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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05547152

Collaborator

University Hospital, Rouen (Other)

100

Enrollment

Location

Arms

35.8

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Facial Palsy Rehabilitation Virtual Reality	Other: massages Other: motor stimulation and stretching Other: virtual reality	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 6, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

variation of number of involuntary facial spasm between both groups of patients [12 months]
variation of synkinesis in patients with recent onset (≤ 12 months) peripheral facial palsy compared with the conventional rehabilitation protocol

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)