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临床试验/NCT00592761
NCT00592761已完成1 期

Treatment of Dysphagia Using the Mendelsohn Maneuver

University of Arkansas2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2003年7月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
18
试验地点
2
主要终点
Change in Duration of Superior Hyolaryngeal Movement

研究概览

简要总结

The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia.

详细描述

The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver (voluntary prolongation of laryngeal excursion at the midpoint of the swallow) on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia (specifically, reduced duration of hyoid maximum elevation, reduced extent of hyoid maximum elevation, reduced duration of hyoid maximum anterior excursion, reduced extent of hyoid maximum anterior excursion, and reduced duration of upper esophageal sphincter (UES) opening with subsequent residue in the pyriform sinuses and, potentially, aspiration). Participants are assessed with videofluoroscopy at the initiation of the study and after each week of the study. After the 4 weeks of participation are complete, all participants will be discharged from treatment and will be brought back to the clinic for a final Videofluoroscopic Swallow Study (VFSS) evaluation after 2 weeks. This means that individuals in Group 1 will be re-analyzed after 1 month of additional no-treatment, and Group 2 will be re-analyzed after 2 additional weeks of no-treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Stroke (1-18 months post)
  • Pharyngeal Dysphagia

排除标准

  • Other neurologic or structural abnormality to oropharynx
  • History of dysphagia prior to latest stroke

研究组 & 干预措施

Within subjects treatment, no-treatment

Experimental

Within subject, treatment and no-treatment periods. Each participant served as his/her own control in this AABB/BBAA alternating treatment conditions design. Results were also compared across groups (treatment v. no-treatment).

干预措施: Mendelsohn Maneuver (Behavioral)

结局指标

主要结局

Change in Duration of Superior Hyolaryngeal Movement

时间窗: baseline and six weeks

Change in duration of superior elevation of hyoid bone.

Change in Duration of Hyoid Maximum Anterior Excursion

时间窗: Baseline and 6 weeks

Change in the duration of maximum anterior movement of the hyoid bone during swallowing.

次要结局

  • Change in Oral Intake Ability(Baseline and 6 weeks)
  • Change in Duration of Opening of Upper Esophageal Sphincter(Baseline and 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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