AI-based Physiotherapy for Oral Cancer Patients

NCT06785051 | Recruiting

• 1 other identifier: 202411044RINC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Oral Cancer

Keywords

Artificial intelligence; Oral cancer; Maximum interincisal opening; Physical function; Prehabilitation; Physiotherapy

Outcome Measures

Primary Outcomes (2)

• Change from baseline in maximal mouth opening

  Average maximal mouth opening measured 3 times in mm

  baseline, pre-intervention, 3-months post-intervention

• Change from baseline in shoulder joint range of motion

  Average range of motion of shoulder abduction measured 3 times in degrees

  baseline, pre-intervention, 3-months post-intervention

Secondary Outcomes (4)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

AI-based physiotherapy

Behavioral: AI-based physiotherapy; Behavioral: Scar management

Control group

ACTIVE COMPARATOR

Usual care

Behavioral: Conventional physiotherapy; Behavioral: Scar management

Interventions

AI-based physiotherapy BEHAVIORAL

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

Experimental group

Conventional physiotherapy BEHAVIORAL

jaw, neck, shoulder ROM exercises, and scapular-focused exercises, 30 minutes of intervention, once a week, and a total of 12 weeks

Control group

Scar management BEHAVIORAL

scar massage and jaw-mobilizing exercises combined with devices or depressors

Control group; Experimental group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

NOT YET RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Yueh-Hsia Chen, PhD

  National Taiwan University, College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueh-Hsia Chen, PhD

CONTACT

+886-2-33668133; yuehhsiachen@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: February 19, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 16, 2025

Record last verified: 2024-12

Locations

TW (2)