Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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).
- 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.
- Quality of life [ Time Frame: Visit 2 (12 months of rehabilitation) ]Quality of life assessed by a questionnaire at V0, V1 and V2.
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
|Contact: Anne de Saint Martin, MD||03 88 12 83 28 ext +email@example.com|
|CRTLA - Hôpital de Hautepierre- CHRU Strasbourg||Recruiting|
|Strasbourg, France, 67098|
|Contact: Anne de Saint-Martin, MD 03 88 12 83 28 ext +33 firstname.lastname@example.org|
|Principal Investigator: Anne de Saint-Martin, MD|
|Sub-Investigator: Claire de Sèze, MD|