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临床试验/NCT06308250
NCT06308250已完成不适用

Comparative Effects of Mime Therapy and Action Observation Therapy on Facial Symmetry and Quality of Life in Bell's Palsy

Riphah International University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年2月25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
62
试验地点
2
主要终点
Sunny Brook Facial Grading System

研究概览

简要总结

The aim of this study is to determine comparative effects of mime therapy and action observation therapy on facial symmetry and quality of life in Bell's palsy. Bell's palsy is characterized as an abrupt paralysis of the peripheral facial nerve, typically without a known cause. Mime Therapy is a performing technique that helps patients regain the ability to use their face muscles. Action observation therapy is novel rehabilitation approach exploiting this mirror mechanism.

详细描述

This randomized clinical trial will be conducted at Sir Ganga Ram Hospital in 7 months. 62 participants with Bell's palsy will be included as per sample size calculation through convenience sampling technique. Participants which meet inclusion criteria will be randomly allocated using online randomization tool into two groups. Group A will receive Mime therapy for 30 minutes with short resting interval and Group B will receive action observation therapy for 30 minutes. Each group will receive treatment session of 5 days per week for 6 weeks.

Facial symmetry will be measured using the 13-item Sunny Brook facial Grading System, Facial disability index will be used to assess the quality of life and The House-Brackmann Facial Nerve Grading System will be used to characterize the degree of facial paralysis. The data will be analyzed using SPSS version 24 for Windows software.

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 (Outcomes Assessor)

盲法说明

The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated.

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Bell's Palsy with acute onset of 1-3 weeks.
  • Unilateral loss of facial weakness.
  • Patients with intact taste sensation.
  • Bell's Palsy of House Brackmann grade 3 and
  • Idiopathic Bell's Palsy.

排除标准

  • History of facial palsy recurrence.
  • Stroke associated Bells palsy.
  • History of pregnancy
  • Subjects with any disability, fracture, or tumor.
  • History of facial surgery.
  • Subject having skin allergy on face.

结局指标

主要结局

Sunny Brook Facial Grading System

时间窗: 6th week

The system includes three components: resting symmetry, the symmetry of voluntary movements, and synkinesis. A composite facial symmetry score is calculated as \[4 × symmetry of voluntary movement - 5 × resting asymmetry + 1 × synkinesis\] with 100 representing normal facial symmetry.

Facial Disability Index

时间窗: 6th week

it is used to assess the quality of life in patients with bell's palsy. It also helps to measure the difficulties of the face in activities of daily living. It represents the relationship between impairments, disability, and psychosocial status and also focuses on the disability of individuals with disorders of the facial motor system. The individual subscales are scored out of a total of 100 where the highest score is the best result.

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 (2)

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