Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02061501
Recruitment Status : Unknown
Verified June 2014 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : February 12, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Visual Cognitive Deficits Other: Optometric therapy during 6 months Other: Optometric therapy during 12 months Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children
Study Start Date : June 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Quality of life [ Time Frame: Visit 2 (12 months of rehabilitation) ]
    Quality of life assessed by a questionnaire at V0, V1 and V2.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • visual cognitive deficits
  • normal intelligence

Exclusion Criteria:

  • cerebral palsy
  • mental deficiency
  • visual acuity deficit

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): NCT02061501


Contacts
Layout table for location contacts
Contact: Anne de Saint Martin, MD 03 88 12 83 28 ext +33 anne.desaintmartin@chru-strasbourg.fr

Locations
Layout table for location information
France
CRTLA - Hôpital de Hautepierre- CHRU Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Anne de Saint-Martin, MD    03 88 12 83 28 ext +33    anne.desaintmartin@chru-strasbourg.fr   
Principal Investigator: Anne de Saint-Martin, MD         
Sub-Investigator: Claire de Sèze, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France

Layout table for additonal information
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02061501     History of Changes
Other Study ID Numbers: 5542
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

Keywords provided by University Hospital, Strasbourg, France:
visual cognitive deficits

Additional relevant MeSH terms:
Layout table for MeSH terms
Cognition Disorders
Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders