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临床试验/NCT02822391
NCT02822391已完成不适用

Tactile Sensitivity of the Oral Tissues and Chewing Efficiency Are Impaired in Stroke Patients

University of Bern1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Tactile detection threshold (0.25 - 512 mN) of mechanoreceptors of oral mucosa and lips as assessed with monofilaments of pre-defined thicknesses

研究概览

简要总结

Orofacial impairment following stroke frequently involves a reduced chewing performance and dysphagia. This study investigated the sensitivity of oral tissues following stroke and its potential impact on chewing efficiency.

The following two Null-hypotheses (H0) were tested:

i. Post-stroke patients do not show a reduced intra-oral sensitivity compared to a healthy controls.

ii. Intra-oral sensitivity is not correlated to chewing efficiency.

详细描述

Material and Methods:

Ethical approval was granted (Psy11-259, Psy 11-032) and written informed consent was obtained from all participants and/or their legal guardian. Patients were screened and recruited from the Division of Neurorehabilitation, Department of Clinical Neurosciences, University Hospital and University of Geneva, Geneva, Switzerland by a senior consultant neurologist (BL). Patients were included if they were hospitalized for stroke rehabilitation, were able to undergo psychophysical testing and presented with a facial impairment according to the House-Brackmann criteria ≥2 15. They were excluded if they presented with acute pain in the oro-facial sphere (nominal question) or an additional neuro-muscular disease.

For the experiments, an in-depth oral examination was performed and the number of functional premolar units (OU) was noted. A premolar tooth with occluding antagonist counts as one OU whereas a molar is considered two OU (including third molars). Participants were asked with a simple dichotomic question if they perceived a dry mouth.

Food-hoarding Food-hoarding was assessed with an ordinal Likert scale. Participants were asked if they currently "lost" foodstuff in the oral vestibule: Never (score 0), rarely (score1), occasionally (score2), frequently (score 3), very frequently (score 4) or always (score 5).

Maximum voluntary bite force Maximum voluntary Bite Force (MBF) was assessed by means of an Occlusal Force-Meter GM 10® (Nagano Keiki, Higashimagome, Ohta-ku, Tokyo, Japan), which has an 8.6 mm thick bite element. The gauge was placed in-between the first molars and the participants were asked to bite three times as hard as possible for about three seconds. The MBF was tested independently on the right and left side. For the analysis, the peak MBF of each side was noted.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

  • Written informed consent
  • Hospitalized for stroke rehabilitation
  • Able to undergo psychophysical testing
  • Presented with a facial impairment according to the House-Brackmann criteria ≥2

排除标准

  • Presented with acute pain in the oro-facial sphere (nominal question)
  • Additional neuro-muscular disease.

结局指标

主要结局

Tactile detection threshold (0.25 - 512 mN) of mechanoreceptors of oral mucosa and lips as assessed with monofilaments of pre-defined thicknesses

时间窗: maximum 2 weeks post-stroke

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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