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Recruiting NCT06629038

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

— Observational Oral Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: observation alone.
Who it may be relevant to
Registry conditions: Oral Cancer. Basic parameters: 20 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • maximal mouth opening [Time frame: The date of enrollment]
  • maximal lateral excursion of mandible [Time frame: The date of enrollment]
  • range of motion of shoulder abduction [Time frame: The date of enrollment]
  • range of motion of neck [Time frame: The date of enrollment]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Taiwan · 1 center
  • School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan Un — Taipei

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 35821447

Identifiers

NCT: NCT06629038 · 202403103RINA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗