A Feasibility Study of AI-Assisted Physiotherapy for Oral Cancer Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Could not communicate
Had any disorder that could influence movement performance (e.g., stroke, Parkinsonism, head injury)
Trial design
Design model
Single group
Treatments tested in this trial
AI-assisted physiotherapy
BehavioralThis study will recruit 15 oral cancer patients for feasibility testing, and the duration of participation for each subject is 4 to 6 weeks
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: AI-Assisted Physiotherapy GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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