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
NCT Number: NCT07509619
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.
Interested in participating?
Request Info20 year–70 year
All sexes
Observational
Taipei, 100, Taiwan
Location status: Recruiting
Yueh-Hsia Chen, Ph.D
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Agreement between AI-based and manual measurements assessed using Intraclass correlation coefficients (ICC) and Bland-Altman analysis
Time frame: Baseline
Average absolute difference between AI measurements and manual measurements
Time frame: Baselinte
Consistency of manual measurements by Rater 1 and Rater 2 across repeated trials using intraclass correlation coefficients (ICC)
Time frame: Baseline
Agreement among measurements obtained from the AI system, Rater 1, and Rater 2 will be assessed using intraclass correlation coefficients (ICC)
Time frame: Baseline
Consistency of AI-based measurements across three repeated trials using intraclass correlation coefficients (ICC)
Time frame: Baseline
Mean difference between AI-based and manual measurements
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
Validity and Reliability of an AI-based Physiotherapy Evaluation System for Oromandibular and Neck-Shoulder Range of Motion in Oral Cancer Patients
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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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