UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062463 |
|---|---|
| Receipt number | R000071472 |
| Scientific Title | Development of a Rehabilitation Application for Facial Nerve Palsy and Validation of AI-Based Automated Assessment Against Specialist Assessment |
| Date of disclosure of the study information | 2026/08/04 |
| Last modified on | 2026/08/04 13:00:38 |
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Basic information
Public title
Development of a Rehabilitation Application for Facial Nerve Palsy and Validation of AI-Based Automated Assessment Against Specialist Assessment
Acronym
AI-Facial palsy Rehabilitation Study
Scientific Title
Development of a Rehabilitation Application for Facial Nerve Palsy and Validation of AI-Based Automated Assessment Against Specialist Assessment
Scientific Title:Acronym
AI-Facial palsy Rehabilitation study
Region
| Japan |
Condition
Condition
Facial palsy
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop an AI algorithm for automated assessment of facial nerve palsy severity and pathological synkinesis using facial movement videos obtained from patients with facial nerve palsy and healthy participants. AI-generated assessment scores and synkinesis classifications will be compared with specialist assessments using the Yanagihara grading system, House-Brackmann grading system, and Sunnybrook Facial Grading System to evaluate correlation, agreement, and validity. The resulting algorithm will be used to develop an application that supports appropriate rehabilitation for patients with facial nerve palsy.
Basic objectives2
Others
Basic objectives -Others
Development and validation of an AI-based automated assessment algorithm and rehabilitation support application for facial nerve palsy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation coefficients between AI-generated facial nerve palsy severity scores derived from facial movement videos and specialist assessment scores using the Yanagihara 40-point grading system, Sunnybrook Facial Grading System, and House-Brackmann grading system (Grades I-VI). Pearson's correlation coefficient or Spearman's rank correlation coefficient will be used as appropriate according to the data distribution. The target correlation coefficient is 0.8 or higher. The assessment time point is the time of facial movement video recording and specialist assessment for each participant.
Key secondary outcomes
To evaluate the agreement between AI-based classification of the presence and location of pathological synkinesis and specialist classification using the Sunnybrook Facial Grading System and related clinical assessments.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with facial nerve palsy caused by Bell's palsy or Ramsay Hunt syndrome, or healthy participants with no history of facial nerve palsy
2. Participants aged 20 to 80 years at the time of informed consent
3. Participants who have received sufficient information about the study and provided written informed consent
Key exclusion criteria
1. Individuals with facial nerve palsy caused by conditions other than Bell's palsy or Ramsay Hunt syndrome
2. Individuals with marked facial deformities that may affect facial movement recording or assessment
3. Individuals who are unable to provide written informed consent or follow study instructions
4. Individuals considered unsuitable for participation by the principal investigator or other investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | kenji |
| Middle name | |
| Last name | kondo |
Organization
The University of Tokyo Hospital
Division name
Department of Otolaryngology and Head and Neck Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8665
kondok@umin.ac.jp
Public contact
Name of contact person
| 1st name | junko |
| Middle name | |
| Last name | nakajima |
Organization
University of Toyama
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
930-0194
Address
2630 Sugitani, Toyama city, Toyama Prefecture
TEL
076-434-7368
Homepage URL
jnkonkj@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
no funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
Faculty of Medicine Building 2, 4th Floor 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京大学病院（東京都）、富山大学病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter, cross-sectional observational study conducted at The University of Tokyo Hospital and Toyama University Hospital. A total of 100 participants will be enrolled: 70 patients with facial nerve palsy caused by Bell's palsy or Ramsay Hunt syndrome and 30 healthy participants with no history of facial nerve palsy. Facial movement videos will be recorded while participants perform predefined facial expressions. Specialists will assess the videos using the Yanagihara grading system, House-Brackmann grading system, and Sunnybrook Facial Grading System. The same videos will be analyzed by AI to determine facial nerve palsy severity scores and the presence and location of pathological synkinesis. Correlation and agreement between the AI-based and specialist assessments will be evaluated. No study-specific treatment intervention or alteration of usual clinical care will be performed.
Management information
Registered date
| 2026 | Year | 08 | Month | 04 | Day |
Last modified on
| 2026 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071472
