Rehabilitation assessment and progress tracking system based on video images for dysphagic patients

Phase 2

Recruiting

• Conditions: HealthyDysphagiaHead and neck cancer; Head and Neck Neoplasms; DNA Damage; Fibrosis; Humans; Inflammation; Neoplasms; Radiation Injuries; Radiotherapy; Transforming Growth Factor beta

• Registration Number: TCTR20211113001
• Lead Sponsor: Research Management and Development Division, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-13
• Study Completion: 2022-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Phase 2
Occupational Therapist in Phase 2
(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.

Inclusion Criteria of head and neck cancer patients in Phase 2
(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) EAT-10 score is more than or equals 3.
(6) MOCA score is more than or equals 23.
(7) The subject is consent.

Phase 3
Inclusion criteria of dysphagic specialist in Phase 3
(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.

Inclusion criteria of 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.

Inclusion criteria of 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

Phase 2
Exclusion Criteria of an occupational therapist in Phase 2.
(1) Cannot participate in the experiment.
(2) The therapist denied or withdrew.

Exclusion Criteria of head and neck cancer patients in Phase 2
(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.

Phase 3
Exclusion criteria of dysphagic specialist in Phase 3
(1) Cannot participant in the experiment.
(2) The specialist denied or withdrew.

Exclusion criteria of observers in Phase 3
(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.

Exclusion criteria of head and neck cancer patients in Phase 3.
The criteria are the same as the exclusion criteria of head and neck cancer patients in phase 2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reliability and Validity 1 month after the intervention. Measurement outcome between the developed software and the standard measurement method.

Secondary Outcome Measures

Name	Time	Method
Criterion-related validity 1 month after the intervention. Measurement outcome between the developed software, and VFSS and FOIS.