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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
This study will recruit 15 oral cancer patients for feasibility testing, and the duration of participation for each subject is 4 to 6 weeks
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Taipei, Taiwan
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.
Time frame: 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.
Time frame: At the post-intervention endpoint (4 to 6 weeks)
Maximal mouth opening (MMO)
Measured clinically in millimeters (mm) using TheraBite ROM scale to assess the severity and changes in trismus.
Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)
Cervical Range of Motion (ROM)
Cervical range of motion will be measured in degrees using standard clinical goniometry
Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)
Shoulder Range of Motion (ROM)
Shoulder joint range of motion will be measured in degrees using standard clinical goniometry
Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)
Upper Extremity Function
Evaluated using a standardized upper extremity function questionnaire. Lower scores represent better functional status.
Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)
Quality of Life (QoL)
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.
Time frame: Baseline and post-intervention endpoint (4 to 6 weeks)
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