Profound Multiple Intellectual Disabilities
Conditions
Keywords
Profound Multiple Intellectual Disabilities, Visual-Behavioral Scale
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: * 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.
Detailed description
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.
Interventions
BEHAVIORALVisual-behavioral Scale at day 1
To perform the classification with the scale by caregiver.
BEHAVIORALTest-retest at the end of 2 weeks
To perform the classification with the scale by orthoptist at the end of 2 weeks
BEHAVIORALTest at 6 months
To perform the classification with the scale by orthoptist at the end 6 months.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Causal brain injury occurred before the age of 3 years. * 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
* Acute intercurrent pathology precluding examinations. * Patient with hypersensitivity to tropicamide, atropine or benzalkonium chloride. * Angle closure glaucoma suspect patient. * Patient with severe hypertension. * Short life expectancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Structure of the scale | throughout the study: 31 months | Statistical analysis to validate the structure of the scale. |
| 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. |
| Sensitivity to change | throughout the study: 31 months | Statistical analysis to evaluate the sensitivity to change. |
Countries
France
Outcome results
None listed