Clinical trial NCT03040609: Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)
Official title: Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Profound Multiple Intellectual Disabilities
Keywords: Profound Multiple Intellectual Disabilities
Visual-Behavioral Scale
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 232
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Profound multiple intellectual disabilities patients aged 3 years or older.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concordance of classification
timeFrame: throughout the study: 31 months
Secondary outcomes:
measure: Structure of the scale
timeFrame: throughout the study: 31 months
measure: Reproducibility of scale
timeFrame: throughout the study: 31 months
measure: Feasibility of visio-behavioral scale
timeFrame: throughout the study: 31 months
measure: Sensitivity to change
timeFrame: throughout the study: 31 months
measure: Uniformity of use of the scale
timeFrame: throughout the study: 31 months
measure: Prevalence of the visual disorder
timeFrame: throughout the study: 31 months
Other outcomes:
Locations:
city: Hyères
country: France
facility: Hôpital San Salvadour
state: Var
Study officials:
affiliation: AP-HP, Hôpital San Salvadour, 83407 Hyères
name: Marie-Christine ROUSSEAU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cabinet du Lycée
name: Soizic CHARBONNIER, Orthoptist
role: STUDY_CHAIR
References: