Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629038
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Estimating Mouth Opening and Shoulder Range of Motion Using an AI Model
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Novel Technique for Estimating Maximal Mouth Opening and Shoulder Joint Range of Motion Using an Artificial Intelligence Model
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study aims to develop an AI-based system for tracking mandibular and shoulder movements using deep learning techniques It will compare AI-generated pose estimations with gold standard measurements to assess accuracy particularly in patients with functional impairments from oral cancer treatment such as trismus spinal accessory nerve dysfunction neck dystonia and radiation fibrosis
Detailed Description:
Due to the involvement of various structures patients with oral cancer may experience functional impairments after treatment such as trismus spinal accessory nerve dysfunction neck dystonia radiation fibrosis and fatigue This observational study aims to develop an AI-based system for tracking mandibular and shoulder movements using deep learning techniques AI-generated pose estimations will be compared with gold standard measurements maximal mouth opening will be compared with caliper measurements while shoulder abduction range of motion will be compared with electrogoniometer and universal goniometer measurements We will recruit 20 healthy adults and 20 oral cancer patients Data on maximal mouth opening and shoulder abduction will be collected through video recordings calipers electrogoniometers and universal goniometers The videos will be analyzed using deep learning to estimate mouth opening and shoulder abduction angles These estimates will then be compared with the gold standard measurements The Intraclass Correlation Coefficient ICC Mean Absolute Error MAE and Coefficient of Variation CV will be used as performance indicators to assess and compare the reliability accuracy and consistency of the models
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None