Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis (RéMiFaSy)
Primary Purpose
Peripheral Facial Palsy, Rehabilitation, Virtual Reality
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
massages
motor stimulation and stretching
virtual reality
Sponsored by
About this trial
This is an interventional supportive care trial for Peripheral Facial Palsy focused on measuring Peripheral Facial Palsy, rehabilitation, virtual reality
Eligibility Criteria
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)
Sites / Locations
- CHU Amiens PicardieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental arm
Control arm
Arm Description
patients benefiting from rehabilitation associated with virtual reality
patients benefiting from rehabilitation without virtual reality
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05547152
First Posted
September 6, 2022
Last Updated
September 15, 2022
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT05547152
Brief Title
Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis
Acronym
RéMiFaSy
Official Title
Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Facial Palsy, Rehabilitation, Virtual Reality
Keywords
Peripheral Facial Palsy, rehabilitation, virtual reality
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
patients benefiting from rehabilitation associated with virtual reality
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
patients benefiting from rehabilitation without virtual reality
Intervention Type
Other
Intervention Name(s)
massages
Intervention Description
The experimental rehabilitation protocol includes massages
Intervention Type
Other
Intervention Name(s)
motor stimulation and stretching
Intervention Description
motor stimulation and stretching
Intervention Type
Other
Intervention Name(s)
virtual reality
Intervention Description
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 Outcome Measure Information:
Title
variation of number of involuntary facial spasm between both groups of patients
Description
variation of synkinesis in patients with recent onset (≤ 12 months) peripheral facial palsy compared with the conventional rehabilitation protocol
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François-Régis SARHAN
Phone
03 22 45 59 93
Email
sarhan.francois-regis@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François-Régis SARHAN
Phone
03 22 45 59 93
Email
sarhan.francois-regis@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Isabelle DEMONT
First Name & Middle Initial & Last Name & Degree
Stéphanie DAKPE, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis
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