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Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)

NCT03040609 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 232

Last updated 2021-09-23

No results posted yet for this study

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.

Conditions

  • Profound Multiple Intellectual Disabilities

Interventions

BEHAVIORAL

Visual-behavioral Scale at day 1

To perform the classification with the scale by caregiver.

BEHAVIORAL

Test-retest at the end of 2 weeks

To perform the classification with the scale by orthoptist at the end of 2 weeks

BEHAVIORAL

Test at 6 months

To perform the classification with the scale by orthoptist at the end 6 months.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Marie-Christine ROUSSEAU, MD · AP-HP, Hôpital San Salvadour, 83407 Hyères

  • Soizic CHARBONNIER, Orthoptist · Cabinet du Lycée

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2021-04-13
Completion
2021-04-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03040609 on ClinicalTrials.gov