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Completed

NCT Number: NCT03040609

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

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.

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Key information

Conditions

Profound Multiple Intellectual Disabilities

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital San Salvadour

Hyères, Var, 83407, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Visual-behavioral Scale at day 1

Behavioral

To perform the classification with the scale by caregiver.

Test-retest at the end of 2 weeks

Behavioral

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

Test at 6 months

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Structure of the scale

    Time frame: throughout the study: 31 months

    Statistical analysis to validate the structure of the scale.

  2. 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.

  3. 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.

  4. Sensitivity to change

    Time frame: throughout the study: 31 months

    Statistical analysis to evaluate the sensitivity to change.

  5. 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).

  6. 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PLH-Vision

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 2, 2017
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.