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

Mahidol University

Status: Completed

Conditions: Healthy; Head and Neck Cancer

Treatments: Device: VFSS and FOIS; Device: Rehabilitation assessment software

Study type: Interventional

Funder types: Other

Identifiers

NCT05141539

COA. MURA2021/73

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria in Phase 2

• Occupational therapist

  1. This study requires the subject to be between 18 and 80 years old.
  2. The subject needs to be Thai.
  3. The subject can communicate in the Thai language.
  4. Working as an occupational therapist in Ramathibodhi hospital.
  5. The subject is consent.

• Head and neck cancer patients

  1. This study requires the subject to be between 18 and 80 years old.
  2. The subject needs to have stable vital signs.
  3. The subject can make the body steady sit on the chair longer than 30 minutes.
  4. The subject is diagnosed with head and neck cancer and treated at Ramathibodhi hospital.
  5. Eating Assessment Tool (EAT-10) score is more than or equals 3.
  6. Montreal Cognitive Assessment (MOCA) score is more than or equals 23.
  7. The subject is consent.

Exclusion Criteria in Phase 2

• Occupational therapist

  1. Cannot participate in the experiment.
  2. The therapist denied or withdrew.

• Head and neck cancer patients

  1. Have pain around the examination area such as oral mucosa, tongue, and neck.
  2. Participate in chemotherapy.
  3. Cannot participant until the end of the experiment.
  4. The subject denied or withdrew.

Inclusion Criteria in Phase 3

• Dysphagic Specialist

  1. The age is more than 18 years old.
  2. The specialist is required to be Thai.
  3. The specialist can communicate in the Thai language.
  4. Working in oropharyngeal swallowing rehabilitation in the dysphagic unit at Ramathibodhi hospital for more than 3 years.
  5. The specialist has papers related to swallowing rehabilitation.
  6. The specialist is consent.

• Observers

  1. This study requires the subject to be between 18 and 80 years old.
  2. The observer can communicate in the Thai language.
  3. The observer needs to be Thai.
  4. Working in swallowing rehabilitation in Ramathibodhi hospital for more than a year.
  5. 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

  1. Cannot participant in the experiment.
  2. The specialist denied or withdrew.

• Observers

  1. Have a relationship with software development.
  2. Cannot participate in the study until the end of the experiment.
  3. 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Rehabilitation assessment software

Experimental group

Description:

This arm applies the developed rehabilitation assessment software by using two web cameras placed in the front and the side of the subject. The subject sits between two cameras. The observer asks the subject to move the head in each direction, to open the mouth, and to move the tongue. The software will measure CROM, mouth opening, and tongue movement.

Treatment:

Device: Rehabilitation assessment software

video-fluoroscopic swallowing and FOIS.

Experimental group

Description:

This arm applies video-fluoroscopic swallowing (VFSS) and functional oral intake scale (FOIS) to measure the direct, dynamic view of oral, pharyngeal, and upper esophageal function during swallowing with food and liquid mixed with barium, and the functional intake of dysphagic patients, respectively.

Treatment:

Device: Rehabilitation assessment software

Device: VFSS and FOIS