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

June 20, 2014 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67098
        • Recruiting
        • CRTLA - Hôpital de Hautepierre- CHRU Strasbourg
        • Contact:
        • Principal Investigator:
          • Anne de Saint-Martin, MD
        • Sub-Investigator:
          • Claire de Sèze, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • visual cognitive deficits
  • normal intelligence

Exclusion Criteria:

  • cerebral palsy
  • mental deficiency
  • visual acuity deficit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Speech therapy
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.
Other: Optometric therapy during 6 months
Optometric therapy during 6 months, once a week
Experimental: Speech therapy and optometric therapy
Speech therapy (30 min per week) and optometric therapy (30 min per week) for 12 months.
Other: Optometric therapy during 12 months
Optometric therapy once a week, during 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calculation of a composite score at Visit 1
Time Frame: Visit 1 (6 months of rehabilitation)

The composite score is calculated from the results obtained at several neuropsychology and optometric tests.

Basal score is calculated at Visit 0 (inclusion visit).
Visit 1 (6 months of rehabilitation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calculation of a composite score at Visit 2
Time Frame: Visit 2 (12 months of rehabilitation)
The composite score is calculated from the results obtained at several neuropsychology and optometric tests.
Visit 2 (12 months of rehabilitation)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Visit 2 (12 months of rehabilitation)
Quality of life assessed by a questionnaire at V0, V1 and V2.
Visit 2 (12 months of rehabilitation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimate)

February 12, 2014

Study Record Updates

Last Update Posted (Estimate)

June 23, 2014

Last Update Submitted That Met QC Criteria

June 20, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5542

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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