Profound Multiple Intellectual Disabilities Clinical Trial
Official title:
Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)
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. ;