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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yueh-Hsia Chen, PhD
- Número de teléfono: +886-2-33668133
- Correo electrónico: yuehhsiachen@ntu.edu.tw
Ubicaciones de estudio
-
-
-
Taipei, Taiwán, 100
- School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
-
Contacto:
- Yueh-Hsia Chen, Ph.D.
- Número de teléfono: +886-2-33668133
- Correo electrónico: yuehhsiachen@ntu.edu.tw
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility and Intervention Adherence
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximal mouth opening (MMO)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yueh-Hsia Chen, PhD, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202601018RIND
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .