NCT06629038

Brief 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, such as trismus, spinal accessory nerve dysfunction, neck dystonia, and radiation fibrosis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Dec 2024

Typical duration for all trials

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 Progress69%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

October 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 5, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

October 3, 2024

Last Update Submit

February 9, 2026

Conditions

Keywords

oral cancershoulderrange of motionartificial intelligencepose estimationmaximal mouth opening

Outcome Measures

Primary Outcomes (4)

  • maximal mouth opening

    maximal mouth opening

    The date of enrollment

  • maximal lateral excursion of mandible

    maximal lateral excursion of mandible

    The date of enrollment

  • range of motion of shoulder abduction

    range of motion of shoulder abduction

    The date of enrollment

  • range of motion of neck

    lateral side bending and rotation of the neck

    The date of enrollment

Study Arms (2)

oral cancer patients

oral cancer patients with trismus, neck, or shoulder problems

Behavioral: observation alone

healthy adults

healthy adults without history of trismus, neck, or shoulder problems

Behavioral: observation alone

Interventions

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

healthy adultsoral cancer patients

Eligibility Criteria

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

primary care clinic, community, university

You may qualify if:

  • 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

You may not qualify if:

  • Could not communicate
  • Had any disorder that could influence 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 (14)

  • 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: 34577204BACKGROUND
  • 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: 31407421BACKGROUND
  • 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: 31701267BACKGROUND
  • 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: 32890607BACKGROUND
  • 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: 27002678BACKGROUND
  • 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: 31215723BACKGROUND
  • 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: 34770620BACKGROUND
  • 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: 35821447BACKGROUND
  • 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.

    PMID: 32760097BACKGROUND
  • 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.

    PMID: 34412536BACKGROUND
  • 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.

    PMID: 33348775BACKGROUND
  • 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.

    PMID: 39318409BACKGROUND
  • 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.

    PMID: 38733018BACKGROUND
  • 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.

    PMID: 38257626BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Yueh-Hsia Chen, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueh-Hsia Chen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 8, 2024

Study Start

December 5, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations