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

NCT05547152 | Unknown

• 1 other identifier: PI2019_843_0100
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Peripheral Facial Palsy; rehabilitation; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental arm

EXPERIMENTAL

patients benefiting from rehabilitation associated with virtual reality

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

Control arm

ACTIVE COMPARATOR

patients benefiting from rehabilitation without virtual reality

Other: massages; Other: motor stimulation and stretching

Interventions

massages OTHER

The experimental rehabilitation protocol includes massages

Control arm; Experimental arm

motor stimulation and stretching OTHER

motor stimulation and stretching

Control arm; Experimental arm

virtual reality 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.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• University Hospital, Rouen: collaborator

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

François-Régis SARHAN

CONTACT

03 22 45 59 93; sarhan.francois-regis@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 21, 2022
• Study Start: September 6, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)