AI (Artificial Intelligence)NCT07635381
A Feasibility Study of AI-Assisted Physiotherapy for Oral Cancer Patients
A study testing AI-assisted physiotherapy in people with AI (Artificial Intelligence) and Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- AI (Artificial Intelligence), Oral Cancer
- What is being tested?
- AI-assisted physiotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Could not communicate
- Had any disorder that could influence movement performance (e.g., stroke, Parkinsonism, head injury)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Taipei, 100
Yueh-Hsia Chen, Ph.D., +886-2-33668133, yuehhsiachen@ntu.edu.tw
About this study
Official title: A Feasibility Study of AI-Assisted Physiotherapy for Oromandibular and Neck-Shoulder Mobility in 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.
Read the 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.
- Conditions
- AI (Artificial Intelligence), Oral Cancer
- Being tested
- AI-assisted physiotherapy
- Keywords
- Oral cancer, Artificial intelligence, Maximum interincisal opening, Physiotherapy, Range of motion, Neck and shoulder
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted physiotherapyBehavioural
This study will recruit 15 oral cancer patients for feasibility testing, and the duration of participation for each subject is 4 to 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Physiotherapy Group | Experimental | AI-assisted physiotherapy system Receives: Behavioral: AI-assisted physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the post-intervention endpoint (4 to 6 weeks)
Secondary outcomes (5)
Maximal mouth opening (MMO)
Measured clinically in millimeters (mm) using TheraBite ROM scale to assess the severity and changes in trismus.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention endpoint (4 to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start27 Jul 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AI (Artificial Intelligence)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yueh-Hsia Chen, PhD, Principal investigator, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635381
- Sponsor's protocol ID
- 202601018RIND
- Status last verified
- Jul 2026
- First submitted
- 26 May 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy considerations and institutional regulations. Although the AI system processes de-identified keypoint data, the dataset may still contain information that could potentially be re-identified. Data sharing may be considered upon reasonable request and subject to institutional review and data protection policies.
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.
PubMed 31407421Pauli 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.
PubMed 26878553Pauli 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.
PubMed 24175896
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of AI-Assisted Physiotherapy for Oromandibular and Neck-Shoulder Mobility in Oral Cancer Patients
- ClinicalTrials.gov ID
- NCT07635381
- Acronym / sponsor ID
- 202601018RIND
- Conditions
- AI (Artificial Intelligence), Oral Cancer
- Keywords
- Oral cancer, Artificial intelligence, Maximum interincisal opening, Physiotherapy, Range of motion, Neck and shoulder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 27 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Physiotherapy Group | Experimental | Behavioral: AI-assisted physiotherapyAI-assisted physiotherapy system |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Could not communicate
- Had any disorder that could influence movement performance (e.g., stroke, Parkinsonism, head injury)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-assisted physiotherapyThis study will recruit 15 oral cancer patients for feasibility testing, and the duration of participation for each subject is 4 to 6 weeks | Behavioural | AI-Assisted Physiotherapy Group |
Primary outcome
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.
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.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 31407421Sandler 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.
- Background: PubMed 26878553Pauli 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.
- Background: PubMed 24175896Pauli 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy considerations and institutional regulations. Although the AI system processes de-identified keypoint data, the dataset may still contain information that could potentially be re-identified. Data sharing may be considered upon reasonable request and subject to institutional review and data protection policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yueh-Hsia Chen, PhD principal investigator
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted physiotherapy in people with AI (Artificial Intelligence) and Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueh-Hsia Chen, PhD (+886-2-33668133, yuehhsiachen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Intervention Adherence (time frame: At the post-intervention endpoint (4 to 6 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07635381, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.