Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)
NCT ID: NCT03040609
Last Updated: 2021-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
232 participants
OBSERVATIONAL
2017-07-20
2021-04-13
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
The duration of follow-up of group 1 in the study is 1 day.
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.
Group 2
The duration of follow-up of group 2 in the study is 2 weeks.
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.
Group 3
The duration of follow-up of group 3 in the study is 6 months.
Test at 6 months
To perform the classification with the scale by orthoptist at the end 6 months.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient with hypersensitivity to tropicamide, atropine or benzalkonium chloride.
* Angle closure glaucoma suspect patient.
* Patient with severe hypertension.
* Short life expectancy.
3 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Marie-Christine ROUSSEAU, MD
Role: PRINCIPAL_INVESTIGATOR
AP-HP, Hôpital San Salvadour, 83407 Hyères
Soizic CHARBONNIER, Orthoptist
Role: STUDY_CHAIR
Cabinet du Lycée
Locations
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Hôpital San Salvadour
Hyères, Var, France
Countries
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Other Identifiers
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RCB: 2016-A00278-43
Identifier Type: OTHER
Identifier Source: secondary_id
P140712
Identifier Type: -
Identifier Source: org_study_id
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