跳至主要内容
临床试验/NCT04237961
NCT04237961Unknown不适用

Ancillary Procedures in Patients of Refractory Facial Palsy Patients Selection and Evaluation of the Outcomes

Assiut University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Ancillary Procedures in Patients of Refractory Facial Palsy Patients Selection and Evaluation of the Outcomes

研究概览

简要总结

Introduction:

There are numerous causes of facial palsy (FP), though hemifacial weakness is often generally termed Bell's palsy, named after the Scottish neurologist Charles Bell, who described sudden onset unilateral facial paralysis in 1821.

Virally triggered, acute FP, to which the term Bell's palsy (BP) refers, is one of the most common, and fortunately the most likely condition to result in eventual return to premorbid status; 70% to 90% of patients recover spontaneously. Other causes of FP routinely result in poorer recovery, and the clinician must discern among these to formulate a treatment plan.

In facial palsy, paralysis of muscles on the affected side of the face results in loss of forehead creases, loss of the nasolabial fold, lagophthalmos, brow droop, and drooping of the corner of the mouth. In contrast, muscles on the unaffected side of the face no longer have opposing forces.

This may cause difficulty in articulation, eating, drinking, and is often cosmetically unacceptable to patients because of asymmetry, especially when speaking, smiling, and laughing. There are significant psychological effects as patients lack the confidence to carry out many daily activities in public, such as appearing in photographs.

Although management is difficult, there are a range of reanimation options available. These include nerve grafts, muscle transfers, myofunctional approaches, and microsurgical patches usually for the more severe facial palsies (House-Brackmann grades 4 to 6). However, despite these procedures, facial symmetry may not improve.

详细描述

Ancillary procedures in patients of refractory facial palsy. Patients selection and evaluation of the outcomes.

Introduction:

There are numerous causes of facial palsy (FP), though hemifacial weakness is often generally termed Bell's palsy, named after the Scottish neurologist Charles Bell, who described sudden onset unilateral facial paralysis in 1821.

Virally triggered, acute FP, to which the term Bell's palsy (BP) refers, is one of the most common, and fortunately the most likely condition to result in eventual return to premorbid status; 70% to 90% of patients recover spontaneously. Other causes of FP routinely result in poorer recovery, and the clinician must discern among these to formulate a treatment plan.

In facial palsy, paralysis of muscles on the affected side of the face results in loss of forehead creases, loss of the nasolabial fold, lagophthalmos, brow droop, and drooping of the corner of the mouth. In contrast, muscles on the unaffected side of the face no longer have opposing forces.

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
Single (Participant)

盲法说明

Patients could be divided into three groups according to the anatomical site of interferences:

  • Group 1: Upper third interferences
  • Group 2: Mid third interferences
  • Group 3: Lower third interferences

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with refractory Facial Palsy who did not respond well to other concerned interferences and those who presented the maximum benefit possible of a performed procedure.

排除标准

  • 未提供

研究组 & 干预措施

Lower third

Experimental

Suspension suture

干预措施: Suture (Procedure)

Middle third

Experimental

Botox and fat injection

干预措施: Injection (Procedure)

Upper third interference

Experimental

Botox & brow lift

干预措施: Botox and brow lift (Procedure)

结局指标

主要结局

Ancillary Procedures in Patients of Refractory Facial Palsy Patients Selection and Evaluation of the Outcomes

时间窗: 2 years

measurement the change in vertical length of the palpebral fissure of the affected eye before and after the operation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

saleh ali ibrahim elazoumi

Principal Investigator

Assiut University

研究点 (2)

Loading locations...

相似试验