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

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: Visual Cognitive Deficits
• Intervention / Treatment: Other: Optometric therapy during 6 months; Other: Optometric therapy during 12 months

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67098
    • Recruiting
    • CRTLA - Hôpital de Hautepierre- CHRU Strasbourg
    • Contact: Anne de Saint-Martin, MD; Phone Number: +33 03 88 12 83 28; Email: anne.desaintmartin@chru-strasbourg.fr
    • Principal Investigator: Anne de Saint-Martin, MD
    • Sub-Investigator: Claire de Sèze, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	Quality of life assessed by a questionnaire at V0, V1 and V2.	Visit 2 (12 months of rehabilitation)

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

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: visual cognitive deficits
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognitive Dysfunction; Cognition Disorders
• Other Study ID Numbers: 5542