Oral CancerNCT07237672
AI Based Physiotherapy 3- and 9-Month Follow-Up in Oral Cancer Patients
A study testing AI-based physiotherapy follow-up assessments and conventional physiotherapy follow-up assessments in people with Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Oral Cancer
- What is being tested?
- AI-based physiotherapy follow-up assessments and conventional physiotherapy follow-up assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Dec 2025to Dec 2027
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan
Taipei, 100
Yueh-Hsia Chen, Ph.D
Yueh-Hsia Chen, Ph.D
About this study
Official title: Effects of AI Based Physiotherapy on Mandibular Mobility Shoulder Function Whole Body Physical Function Quality of Life and Return to Work in Oral Cancer Patients: 3- and 9-Month Postintervention Follow-Up
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.
Read the detailed description
This study is a continuation of our prior trial (ClinicalTrials.gov ID: 202411044RINC), which investigated the short-term effects of AI-based physiotherapy compared with conventional physiotherapy in oral cancer patients.
The current follow-up phase evaluates both groups at 3 and 9 months post-intervention to determine whether initial improvements are maintained and whether they translate into better long-term physical function, quality of life, and return-to-work outcomes. No additional interventions will be delivered; only follow-up assessments are planned.
- Conditions
- Oral Cancer
- Being tested
- AI-based physiotherapy follow-up assessments, conventional physiotherapy follow-up assessments
- Keywords
- Artificial intelligence, Oral cancer, Maximum interincisal opening, Physical function, Prehabilitation, Physiotherapy
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based physiotherapy follow-up assessmentsOther
AI-based physiotherapy and 3 and 9 months follow-up assessments
conventional physiotherapy follow-up assessmentsOther
conventional physiotherapy and 3 and 9 months follow-up assessments
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (Follow-up) | Experimental | Participants who originally received AI-based physiotherapy will undergo follow-up assessments at 3 and 9 months post-intervention. Receives: 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. Receives: Other: conventional physiotherapy follow-up assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder, and Hand outcome questionnaire
A total scale from 1 to 100. Higher scores indicate greater disability
Measured: 3 months, 9 months post-intervention
EORTC QLQ-C30 questionnaire
A total scale from 1 to 100. Higher scores indicate greater function
Measured: 3 months, 9 months post-intervention
Secondary outcomes (1)
Return-to-work status
yes/no, time to return, % returned
Measured: 3 months, 9 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start6 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yueh-Hsia Chen, Ph.D., Principal investigator, National Taiwan University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237672
- Sponsor's protocol ID
- 202412109RIND
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 34577204Baranano CF, Rosenthal EL, Morgan BA, McColloch NL, Magnuson JS. Dynasplint for the management of trismus after treatment of upper aerodigestive tract cancer: a retrospective study. Ear Nose Throat J. 2011 Dec;90(12):584-90. doi: 10.1177/014556131109001209.
PubMed 22180114Chen CC, Lin CC, Hsieh HP, Fu YC, Chen YJ, Lu TW. In vivo three-dimensional mandibular kinematics and functional point trajectories during temporomandibular activities using 3d fluoroscopy. Dentomaxillofac Radiol. 2021 Feb 1;50(2):20190464. doi: 10.1259/dmfr.20190464. Epub 2020 Aug 12.
PubMed 32783637Chen SC, Huang BS, Hung TM, Lin CY, Chang YL. Impact of physical and psychosocial dysfunction on return to work in survivors of oral cavity cancer. Psychooncology. 2019 Sep;28(9):1910-1917. doi: 10.1002/pon.5173. Epub 2019 Jul 23.
PubMed 31291694Chen 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 35821447Chen 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 34412536Chen 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 32760097Chen 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.
PubMed 29492348Cocks 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.
PubMed 36436330Cohen 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 27002678Dijkstra 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.
PubMed 16280237Falz 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.
PubMed 35695931Furtado DA, Pereira AA, Andrade Ade O, Bellomo DP Jr, da Silva MR. A specialized motion capture system for real-time analysis of mandibular movements using infrared cameras. Biomed Eng Online. 2013 Feb 22;12:17. doi: 10.1186/1475-925X-12-17.
PubMed 23433470Jehn P, Spalthoff S, Lentge F, Zeller AN, Tavassol F, Neuhaus MT, Eckstein FM, Kruskemper G, Gellrich NC, Korn P. Postoperative quality of life and therapy-related impairments of oral cancer in relation to time-distance since treatment. J Cancer Surviv. 2022 Dec;16(6):1366-1378. doi: 10.1007/s11764-021-01118-3. Epub 2021 Oct 5.
PubMed 34609700Johnson J, Johansson M, Ryden A, Houltz E, Finizia C. Impact of trismus on health-related quality of life and mental health. Head Neck. 2015 Nov;37(11):1672-9. doi: 10.1002/hed.23816. Epub 2015 Jan 27.
PubMed 24985733
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of AI Based Physiotherapy on Mandibular Mobility Shoulder Function Whole Body Physical Function Quality of Life and Return to Work in Oral Cancer Patients: 3- and 9-Month Postintervention Follow-Up
- ClinicalTrials.gov ID
- NCT07237672
- Acronym / sponsor ID
- 202412109RIND
- Conditions
- Oral Cancer
- Keywords
- Artificial intelligence, Oral cancer, Maximum interincisal opening, Physical function, Prehabilitation, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a continuation of our prior trial (ClinicalTrials.gov ID: 202411044RINC), which investigated the short-term effects of AI-based physiotherapy compared with conventional physiotherapy in oral cancer patients.
The current follow-up phase evaluates both groups at 3 and 9 months post-intervention to determine whether initial improvements are maintained and whether they translate into better long-term physical function, quality of life, and return-to-work outcomes. No additional interventions will be delivered; only follow-up assessments are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (Follow-up) | Experimental | Other: AI-based physiotherapy follow-up assessmentsParticipants who originally received AI-based physiotherapy will undergo follow-up assessments at 3 and 9 months post-intervention. |
| Control group (Follow-up) | Active comparator | Other: conventional physiotherapy follow-up assessmentsParticipants who originally received conventional physiotherapy will undergo follow-up assessments at 3 and 9 months post-intervention. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-based physiotherapy follow-up assessmentsAI-based physiotherapy and 3 and 9 months follow-up assessments | Other | Experimental group (Follow-up) |
| conventional physiotherapy follow-up assessmentsconventional physiotherapy and 3 and 9 months follow-up assessments | Other | Control group (Follow-up) |
Primary outcome
Disabilities of the Arm, Shoulder, and Hand outcome questionnaire
Time frame: 3 months, 9 months post-intervention
A total scale from 1 to 100. Higher scores indicate greater disability
EORTC QLQ-C30 questionnaire
Time frame: 3 months, 9 months post-intervention
A total scale from 1 to 100. Higher scores indicate greater function
1 secondary outcome
Return-to-work status
Time frame: 3 months, 9 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 34577204Badiola-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.
- Background: PubMed 22180114Baranano CF, Rosenthal EL, Morgan BA, McColloch NL, Magnuson JS. Dynasplint for the management of trismus after treatment of upper aerodigestive tract cancer: a retrospective study. Ear Nose Throat J. 2011 Dec;90(12):584-90. doi: 10.1177/014556131109001209.
- Background: PubMed 32783637Chen CC, Lin CC, Hsieh HP, Fu YC, Chen YJ, Lu TW. In vivo three-dimensional mandibular kinematics and functional point trajectories during temporomandibular activities using 3d fluoroscopy. Dentomaxillofac Radiol. 2021 Feb 1;50(2):20190464. doi: 10.1259/dmfr.20190464. Epub 2020 Aug 12.
- Background: PubMed 31291694Chen SC, Huang BS, Hung TM, Lin CY, Chang YL. Impact of physical and psychosocial dysfunction on return to work in survivors of oral cavity cancer. Psychooncology. 2019 Sep;28(9):1910-1917. doi: 10.1002/pon.5173. Epub 2019 Jul 23.
- Background: PubMed 35821447Chen 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.
- Background: PubMed 34412536Chen 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.
- Background: PubMed 32760097Chen 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.
- Background: PubMed 29492348Chen 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.
- Background: PubMed 36436330Cocks 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.
- Background: PubMed 27002678Cohen 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.
- Background: PubMed 16280237Dijkstra 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.
- Background: PubMed 35695931Falz 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.
Related trials for Oral Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 1/2
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
ALK-positive NSCLC, ALK-Positive Lung Cancer
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yueh-Hsia Chen, Ph.D. principal investigator
National Taiwan University, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based physiotherapy follow-up assessments and conventional physiotherapy follow-up assessments in people with 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 3 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 16 Dec 2025. 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, Ph.D. (+886-2-33668133, yuehhsiachen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder, and Hand outcome questionnaire (time frame: 3 months, 9 months post-intervention). The study lists 2 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 NCT07237672, which also lists 25 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 16 Dec 2025.