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临床试验/NCT05581680
NCT05581680招募中不适用

Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2022年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
720
试验地点
2
主要终点
determination of the maximum range of motion of eye-tracking (in millimetres) in patients

研究概览

简要总结

The facial palsy is a frequent disease with a lot of etiologies. It has variable severities with sometimes heavy functional repercussions and different recovery potentials. The proposed 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. Thanks to Motion Capture and Electromyography, a quantification of the facial mimicry is now possible with a great precision. In addition with the quantification of the facial mimicry, eye-tracking, wich is widely used in the marketing field, but it also finds medical applications including head and neck lesions and facial palsy in particular, will be used to evaluate the visio of the patients on their pathology in function of the movement quantification measured with MoCap and Electromyography. The aim of this research is to measure in a combined way the action potentials by sEMG and the amplitudes of displacement of the markers in motion capture, for movements determined in a population of patients presenting a facial pathology, in order to compare them with reference values obtained in healthy subjects. In a second step, the aim will be to study if there is a link between the way the patient looks at his pathology and the results of his management (treatment, rehabilitation) which will be quantitatively evaluated thanks to MoCap and sEMG.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Subjects with no known facial pathology (healthy volunteers) OR
  • Patients with peripheral facial palsy, irrespective of grade, whether or not previously treated
  • Subject with written informed consent
  • Subject over 18 years of age
  • Subject affiliated to a social security scheme

排除标准

  • Subjects with severe skin disorders that do not allow the application of electrodes or photo reflective markers
  • Subjects with speech disorders making it impossible to pronounce the sounds [o] and [pu]
  • Subject unable to provide written informed consent
  • Subjects under guardianship, curators or safeguard of justice

结局指标

主要结局

determination of the maximum range of motion of eye-tracking (in millimetres) in patients

时间窗: one year

determination of the maximum range of motion of eye-tracking (in millimetres) in patients

determination of baseline values of eye-tracking (in millimetres) in healthy volunteers

时间窗: one month

determination of baseline values of eye-tracking (in millimetres) in healthy volunteers

determination of baseline values of facial mimicry (in millimetres) in healthy volunteers

时间窗: one month

determination of baseline values of facial mimicry (in millimetres) in healthy volunteers

determination of the maximum range of motion of facial mimicry (in millimetres) in patients

时间窗: one year

determination of the maximum range of motion facial mimicry (in millimetres) in patients

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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