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Идёт набор NCT07509619

AI-based Physiotherapy Evaluation System for Range of Motion in Oral Cancer Patients

— Наблюдательное Oral Cancer AI (Artificial Intelligence)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Oral Cancer, AI (Artificial Intelligence). Базовые параметры: 20 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
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Официальное название

Validity and Reliability of an AI-based Physiotherapy Evaluation System for Oromandibular and Neck-Shoulder Range of Motion in Oral Cancer Patients

Обзор

This study aims to evaluate the validity and reliability of a novel AI-based physiotherapy evaluation system for measuring oromandibular and neck-shoulder range of motion (ROM). Traditional ROM assessments rely on manual measurements, which may be influenced by rater experience and variability. The proposed AI system uses automated keypoint tracking to provide objective and standardized measurements. In this cross-sectional study, healthy adult participants will perform standardized ROM tasks. Measurements obtained from the AI system will be compared with those from two independent raters using conventional clinical tools. Repeated measurements will be conducted to assess intra-rater and inter-rater reliability. The agreement between the AI system and human raters will be evaluated to determine the system's clinical applicability.

Подробное описание

This study is a cross-sectional measurement study designed to evaluate the reliability and concurrent validity of an AI-based physiotherapy evaluation system for assessing oromandibular and neck-shoulder range of motion (ROM). Participants will be healthy adults aged 20 to 70 years who meet predefined inclusion and exclusion criteria. After providing informed consent, participants will perform standardized movements, including mouth opening and cervical and shoulder ROM tasks.

Each participant will undergo three repeated measurements for each movement. ROM will be assessed using three methods: (1) an AI-based system utilizing real-time keypoint tracking and automated angle calculation, (2) manual measurement by Rater 1, and (3) independent manual measurement by Rater 2 using a goniometer or TheraBite ROM scale.

To minimize measurement bias and fatigue effects, the order of the three assessment methods will be randomized for each participant. Raters will be blinded to each other's measurements and to the AI-generated results.

The primary outcomes include inter-rater reliability and intra-rater reliability of the AI system, as well as agreement between AI-based and manual measurements. Reliability will be assessed using intraclass correlation coefficients (ICC), while agreement will be evaluated using Bland-Altman analysis and mean absolute error (MAE).

This study is expected to provide evidence supporting the clinical applicability of AI-based physiotherapy assessment tools, particularly for standardized and scalable musculoskeletal evaluations.

Первичные конечные точки

  • Agreement Between AI and Manual Measurements [Срок оценки: Baseline]
Вторичные конечные точки (5)
  • Mean Absolute Error (MAE) [Срок оценки: Baseline]
  • Intra-rater reliability of human raters [Срок оценки: Baselinte]
  • Inter-rater reliability among all raters [Срок оценки: Baseline]
  • Intra-rater reliability of AI system [Срок оценки: Baseline]
  • Systematic measurement bias [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Healthy adults aged 20 to 70 years
  • No trismus
  • No history of head, neck, or shoulder injury or surgery
  • No history of head and neck cancer-related radiotherapy or chemotherapy

Критерии исключения

  • Inability to communicate or follow instructions
  • Any condition that may affect movement performance

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Тайвань · 1 центр
  • School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan Un — Taipei

Публикации

  • Deb S, Islam MF, Rahman S, Rahman S. Graph Convolutional Networks for Assessment of Physical Rehabilitation Exercises. IEEE Trans Neural Syst Rehabil Eng. 2022;30:410-419. doi: 10.1109/TNSRE.2022.3150392. Epub 2022 Feb 23. PMID 35139022
  • Agarwal P, Shiva Kumar HR, Rai KK. Trismus in oral cancer patients undergoing surgery and radiotherapy. J Oral Biol Craniofac Res. 2016 Nov;6(Suppl 1):S9-S13. doi: 10.1016/j.jobcr.2016.10.004. Epub 2016 Oct 22. PMID 27900243

Идентификаторы

NCT: NCT07509619 · 202603023RIND

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗