Clinical trial NCT06785051: AI-based Physiotherapy for Oral Cancer Patients
Official title: Effects of AI-Based Physiotherapy on Mandibular Mobility, Shoulder Function, Whole-Body Physical Function, and Quality of Life in Oral Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Cancer
Keywords: Artificial intelligence
Oral cancer
Maximum interincisal opening
Physical function
Prehabilitation
Physiotherapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline in maximal mouth opening
timeFrame: baseline, pre-intervention, 3-months post-intervention
measure: Change from baseline in shoulder joint range of motion
timeFrame: baseline, pre-intervention, 3-months post-intervention
Secondary outcomes:
measure: Change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire
timeFrame: baseline, pre-intervention, 3-months post-intervention
measure: Change from baseline in health-related function on EORTC QLQ-C30 questionnaire
timeFrame: baseline, pre-intervention, 3-months post-intervention
measure: Change from baseline in whole-body physical function on 6-minute walk test
timeFrame: baseline, pre-intervention, 3-months post-intervention
measure: Change from baseline in shoulder pain
timeFrame: baseline, pre-intervention, 3-months post-intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University, College of Medicine
name: Yueh-Hsia Chen, PhD
role: PRINCIPAL_INVESTIGATOR
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