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

NCT07635381 | Not Yet Recruiting

• 1 other identifier: 202601018RIND
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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 4 to 6 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.

Conditions

Oral Cancer; AI (Artificial Intelligence)

Keywords

Oral cancer; Artificial intelligence; Maximum interincisal opening; Physiotherapy; Range of motion; Neck and shoulder

Outcome Measures

Primary Outcomes (2)

• Feasibility and Intervention Adherence

  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.

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

• System Usability and Acceptability

  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.

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

Secondary Outcomes (5)

• Maximal mouth opening (MMO)

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

• Cervical Range of Motion (ROM)

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

• Shoulder Range of Motion (ROM)

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

• Upper Extremity Function

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

• Quality of Life (QoL)

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

Study Arms (1)

AI-Assisted Physiotherapy Group

EXPERIMENTAL

AI-assisted physiotherapy system

Behavioral: AI-assisted physiotherapy

Interventions

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

AI-Assisted Physiotherapy Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

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

Taipei, 100, Taiwan

Location

Related Publications (3)

• Sandler ML, Lazarus CL, Ru M, Sharif KF, Yue LE, Griffin MJ, Likhterov I, Chai RL, Buchbinder D, Urken ML, Ganz C. Effects of jaw exercise intervention timing on outcomes following oral and oropharyngeal cancer surgery: Pilot study. Head Neck. 2019 Nov;41(11):3806-3817. doi: 10.1002/hed.25908. Epub 2019 Aug 12.

  PMID: 31407421 BACKGROUND

• Pauli N, Svensson U, Karlsson T, Finizia C. Exercise intervention for the treatment of trismus in head and neck cancer - a prospective two-year follow-up study. Acta Oncol. 2016 Jun;55(6):686-92. doi: 10.3109/0284186X.2015.1133928. Epub 2016 Feb 15.

  PMID: 26878553 BACKGROUND

• Pauli N, Fagerberg-Mohlin B, Andrell P, Finizia C. Exercise intervention for the treatment of trismus in head and neck cancer. Acta Oncol. 2014 Apr;53(4):502-9. doi: 10.3109/0284186X.2013.837583. Epub 2013 Oct 31.

  PMID: 24175896 BACKGROUND

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

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

  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: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, prospective, non-randomized pilot study where all recruited participants receive the same AI-assisted physiotherapy intervention. Pre- and post-intervention evaluations are performed on the same group to analyze functional changes.

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 9, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)