Facial PalsyNCT05981651
Development and Application of a Dynamic Three-dimensional Quantitative Facial Measurement Device
An observational study of Facial Palsy, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Palsy
- What is being tested?
- non-intervention
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Guodong Feng, 15001275266 ext. 010, fengguodong2013@163.com
About this study
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.
Read the detailed description
Based on the current optimal high-precision face key point technology, the effective high-precision automatic face recognition model conforming to the Asian face is established through specialised training with targeted marker data, time series training optimisation based on optical flow, and local image tracking technology. The 3D reconstruction technique is then used to reconstruct the 3D spatial coordinates of the face keypoints, so as to realise the multi-camera 3D tracking of the face keypoints. The displacement of the key points is used to respond to the facial muscle activity characteristics of facial paralysis patients.
- Conditions
- Facial Palsy
- Being tested
- non-intervention
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionOther
non-intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: non-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Jul 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PalsyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guodong Feng, Peking Union Medical College Hospital
- Investigators
- Guodong Feng, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981651
- Sponsor's protocol ID
- PekingUMCH record I-22PJ1121
- Status last verified
- Aug 2023
- First submitted
- 27 Jul 2023
- Last updated
- 8 Aug 2023
- 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a Dynamic Three-dimensional Quantitative Facial Measurement Device
- ClinicalTrials.gov ID
- NCT05981651
- Acronym / sponsor ID
- PekingUMCH record I-22PJ1121
- Conditions
- Facial Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 Aug 2023 (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.
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.
Detailed description
Based on the current optimal high-precision face key point technology, the effective high-precision automatic face recognition model conforming to the Asian face is established through specialised training with targeted marker data, time series training optimisation based on optical flow, and local image tracking technology. The 3D reconstruction technique is then used to reconstruct the 3D spatial coordinates of the face keypoints, so as to realise the multi-camera 3D tracking of the face keypoints. The displacement of the key points is used to respond to the facial muscle activity characteristics of facial paralysis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training session | – | Other: non-interventionA total of 150 facial expression videos of healthy volunteers and facial palsy patients were collected as a training set for the algorithm |
| test set | – | Other: non-interventionA total of 50 cases of healthy volunteers and patients with facial palsy were used as the test set for the algorithm |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| non-interventionnon-intervention | Other | test set, training session |
Primary outcome
Facial feature point displacement distance
Time frame: 3 months
Displacement of corresponding facial feature points when volunteers perform specific actions such as specific expressions (raising eyebrow, closing eyes, shrugging nose, smiling and whistling)
Facial Feature Point Velocity
Time frame: 3 months
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- 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. This study is not recruiting at the moment.
Guodong Feng principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Palsy, run by Peking Union Medical College Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Aug 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guodong Feng (15001275266 ext. 010, fengguodong2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial feature point displacement distance (time frame: 3 months). The study lists 2 primary outcomes in all. 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 8 Aug 2023.