Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence of facial movement abnormality between facial palsy patients and healthy volunteers
研究概览
简要总结
The facial palsy concerns between 15 and 40 people per 100000 inhabitants. They are of various etiologies such as infectious, tumoral, traumatic or idiopathic.
It has variable severities with sometimes heavy functional repercussions and different recovery potentials. The proposed palliative treatments are based on surgery, physiotherapy and botulinum toxin injections. However, when recovery is incomplete, acceptance is more difficult, with an impacted quality of life. In this context, patients' expectations and feelings about their care may become difficult for clinicians to apprehend.
The eye-tracking is widely used in the marketing field, but it also finds medical applications including head and neck lesions and facial palsy in particular. Published studies focus on the gaze of photographs, excluding any notion of dynamics and by the analysis of the gaze of outside observers, ignoring the patient's gaze.The main objective is to evaluate the attention paid to the facial side with abnormal facial movement by patients with facial paralysis compared to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patient with facial paralysis:
- •Patient with peripheral facial palsy, irrespective of grade, whether or not previously treated
- •Patient providing written informed consent
- •Patient aged ≥ 18 years
- •Patient affiliated to a social security system
- •for Healthy voluntary subject :
- •Subject without major facial sequelae
- •Subject who provided written informed consent
- •Major subject ≥ 18 years old
- •Subject affiliated to a social security system
排除标准
- •for Patient with facial paralysis:
- •Patient with recent peripheral facial palsy whose total recovery is possible
- •Patient unable to provide written informed consent
- •Patient with difficulties to follow instructions and especially to stand in front of a computer screen
- •Minor patient <18 years
- •Patient under guardianship or curators or judicial safeguard
- •for Healthy voluntary subject :
- •Subject with major facial sequelae
- •Subject not able to provide written informed consent
- •Subject presenting difficulties in following instructions and in particular in standing still in front of a computer screen
- •Minor subject < 18 years old
- •Subject under guardianship or curators or judicial safeguard
研究组 & 干预措施
facial palsy
Patient with peripheral facial palsy, irrespective of grade, whether or not previously treated
干预措施: Video sequences (Other)
healthy volunteers
- Subject without major facial sequelae
干预措施: Video sequences (Other)
结局指标
主要结局
Incidence of facial movement abnormality between facial palsy patients and healthy volunteers
时间窗: 30 days
Variation of facial fixation day number between facial palsy patients and healthy volunteers
时间窗: 30 days
次要结局
未报告次要终点