Peripheral Facial PalsyRéMiFaSyNCT05547152
Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis
A study testing massages, motor stimulation and stretching and virtual reality in people with Peripheral Facial Palsy and Rehabilitation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Facial Palsy, Rehabilitation, Virtual Reality
- What is being tested?
- massages, motor stimulation and stretching and virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2022to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
François-Régis SARHAN, 03 22 45 59 93, sarhan.francois-regis@chu-amiens.fr
Isabelle DEMONT
About this study
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
- Being tested
- massages, motor stimulation and stretching, virtual reality
- Keywords
- Peripheral Facial Palsy, rehabilitation, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massagesOther
The experimental rehabilitation protocol includes massages
motor stimulation and stretchingOther
motor stimulation and stretching
virtual realityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | patients benefiting from rehabilitation associated with virtual reality Receives: Other: massages; Other: motor stimulation and stretching; Other: virtual reality |
| Control arm | Active comparator | patients benefiting from rehabilitation without virtual reality Receives: Other: massages; Other: motor stimulation and stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start2 Aug 2022
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Facial PalsyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547152
- Sponsor's protocol ID
- PI2019_843_0100
- Acronym
- RéMiFaSy
- Status last verified
- Jun 2026
- First submitted
- 6 Sep 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis
- ClinicalTrials.gov ID
- NCT05547152
- Acronym / sponsor ID
- RéMiFaSy / PI2019_843_0100
- Conditions
- Peripheral Facial Palsy, Rehabilitation, Virtual Reality
- Keywords
- Peripheral Facial Palsy, rehabilitation, virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Rouen
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: massages, Other: motor stimulation and stretching, Other: virtual realitypatients benefiting from rehabilitation associated with virtual reality |
| Control arm | Active comparator | Other: massages, Other: motor stimulation and stretchingpatients benefiting from rehabilitation without virtual reality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massagesThe experimental rehabilitation protocol includes massages | Other | Control arm, Experimental arm |
| motor stimulation and stretchingmotor stimulation and stretching | Other | Control arm, Experimental arm |
| virtual realityPatient watches an avatar of his face performing different movements on a screen, and will have to imagine performing these movements without actually doing them. | Other | Experimental arm |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massages, motor stimulation and stretching and virtual reality in people with Peripheral Facial Palsy and Rehabilitation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François-Régis SARHAN (03 22 45 59 93, sarhan.francois-regis@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of number of involuntary facial spasm between both groups of patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.