AI-based Physiotherapy for Oral Cancer Patients

Not Applicable

Recruiting

• Conditions: Oral Cancer

• Registration Number: NCT06785051
• Lead Sponsor: National Taiwan University Hospital

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-20
• Study Start: 2025-02-19
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in maximal mouth opening	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	baseline, pre-intervention, 3-months post-intervention	Average range of motion of shoulder abduction measured 3 times in degrees

Secondary Outcome Measures

Name	Time	Method
Change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire	baseline, pre-intervention, 3-months post-intervention	A total scale from 1 to 100. Higher scores indicate greater disability.
Change from baseline in health-related function on EORTC QLQ-C30 questionnaire	baseline, pre-intervention, 3-months post-intervention	A total scale from 1 to 100. Higher scores indicate greater function.
Change from baseline in whole-body physical function on 6-minute walk test	baseline, pre-intervention, 3-months post-intervention	Walking distance measured in meters.
Change from baseline in shoulder pain	baseline, pre-intervention, 3-months post-intervention	Visual analog scale from 0 to 10. Higher scores indicate most pain.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan