跳至主要内容
临床试验/NCT02892864
NCT02892864终止不适用

Relevance of a Virtual Rehabilitation Program in Peripheral Facial Paralysis

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年10月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
Facial muscle function using Sunnybrook Facial Grading System (SFGS).

研究概览

简要总结

Facial palsy can be divided into supranuclear lesion (central facial palsy) and infranuclear lesion such as Bell's Palsy, an idiopathic disease. The peripheral facial paralysis (PFP) is a frequent but little-known pathology (20 / 100 000 inhabitants in France a year). Oro-facial functions and the ability to convey emotional facial information are seriously affected by facial palsy, thereby reducing patient's quality of life. The PFP can have several repercussions on the functional, aesthetic, social, occupational and psychological levels. Evolution and prognosis depend not only on its etiology and gravity, but also on the precocity and the quality of the medical and paramedical care. It is essential to assess functional and psychological issues before beginning an adapted global therapeutic care. If these depressive symptoms can be explained by multiple factors, the inability to smile would be one of the triggering factors of depression. The facial feedback hypothesis could be one of many explications because smiling induces a positive emotional state and a feeling of well-being. In PFP, patients must cope with their difficulties to smile. Their facial behaviour affected their own emotional experiences.

The main purpose of the present study is to determine if virtual rehabilitation program is relevant compared to standard therapy. The second aim is to characterize the efficiency by analysing the time required to obtain a stable score of 4 in the Sunnybrook test. A secondary objective will be to decrease the functional and social repercussions of the facial paralysis with an intensive and targeted therapy of the smile. Furthermore, a virtual rehabilitation program will be implemented in an interactive platform.

To this end, a parallel randomized controlled trial (RCT) of the two groups will be conducted: standard therapy versus virtual rehabilitation program. RCT involves a treatment in which active participation of the patient is necessary so only the assessment will be blinded. Facial motor skills (tongue, mouth and face motricity) are measured using electronic devices, objective and subjective evaluation with pragmatic fields such as communication, emotion and quality of life. The severity of patient's facial paralysis is appraised by the House and Brackmann scale. This global assessment will be conducted before the beginning of the therapy and every 3 months during 18 months.

The patients will be recruited within the Ear, Nose, and Throat (ENT) service after a baseline assessment. Simple randomization will be used in order to establish both therapeutic groups with 45 patients in each group.

Group A: Patients taken care in consultation within the ENT service which provides oro-myo-functional classical rehabilitation.

Group B: Patients taken care in external consultation who receive oro-myo-functional rehabilitation through a virtual rehabilitation program targeted at the smile, in their place of living in virtual conditions.

The patients must have been diagnosed with unilateral peripheral facial palsy, according to House and Brackmann international classification.

Inclusion time : 18 months

Between-two-groups analysis will be conducted in order to compare a targeted and intensive implementation-intention rehabilitation such as virtual rehabilitation program to standard therapy. This virtual therapy will consist in repeating mentally movement desired, so that it will be more spontaneously executed in the every-day-life situation.

详细描述

Facial palsy can be divided into supranuclear lesion (central facial palsy) and infranuclear lesion such as Bell's Palsy, an idiopathic disease. The peripheral facial paralysis (PFP) is a frequent but little-known pathology (20 / 100 000 inhabitants in France a year). Oro-facial functions and the ability to convey emotional facial information are seriously affected by facial palsy, thereby reducing patient's quality of life. The PFP can have several repercussions on the functional, aesthetic, social, occupational and psychological levels. Evolution and prognosis depend not only on its etiology and gravity, but also on the precocity and the quality of the medical and paramedical care. It is essential to assess functional and psychological issues before beginning an adapted global therapeutic care. Although these depressive symptoms can be explained by multiple factors, the inability to smile would be one of the triggering factors of depression. The facial feedback hypothesis could be one of many explications because smiling induces a positive emotional state and a feeling of well-being. In PFP, patients must cope with their difficulties to smile. Their facial behaviour affected their own emotional experiences.

Time required for improvement and risk of sequelae are proportional in the severity of the paralysis (speed of installation and axonal loss). Do the patients benefiting from virtual care have a deadline of recovery faster than control patients? Does a virtual rehabilitation program, home delivered, which is targeted at the smile improve symmetric movements and reduce psychological and functional issues?

The main purpose of the present study is to determine if virtual rehabilitation program is relevant compared to standard therapy. The second aim is to characterize the efficiency by analysing the time required to obtain a stable score of 4 in the Sunnybrook test.

A secondary objective will be to decrease the functional and social repercussions of the facial paralysis with an intensive and targeted therapy of the smile. Furthermore, a virtual rehabilitation program will be implemented in an interactive platform.

To this end, a parallel randomized controlled trial (RCT) of the two groups will be conducted: standard therapy versus virtual rehabilitation program. RCT involves a treatment in which active participation of the patient is necessary so only the assessment will be blinded. Facial motor skills (tongue, mouth and face motricity) are measured using electronic devices, objective and subjective evaluation with pragmatic fields such as communication, emotion and quality of life. The severity of patient's facial paralysis is appraised by the House and Brackmann scale. This global assessment will be conducted before the beginning of the therapy and every 3 months during 18 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Man or women ≥ 18 years
  • Diagnosed with UNILATERAL peripheral facial palsy according to the criteria of the International Classification of House and Brackmann (HB) between grades III and VI.
  • Informed and having signed the consent form
  • Patient who has a computer with webcam and an internet connection
  • Affiliated to social security scheme (not accepted AME)

排除标准

  • Major unable, protected, deprived of freedom
  • Patients with facial palsy with a tumoral origin
  • Patients with uncorrected vision problems
  • Patient who have had botulinum toxin injections .
  • Patient who have underwent rehabilitation of type electrical stimulations
  • Patient who has a facial diplegia , a graft of the face or a grade I or II House and Brackmann (HB) .
  • Patient who underwent rehabilitation of the paralyzed face

研究组 & 干预措施

Control arm

Active Comparator

Patients taken care in consultation within the ENT service which provides oro-myo-functional classical rehabilitation.

干预措施: Oro-myo-functional classical rehabilitation (Other)

Experimental Virtual Arm

Experimental

Patients taken care in external consultation who receive oro-myo-functional rehabilitation through a virtual rehabilitation program targeted at the smile, in their place of living in virtual conditions.

干预措施: Neuromuscular Retraining and Virtual therapy (Other)

结局指标

主要结局

Facial muscle function using Sunnybrook Facial Grading System (SFGS).

时间窗: 18 months

Assessment of facial muscle function using SFGS was performed blindly by a therapist who was unaware of the type of rehabilitation program which the patient had received (virtual or standard therapy). The time required to obtain a stable score of 4 under the SFGS will be compared between both therapies.

次要结局

  • Functional and psychological impacts using a specific questionnaire(18 months)
  • Implementation of a virtual rehabilitation platform using questionnaires(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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