AI-based Physiotherapy for Oral Cancer Patients

Официальное название

Effects of AI-Based Physiotherapy on Mandibular Mobility, Shoulder Function, Whole-Body Physical Function, and Quality of Life in Oral Cancer Patients

Обзор

This study examines the effects of AI-based physiotherapy on oral function, shoulder function, whole-body physical function, and quality of life in oral cancer patients. One hundred patients will be recruited before surgery, chemotherapy, or radiotherapy and randomly assigned to an experimental group receiving 12 weeks of AI-guided physiotherapy or a control group receiving usual care. Both groups will perform jaw, neck, and shoulder exercises, with the experimental group using a mobile app to monitor progress. Assessments at baseline, pre-intervention, and 3 months post-intervention will measure maximal in the maximum interincisal opening (MIO), joint range of motion (ROM), pain, endurance (e.g., 6-minute walk test), upper extremity function, and quality of life.

Подробное описание

This study examines the effects of AI-based physiotherapy on oral function (e.g., mouth opening), shoulder function (e.g., shoulder joint range of motion and upper extremity function), whole-body physical function (e.g., 6-minute walk test), and health-related quality of life. 100 newly diagnosed oral cancer patients will be recruited before surgery, chemotherapy, or radiotherapy and randomly assigned to two groups. The experimental group will receive AI-based physiotherapy for 12 weeks, including postural correction exercises guided by AI technology, while the control group will receive usual care. Both groups will perform jaw, neck, and shoulder exercises, with the experimental group using a mobile app to monitor progress and record their exercise diaries. Assessments at baseline, pre-intervention, and 3 months post-intervention will measure the maximum interincisal opening (MIO), joint range of motion (ROM), pain, endurance, and upper extremity function using the Disabilities of the Arm, Shoulder, and Hand (DASH) scores, and quality of life using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).

Вмешательства

• Поведенческое AI-based physiotherapy
  jaw, neck, shoulder ROM exercises, and scapular-focused exercises guided by AI technology, 30 minutes of intervention, once a week, and a total of 12 weeks
• Поведенческое Conventional physiotherapy
  jaw, neck, shoulder ROM exercises, and scapular-focused exercises, 30 minutes of intervention, once a week, and a total of 12 weeks
• Поведенческое Scar management
  scar massage and jaw-mobilizing exercises combined with devices or depressors

Первичные конечные точки

• Change from baseline in maximal mouth opening [Срок оценки: baseline, pre-intervention, 3-months post-intervention]
• Change from baseline in shoulder joint range of motion [Срок оценки: baseline, pre-intervention, 3-months post-intervention]

Вторичные конечные точки (4)

• Change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire [Срок оценки: baseline, pre-intervention, 3-months post-intervention]
• Change from baseline in health-related function on EORTC QLQ-C30 questionnaire [Срок оценки: baseline, pre-intervention, 3-months post-intervention]
• Change from baseline in whole-body physical function on 6-minute walk test [Срок оценки: baseline, pre-intervention, 3-months post-intervention]
• Change from baseline in shoulder pain [Срок оценки: baseline, pre-intervention, 3-months post-intervention]

Критерии участия

Критерии включения

• Newly diagnosed oral cancer patients who are scheduled to receive cancer-related treatments (e.g., oral cancer surgery, radiotherapy, chemotherapy, or chemoradiotherapy).
• Age between 20 and 65 years.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 2 центра

• National Taiwan University Hospital — Taipei
• Taipei Veterans General Hospital — Taipei

Публикации

• 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
• 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. PMID 22180114
• 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. PMID 32783637
• Chen 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. PMID 31291694
• 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
• 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 34412536
• 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 32760097
• 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 29492348

Идентификаторы

NCT: NCT06785051 · 202411044RINC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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