跳至主要内容
临床试验/NCT05141539
NCT05141539已完成不适用

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

Mahidol University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Intra-rater reliability between the developed rehabilitation assessment software and the standard CROM measurement method.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 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.

时间窗: 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.

时间窗: 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.

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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