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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03040609
Other study ID # P140712
Secondary ID RCB: 2016-A00278
Status Completed
Phase
First received
Last updated
Start date July 20, 2017
Est. completion date April 13, 2021

Study information

Verified date February 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 232
Est. completion date April 13, 2021
Est. primary completion date April 13, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Visual-behavioral Scale at day 1
To perform the classification with the scale by caregiver.
Test-retest at the end of 2 weeks
To perform the classification with the scale by orthoptist at the end of 2 weeks
Test at 6 months
To perform the classification with the scale by orthoptist at the end 6 months.

Locations

Country Name City State
France Hôpital San Salvadour Hyères Var

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Structure of the scale Statistical analysis to validate the structure of the scale. throughout the study: 31 months
Secondary 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. throughout the study: 31 months
Secondary 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
Secondary Sensitivity to change Statistical analysis to evaluate the sensitivity to change. throughout the study: 31 months
Secondary 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
Secondary 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