Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)

Conditions
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Profound Multiple Intellectual Disabilities

Intervention / Treatment
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* Behavioral: Visual-behavioral Scale at day 1
* Behavioral: Test-retest at the end of 2 weeks
* Behavioral: Test at 6 months


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>The duration of follow-up of group 1 in the study is 1 day. | Behavioral: Visual-behavioral Scale at day 1<br>* To perform the classification with the scale by caregiver.<br>Behavioral: Test-retest at the end of 2 weeks<br>* To perform the classification with the scale by orthoptist at the end of 2 weeks<br>Behavioral: Test at 6 months<br>* To perform the classification with the scale by orthoptist at the end 6 months.<br>|
| Group 2<br>The duration of follow-up of group 2 in the study is 2 weeks. | Behavioral: Test-retest at the end of 2 weeks<br>* To perform the classification with the scale by orthoptist at the end of 2 weeks<br>Behavioral: Test at 6 months<br>* To perform the classification with the scale by orthoptist at the end 6 months.<br>|
| Group 3<br>The duration of follow-up of group 3 in the study is 6 months. | Behavioral: Test at 6 months<br>* To perform the classification with the scale by orthoptist at the end 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of classification | Statistical analysis: concordance between the classification obtained by caregiver with the scale, and the classification obtained by orthoptist-ophthalmology. | throughout the study: 31 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structure of the scale | Statistical analysis to validate the structure of the scale. | throughout the study: 31 months | 
| Reproducibility of scale | 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 | 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 | Statistical analysis to evaluate the sensitivity to change. | throughout the study: 31 months | 
| Uniformity of use of the scale | 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 | Statistical analysis to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects. | throughout the study: 31 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Profound Multiple Intellectual Disabilities, Visual-Behavioral Scale