Clinical trial NCT05547152: Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis
Official title: Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Facial Palsy
Rehabilitation
Virtual Reality
Keywords: Peripheral Facial Palsy
rehabilitation
virtual reality
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: University Hospital, Rouen
First posted: 2022-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: variation of number of involuntary facial spasm between both groups of patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References: