Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)
Study Details
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:
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to validate the structure of the scale.
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to evaluate the reproducibility of scale with the intra- and inter-examiners, and the influence of the different professions of examiners.
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to evaluate the feasibility of visio-behavioral scale.
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to evaluate the sensitivity to change.
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to study the uniformity of use of the scale depending on the type of patients (age, disability level, pathology).
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to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This study includes 3 phases:
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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.
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Development of the scale based on the sample obtained by a prospective multicenter research trial.
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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
Arms and Interventions
| Arm | 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
- 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
- Structure of the scale [throughout the study: 31 months]
Statistical analysis to validate the structure of the scale.
- 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.
- 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.
- Sensitivity to change [throughout the study: 31 months]
Statistical analysis to evaluate the sensitivity to change.
- 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).
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Causal brain injury occurred before the age of 3 years.
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Severe or deep mental retardation as defined by DSM IV.
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Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders.
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Score of Gross Motor Function Classification System [Palisano 1997] is III, IV or V.
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Score of Functional Independence Measure < 55.
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Subject aged ≥3 years (because the visio-behavioral scale is not adapted for children younger than 3 years).
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Beneficiary of a social protection.
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Written consent signed by guardian or legal representative, or parents in case of a minor subject.
Exclusion Criteria:
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Acute intercurrent pathology precluding examinations.
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Patient with hypersensitivity to tropicamide, atropine or benzalkonium chloride.
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Angle closure glaucoma suspect patient.
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Patient with severe hypertension.
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Short life expectancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P140712
- RCB: 2016-A00278-43