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NCT Number: NCT07509619

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

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Taipei, 100, Taiwan

Location status: Recruiting

Location contact

Yueh-Hsia Chen, Ph.D

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Agreement Between AI and Manual Measurements

    Time frame: Baseline

    Agreement between AI-based and manual measurements assessed using Intraclass correlation coefficients (ICC) and Bland-Altman analysis

Secondary outcomes

  1. Mean Absolute Error (MAE)

    Time frame: Baseline

    Average absolute difference between AI measurements and manual measurements

  2. Intra-rater reliability of human raters

    Time frame: Baselinte

    Consistency of manual measurements by Rater 1 and Rater 2 across repeated trials using intraclass correlation coefficients (ICC)

  3. Inter-rater reliability among all raters

    Time frame: Baseline

    Agreement among measurements obtained from the AI system, Rater 1, and Rater 2 will be assessed using intraclass correlation coefficients (ICC)

  4. Intra-rater reliability of AI system

    Time frame: Baseline

    Consistency of AI-based measurements across three repeated trials using intraclass correlation coefficients (ICC)

  5. Systematic measurement bias

    Time frame: Baseline

    Mean difference between AI-based and manual measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Yueh-Hsia Chen, Ph.D.

CONTACT

[email protected]

+886-2-33668133

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 3, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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