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

Profound Multiple Intellectual Disabilities Clinical Trial

— PLH-Vision  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040609
• Other study ID #: P140712
• Secondary ID: RCB: 2016-A00278
• Status: Completed
• Start date: July 20, 2017
• Est. completion date: April 13, 2021

Study information

• Verified date: February 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: April 13, 2021
• Est. primary completion date: April 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intellectual Disability
• Profound Multiple Intellectual Disabilities

Intervention

Behavioral:
• Visual-behavioral Scale at day 1
To perform the classification with the scale by caregiver.
• Test-retest at the end of 2 weeks
To perform the classification with the scale by orthoptist at the end of 2 weeks
• Test at 6 months
To perform the classification with the scale by orthoptist at the end 6 months.

Locations

Country	Name	City	State
France	Hôpital San Salvadour	Hyères	Var

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Structure of the scale	Statistical analysis to validate the structure of the scale.	throughout the study: 31 months
Secondary	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
Secondary	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
Secondary	Sensitivity to change	Statistical analysis to evaluate the sensitivity to change.	throughout the study: 31 months
Secondary	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
Secondary	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