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临床试验/NCT05981482
NCT05981482招募中不适用

Accuracy and Utility of the Oxford Visual Perception Screening (OxVPS), a Screening for Visual Perception Difficulties in Stroke Survivors

Durham University3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
3
主要终点
Reliability of OxVPS

研究概览

简要总结

The goal of this observational study is to learn how well the Oxford Visual Perception Screening (OxVPS) tool can identify stroke survivors with visual perception difficulties.

The main aim is to determine the accuracy and utility of the OxVPS compared to the current gold standard assessment in stroke survivors. In other words, how well can the Oxford Visual Perception Screening tool (OxVPS) identify stroke patients with visual perception problems?

Participants will completed the OxVPS and the current gold standards visual perception screening tool.

详细描述

This is a non-experimental cross-sectional study. It aims to compare the new screening test OxVPS to the gold standard tests for visual perception difficulties.

Patients will be recruited at stroke rehabilitation units at hospitals in the North East of England and in Oxfordshire.

Following consent:

  • Participants will complete the paper version of the Oxford Visual Perception Screen OxVPS (~15 min).
  • Participants will complete screening for visual perception problems with a validated screening tool (~30-120 min).
  • Participants will complete screening for cognition alterations and sensory vision with validated screening tools. (~30 min)
  • Stroke details (time since stroke, severity) and demographic data (age, socio-economic status) will be collected to evaluated representativeness of the sample.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patients with a clinical diagnosis of stroke (ischemic stroke and/or intracerebral haemorrhage).
  • Within 6 weeks of confirmed stroke.

排除标准

  • Insufficient understanding of English
  • Clinical concerns that patient is unable follow simple instructions.
  • Clinical concerns that patient is unable to concentrate for 15 minutes.
  • No capacity to provide informed consent.

结局指标

主要结局

Reliability of OxVPS

时间窗: 2 weeks

The inter-rater reliability of OxVPS will be evaluated through a Bland-Altman analysis \[26\]: we will calculate the difference in OxVPS scores between raters for each patient. Subsequently, we will plot the difference in scores as a function on the average score to evaluate a bias between the raters (mean difference) that might vary based on severity of a patient's visual perceptual problems. We will report the mean difference, standard deviation, and limits of agreement within where 95% of differences between raters fall. A t-test will indicate if the mean difference is significantly different from 0. Analyses will be performed in R with the functions from blandr package (e.g. blandr.statistics and blandr.draw) or functions from a similar package.

Validity of OxVPS

时间窗: All testing completed in 2 weeks

Convergent and discriminate validity will be assessed. Convergent validity expressed as a correlation between total score on OxVPS and RPAB. Discriminate validity to be expressed as correlation between OxVPS score and scores of cognitive and sensory vision assessments. Both calculated by a non-parametric Spearman correlation and estimate a 95% confidence interval. The analysis can be completed through the cor.test function in the base package of R.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kate Cowen

Postdoc researcher

Durham University

研究点 (3)

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