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

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.

Study Overview

• Status: Recruiting
• Conditions: Rehabilitation; Virtual Reality; Peripheral Facial Palsy
• Intervention / Treatment: Other: massages; Other: motor stimulation and stretching; Other: virtual reality

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François-Régis SARHAN; Phone Number: 03 22 45 59 93; Email: sarhan.francois-regis@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • CHU Amiens Picardie
      • Contact: François-Régis SARHAN; Phone Number: 03 22 45 59 93; Email: sarhan.francois-regis@chu-amiens.fr
      • Sub-Investigator: Isabelle DEMONT
      • Sub-Investigator: Stéphanie Dakpé, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; patients benefiting from rehabilitation associated with virtual reality	Other: massages; The experimental rehabilitation protocol includes massages; Other: motor stimulation and stretching; motor stimulation and stretching; Other: 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.
Active Comparator: Control arm; patients benefiting from rehabilitation without virtual reality	Other: massages; The experimental rehabilitation protocol includes massages; Other: motor stimulation and stretching; motor stimulation and stretching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation; virtual reality; Peripheral Facial Palsy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Dyskinesias; Cranial Nerve Diseases; Herpesviridae Infections; Facial Nerve Diseases; Paralysis; Bell Palsy; Facial Paralysis; Facies; Synkinesis
• Other Study ID Numbers: PI2019_843_0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No