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临床试验/NCT06775717
NCT06775717Enrolling By Invitation不适用

Comparative Effects of Motor Imagery and Mirror Therapy on Synkinesis, Facial Asymmetry, Facial Function and Quality of Life in Bell's Palsy Patients.

Riphah International University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
42
试验地点
2
主要终点
The Facial Clinometric Scale:

研究概览

简要总结

Bell's palsy is a condition that causes sudden weakness in the muscles on one side of the face. The weakness makes half of the face appear to droop, difficulty in closing eyes and synkinesis. Mirror therapy and Motor imagery have shown promise in improving motor function and overall well-being.

Participant will be assigned two groups, A and B. All the groups will receive interventions for five days a week for 8 weeks and treatment time will be 35 minutes. The outcome measuring scales used will be facial Clinometric Scale (FaCE), Synkinesis Assessment Scale and Sunnybrook facial grading system to assess facial symmetry, synkinesis and facial movements, data will be collected on SPSS.

详细描述

Bell's palsy is a condition that causes sudden weakness in the muscles on one side of the face. The weakness makes half of the face appear to droop, difficulty in closing eyes and synkinesis. These symptoms significantly impact facial symmetry and quality of life. Mirror therapy and Motor imagery have shown promise in improving motor function and overall well-being. The primary objective of this study is to compare the effects of the Mirror therapy and Motor Imagery on facial symmetry, synkinesis and quality of life in patients with Bell's palsy. This randomized clinical trial will be carried in 10 months after the approval of synopsis. Total number of 36 participants meeting the inclusion criteria will be included in this study through a non-probability convenience sampling technique. Participants will be randomly assigned into 2 groups using computer generated randomization method. Group A and Group participants will receive Motor Imagery and Mirror therapy, respectively. All the groups will receive interventions for five days a week for 8 weeks. Total treatment time will be 35 minutes. The outcome measuring scales used will be facial Clinometric Scale (FaCE), Synkinesis Assessment Scale and Sunnybrook facial grading system to assess facial symmetry, synkinesis and facial movements. The data will be analyze using SPSS version 28 for windows. Assessment will be carried out at baseline and four weeks, after discontinuation of treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Age 18 years and above.
  • Both genders male and female will be included.
  • Patients diagnosed with Bell's palsy with relevant diagnostic criteria, including history. (tick bite, erythema migraine, pain), neurological examination including inspection of ear and infection of HIV, Herpes virus.
  • Patient having asymmetry in face (Sunnybrook Facial Grading Scale SFGS, use to check asymmetry in both sides of face).
  • Appearance of synkinesis on affected side (Synkinesis Assessment Scale)
  • Onset of symptoms must be first week.
  • Patient having sufficient, physical, and mental ability to understand instructions and cooperate throughout the session.

排除标准

  • Patients diagnosed with other than Bell's palsy (e.g., facial nerve trauma) (25).
  • Patients with severe co-morbidities (e.g., uncontrolled hypertension, diabetes, cardiovascular diseases).
  • Patients with significant cognitive impairment or communication difficulties who have undergone previous facial nerve surgery or interventions.
  • Patients with severe psychiatric conditions affecting compliance or participation and on psychiatric medications.
  • Patients with central nervous system tumor.

结局指标

主要结局

The Facial Clinometric Scale:

时间窗: 4 weeks

The FaCE scale is a fascial palsy-related self-assessment QoL questionnaire comprising 15 questions based on a 5-point Likert-scale that evaluates the intensity and frequency of physical and psychosocial impairments in 6 domains of facial function: facial movement, facial comfort, eye comfort, oral function, lacrimal control and social function.

Sunnybrook Facial Grading Scale:

时间窗: 4 weeks

Sunnybrook scale is considered the current standard in evaluating outcomes and synkinesis due to its comprehensive scope, ease of use, and rapid results interpretation (27). The Sunnybrook facial grading scale, unlike others, systematically focuses on each subunit of facial movement (eyebrows, eyelids, nasal base, upper lip, and lower lip), while subjects are instructed to make six simple facial expressions.

Synkinesis Assessment Scale:

时间窗: 4 weeks

The phenomenon known as synkinesis occurs when there is intentional movement in one or more ipsilateral facial regions but involuntary movement in another area of the face.

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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