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

NCT ID: NCT05547152

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2025-09-30

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.

Conditions

Peripheral Facial Palsy; Rehabilitation; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental arm

patients benefiting from rehabilitation associated with virtual reality

Group Type: EXPERIMENTAL

massages

Intervention Type: OTHER

The experimental rehabilitation protocol includes massages

motor stimulation and stretching

Intervention Type: OTHER

motor stimulation and stretching

virtual reality

Intervention Type: OTHER

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.

Control arm

patients benefiting from rehabilitation without virtual reality

Group Type: ACTIVE_COMPARATOR

massages

Intervention Type: OTHER

The experimental rehabilitation protocol includes massages

motor stimulation and stretching

Intervention Type: OTHER

motor stimulation and stretching

Interventions

massages

The experimental rehabilitation protocol includes massages

Intervention Type: OTHER

motor stimulation and stretching

motor stimulation and stretching

Intervention Type: 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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, Picardie, France

Site Status: RECRUITING

Countries

France

Central Contacts

François-Régis SARHAN

Role: CONTACT

sarhan.francois-regis@chu-amiens.fr

03 22 45 59 93

Facility Contacts

François-Régis SARHAN

Role: primary

sarhan.francois-regis@chu-amiens.fr

03 22 45 59 93

Other Identifiers

PI2019_843_0100

Identifier Type: -

Identifier Source: org_study_id