NCT05981651

Brief Summary

The aim of this project is to successfully develop and industrialise the "Facial Movement 3D Dynamic Quantitative Measurement Device", which is a commercial device that can provide dynamic indicators of facial movement, and can practically solve the evaluation problems of facial paralysis for doctors and patients, and has important clinical value and social benefits.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

July 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

July 27, 2023

Last Update Submit

August 7, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Facial feature point displacement distance

    Displacement of corresponding facial feature points when volunteers perform specific actions such as specific expressions (raising eyebrow, closing eyes, shrugging nose, smiling and whistling)

    3 months

  • Facial Feature Point Velocity

    Velocity of the corresponding facial feature points of volunteers when accomplishing specific actions such as specific expressions (raising eyebrows, closing eyes, shrugging nose, smiling, whistling)

    3 months

Study Arms (2)

training session

A total of 150 facial expression videos of healthy volunteers and facial palsy patients were collected as a training set for the algorithm

Other: non-intervention

test set

A total of 50 cases of healthy volunteers and patients with facial palsy were used as the test set for the algorithm

Other: non-intervention

Interventions

non-intervention

test settraining session

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Based on previous face data collection often use larger public datasets, such as the AFLW dataset with 20,000 images. we need the same order of magnitude of local ethnographic data for migration learning. At the same time, the data in the dataset is improved according to the need to improve the accuracy of the labelled data at key points. Take about 100 effective frames for each data set. Need to complete about 200 people of various types of face data acquisition. The test group data is generally designed to be more than 20% of the training data, so the number of test group samples is designed to be 50 groups.

You may qualify if:

  • Older than 14 years
  • No history of facial surgery, facial trauma, or scars obscuring the facial features.
  • Able to perform relevant actions according to instructions
  • Willingness to participate in the study

You may not qualify if:

  • Unwillingness to participate in the study
  • Unable to co-operate with relevant command actions
  • Obvious trauma, scars, etc. obscuring the facial features
  • Less than 14 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Guodong Feng

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 8, 2023

Study Start

July 1, 2022

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations