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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group (Follow-up) | Experimental | Participants who originally received AI-based physiotherapy will undergo follow-up assessments at 3 and 9 months post-intervention. |
|
| Control group (Follow-up) | Active Comparator | Participants who originally received conventional physiotherapy will undergo follow-up assessments at 3 and 9 months post-intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-based physiotherapy follow-up assessments | Other | AI-based physiotherapy and 3 and 9 months follow-up assessments |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Return-to-work status | yes/no, time to return, % returned | 3 months, 9 months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueh-Hsia Chen, Ph.D. | Contact | +886-2-33668133 | yuehhsiachen@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yueh-Hsia Chen, Ph.D. | National Taiwan University, College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan | Recruiting | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34577204 | Background | 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. | |
| 22180114 | Background | Baranano 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. |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
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Follow-up only, no new intervention
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| conventional physiotherapy follow-up assessments | Other | conventional physiotherapy and 3 and 9 months follow-up assessments |
|
| 32783637 | Background | Chen 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. |
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| 27002678 | Background | 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. |
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| 35695931 | Background | 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. |
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| 34609700 | Background | Jehn 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. |
| 24985733 | Background | Johnson 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. |
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| 29696422 | Background | 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. |
| 33407922 | Background | Loewen I, Jeffery CC, Rieger J, Constantinescu G. Prehabilitation in head and neck cancer patients: a literature review. J Otolaryngol Head Neck Surg. 2021 Jan 6;50(1):2. doi: 10.1186/s40463-020-00486-7. |
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| D009057 |
| Stomatognathic Diseases |