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

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Profound Multiple Intellectual Disabilities

Treatments

Behavioral: Test at 6 months

Behavioral: Test-retest at the end of 2 weeks

Behavioral: Visual-behavioral Scale at day 1

Study type

Observational

Funder types

Other

Identifiers

NCT03040609

P140712

RCB: 2016-A00278-43 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

232 patients

Sex

All

Ages

3+ years old

Volunteers

No Healthy Volunteers

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.