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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

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 Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Concordance of classification [ Time Frame: throughout the study: 31 months ]

Statistical analysis: concordance between the classification obtained by caregiver with the scale, and the classification obtained by orthoptist-ophthalmology.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Structure of the scale [ Time Frame: throughout the study: 31 months ]
    Statistical analysis to validate the structure of the scale.
  • Reproducibility of scale [ Time Frame: 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 [ Time Frame: 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.

  • Sensitivity to change [ Time Frame: throughout the study: 31 months ]
    Statistical analysis to evaluate the sensitivity to change.
  • Uniformity of use of the scale [ Time Frame: 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 [ Time Frame: throughout the study: 31 months ]
    Statistical analysis to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: December 12, 2016
Date Started: May 15, 2017
Date Completion: October 15, 2019
Last Updated: May 2, 2017
Last Verified: November 2016