NCT07237672

Brief Summary

This follow-up clinical study aims to evaluate the sustained effects of two rehabilitation programs (AI-based physiotherapy vs. conventional physiotherapy) for oral cancer patients. Participants who completed the original intervention trial (ClinicalTrials.gov ID: 202411044RINC) will be assessed at 3 and 9 months post-intervention. Outcomes include mandibular mobility, shoulder joint range of motion, functional performance, quality of life, pain, and return-to-work status.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Dec 2025

Typical duration for not_applicable

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 Progress21%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

October 2, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

December 6, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 16, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

October 2, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

Artificial intelligenceOral cancerMaximum interincisal openingPhysical functionPrehabilitationPhysiotherapy

Outcome Measures

Primary Outcomes (2)

  • Disabilities of the Arm, Shoulder, and Hand outcome questionnaire

    A total scale from 1 to 100. Higher scores indicate greater disability

    3 months, 9 months post-intervention

  • EORTC QLQ-C30 questionnaire

    A total scale from 1 to 100. Higher scores indicate greater function

    3 months, 9 months post-intervention

Secondary Outcomes (1)

  • Return-to-work status

    3 months, 9 months post-intervention

Study Arms (2)

Experimental group (Follow-up)

EXPERIMENTAL

Participants who originally received AI-based physiotherapy will undergo follow-up assessments at 3 and 9 months post-intervention.

Other: AI-based physiotherapy follow-up assessments

Control group (Follow-up)

ACTIVE COMPARATOR

Participants who originally received conventional physiotherapy will undergo follow-up assessments at 3 and 9 months post-intervention.

Other: conventional physiotherapy follow-up assessments

Interventions

AI-based physiotherapy and 3 and 9 months follow-up assessments

Experimental group (Follow-up)

conventional physiotherapy and 3 and 9 months follow-up assessments

Control group (Follow-up)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who completed the intervention phase of the previous trial (202411044RINC)
  • Age 20-65 years
  • Able to attend follow-up assessments at 3 and 9 months

You may not qualify if:

  • Withdrawal from the original trial
  • Cancer recurrence or new cancer-related treatment interfering with functional assessment
  • Unable to communicate or comply with follow-up visits

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, Taiwan

Taipei, 100, Taiwan

RECRUITING

Related Publications (25)

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    PMID: 35821447BACKGROUND
  • 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
  • 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, Liang WA, Hsu CY, Guo SL, Lien SH, Tseng HJ, Chao YH. Functional outcomes and quality of life after a 6-month early intervention program for oral cancer survivors: a single-arm clinical trial. PeerJ. 2018 Feb 21;6:e4419. doi: 10.7717/peerj.4419. eCollection 2018.

    PMID: 29492348BACKGROUND
  • Cocks K, Wells JR, Johnson C, Schmidt H, Koller M, Oerlemans S, Velikova G, Pinto M, Tomaszewski KA, Aaronson NK, Exall E, Finbow C, Fitzsimmons D, Grant L, Groenvold M, Tolley C, Wheelwright S, Bottomley A; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group. Content validity of the EORTC quality of life questionnaire QLQ-C30 for use in cancer. Eur J Cancer. 2023 Jan;178:128-138. doi: 10.1016/j.ejca.2022.10.026. Epub 2022 Nov 1.

    PMID: 36436330BACKGROUND
  • 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
  • Dijkstra PU, Huisman PM, Roodenburg JL. Criteria for trismus in head and neck oncology. Int J Oral Maxillofac Surg. 2006 Apr;35(4):337-42. doi: 10.1016/j.ijom.2005.08.001. Epub 2005 Nov 8.

    PMID: 16280237BACKGROUND
  • Falz R, Bischoff C, Thieme R, Lassing J, Mehdorn M, Stelzner S, Busse M, Gockel I. Effects and duration of exercise-based prehabilitation in surgical therapy of colon and rectal cancer: a systematic review and meta-analysis. J Cancer Res Clin Oncol. 2022 Sep;148(9):2187-2213. doi: 10.1007/s00432-022-04088-w. Epub 2022 Jun 13.

    PMID: 35695931BACKGROUND
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    PMID: 23433470BACKGROUND
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    PMID: 34609700BACKGROUND
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    PMID: 24985733BACKGROUND
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    PMID: 26956713BACKGROUND
  • Li YH, Chang WC, Chiang TE, Lin CS, Chen YW. Mouth-opening device as a treatment modality in trismus patients with head and neck cancer and oral submucous fibrosis: a prospective study. Clin Oral Investig. 2019 Jan;23(1):469-476. doi: 10.1007/s00784-018-2456-4. Epub 2018 Apr 26.

    PMID: 29696422BACKGROUND
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    PMID: 33407922BACKGROUND
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    PMID: 36290545BACKGROUND
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    PMID: 35297966BACKGROUND
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    PMID: 34110101BACKGROUND
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    PMID: 26878553BACKGROUND
  • 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
  • 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
  • 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

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Yueh-Hsia Chen, Ph.D.

    National Taiwan University, College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueh-Hsia Chen, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Follow-up only, no new intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2025

First Posted

November 20, 2025

Study Start

December 6, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 16, 2025

Record last verified: 2025-10

Locations