Function and Form Outcomes in Patients With Facial Paralysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
研究概览
简要总结
This study will be unique for the rehabilitation of patients with facial paralysis in that the focus is to generate novel 3D facial soft tissue measures to characterize the condition and temporal changes, and on the generation of future testable hypotheses to optimize surgical interventions and outcomes. In addition, the investigators will extend our previous work, beyond the facial circumoral and lip areas/zones, to characterize additional facial zones specific for facial paralysis.
The approach for facial mapping of soft tissue movement, when validated through this proposed study, can be used for both surgical planning and to support the development and training of implantable facial pacing devices. Mapping both normal facial movements and movements of patients with unilateral facial paralysis are vital to describe the temporal and spatial course of the recovery process. Ultimately, this information can be used to inform clinicians on the precise placement of these devices and the signal strength needed to facilitate movements in the required 'paralyzed' facial zones until the recovery process has been completed.
详细描述
Patients with facial paralysis have an obvious facial disability. The resultant facial disability includes facial disfigurement and impairment in soft tissue movements, particularly in facial expressive behaviors. These negative physical sequelae not only impact facial esthetics and function, but also patients' social and emotional quality of life. Treatments range from non-surgical interventions and facial reanimation surgery to new implantable facial pacing devices that would potentially initiate artificial movement on the paralyzed side of the face. Traditionally, surgeons' plan treatment based on isolated measurements made from 2D photographs and subjective grading of the patient's face, both of which are limited in scope and dimension. Our research group has demonstrated the utility of a novel 3D dynamic and static quantitative (objective) measures for the evaluation of facial soft tissue function. The measures are objective and quantitative, and they provide a more precise diagnosis of facial soft tissue disability and evaluation of surgical outcomes. The main goal of this prospective, observational study is to determine the applicability of these novel 3D dynamic and static measures for quantification and measurement of impairment and disfigurement, as well as change over time, in patients with facial paralysis. The global hypothesis is that the use of the measures will provide a more comprehensive analysis of the severity of facial paralysis and the changes over time (recovery) when compared with current assessment methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
In patients with acute, unilateral, flaccid facial paralysis, to compare the current, qualitative, clinical assessment methods for facial disability.
时间窗: December 2019
Sixth outcome measure = average correlation across surgeons for their ratings on the Sunnybrook Facial Grading System and the patients' mean measures of asymmetry of facial soft tissue landmarks
To assess perceptions of quality of life over time in patients with acute, unilateral, flaccid facial paralysis and to compare these perceptions with those of control subjects.
时间窗: December 2019
Measurement Tools: PSP questionnaire.
To correlate the patients' perceptions over time with the quantitative measures of facial disability.
时间窗: December 2019
Relationship between the quantitative measurements of facial movement with the quality of life and patient perception measures. This relationship will be measured using the linear mixed effects model or generalized estimating equations as appropriate.
To quantitatively evaluate the range of facial soft tissue disability in patients with acute, unilateral, flaccid facial paralysis and track the changes over time (3-month recovery period).
时间窗: December 2019
Third outcome measure for facial soft tissue disability = and asymmetry of facial soft tissue landmarks (this is a ratio measure)
To compare the facial disability in the patients with a group of age- and sex-frequency matched normal subjects.
时间窗: December 2019
Third outcome measure for group comparison = asymmetry of facial soft tissue landmarks (ratio)
To assess perceptions of facial appearance over time in patients with acute, unilateral, flaccid facial paralysis and to compare these perceptions with those of control subjects.
时间窗: December 2019
Measurement Tools: SP36 questionnaire, FaCE questionnaire.
次要结局
未报告次要终点