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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Rehabilitation; Virtual Reality; Peripheral Facial Palsy

Treatments: Other: motor stimulation and stretching; Other: virtual reality; Other: massages

Study type: Interventional

Funder types: Other

Identifiers

NCT05547152

PI2019_843_0100

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Experimental arm

Experimental group

Description:

patients benefiting from rehabilitation associated with virtual reality

Treatment:

Other: motor stimulation and stretching

Other: virtual reality

Other: massages

Control arm

Active Comparator group

Description:

patients benefiting from rehabilitation without virtual reality

Treatment:

Other: motor stimulation and stretching

Other: massages