AI-based Physiotherapy Evaluation System for Range of Motion in Oral Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-70
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Inability to communicate or follow instructions
Any condition that may affect movement performance
Trial population
The study population consists of healthy adult volunteers aged 20 to 70 years recruited through non-probability sampling. Participants without a history of trismus, head and neck cancer, or musculoskeletal conditions affecting the head, neck, or shoulder regions are eligible. All participants are capable of following instructions and performing standardized movement tasks. This population is selected to establish baseline measurement performance and to evaluate the reliability and validity of the AI-based physiotherapy evaluation system under controlled conditions.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 1 trial groupGroup A: Healthy group
Trial outcomes
Primary outcomes
1
Agreement Between AI and Manual Measurements
Agreement between AI-based and manual measurements assessed using Intraclass correlation coefficients (ICC) and Bland-Altman analysis
Time frame
BaselineSecondary outcomes
1
Mean Absolute Error (MAE)
Average absolute difference between AI measurements and manual measurements
Time frame
Baseline2
Intra-rater reliability of human raters
Consistency of manual measurements by Rater 1 and Rater 2 across repeated trials using intraclass correlation coefficients (ICC)
Time frame
Baselinte3
Inter-rater reliability among all raters
Agreement among measurements obtained from the AI system, Rater 1, and Rater 2 will be assessed using intraclass correlation coefficients (ICC)
Time frame
Baseline4
Intra-rater reliability of AI system
Consistency of AI-based measurements across three repeated trials using intraclass correlation coefficients (ICC)
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov