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临床试验/NCT02326116
NCT02326116已完成不适用

Investigating the Role of Tracheal Traction Exercises (TTE) in Reducing Dysphagia Following Anterior Cervical Surgery

University of Rochester1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
SWAL-QOL

研究概览

简要总结

The purpose of this study is to evaluate if Tracheal Traction Exercises (TTE) performed prior to anterior cervical spine surgery can result in a decreased rate of dysphagia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Elective Anterior cervical spine surgery (C2-C7) for degenerative disc disease or myelopathy

排除标准

  • •More than four levels of fusion
  • •Trauma or urgent cases of anterior cervical spine surgery
  • •Prior anterior cervical spine surgery (a known risk factor for dysphagia),
  • •Prior neck surgery (eg. Thyroidectomy)
  • •Infections
  • •Neurological disorders that can predispose to dysphagia such as Parkinson's, Cerebrovascular Accidents (CVA), Alzheimer's and Amyotrophic Lateral Sclerosis.

研究组 & 干预措施

Group 1

Experimental

Trachael Traction Exercises

干预措施: Trachael Preparation Education (Other)

Group 2

Placebo Comparator

Trachael Massage

干预措施: Trachael Preparation Education (Other)

结局指标

主要结局

SWAL-QOL

时间窗: 12 months

30% difference in dysphagia as quantified by the SWAL-QOL (validated measure of dysphagia)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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