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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040609
Recruitment Status : Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment
Profound Multiple Intellectual Disabilities Behavioral: Visual-behavioral Scale at day 1 Behavioral: Test-retest at the end of 2 weeks Behavioral: Test at 6 months

Detailed 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.

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Study Type : Observational
Actual Enrollment : 232 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : September 20, 2020
Estimated Study Completion Date : September 20, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
The duration of follow-up of group 1 in the study is 1 day.
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.

Group 2
The duration of follow-up of group 2 in the study is 2 weeks.
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.

Group 3
The duration of follow-up of group 3 in the study is 6 months.
Behavioral: Test at 6 months
To perform the classification with the scale by orthoptist at the end 6 months.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Profound multiple intellectual disabilities patients aged 3 years or older.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040609


Locations
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France
Hôpital San Salvadour
Hyères, Var, France, 83407
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Marie-Christine ROUSSEAU, MD AP-HP, Hôpital San Salvadour, 83407 Hyères
Study Chair: Soizic CHARBONNIER, Orthoptist Cabinet du Lycée
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03040609    
Other Study ID Numbers: P140712
RCB: 2016-A00278-43 ( Other Identifier: ANSM )
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Profound Multiple Intellectual Disabilities
Visual-Behavioral Scale
Additional relevant MeSH terms:
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Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders