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

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Healthy
• Interventions: Device: Rehabilitation assessment software; Device: VFSS and FOIS

• Registration Number: NCT05141539
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-02
• Primary Completion: 2023-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
video-fluoroscopic swallowing and FOIS.	Rehabilitation assessment software	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.
Rehabilitation assessment software	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.
video-fluoroscopic swallowing and FOIS.	VFSS 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.

Primary Outcome Measures

Name	Time	Method
Intra-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.	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.	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.	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.	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.

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, Ramathibodhi Hospital; 🇹🇭 Phaya Thai, Bangkok, Thailand