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临床试验/NCT05547152
NCT05547152招募中不适用

Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
variation of number of involuntary facial spasm between both groups of patients

研究概览

简要总结

Peripheral facial palsy affects 15 to 40 people per 100,000 inhabitants and induces important functional and social repercussions. Synkinesis is a frequent after-effect of facial palsy recovery, consisting of involuntary facial spasms that disturb the gestural harmony and can go as far as a painful hypertonic spasm. More than 55% of patients recovering from facial palsy will develop transient or permanent synkinesis. These facial hypertonias have two main causes: imperfect axonal regeneration, which is all the more important as the damage is proximal, and hyperexcitability of the facial nerve nucleus due to a lack of central control. Management is therefore essential for the functional restoration of the face, especially since synkinesis do not evolve spontaneously. The main treatments are currently botulinum toxin injection, acting on the motor plate, and functional rehabilitation, consisting on local muscle relaxation and central motor control work. In recent years, therapies based on biofeedback and acting on central motor control have shown interesting results, and technological advances in virtual reality have made it possible to deepen this treatment in patients suffering from stroke, limb trauma or Parkinson's disease. In this project, the investigators evaluate the contribution of virtual reality to the management of facial palsy, and hypothesize that self-rehabilitation using this technology will improve motor control of the skin muscles and reduce complications related to their hypertonia such as synkinesis.

研究设计

研究类型
Interventional
分配方式
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
否

入选标准

  • •Patient with recent onset peripheral facial palsy (≤ 12 months).
  • •Patient with peripheral facial palsy of grade ≥ III on the House & Brackmann score
  • •Patient of legal age (≥ 18 years)
  • •Patient with appropriate information and informed consent

排除标准

  • •Patient with central facial palsy
  • •Patient with peripheral facial palsy of > 12 months onset
  • •Patient with peripheral facial palsy of grade < III House & Brackmann score
  • •Patient who has previously undergone palliative surgery
  • •Patient undergoing a botulinum toxin injection protocol
  • •Patients benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, pregnant or breast-feeding women and patients in emergency situations
  • •Patients who have not provided informed consent
  • •Patients with cognitive disorders that do not allow them to follow the proposed self-education protocol
  • •Blind or visually impaired patients (visual acuity of the better eye after correction ≤ 4/10)

研究组 & 干预措施

Experimental arm

Experimental

patients benefiting from rehabilitation associated with virtual reality

干预措施: massages (Other)

Experimental arm

Experimental

patients benefiting from rehabilitation associated with virtual reality

干预措施: motor stimulation and stretching (Other)

Experimental arm

Experimental

patients benefiting from rehabilitation associated with virtual reality

干预措施: virtual reality (Other)

Control arm

Active Comparator

patients benefiting from rehabilitation without virtual reality

干预措施: massages (Other)

Control arm

Active Comparator

patients benefiting from rehabilitation without virtual reality

干预措施: motor stimulation and stretching (Other)

结局指标

主要结局

variation of number of involuntary facial spasm between both groups of patients

时间窗: 12 months

variation of synkinesis in patients with recent onset (≤ 12 months) peripheral facial palsy compared with the conventional rehabilitation protocol

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 (1)

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