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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05547152
Acronym
RéMiFaSy
Enrollment
100
Registered
2022-09-21
Start date
2022-08-02
Completion date
2029-08-01
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Facial Palsy, Rehabilitation, Virtual Reality

Keywords

Peripheral Facial Palsy, rehabilitation, virtual reality

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.

Interventions

The experimental rehabilitation protocol includes massages

OTHERmotor stimulation and stretching

motor stimulation and stretching

OTHERvirtual 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.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER
University Hospital, Rouen
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
variation of number of involuntary facial spasm between both groups of patients12 monthsvariation of synkinesis in patients with recent onset (≤ 12 months) peripheral facial palsy compared with the conventional rehabilitation protocol

Countries

France

Contacts

CONTACTFrançois-Régis SARHAN
sarhan.francois-regis@chu-amiens.fr03 22 45 59 93

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026