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

Completed

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

• Registration Number: NCT03040609
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-02
• Study Start: 2017-07-20
• Status Verified: 2021-02
• Primary Completion: 2021-04-13
• Study Completion: 2021-04-13
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Test-retest at the end of 2 weeks	The duration of follow-up of group 2 in the study is 2 weeks.
Group 2	Test at 6 months	The duration of follow-up of group 2 in the study is 2 weeks.
Group 3	Test at 6 months	The duration of follow-up of group 3 in the study is 6 months.
Group 1	Test-retest at the end of 2 weeks	The duration of follow-up of group 1 in the study is 1 day.
Group 1	Visual-behavioral Scale at day 1	The duration of follow-up of group 1 in the study is 1 day.
Group 1	Test at 6 months	The duration of follow-up of group 1 in the study is 1 day.

Primary Outcome Measures

Name	Time	Method
Concordance of classification	throughout the study: 31 months	Statistical analysis: concordance between the classification obtained by caregiver with the scale, and the classification obtained by orthoptist-ophthalmology.

Secondary Outcome Measures

Name	Time	Method
Sensitivity to change	throughout the study: 31 months	Statistical analysis to evaluate the sensitivity to change.
Reproducibility of scale	throughout the study: 31 months	Statistical analysis to evaluate the reproducibility of scale with the intra- and inter-examiners, and the influence of the different professions of examiners.
Prevalence of the visual disorder	throughout the study: 31 months	Statistical analysis to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.
Structure of the scale	throughout the study: 31 months	Statistical analysis to validate the structure of the scale.
Feasibility of visio-behavioral scale	throughout the study: 31 months	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.
Uniformity of use of the scale	throughout the study: 31 months	Statistical analysis to assess the uniformity of use of the scale depending on the type of patients (age, disability level, pathology).

Trial Locations

Locations (1)

Hôpital San Salvadour; 🇫🇷 Hyères, Var, France