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Completed

NCT Number: NCT05141539

Rehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients

The current cervical range of motion (CROM) and tongue movement measurement methods are not reliable between observers, which is not practical in real-world usage. This research is to develop the cervical range of motion measurement, and tongue movement estimation software, to compare between the developed software and the current measurement techniques, and to test in clinical aspects for reliability and validity assessment. The investigators investigate the developed software in healthy people in phase 1. In phases 2 and 3, the investigators compare the software to the standard measurement methods in dysphagic patients who have head and neck cancer for reliability and validity.

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Key information

Conditions

Healthy Bone Diseases Bone Diseases, Developmental Camurati-Engelmann Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fibrosis Genetic Diseases, Inborn Head and Neck Cancer Head and Neck Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site Osteochondrodysplasias Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine, Ramathibodhi Hospital

Phaya Thai, Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

in Phase 2

  • Occupational therapist
  • This study requires the subject to be between 18 and 80 years old.
  • The subject needs to be Thai.
  • The subject can communicate in the Thai language.
  • Working as an occupational therapist in Ramathibodhi hospital.
  • The subject is consent.
  • Head and neck cancer patients
  • This study requires the subject to be between 18 and 80 years old.
  • The subject needs to have stable vital signs.
  • The subject can make the body steady sit on the chair longer than 30 minutes.
  • The subject is diagnosed with head and neck cancer and treated at Ramathibodhi hospital.
  • Eating Assessment Tool (EAT-10) score is more than or equals 3.
  • Montreal Cognitive Assessment (MOCA) score is more than or equals 23.
  • The subject is consent.

Exclusion criteria

in Phase 2

  • Occupational therapist
  • Cannot participate in the experiment.
  • The therapist denied or withdrew.
  • Head and neck cancer patients
  • Have pain around the examination area such as oral mucosa, tongue, and neck.
  • Participate in chemotherapy.
  • Cannot participant until the end of the experiment.
  • The subject denied or withdrew.

Inclusion criteria

in Phase 3

  • Dysphagic Specialist
  • The age is more than 18 years old.
  • The specialist is required to be Thai.
  • The specialist can communicate in the Thai language.
  • Working in oropharyngeal swallowing rehabilitation in the dysphagic unit at Ramathibodhi hospital for more than 3 years.
  • The specialist has papers related to swallowing rehabilitation.
  • The specialist is consent.
  • Observers
  • This study requires the subject to be between 18 and 80 years old.
  • The observer can communicate in the Thai language.
  • The observer needs to be Thai.
  • Working in swallowing rehabilitation in Ramathibodhi hospital for more than a year.
  • The observer is consent.
  • Head and neck cancer patients The criteria are the same as the inclusion criteria of head and neck cancer patients in phase 2.

Exclusion criteria

in Phase 3

  • Dysphagic Specialist
  • Cannot participant in the experiment.
  • The specialist denied or withdrew.
  • Observers
  • Have a relationship with software development.
  • Cannot participate in the study until the end of the experiment.
  • The subject denied or withdrew.
  • Head and neck cancer patients The criteria are the same as the exclusion criteria of head and neck cancer patients in phase 2.

Treatment and study plan

Rehabilitation assessment software

Device

In phase 2, this software will be tested in occupational therapists, and head and neck cancer patients results for reliability and validity.

In phase 3, the experiment in the oropharyngeal dysphagia specialists results in content validity, the comparison between the developed software, and VFSS and FOIS results in criterion-related validity, and the experiment in head and neck cancer patients results in reliability.

VFSS and FOIS

Device

In phase 3, this study applies VFSS and FOIS for the head and neck cancer patients for comparison with the developed rehabilitation assessment software for criterion-related validity.

Primary outcomes

  1. Intra-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.

    Time frame: One hour

    The same investigator will repeat cervical range of motion measurement by using the developed rehabilitation software and the standard cervical range of motion (CROM) measurement method from the goniometer.

  2. Inter-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.

    Time frame: One hour

    The cervical range of motion (CROM) measurement by using the developed rehabilitation software and the standard CROM measurement method from the goniometer will be repeated by different observers.

  3. Concurrent measurement validity between the developed rehabilitation assessment software and the standard CROM measurement method.

    Time frame: One hour

    The correlation of the concurrent cervical range of motion (CROM) measurement outcome at approximately the same time between the developed rehabilitation assessment software and the standard CROM measurement method from the goniometer.

  4. Criterion-related validity between the developed rehabilitation assessment software, and VFSS and FOIS.

    Time frame: One month

    The criterion-related validity of the rehabilitation assessment software will be assessed by the correlation between the cervical range of motion measurement by the developed rehabilitation assessment software and the functional swallowing assessment by videofluoroscopic Swallowing Study (VFSS), and functional oral intake scale (FOIS).

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 2, 2021
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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