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.
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 Type
OBSERVATIONAL
Enrollment
232
To perform the classification with the scale by caregiver.
To perform the classification with the scale by orthoptist at the end of 2 weeks
To perform the classification with the scale by orthoptist at the end 6 months.
Hôpital San Salvadour
Hyères, Var, France
Concordance of classification
Statistical analysis: concordance between the classification obtained by caregiver with the scale, and the classification obtained by orthoptist-ophthalmology.
Time frame: throughout the study: 31 months
Structure of the scale
Statistical analysis to validate the structure of the scale.
Time frame: throughout the study: 31 months
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.
Time frame: throughout the study: 31 months
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.
Time frame: throughout the study: 31 months
Sensitivity to change
Statistical analysis to evaluate the sensitivity to change.
Time frame: throughout the study: 31 months
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).
Time frame: throughout the study: 31 months
Prevalence of the visual disorder
Statistical analysis to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.
Time frame: throughout the study: 31 months
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