跳至主要内容
临床试验/NCT06629038
NCT06629038招募中不适用

A Novel Technique for Estimating Maximal Jaw Movement, Neck and Shoulder Joint Range of Motion Using an Artificial Intelligence Model

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
maximal mouth opening

研究概览

简要总结

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.

详细描述

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, and Therabilte scale, while shoulder abduction range of motion will be compared with 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, Therabilte scale, 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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy adults without a history of head, neck or shoulder injury or surgery, and without HNC-related radiotherapy or chemoradiotherapy
  • •Oral cancer patients with trismus, clinical signs of neck or shoulder joint impairment after oral cancer surgery or radiotherapy
  • •Age between 20 and 65 years

排除标准

  • •Could not communicate
  • •Had any disorder that could influence movement performance

研究组 & 干预措施

oral cancer patients

oral cancer patients with trismus, neck, or shoulder problems

干预措施: observation alone (Behavioral)

healthy adults

healthy adults without history of trismus, neck, or shoulder problems

干预措施: observation alone (Behavioral)

结局指标

主要结局

maximal mouth opening

时间窗: The date of enrollment

maximal mouth opening

maximal lateral excursion of mandible

时间窗: The date of enrollment

maximal lateral excursion of mandible

range of motion of shoulder abduction

时间窗: The date of enrollment

range of motion of shoulder abduction

range of motion of neck

时间窗: The date of enrollment

lateral side bending and rotation of the neck

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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