Clinical trial NCT05141539: Rehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients
Official title: Rehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Head and Neck Cancer
Keywords: Head and Neck Neoplasms
DNA Damage
Fibrosis
Humans Inflammation
Neoplasms
Radiation Injuries
Radiotherapy
Transforming Growth Factor beta
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Intra-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.
timeFrame: One hour
measure: Inter-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.
timeFrame: One hour
measure: Concurrent measurement validity between the developed rehabilitation assessment software and the standard CROM measurement method.
timeFrame: One hour
measure: Criterion-related validity between the developed rehabilitation assessment software, and VFSS and FOIS.
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Phaya Thai
country: Thailand
facility: Department of Rehabilitation Medicine, Ramathibodhi Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Panrasee Ritthipravat
role: PRINCIPAL_INVESTIGATOR
References: