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Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children

Primary Purpose

Visual Cognitive Deficits

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Optometric therapy during 6 months
Optometric therapy during 12 months
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Cognitive Deficits focused on measuring visual cognitive deficits

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • visual cognitive deficits
  • normal intelligence

Exclusion Criteria:

  • cerebral palsy
  • mental deficiency
  • visual acuity deficit

Sites / Locations

  • CRTLA - Hôpital de Hautepierre- CHRU StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Speech therapy

Speech therapy and optometric therapy

Arm Description

Speech therapy (30 min per week) alone for the 6 first months. Then speech therapy (30 min per week) and optometric therapy (30 min per week) for the 6 last months.

Speech therapy (30 min per week) and optometric therapy (30 min per week) for 12 months.

Outcomes

Primary Outcome Measures

Calculation of a composite score at Visit 1
The composite score is calculated from the results obtained at several neuropsychology and optometric tests. Basal score is calculated at Visit 0 (inclusion visit).

Secondary Outcome Measures

Calculation of a composite score at Visit 2
The composite score is calculated from the results obtained at several neuropsychology and optometric tests.

Full Information

First Posted
February 10, 2014
Last Updated
June 20, 2014
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02061501
Brief Title
Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children
Official Title
Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Visual cognitive deficits in children are frequent, with an impact on working and daily activities. Optometric therapy may improve those functions, however few studies have been performed. We aim to evaluate the efficacy of such therapy by a comparative study between two groups of children aged between 5 and 12 after 6 months of rehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Cognitive Deficits
Keywords
visual cognitive deficits

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Speech therapy
Arm Type
Active Comparator
Arm Description
Speech therapy (30 min per week) alone for the 6 first months. Then speech therapy (30 min per week) and optometric therapy (30 min per week) for the 6 last months.
Arm Title
Speech therapy and optometric therapy
Arm Type
Experimental
Arm Description
Speech therapy (30 min per week) and optometric therapy (30 min per week) for 12 months.
Intervention Type
Other
Intervention Name(s)
Optometric therapy during 6 months
Intervention Description
Optometric therapy during 6 months, once a week
Intervention Type
Other
Intervention Name(s)
Optometric therapy during 12 months
Intervention Description
Optometric therapy once a week, during 12 months
Primary Outcome Measure Information:
Title
Calculation of a composite score at Visit 1
Description
The composite score is calculated from the results obtained at several neuropsychology and optometric tests. Basal score is calculated at Visit 0 (inclusion visit).
Time Frame
Visit 1 (6 months of rehabilitation)
Secondary Outcome Measure Information:
Title
Calculation of a composite score at Visit 2
Description
The composite score is calculated from the results obtained at several neuropsychology and optometric tests.
Time Frame
Visit 2 (12 months of rehabilitation)
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
Quality of life assessed by a questionnaire at V0, V1 and V2.
Time Frame
Visit 2 (12 months of rehabilitation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: visual cognitive deficits normal intelligence Exclusion Criteria: cerebral palsy mental deficiency visual acuity deficit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne de Saint Martin, MD
Phone
03 88 12 83 28
Ext
+33
Email
anne.desaintmartin@chru-strasbourg.fr
Facility Information:
Facility Name
CRTLA - Hôpital de Hautepierre- CHRU Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne de Saint-Martin, MD
Phone
03 88 12 83 28
Ext
+33
Email
anne.desaintmartin@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Anne de Saint-Martin, MD
First Name & Middle Initial & Last Name & Degree
Claire de Sèze, MD

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children

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