Back to resultsRehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients
Primary Purpose
Healthy, Head and Neck Cancer
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Rehabilitation assessment software
VFSS and FOIS
Sponsored by
About this trial
This is an interventional diagnostic trial for Healthy focused on measuring Head and Neck Neoplasms, DNA Damage, Fibrosis, Humans Inflammation, Neoplasms, Radiation Injuries, Radiotherapy, Transforming Growth Factor beta
Eligibility Criteria
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.
Sites / Locations
- Department of Rehabilitation Medicine, Ramathibodhi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Rehabilitation assessment software
video-fluoroscopic swallowing and FOIS.
Arm 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.
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.
Outcomes
Primary Outcome Measures
Intra-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.
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.
Inter-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.
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.
Concurrent measurement validity between the developed rehabilitation assessment software and the standard CROM measurement method.
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.
Criterion-related validity between the developed rehabilitation assessment software, and VFSS and FOIS.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05141539
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Head and Neck Cancer
Keywords
Head and Neck Neoplasms, DNA Damage, Fibrosis, Humans Inflammation, Neoplasms, Radiation Injuries, Radiotherapy, Transforming Growth Factor beta
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation assessment software
Arm Type
Experimental
Arm 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.
Arm Title
video-fluoroscopic swallowing and FOIS.
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Rehabilitation assessment software
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
VFSS and FOIS
Intervention Description
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 Outcome Measure Information:
Title
Intra-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.
Description
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.
Time Frame
One hour
Title
Inter-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.
Description
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.
Time Frame
One hour
Title
Concurrent measurement validity between the developed rehabilitation assessment software and the standard CROM measurement method.
Description
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.
Time Frame
One hour
Title
Criterion-related validity between the developed rehabilitation assessment software, and VFSS and FOIS.
Description
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).
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panrasee Ritthipravat
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Ramathibodhi Hospital
City
Phaya Thai
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data requires to be confidential. It is prohibited to share the participant-level data.
Learn more about this trial
Rehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients
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