NCT07509619

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

March 29, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

April 7, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 29, 2026

Last Update Submit

April 6, 2026

Conditions

Oral CancerAI (Artificial Intelligence)

Keywords

Oral cancerArtificial intelligenceMaximum interincisal openingPhysiotherapyRange of motionNeck and shoulder

Outcome Measures

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

    Baseline

Secondary Outcomes (5)

  • Mean Absolute Error (MAE)

    Baseline

  • Intra-rater reliability of human raters

    Baselinte

  • Inter-rater reliability among all raters

    Baseline

  • Intra-rater reliability of AI system

    Baseline

  • Systematic measurement bias

    Baseline

Study Arms (1)

Healthy group

Healthy adults aged between 20 and 70 years without a history of trismus, head, neck or shoulder injury or surgery, HNC-related radiotherapy or chemoradiotherapy were recruited.

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taipei, 100, Taiwan

RECRUITING

Related Publications (2)

  • 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: 35139022BACKGROUND

  • 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: 27900243BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Yueh-Hsia Chen, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueh-Hsia Chen, Ph.D.

CONTACT

+886-2-33668133yuehhsiachen@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2026

First Posted

April 3, 2026

Study Start

April 7, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to privacy considerations and institutional regulations. Although the AI system processes de-identified keypoint data, the dataset may still contain information that could potentially be re-identified. Data sharing may be considered upon reasonable request and subject to institutional review and data protection policies.

Locations

TW(1)