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临床试验/NCT02480452
NCT02480452已完成不适用

Brain Lesions in Relation to Motor Profiles of Children With Cerebral Visual Impairment.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
L94 visual perceptual battery

研究概览

简要总结

The overall goal of this research proposal is the early prediction of the emergence of CVI and its characteristics on the basis of neuroimaging data.

The different steps that will be taken to achieve this goal will be:

  1. To characterize CVI deficits in children;
  2. To correlate the CVI characteristics with their motor profiles;
  3. To characterize brain lesions in children with CVI;
  4. To link the motor profile, CVI profile and brain metrics of the children.

Over the last 10 years, 488 children with and without CP have consulted at the CVI clinic in Leuven. All these children had a comprehensive visual perceptual assessment, cognitive evaluation and an ophthalmological assessment. Summarizing these data results in a quantitative visual perceptual profile for each individual patient. The goal is to prospectively extend this database to a number of 600 children. The project's primary objective is to relate the presence of CVI to the motor profiles of these children.

Of these 488 children, 300 have an MRI available. The goal is to analyze the retrospective MRI data of this clinical group and to prospectively extend this database by reassuring newly registered children will receive MRI with DTI. This will allow the investigation of the correlation between the brain metrics and the CVI characteristics in a large cohort.

详细描述

Objective 1 &2: to investigate the relationship between the presence of CVI and the motor profiles of children diagnosed with CVI.

Part 1 Retrospective data A database, registering all children diagnosed with or at risk for CVI, is available through the Centre For Developmental Disabilities, Leuven. All these children have consulted at the CVI clinic. Their developmental age ranges between 3 and 6 years. All these children have had a thorough work-up, so that information is available regarding the diagnosis of CVI (L94 visual perceptual battery test score10 and CVI questionnaire11), the cognitive abilities of the child (performance and verbal IQ using WISC-II, SON-R or WPPSI-III-NL) together with the test results regarding motor functioning: visuospatial functioning (VMI12 and TVPS13), motor coherence tasks and gross motor function (movement ABC14).

All children standardly received a complete ophthalmological assessment. The consensus eye protocol, as introduced by the Flemish working group on CVI, was performed in each child, evaluating fixation of eyes, position and motility, acuity, refraction, contrast sensitivity, visual field, visual attention and viewing distance.

Part 2 Prospective data The database will continuously be updated and therefore, data from all new consulting children will be added consecutively.

Prospectively, a new test for the diagnosis of CVI will be applied. It concerns a newly developed tool for diagnosis of CVI, based on the L-POST and developed in collaboration with the research group of J. Wagemans. Normative data have been gathered for the age ranges 3 to 6 years. The diagnosis of CVI is made by comparing the results of the visual perceptual tests to the developmental age of the child, with a result <Pc 5 necessary for CVI to be confirmed.15 These tests are standardly performed during the consultations and do not require any additional time nor tests.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • mental age between 3 y and 6 y
  • suspicion of CVI

排除标准

  • mental age below 3y

结局指标

主要结局

L94 visual perceptual battery

时间窗: baseline

Diagnostic assessment for CVI

FIORI scale

时间窗: baseline

Outcome parameters for quantitative scoring of brain MRI

次要结局

  • Visual motor assessment(baseline)
  • Gross motor function(baseline)
  • Motion coherence tasks(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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