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Clinical Trials/NCT05141539
NCT05141539
Completed
Not Applicable

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

Mahidol University1 site in 1 country30 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Mahidol University
Enrollment
30
Locations
1
Primary Endpoint
Intra-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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).

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.

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.

Study Sites (1)

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