A Feasibility Study of AI-Assisted Physiotherapy for Oral Cancer Patients
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Yueh-Hsia Chen, PhD
- 電話番号：+886-2-33668133
- メール：yuehhsiachen@ntu.edu.tw
研究場所
-
-
-
Taipei、台湾、100
- School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
-
コンタクト：
- Yueh-Hsia Chen, Ph.D.
- 電話番号：+886-2-33668133
- メール：yuehhsiachen@ntu.edu.tw
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：AI-Assisted Physiotherapy Group
AI-assisted physiotherapy system
|
This study will recruit 15 oral cancer patients for feasibility testing, and the duration of participation for each subject is 4 to 6 weeks
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility and Intervention Adherence
時間枠：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
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximal mouth opening (MMO)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
|
協力者と研究者
捜査官
- 主任研究者：Yueh-Hsia Chen, PhD、School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 202601018RIND
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。