NCT05581680

Brief Summary

The facial palsy is a frequent disease with a lot of etiologies. It has variable severities with sometimes heavy functional repercussions and different recovery potentials. The proposed treatments are based on surgery, physiotherapy and botulinum toxin injections. However, when recovery is incomplete, acceptance is more difficult, with an impacted quality of life. Thanks to Motion Capture and Electromyography, a quantification of the facial mimicry is now possible with a great precision. In addition with the quantification of the facial mimicry, eye-tracking, wich is widely used in the marketing field, but it also finds medical applications including head and neck lesions and facial palsy in particular, will be used to evaluate the visio of the patients on their pathology in function of the movement quantification measured with MoCap and Electromyography. The aim of this research is to measure in a combined way the action potentials by sEMG and the amplitudes of displacement of the markers in motion capture, for movements determined in a population of patients presenting a facial pathology, in order to compare them with reference values obtained in healthy subjects. In a second step, the aim will be to study if there is a link between the way the patient looks at his pathology and the results of his management (treatment, rehabilitation) which will be quantitatively evaluated thanks to MoCap and sEMG.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Oct 2022Oct 2028

First Submitted

Initial submission to the registry

October 12, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

October 12, 2022

Last Update Submit

May 22, 2025

Conditions

Keywords

facial mimicsmotion captureelectromyographyeye-trackingFacial Palsy

Outcome Measures

Primary Outcomes (4)

  • determination of baseline values of facial mimicry (in millimetres) in healthy volunteers

    determination of baseline values of facial mimicry (in millimetres) in healthy volunteers

    one month

  • determination of baseline values of eye-tracking (in millimetres) in healthy volunteers

    determination of baseline values of eye-tracking (in millimetres) in healthy volunteers

    one month

  • determination of the maximum range of motion of facial mimicry (in millimetres) in patients

    determination of the maximum range of motion facial mimicry (in millimetres) in patients

    one year

  • determination of the maximum range of motion of eye-tracking (in millimetres) in patients

    determination of the maximum range of motion of eye-tracking (in millimetres) in patients

    one year

Study Arms (2)

patients with facial palsy

EXPERIMENTAL
Other: dental impressionsOther: Simultaneous MoCap and EMG acquisitionOther: Eye-tracking acquisition for pathological subjectsOther: Follow-up visit for pathological subjects

healthy volunteers

ACTIVE COMPARATOR
Other: dental impressionsOther: Simultaneous MoCap and EMG acquisition

Interventions

dental impressions

healthy volunteerspatients with facial palsy

Simultaneous MoCap and EMG acquisition

healthy volunteerspatients with facial palsy

Eye-tracking acquisition for pathological subjects

patients with facial palsy

Follow-up visit for pathological subjects

patients with facial palsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with no known facial pathology (healthy volunteers) OR
  • Patients with peripheral facial palsy, irrespective of grade, whether or not previously treated
  • Subject with written informed consent
  • Subject over 18 years of age
  • Subject affiliated to a social security scheme

You may not qualify if:

  • Subjects with severe skin disorders that do not allow the application of electrodes or photo reflective markers
  • Subjects with speech disorders making it impossible to pronounce the sounds \[o\] and \[pu\]
  • Subject unable to provide written informed consent
  • Subjects under guardianship, curators or safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Facial Paralysis

Interventions

Dental Impression Technique

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Technology, DentalDentistry

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 14, 2022

Study Start

October 12, 2022

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations