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| ID | Type | Description | Link |
|---|---|---|---|
| RCB: 2016-A00278-43 | Other Identifier | ANSM |
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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:
This study includes 3 phases:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | The duration of follow-up of group 1 in the study is 1 day. |
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| Group 2 | The duration of follow-up of group 2 in the study is 2 weeks. |
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| Group 3 | The duration of follow-up of group 3 in the study is 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual-behavioral Scale at day 1 | Behavioral | To perform the classification with the scale by caregiver. |
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| Measure | Description | Time Frame |
|---|---|---|
| Concordance of classification | Statistical analysis: concordance between the classification obtained by caregiver with the scale, and the classification obtained by orthoptist-ophthalmology. | throughout the study: 31 months |
| Measure | Description | Time Frame |
|---|---|---|
| Structure of the scale | Statistical analysis to validate the structure of the scale. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Profound multiple intellectual disabilities patients aged 3 years or older.
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Christine ROUSSEAU, MD | AP-HP, Hôpital San Salvadour, 83407 Hyères | Principal Investigator |
| Soizic CHARBONNIER, Orthoptist | Cabinet du Lycée | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital San Salvadour | Hyères | Var | 83407 | France |
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| Test-retest at the end of 2 weeks | Behavioral | To perform the classification with the scale by orthoptist at the end of 2 weeks |
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| Test at 6 months | Behavioral | To perform the classification with the scale by orthoptist at the end 6 months. |
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| 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. | throughout the study: 31 months |
| Sensitivity to change | Statistical analysis to evaluate the sensitivity to change. | 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). | 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. | throughout the study: 31 months |