Clinical Trial: Virtual Rehabilitation Program in Peripheral Facial Paralysis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Relevance of a Virtual Rehabilitation Program in Peripheral Facial Paralysis

Brief Summary:

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 ve

Detailed Summary:

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 obtai
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Facial muscle function using Sunnybrook Facial Grading System (SFGS). [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Functional and psychological impacts using a specific questionnaire [ Time Frame: 18 months ]
    Assessment of the functional and psychological impacts of the facial paralysis by using a specific quality-of-life questionnaire graduated from 0 to 3 per item and up to 99 points maximum score.
  • Implementation of a virtual rehabilitation platform using questionnaires [ Time Frame: 18 months ]
    The relevance of a virtual rehabilitation will be assessed by specific questionnaires. Moreover, time-comparison to obtain a stable score of 4 at the Sunnybrook Grading Scale will be conducted between both therapies.


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: July 19, 2016
Date Started: October 2016
Date Completion: September 2019
Last Updated: September 1, 2016
Last Verified: July 2016