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

• ClinicalTrials.gov Identifier: NCT03040609
• Recruitment Status: Active, not recruiting
• First Posted: February 2, 2017
• Last Update Posted: February 5, 2020
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease	Intervention/treatment
Profound Multiple Intellectual Disabilities	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 Design

• Study Type: Observational
• Actual Enrollment: 232 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)
• Actual Study Start Date: July 20, 2017
• Estimated Primary Completion Date: September 20, 2020
• Estimated Study Completion Date: September 20, 2020

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Concordance of classification [ Time Frame: 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 :

1. Structure of the scale [ Time Frame: throughout the study: 31 months ]
   Statistical analysis to validate the structure of the scale.
2. Reproducibility of scale [ Time Frame: 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.
3. Feasibility of visio-behavioral scale [ Time Frame: 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.

4. Sensitivity to change [ Time Frame: throughout the study: 31 months ]
   Statistical analysis to evaluate the sensitivity to change.
5. Uniformity of use of the scale [ Time Frame: 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).
6. Prevalence of the visual disorder [ Time Frame: throughout the study: 31 months ]
   Statistical analysis to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.

Eligibility Criteria

• Ages Eligible for Study: 3 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Profound multiple intellectual disabilities patients aged 3 years or older.

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.

Contacts and Locations

Locations

France

Hôpital San Salvadour

Hyères, Var, France, 83407

Sponsors and Collaborators

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

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT03040609
• Other Study ID Numbers: P140712; RCB: 2016-A00278-43 ( Other Identifier: ANSM )
• First Posted: February 2, 2017
• Last Update Posted: February 5, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Profound Multiple Intellectual Disabilities; Visual-Behavioral Scale

Additional relevant MeSH terms:

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders