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

Not Applicable

• Conditions: Visual Cognitive Deficits
• Interventions: Other: Optometric therapy during 12 months; Other: Optometric therapy during 6 months

• Registration Number: NCT02061501
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-12
• Status Verified: 2014-06
• Study Start: 2014-06
• Last Update Submitted: 2014-06-20
• Last Update Posted: 2014-06-23
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• visual cognitive deficits
• normal intelligence

Exclusion Criteria

• cerebral palsy
• mental deficiency
• visual acuity deficit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Speech therapy and optometric therapy	Optometric therapy during 12 months	Speech therapy (30 min per week) and optometric therapy (30 min per week) for 12 months.
Speech therapy	Optometric therapy during 6 months	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.

Primary Outcome Measures

Name	Time	Method
Calculation of a composite score at Visit 1	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

Name	Time	Method
Calculation of a composite score at Visit 2	Visit 2 (12 months of rehabilitation)	The composite score is calculated from the results obtained at several neuropsychology and optometric tests.

Trial Locations

Locations (1)

CRTLA - Hôpital de Hautepierre- CHRU Strasbourg; 🇫🇷 Strasbourg, France