Effects of AI-Based Physiotherapy on Mandibular Mobility, Shoulder Function, Whole-Body Physical Function, and Quality of Life in Oral Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change from baseline in maximal mouth opening
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Experimental group
AI-based physiotherapy
Intervention: AI-based physiotherapy (Behavioral)
Experimental group
AI-based physiotherapy
Intervention: Scar management (Behavioral)
Control group
Usual care
Intervention: Conventional physiotherapy (Behavioral)
Control group
Usual care
Intervention: Scar management (Behavioral)
Outcomes
Primary Outcomes
Change from baseline in maximal mouth opening
Time Frame: baseline, pre-intervention, 3-months post-intervention
Average maximal mouth opening measured 3 times in mm
Change from baseline in shoulder joint range of motion
Time Frame: baseline, pre-intervention, 3-months post-intervention
Average range of motion of shoulder abduction measured 3 times in degrees
Secondary Outcomes
- Change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire(baseline, pre-intervention, 3-months post-intervention)
- Change from baseline in health-related function on EORTC QLQ-C30 questionnaire(baseline, pre-intervention, 3-months post-intervention)
- Change from baseline in whole-body physical function on 6-minute walk test(baseline, pre-intervention, 3-months post-intervention)
- Change from baseline in shoulder pain(baseline, pre-intervention, 3-months post-intervention)