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临床试验/NCT03284125
NCT03284125已完成不适用

Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2017年9月2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 from baseline lips pressure at 6 months

研究概览

简要总结

The facial paralysis is a frequent disease causing important functionals swallowing dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis.

This prospective study has realised on the following of patients affected by facial paralysis treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze three components oh the oral phase of the swallowing ( drooling, mastication and handicap). The evaluations was realized before the surgery and at 3 and 6 months after .

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
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic peripheral facial paralysis
  • Freyss score inferior at 15
  • Benefiting of a lengthening temporalis myoplasty

排除标准

  • Malformative syndrome
  • Other swallowing trouble
  • Psychiatric trouble
  • Opposed at this study

结局指标

主要结局

Change from baseline lips pressure at 6 months

时间窗: Baseline, 3 and 6 months

Patients must contracted their lips of the paretic side in a manometer to evaluate the pressure of the lips before surgery and at 3 and 6 months after

次要结局

  • Drooling Severity and Frequency Scale (DSFS)(Baseline, 3 and 6 months)
  • Dysphagia handicap index (DHI)(Baseline, 3 and 6 months)
  • Visual scale of food residue(Baseline, 3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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