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NCT Number: NCT06785051

AI-based Physiotherapy for Oral Cancer Patients

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.

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Key information

Conditions

Oral Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital, Taipei, Taiwan

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Scar management

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  1. Change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire

    Time frame: baseline, pre-intervention, 3-months post-intervention

    A total scale from 1 to 100. Higher scores indicate greater disability.

  2. Change from baseline in health-related function on EORTC QLQ-C30 questionnaire

    Time frame: baseline, pre-intervention, 3-months post-intervention

    A total scale from 1 to 100. Higher scores indicate greater function.

  3. Change from baseline in whole-body physical function on 6-minute walk test

    Time frame: baseline, pre-intervention, 3-months post-intervention

    Walking distance measured in meters.

  4. Change from baseline in shoulder pain

    Time frame: baseline, pre-intervention, 3-months post-intervention

    Visual analog scale from 0 to 10. Higher scores indicate most pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Yueh-Hsia Chen, PhD

CONTACT

[email protected]

+886-2-33668133

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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