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

2026年7月16日 更新者：National Taiwan University Hospital

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

15

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 台湾
      • Taipei、台湾、100
        • School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：AI-Assisted Physiotherapy Group
AI-assisted physiotherapy system
行为的：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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Feasibility and Intervention Adherence
大体时间：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.
At the post-intervention endpoint (4 to 6 weeks)
System Usability and Acceptability
大体时间：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.
At the post-intervention endpoint (4 to 6 weeks)

次要结果测量

结果测量
措施说明
大体时间
Maximal mouth opening (MMO)
大体时间：Baseline and post-intervention endpoint (4 to 6 weeks)
Measured clinically in millimeters (mm) using TheraBite ROM scale to assess the severity and changes in trismus.
Baseline and post-intervention endpoint (4 to 6 weeks)
Cervical Range of Motion (ROM)
大体时间：Baseline and post-intervention endpoint (4 to 6 weeks)
Cervical range of motion will be measured in degrees using standard clinical goniometry
Baseline and post-intervention endpoint (4 to 6 weeks)
Shoulder Range of Motion (ROM)
大体时间：Baseline and post-intervention endpoint (4 to 6 weeks)
Shoulder joint range of motion will be measured in degrees using standard clinical goniometry
Baseline and post-intervention endpoint (4 to 6 weeks)
Upper Extremity Function
大体时间：Baseline and post-intervention endpoint (4 to 6 weeks)
Evaluated using a standardized upper extremity function questionnaire. Lower scores represent better functional status.
Baseline and post-intervention endpoint (4 to 6 weeks)
Quality of Life (QoL)
大体时间：Baseline and post-intervention endpoint (4 to 6 weeks)
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.
Baseline and post-intervention endpoint (4 to 6 weeks)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Taiwan University Hospital

调查人员

  • 首席研究员：Yueh-Hsia Chen, PhD、School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月27日

初级完成 (估计的)

2027年7月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年5月26日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年7月20日

上次提交的符合 QC 标准的更新

2026年7月16日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 202601018RIND

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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