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

Study Overview

• Status: Completed
• Conditions: Profound Multiple Intellectual Disabilities
• Intervention / Treatment: Behavioral: Visual-behavioral Scale at day 1; Behavioral: Test-retest at the end of 2 weeks; Behavioral: Test at 6 months

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.

• Study Type: Observational
• Enrollment (Actual): 232

Contacts and Locations

Study Locations

• France
  • Var
    • Hyères, Var, France, 83407
      • Hôpital San Salvadour

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Profound multiple intellectual disabilities patients aged 3 years or older.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Marie-Christine ROUSSEAU, MD, AP-HP, Hôpital San Salvadour, 83407 Hyères; Study Chair: Soizic CHARBONNIER, Orthoptist, Cabinet du Lycée

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Actual): April 13, 2021
• Study Completion (Actual): April 13, 2021

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Profound Multiple Intellectual Disabilities; Visual-Behavioral Scale
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability
• Other Study ID Numbers: P140712; RCB: 2016-A00278-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No