Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision) (PLH-Vision)
2021年9月22日 更新者：Assistance Publique - Hôpitaux de Paris
The main objective of this study is to develop and validate a visio-behavioral scale of visual abilities for subjects with profound multiple intellectual disabilities.
The secondary objectives of the study are:
- to validate the structure of the scale.
- to evaluate the reproducibility of scale with the intra- and inter-examiners, and the influence of the different professions of examiners.
- to evaluate the feasibility of visio-behavioral scale.
- to evaluate the sensitivity to change.
- to study the uniformity of use of the scale depending on the type of patients (age, disability level, pathology).
- to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.
研究概览
地位
完全的
详细说明
This study includes 3 phases:
- Elaboration of a list of behavioral items by a group of multi-disciplinary expertise (physicians, nurses, caregivers, ophthalmologies, orthoptists) based on their clinical experiences.
- Development of the scale based on the sample obtained by a prospective multicenter research trial.
- Validation of the sample obtained by a prospective transversal multicenter study.
This study will be performed in 5 centers in France. The enrollment of patients planned for 24 months targeting 310 patients. The duration of follow-up of the study for each patient will be varied according to the group of patients, il will be 1 day for group 1, 2 weeks for group 2, or 6 months for group 3.
研究类型
观察性的
注册 (实际的)
232
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Var
-
Hyères、Var、法国、83407
- Hôpital San Salvadour
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
3年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Profound multiple intellectual disabilities patients aged 3 years or older.
描述
Inclusion Criteria:
- Causal brain injury occurred before the age of 3 years.
- Severe or deep mental retardation as defined by DSM IV.
- Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders.
- Score of Gross Motor Function Classification System [Palisano 1997] is III, IV or V.
- Score of Functional Independence Measure < 55.
- Subject aged ≥3 years (because the visio-behavioral scale is not adapted for children younger than 3 years).
- Beneficiary of a social protection.
- Written consent signed by guardian or legal representative, or parents in case of a minor subject.
Exclusion Criteria:
- Acute intercurrent pathology precluding examinations.
- Patient with hypersensitivity to tropicamide, atropine or benzalkonium chloride.
- Angle closure glaucoma suspect patient.
- Patient with severe hypertension.
- Short life expectancy.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Group 1
The duration of follow-up of group 1 in the study is 1 day.
|
To perform the classification with the scale by caregiver.
To perform the classification with the scale by orthoptist at the end of 2 weeks
To perform the classification with the scale by orthoptist at the end 6 months.
|
|
Group 2
The duration of follow-up of group 2 in the study is 2 weeks.
|
To perform the classification with the scale by orthoptist at the end of 2 weeks
To perform the classification with the scale by orthoptist at the end 6 months.
|
|
Group 3
The duration of follow-up of group 3 in the study is 6 months.
|
To perform the classification with the scale by orthoptist at the end 6 months.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Concordance of classification
大体时间：throughout the study: 31 months
|
Statistical analysis: concordance between the classification obtained by caregiver with the scale, and the classification obtained by orthoptist-ophthalmology.
|
throughout the study: 31 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Structure of the scale
大体时间：throughout the study: 31 months
|
Statistical analysis to validate the structure of the scale.
|
throughout the study: 31 months
|
|
Reproducibility of scale
大体时间：throughout the study: 31 months
|
Statistical analysis to evaluate the reproducibility of scale with the intra- and inter-examiners, and the influence of the different professions of examiners.
|
throughout the study: 31 months
|
|
Feasibility of visio-behavioral scale
大体时间：throughout the study: 31 months
|
Statistical analysis to evaluate by the proportion of patients who have the complet examination, the average of time to all examens, the tolerance data. feasibility of visio-behavioral scale. |
throughout the study: 31 months
|
|
Sensitivity to change
大体时间：throughout the study: 31 months
|
Statistical analysis to evaluate the sensitivity to change.
|
throughout the study: 31 months
|
|
Uniformity of use of the scale
大体时间：throughout the study: 31 months
|
Statistical analysis to assess the uniformity of use of the scale depending on the type of patients (age, disability level, pathology).
|
throughout the study: 31 months
|
|
Prevalence of the visual disorder
大体时间：throughout the study: 31 months
|
Statistical analysis to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.
|
throughout the study: 31 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Marie-Christine ROUSSEAU, MD、AP-HP, Hôpital San Salvadour, 83407 Hyères
- 学习椅：Soizic CHARBONNIER, Orthoptist、Cabinet du Lycée
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年7月20日
初级完成 (实际的)
2021年4月13日
研究完成 (实际的)
2021年4月13日
研究注册日期
首次提交
2016年12月12日
首先提交符合 QC 标准的
2017年1月31日
首次发布 (估计)
2017年2月2日
研究记录更新
最后更新发布 (实际的)
2021年9月23日
上次提交的符合 QC 标准的更新
2021年9月22日
最后验证
2021年2月1日
更多信息
与本研究相关的术语
其他研究编号
- P140712
- RCB: 2016-A00278-43 (其他标识符：ANSM)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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