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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07509619
Enrollment
20
Registered
2026-04-03
Start date
2026-04-07
Completion date
2027-12-31
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AI (Artificial Intelligence), Oral Cancer

Keywords

Oral cancer, Artificial intelligence, Maximum interincisal opening, Physiotherapy, Range of motion, Neck and shoulder

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Agreement Between AI and Manual MeasurementsBaselineAgreement between AI-based and manual measurements assessed using Intraclass correlation coefficients (ICC) and Bland-Altman analysis

Secondary

MeasureTime frameDescription
Mean Absolute Error (MAE)BaselineAverage absolute difference between AI measurements and manual measurements
Intra-rater reliability of human ratersBaselinteConsistency of manual measurements by Rater 1 and Rater 2 across repeated trials using intraclass correlation coefficients (ICC)
Inter-rater reliability among all ratersBaselineAgreement among measurements obtained from the AI system, Rater 1, and Rater 2 will be assessed using intraclass correlation coefficients (ICC)
Intra-rater reliability of AI systemBaselineConsistency of AI-based measurements across three repeated trials using intraclass correlation coefficients (ICC)
Systematic measurement biasBaselineMean difference between AI-based and manual measurements

Countries

Taiwan

Contacts

CONTACTYueh-Hsia Chen, Ph.D.
yuehhsiachen@ntu.edu.tw+886-2-33668133
PRINCIPAL_INVESTIGATORYueh-Hsia Chen, Ph.D.

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026