<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03040609</url>
  </required_header>
  <id_info>
    <org_study_id>P140712</org_study_id>
    <secondary_id>RCB: 2016-A00278-43</secondary_id>
    <nct_id>NCT03040609</nct_id>
  </id_info>
  <brief_title>Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)</brief_title>
  <acronym>PLH-Vision</acronym>
  <official_title>Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to develop and validate a visio-behavioral scale of&#xD;
      visual abilities for subjects with profound multiple intellectual disabilities.&#xD;
&#xD;
      The secondary objectives of the study are:&#xD;
&#xD;
        -  to validate the structure of the scale.&#xD;
&#xD;
        -  to evaluate the reproducibility of scale with the intra- and inter-examiners, and the&#xD;
           influence of the different professions of examiners.&#xD;
&#xD;
        -  to evaluate the feasibility of visio-behavioral scale.&#xD;
&#xD;
        -  to evaluate the sensitivity to change.&#xD;
&#xD;
        -  to study the uniformity of use of the scale depending on the type of patients (age,&#xD;
           disability level, pathology).&#xD;
&#xD;
        -  to study the prevalence of the visual disorder in profound multiple intellectual&#xD;
           disabilities subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study includes 3 phases:&#xD;
&#xD;
        -  Elaboration of a list of behavioral items by a group of multi-disciplinary expertise&#xD;
           (physicians, nurses, caregivers, ophthalmologies, orthoptists) based on their clinical&#xD;
           experiences.&#xD;
&#xD;
        -  Development of the scale based on the sample obtained by a prospective multicenter&#xD;
           research trial.&#xD;
&#xD;
        -  Validation of the sample obtained by a prospective transversal multicenter study.&#xD;
&#xD;
      This study will be performed in 5 centers in France. The enrollment of patients planned for&#xD;
      24 months targeting 310 patients. The duration of follow-up of the study for each patient&#xD;
      will be varied according to the group of patients, il will be 1 day for group 1, 2 weeks for&#xD;
      group 2, or 6 months for group 3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Actual">April 13, 2021</completion_date>
  <primary_completion_date type="Actual">April 13, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Concordance of classification</measure>
    <time_frame>throughout the study: 31 months</time_frame>
    <description>Statistical analysis: concordance between the classification obtained by caregiver with the scale, and the classification obtained by orthoptist-ophthalmology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Structure of the scale</measure>
    <time_frame>throughout the study: 31 months</time_frame>
    <description>Statistical analysis to validate the structure of the scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproducibility of scale</measure>
    <time_frame>throughout the study: 31 months</time_frame>
    <description>Statistical analysis to evaluate the reproducibility of scale with the intra- and inter-examiners, and the influence of the different professions of examiners.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of visio-behavioral scale</measure>
    <time_frame>throughout the study: 31 months</time_frame>
    <description>Statistical analysis to evaluate by the proportion of patients who have the complet examination, the average of time to all examens, the tolerance data.&#xD;
feasibility of visio-behavioral scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity to change</measure>
    <time_frame>throughout the study: 31 months</time_frame>
    <description>Statistical analysis to evaluate the sensitivity to change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uniformity of use of the scale</measure>
    <time_frame>throughout the study: 31 months</time_frame>
    <description>Statistical analysis to assess the uniformity of use of the scale depending on the type of patients (age, disability level, pathology).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of the visual disorder</measure>
    <time_frame>throughout the study: 31 months</time_frame>
    <description>Statistical analysis to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">232</enrollment>
  <condition>Profound Multiple Intellectual Disabilities</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>The duration of follow-up of group 1 in the study is 1 day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>The duration of follow-up of group 2 in the study is 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>The duration of follow-up of group 3 in the study is 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Visual-behavioral Scale at day 1</intervention_name>
    <description>To perform the classification with the scale by caregiver.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Test-retest at the end of 2 weeks</intervention_name>
    <description>To perform the classification with the scale by orthoptist at the end of 2 weeks</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Test at 6 months</intervention_name>
    <description>To perform the classification with the scale by orthoptist at the end 6 months.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Profound multiple intellectual disabilities patients aged 3 years or older.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Causal brain injury occurred before the age of 3 years.&#xD;
&#xD;
          -  Severe or deep mental retardation as defined by DSM IV.&#xD;
&#xD;
          -  Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor&#xD;
             disorders.&#xD;
&#xD;
          -  Score of Gross Motor Function Classification System [Palisano 1997] is III, IV or V.&#xD;
&#xD;
          -  Score of Functional Independence Measure &lt; 55.&#xD;
&#xD;
          -  Subject aged ≥3 years (because the visio-behavioral scale is not adapted for children&#xD;
             younger than 3 years).&#xD;
&#xD;
          -  Beneficiary of a social protection.&#xD;
&#xD;
          -  Written consent signed by guardian or legal representative, or parents in case of a&#xD;
             minor subject.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute intercurrent pathology precluding examinations.&#xD;
&#xD;
          -  Patient with hypersensitivity to tropicamide, atropine or benzalkonium chloride.&#xD;
&#xD;
          -  Angle closure glaucoma suspect patient.&#xD;
&#xD;
          -  Patient with severe hypertension.&#xD;
&#xD;
          -  Short life expectancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie-Christine ROUSSEAU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP-HP, Hôpital San Salvadour, 83407 Hyères</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Soizic CHARBONNIER, Orthoptist</last_name>
    <role>Study Chair</role>
    <affiliation>Cabinet du Lycée</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital San Salvadour</name>
      <address>
        <city>Hyères</city>
        <state>Var</state>
        <zip>83407</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Profound Multiple Intellectual Disabilities</keyword>
  <keyword>Visual-Behavioral Scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intellectual Disability</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03040609
org study id: P140712
secondary id: RCB: 2016-A00278-43
nct id: NCT03040609
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Concordance of classification
time frame: throughout the study: 31 months
description: Statistical analysis: concordance between the classification obtained by caregiver with the scale, and the classification obtained by orthoptist-ophthalmology.
measure: Structure of the scale
time frame: throughout the study: 31 months
description: Statistical analysis to validate the structure of the scale.
measure: Reproducibility of scale
time frame: throughout the study: 31 months
description: Statistical analysis to evaluate the reproducibility of scale with the intra- and inter-examiners, and the influence of the different professions of examiners.
measure: Feasibility of visio-behavioral scale
time frame: throughout the study: 31 months
description: 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.
measure: Sensitivity to change
time frame: throughout the study: 31 months
description: Statistical analysis to evaluate the sensitivity to change.
measure: Uniformity of use of the scale
time frame: throughout the study: 31 months
description: Statistical analysis to assess the uniformity of use of the scale depending on the type of patients (age, disability level, pathology).
measure: Prevalence of the visual disorder
time frame: throughout the study: 31 months
description: Statistical analysis to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.
arm group label: Group 1
description: The duration of follow-up of group 1 in the study is 1 day.
arm group label: Group 2
description: The duration of follow-up of group 2 in the study is 2 weeks.
arm group label: Group 3
description: The duration of follow-up of group 3 in the study is 6 months.
intervention type: Behavioral
intervention name: Visual-behavioral Scale at day 1
description: To perform the classification with the scale by caregiver.
arm group label: Group 1
intervention type: Behavioral
intervention name: Test-retest at the end of 2 weeks
description: To perform the classification with the scale by orthoptist at the end of 2 weeks
arm group label: Group 1
arm group label: Group 2
intervention type: Behavioral
intervention name: Test at 6 months
description: To perform the classification with the scale by orthoptist at the end 6 months.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: No
last name: Marie-Christine ROUSSEAU, MD
role: Principal Investigator
affiliation: AP-HP, Hôpital San Salvadour, 83407 Hyères
last name: Soizic CHARBONNIER, Orthoptist
role: Study Chair
affiliation: Cabinet du Lycée
facility: 
country: France
responsible party type: Sponsor
mesh term: Intellectual Disability
sharing ipd: No