge to Swallow 70 & 110 Hz(During one session within 1 hour)
  • Change in Urge to Swallow After 30 Hz Stimulation(During one session within 1 hour)
  • Change in Discomfort Level 30 Hz(During one session within 1 hour)
  • Change in Discomfort 70 Hz(During one session within 1 hour)
  • Change in Discomfort 110 Hz(During one session within 1 hour)
  • Change in Swallow Initiation Time(During one session within 1 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christy Ludlow

Professor

James Madison University

研究点 (1)

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