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

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

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.

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.

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.