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You can access this
clinical trial
if you have
Unilateral Peripheral Facial Paralysis
and you are
over 18
years old
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Other: Neuromuscular Retraining and Virtual therapy
  • Other: Oro-myo-functional classical rehabilitation

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02892864. The sponsor of the trial is Assistance Publique - Hôpitaux de Paris and it is looking for 3 volunteers for the current phase.
Official trial title:
Relevance of a Virtual Rehabilitation Program in Peripheral Facial Paralysis