Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062463) titled 'Development of a Rehabilitation Application for Facial Nerve Palsy and Validation of AI-Based Automated Assessment Against Specialist Assessment' on Aug. 4.
Study Type:
Observational
Primary Sponsor:
Institute - University of Tokyo
Condition:
Condition - Facial palsy
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 20
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 Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071472
Disclaimer: Curated by HT Syndication.
