Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Concordance of classification
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <
- •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.
排除标准
- •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.
结局指标
主要结局
Concordance of classification
时间窗: throughout the study: 31 months
Statistical analysis: concordance between the classification obtained by caregiver with the scale, and the classification obtained by orthoptist-ophthalmology.
次要结局
- Sensitivity to change(throughout the study: 31 months)
- Reproducibility of scale(throughout the study: 31 months)
- Prevalence of the visual disorder(throughout the study: 31 months)
- Structure of the scale(throughout the study: 31 months)
- Feasibility of visio-behavioral scale(throughout the study: 31 months)
- Uniformity of use of the scale(throughout the study: 31 months)