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

16. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

15

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Taiwan
      • Taipei, Taiwan, 100
        • School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: AI-Assisted Physiotherapy Group
AI-assisted physiotherapy system
Atferdsmessig: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility and Intervention Adherence
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximal mouth opening (MMO)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Taiwan University Hospital

Etterforskere

  • Hovedetterforsker: Yueh-Hsia Chen, PhD, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

27. juli 2026

Primær fullføring (Antatt)

31. juli 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

26. mai 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 202601018RIND

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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