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Oral CancerNCT06629038

Estimating Jaw, Neck, and Shoulder Range of Motion Using an AI Model

An observational study of Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This observational study aims to develop an AI-based system for tracking mandibular and shoulder movements using deep learning techniques. It will compare AI-generated pose estimations with gold standard measurements to assess accuracy, particularly in patients with functional impairments from oral cancer treatment… Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Oral Cancer
What is being tested?
observation alone
How many people
40 participants
Where
1 siteTaiwan
Study dates
5 Dec 2024to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: primary care clinic, community, university

Who may be able to join

  • Healthy adults without a history of head, neck or shoulder injury or surgery, and without HNC-related radiotherapy or chemoradiotherapy
  • Oral cancer patients with trismus, clinical signs of neck or shoulder joint impairment after oral cancer surgery or radiotherapy
  • Age between 20 and 65 years

Who cannot join

  • Could not communicate
  • Had any disorder that could influence movement performance

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yueh-Hsia Chen, PhD contact

+886 921435981

yuehhsiachen@ntu.edu.tw

Taiwan1 site, 1 recruiting

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

    Taipei, 100

    Yueh-Hsia Chen, PhD, yuehhsiachen@ntu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: A Novel Technique for Estimating Maximal Jaw Movement, Neck and Shoulder Joint Range of Motion Using an Artificial Intelligence Model

This observational study aims to develop an AI-based system for tracking mandibular and shoulder movements using deep learning techniques. It will compare AI-generated pose estimations with gold standard measurements to assess accuracy, particularly in patients with functional impairments from oral cancer treatment, such as trismus, spinal accessory nerve dysfunction, neck dystonia, and radiation fibrosis.

Read the detailed description

Due to the involvement of various structures, patients with oral cancer may experience functional impairments after treatment, such as trismus, spinal accessory nerve dysfunction, neck dystonia, radiation fibrosis, and fatigue. This observational study aims to develop an AI-based system for tracking mandibular and shoulder movements using deep learning techniques. AI-generated pose estimations will be compared with gold standard measurements: maximal mouth opening will be compared with caliper measurements, and Therabilte scale, while shoulder abduction range of motion will be compared with universal goniometer measurements. We will recruit 20 healthy adults and 20 oral cancer patients. Data on maximal mouth opening and shoulder abduction will be collected through video recordings, calipers, Therabilte scale, and universal goniometers. The videos will be analyzed using deep learning to estimate mouth opening and shoulder abduction angles. These estimates will then be compared with the gold standard measurements. The Intraclass Correlation Coefficient (ICC), Mean Absolute Error (MAE), and Coefficient of Variation (CV) will be used as performance indicators to assess and compare the reliability, accuracy, and consistency of the models.

Conditions
Oral Cancer
Being tested
observation alone
Keywords
oral cancer, shoulder, range of motion, artificial intelligence, pose estimation, maximal mouth opening
Medical subject headings
Mouth Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observation aloneBehavioural

    observation of maximal mouth opening, lateral excursion, and range of motion of shoulder abduction, neck joint

Study groups in NCT06629038
Study groupRoleWhat they receive
oral cancer patientsoral cancer patients with trismus, neck, or shoulder problems
Receives: Behavioral: observation alone
healthy adultshealthy adults without history of trismus, neck, or shoulder problems
Receives: Behavioral: observation alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maximal mouth opening

    maximal mouth opening

    Measured: The date of enrollment

  2. maximal lateral excursion of mandible

    maximal lateral excursion of mandible

    Measured: The date of enrollment

  3. range of motion of shoulder abduction

    range of motion of shoulder abduction

    Measured: The date of enrollment

  4. range of motion of neck

    lateral side bending and rotation of the neck

    Measured: The date of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start5 Dec 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06629038
Sponsor's protocol ID
202403103RINA
Status last verified
Feb 2026
First submitted
3 Oct 2024
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Badiola-Bengoa A, Mendez-Zorrilla A. A Systematic Review of the Application of Camera-Based Human Pose Estimation in the Field of Sport and Physical Exercise. Sensors (Basel). 2021 Sep 7;21(18):5996. doi: 10.3390/s21185996.

    PubMed 34577204

  • Sandler ML, Lazarus CL, Ru M, Sharif KF, Yue LE, Griffin MJ, Likhterov I, Chai RL, Buchbinder D, Urken ML, Ganz C. Effects of jaw exercise intervention timing on outcomes following oral and oropharyngeal cancer surgery: Pilot study. Head Neck. 2019 Nov;41(11):3806-3817. doi: 10.1002/hed.25908. Epub 2019 Aug 12.

    PubMed 31407421

  • van der Geer SJ, Reintsema H, Kamstra JI, Roodenburg JLN, Dijkstra PU. The use of stretching devices for treatment of trismus in head and neck cancer patients: a randomized controlled trial. Support Care Cancer. 2020 Jan;28(1):9-11. doi: 10.1007/s00520-019-05075-7. Epub 2019 Nov 7.

    PubMed 31701267

  • Shao CH, Chiang CC, Huang TW. Exercise therapy for cancer treatment-induced trismus in patients with head and neck cancer: A systematic review and meta-analysis of randomized controlled trials. Radiother Oncol. 2020 Oct;151:249-255. doi: 10.1016/j.radonc.2020.08.024. Epub 2020 Sep 3.

    PubMed 32890607

  • Cohen EE, LaMonte SJ, Erb NL, Beckman KL, Sadeghi N, Hutcheson KA, Stubblefield MD, Abbott DM, Fisher PS, Stein KD, Lyman GH, Pratt-Chapman ML. American Cancer Society Head and Neck Cancer Survivorship Care Guideline. CA Cancer J Clin. 2016 May;66(3):203-39. doi: 10.3322/caac.21343. Epub 2016 Mar 22.

    PubMed 27002678

  • Watters AL, Cope S, Keller MN, Padilla M, Enciso R. Prevalence of trismus in patients with head and neck cancer: A systematic review with meta-analysis. Head Neck. 2019 Sep;41(9):3408-3421. doi: 10.1002/hed.25836. Epub 2019 Jun 19.

    PubMed 31215723

  • Stenum J, Cherry-Allen KM, Pyles CO, Reetzke RD, Vignos MF, Roemmich RT. Applications of Pose Estimation in Human Health and Performance across the Lifespan. Sensors (Basel). 2021 Nov 3;21(21):7315. doi: 10.3390/s21217315.

    PubMed 34770620

  • Chen YH, Liang WA, Lin CR, Huang CY. A randomized controlled trial of scapular exercises with electromyography biofeedback in oral cancer patients with accessory nerve dysfunction. Support Care Cancer. 2022 Oct;30(10):8241-8250. doi: 10.1007/s00520-022-07263-4. Epub 2022 Jul 11.

    PubMed 35821447

  • Chen YH, Lin CR, Liang WA, Huang CY. Motor control integrated into muscle strengthening exercises has more effects on scapular muscle activities and joint range of motion before initiation of radiotherapy in oral cancer survivors with neck dissection: A randomized controlled trial. PLoS One. 2020 Aug 6;15(8):e0237133. doi: 10.1371/journal.pone.0237133. eCollection 2020.

    PubMed 32760097

  • Chen YH, Huang CY, Liang WA, Lin CR, Chao YH. Effects of Conscious Control of Scapular Orientation in Oral Cancer Survivors With Scapular Dyskinesis: A Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211040827. doi: 10.1177/15347354211040827.

    PubMed 34412536

  • Beshara P, Chen JF, Read AC, Lagadec P, Wang T, Walsh WR. The Reliability and Validity of Wearable Inertial Sensors Coupled with the Microsoft Kinect to Measure Shoulder Range-of-Motion. Sensors (Basel). 2020 Dec 17;20(24):7238. doi: 10.3390/s20247238.

    PubMed 33348775

  • Shepherd J, Hansjee S, Divall P, Raval P, Singh HP. How do digital range of motion measurement devices 'measure-up' to traditional goniometry in assessing shoulder range of motion? A systematic review and meta-analysis. Shoulder Elbow. 2024 Jul;16(4):363-381. doi: 10.1177/17585732231195554. Epub 2023 Aug 31.

    PubMed 39318409

  • Takigami S, Inui A, Mifune Y, Nishimoto H, Yamaura K, Kato T, Furukawa T, Tanaka S, Kusunose M, Ehara Y, Kuroda R. Estimation of Shoulder Joint Rotation Angle Using Tablet Device and Pose Estimation Artificial Intelligence Model. Sensors (Basel). 2024 May 2;24(9):2912. doi: 10.3390/s24092912.

    PubMed 38733018

  • van den Hoorn W, Lavaill M, Cutbush K, Gupta A, Kerr G. Comparison of Shoulder Range of Motion Quantified with Mobile Phone Video-Based Skeletal Tracking and 3D Motion Capture-Preliminary Study. Sensors (Basel). 2024 Jan 15;24(2):534. doi: 10.3390/s24020534.

    PubMed 38257626

Questions about this trial

What is this clinical trial studying?

An observational study of Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yueh-Hsia Chen, PhD (+886 921435981, yuehhsiachen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximal mouth opening (time frame: The date of enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06629038, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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