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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Head and Neck Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Rehabilitation assessment software

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Rehabilitation assessment software

Intervention Type DEVICE

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 FOIS

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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.

Exclusion Criteria

* 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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No