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

Rehabilitation Clinical Trial

— RéMiFaSy  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547152
• Other study ID #: PI2019_843_0100
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: September 2025

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: François-Régis SARHAN
• Phone: 03 22 45 59 93
• Email: sarhan.francois-regis[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Facies
• Paralysis
• Peripheral Facial Palsy
• Rehabilitation
• Synkinesis
• Virtual Reality

Intervention

Other:
• massages
The experimental rehabilitation protocol includes massages
• motor stimulation and stretching
motor stimulation and stretching
• virtual reality
Patient watches an avatar of his face performing different movements on a screen, and will have to imagine performing these movements without actually doing them.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation of number of involuntary facial spasm between both groups of patients	variation of synkinesis in patients with recent onset (= 12 months) peripheral facial palsy compared with the conventional rehabilitation protocol	12 months