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

February 8, 2023 updated by: Mahidol University
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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Phaya Thai, Bangkok, Thailand, 10400
        • Department of Rehabilitation Medicine, Ramathibodhi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rehabilitation assessment software
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.
Device: Rehabilitation assessment software

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.
EXPERIMENTAL: video-fluoroscopic swallowing and FOIS.
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.
Device: Rehabilitation assessment software

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.

Device: VFSS and FOIS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One hour
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.
One hour
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.
One hour
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).
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

September 30, 2023

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (ACTUAL)

December 2, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA. MURA2021/73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data requires to be confidential. It is prohibited to share the participant-level data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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