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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral AI-assisted physiotherapy
  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 outcome measures

• Feasibility and Intervention Adherence [Time frame: At the post-intervention endpoint (4 to 6 weeks)]
• System Usability and Acceptability [Time frame: At the post-intervention endpoint (4 to 6 weeks)]

Secondary outcome measures (5)

• Maximal mouth opening (MMO) [Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)]
• Cervical Range of Motion (ROM) [Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)]
• Shoulder Range of Motion (ROM) [Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)]
• Upper Extremity Function [Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)]
• Quality of Life (QoL) [Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Taiwan · 1 center

• School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan Un — Taipei

Publications

• 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
• 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
• 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

Identifiers

NCT: NCT07635381 · 202601018RIND

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗