AI-based Physiotherapy for Oral Cancer Patients

NCT ID: NCT06785051

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-19

Study Completion Date

2027-07-31

Brief Summary

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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

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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).

Conditions

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Oral Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

AI-based physiotherapy

Group Type EXPERIMENTAL

AI-based physiotherapy

Intervention Type 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

Scar management

Intervention Type BEHAVIORAL

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

Control group

Usual care

Group Type ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type 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

Intervention Type BEHAVIORAL

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

Interventions

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AI-based physiotherapy

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

Intervention Type BEHAVIORAL

Conventional physiotherapy

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

Intervention Type BEHAVIORAL

Scar management

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yueh-Hsia Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University, College of Medicine

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status NOT_YET_RECRUITING

Countries

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Taiwan

Central Contacts

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Yueh-Hsia Chen, PhD

Role: CONTACT

+886-2-33668133

Facility Contacts

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Yueh-Hsia Chen, PhD

Role: primary

Muh-Hwa Yang, PhD

Role: primary

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Other Identifiers

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202411044RINC

Identifier Type: -

Identifier Source: org_study_id

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