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NCT Number: NCT07635381

A Feasibility Study of AI-Assisted Physiotherapy for Oral Cancer Patients

This study aims to evaluate the feasibility, safety, and acceptability of a newly developed artificial intelligence (AI)-assisted physiotherapy system for oromandibular and neck-shoulder range of motion (ROM) in patients who have undergone treatment for oral cancer.

In this single-group, prospective, non-randomized pilot study, recruited participants will receive 4 to 6 weeks of AI-assisted physiotherapy. Participants will undergo a comprehensive clinical evaluation at baseline and post-intervention. During the intervention period, the AI system will perform a daily automated assessment to dynamically generate and adjust personalized exercise programs. Participants will perform these prescribed programs 3 to 4 times daily. Pre- and post-intervention changes, along with key feasibility parameters, acceptability, and safety metrics, will be statistically analyzed to inform future definitive trials.

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Key information

Conditions

AI (Artificial Intelligence) Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oral Cancer Stomatognathic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Taipei, 100, Taiwan

Location contact

Yueh-Hsia Chen, Ph.D.

CONTACT

[email protected]

+886-2-33668133

About this study

This is a single-group, prospective, non-randomized pilot feasibility study. Oral cancer patients with trismus or neck-shoulder impairment will be trained to exercise their jaw or neck-shoulder muscles using an AI-assisted physiotherapy assessment system, which is reliable and valid. The study aims to recruit approximately 15 patients who meet the inclusion and exclusion criteria. This sample size is sufficient for the primary goal of assessing study procedures, recruitment rates, and study adherence of this supportive care intervention, rather than determining definitive treatment efficacy.

Participants will undergo a comprehensive clinical evaluation at baseline and post-intervention. The 4-to-6-week intervention features a daily automated assessment using a previously validated AI-assisted physiotherapy assessment system. Based on these assessments, an established system clinical workflow then dynamically generates a personalized exercise curriculum for that day. Participants will perform these exercise programs 3 to 4 times daily.

Key feasibility metrics, including recruitment rate, retention rate, intervention adherence, and system acceptability (SUS score), will be summarized using descriptive statistics. Adherence will be monitored automatically via server log data. Following the Intention-to-Treat (ITT) principle, technical dropouts who transition to face-to-face therapy will be documented as a feasibility outcome to identify technical barriers.

Preliminary efficacy will be evaluated by analyzing functional changes from baseline to endpoint, including Maximal Interincisal Opening (MIO), cervical and shoulder ROM, upper extremity function questionnaires, and quality-of-life questionnaires. Depending on data distribution, changes will be analyzed using the Paired t-test or the Wilcoxon Signed-Rank Test. Effect size estimates (Cohen's d) and their 95% confidence intervals will be calculated.

This study is expected to provide essential feasibility and safety evidence of an AI-assisted home-based exercise protocol, establishing a foundation and providing sample size calculations for a subsequent randomized controlled trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Oral cancer patients with trismus, clinical signs of neck or shoulder joint impairment after oral cancer surgery or radiotherapy in recent 12 months
  • Age between 20 and 70 years

Exclusion criteria

  • Could not communicate
  • Had any disorder that could influence movement performance (e.g., stroke, Parkinsonism, head injury)

Treatment and study plan

AI-assisted physiotherapy

Behavioral

This study will recruit 15 oral cancer patients for feasibility testing, and the duration of participation for each subject is 4 to 6 weeks

Primary outcomes

  1. Feasibility and Intervention Adherence

    Time frame: At the post-intervention endpoint (4 to 6 weeks)

    Feasibility will be evaluated by calculating the study retention rate, defined as the percentage of enrolled participants who successfully complete the entire study protocol and the post-intervention assessment. Intervention adherence will be automatically tracked and recorded via the system server log data, calculated as the percentage of completed AI-prescribed exercise sessions out of the total prescribed sessions over the 4-to-6-week period.

  2. System Usability and Acceptability

    Time frame: At the post-intervention endpoint (4 to 6 weeks)

    Evaluated using the Chinese version of the System Usability Scale (SUS). The SUS is a 10-item Likert scale providing a global view of subjective usability assessments. Scores range from 0 to 100, where higher scores indicate better usability and higher patient acceptability of the AI system.

Secondary outcomes

  1. Maximal mouth opening (MMO)

    Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)

    Measured clinically in millimeters (mm) using TheraBite ROM scale to assess the severity and changes in trismus.

  2. Cervical Range of Motion (ROM)

    Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)

    Cervical range of motion will be measured in degrees using standard clinical goniometry

  3. Shoulder Range of Motion (ROM)

    Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)

    Shoulder joint range of motion will be measured in degrees using standard clinical goniometry

  4. Upper Extremity Function

    Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)

    Evaluated using a standardized upper extremity function questionnaire. Lower scores represent better functional status.

  5. Quality of Life (QoL)

    Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)

    Evaluated using a cancer-specific quality of life questionnaire to assess subjective functional recovery and overall well-being. Higher scores represent better functional status and quality of life.

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

A Feasibility Study of AI-Assisted Physiotherapy for Oromandibular and Neck-Shoulder Mobility in Oral Cancer Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jul 20, 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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