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临床试验/NCT05758350
NCT05758350尚未招募不适用

Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia

Taichung Veterans General Hospital0 个研究点目标入组 100 人开始时间: 2023年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Anterior tongue pressure

研究概览

简要总结

Dysphagia is a common problem in post-stroke patients and greatly impaired quality of life. Among them, the strength of tongue and lip muscles played a key role in the oral phase of swallowing and many stroke survivors suffered from these muscles weakness. Iowa oral performance instrument (IOPI) is a standardized portable device that can be used to quantify tongue muscle strength, thus allowing the clinician to set the level of resistance necessary to achieve optimal gains in strength, and also providing visual feedback of performance to the patients to guide training. In this study, we use Videofluoroscopic Swallowing Study (VFSS) to screen for the stroke patient suffering from dysphagia and recruited them into the trial. They then participated in a home based resistance-training program using the tongue depressor, 1 time everyday and each time consisted of 30 repetitions, totally 4 weeks. Various tongue strength variables and subjective scale were obtained before and after the intervention. The purpose of the study was to evaluate the effect of the home based swallowing therapy in the post stroke dysphagia 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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Acute stroke within 1 year, videofluoroscopic swallow study revealed abnormalities
  • Mini-Mental Status Examination >20, could cooperate swallow therapy

排除标准

  • Already known dysphagia before stroke event
  • Malocclusion or severe facial palsy
  • Localized oral lesion interfering swallowing

结局指标

主要结局

Anterior tongue pressure

时间窗: 1 week after treatment

Posterior tongue pressure

时间窗: 1 week after treatment

Right buccal pressure

时间窗: 1 week after treatment

Left buccal pressure

时间窗: 1 week after treatment

Labial pressure

时间窗: 1 week after treatment

次要结局

  • The score of Eat-10 scale(1 week after treatment)

研究者

申办方类型
Other
责任方
Sponsor

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