AI-based Physiotherapy for Oral Cancer Patients

ConditionOral Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Could not communicate.

Had any disorder that could influence movement performance.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from baseline in maximal mouth opening

Average maximal mouth opening measured 3 times in mm

Time frame
baseline, pre-intervention, 3-months post-intervention
2

Change from baseline in shoulder joint range of motion

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

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

Secondary outcomes

1

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

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

Time frame
baseline, pre-intervention, 3-months post-intervention
2

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

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

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

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

Walking distance measured in meters.

Time frame
baseline, pre-intervention, 3-months post-intervention
4

Change from baseline in shoulder pain

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.