HealthyNCT05141539
Rehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients
A study testing Rehabilitation assessment software and VFSS and FOIS in people with Healthy and Head and Neck Cancer, run by Mahidol University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Healthy, Head and Neck Cancer
- What is being tested?
- Rehabilitation assessment software and VFSS and FOIS
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
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- Cannot participant until the end of the experiment.
- The subject denied or withdrew.
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Rehabilitation Medicine, Ramathibodhi Hospital
Phaya Thai, Bangkok, 10400
About this study
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.
- Conditions
- Healthy, Head and Neck Cancer
- Being tested
- Rehabilitation assessment software, VFSS and FOIS
- Keywords
- Head and Neck Neoplasms, DNA Damage, Fibrosis, Humans Inflammation, Neoplasms, Radiation Injuries, Radiotherapy, Transforming Growth Factor beta
- Medical subject headings
- Head and Neck Neoplasms, Fibrosis, Neoplasms, Radiation Injuries, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation assessment softwareDevice
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 FOISDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation assessment software | Experimental | 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. Receives: Device: Rehabilitation assessment software |
| video-fluoroscopic swallowing and FOIS. | Experimental | 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. Receives: Device: Rehabilitation assessment software; Device: VFSS and FOIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One hour
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.
Measured: One hour
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.
Measured: One hour
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).
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Feb 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panrasee Ritthipravat, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141539
- Sponsor's protocol ID
- COA. MURA2021/73
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data requires to be confidential. It is prohibited to share the participant-level data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Assessment and Progress Tracking System Based on Video Images for Dysphagic Patients
- ClinicalTrials.gov ID
- NCT05141539
- Acronym / sponsor ID
- COA. MURA2021/73
- Conditions
- Healthy, Head and Neck Cancer
- Keywords
- Head and Neck Neoplasms, DNA Damage, Fibrosis, Humans Inflammation, Neoplasms, Radiation Injuries, Radiotherapy, Transforming Growth Factor beta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation assessment software | Experimental | Device: Rehabilitation assessment softwareThis 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. |
| video-fluoroscopic swallowing and FOIS. | Experimental | Device: Rehabilitation assessment software, Device: VFSS and FOISThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Occupational therapist
- Head and neck cancer patients
- Dysphagic Specialist
- Observers
- Head and neck cancer patients The criteria are the same as the inclusion criteria of head and neck cancer patients in phase 2.
Key exclusion criteria (16 listed)
- Occupational therapist
- Head and neck cancer patients
- Dysphagic Specialist
- Observers
- Head and neck cancer patients The criteria are the same as the exclusion criteria of head and neck cancer patients in phase 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation assessment softwareIn 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. | Device | Rehabilitation assessment software, video-fluoroscopic swallowing and FOIS. |
| VFSS and FOISIn 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. | Device | video-fluoroscopic swallowing and FOIS. |
Primary outcome
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.
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No. The data requires to be confidential. It is prohibited to share the participant-level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panrasee Ritthipravat principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation assessment software and VFSS and FOIS in people with Healthy and Head and Neck Cancer, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method. (time frame: One hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.