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NCT Number: NCT05547152

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

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.

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Key information

Conditions

Peripheral Facial Palsy Rehabilitation Virtual Reality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

François-Régis SARHAN

CONTACT

[email protected]

03 22 45 59 93

Isabelle DEMONT

SUB_INVESTIGATOR

Stéphanie DAKPE, Pr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

massages

Other

The experimental rehabilitation protocol includes massages

motor stimulation and stretching

Other

motor stimulation and stretching

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.

Primary outcomes

  1. variation of number of involuntary facial spasm between both groups of patients

    Time frame: 12 months

    variation of synkinesis in patients with recent onset (≤ 12 months) peripheral facial palsy compared with the conventional rehabilitation protocol

Study contacts

Contact information is provided by the study sponsor or research team.

François-Régis SARHAN

CONTACT

[email protected]

03 22 45 59 93

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • University Hospital, Rouen

Registry information

Acronym: RéMiFaSy

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Sep 21, 2022
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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