- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05600140
Viewing Strategy Training in Children With (Cerebral) Visual Impairment
Viewing Strategy Training in Children With (Cerebral) Visual Impairment: From Spontaneous Eye Movements to a Structured Viewing Strategy
Viewing strategies are strategies used to process visual Information. Many children with visual impairment seem to lack systematic viewing strategies. However, it is unknown how viewing strategies differ between children with normal vision and children with (cerebral) visual impairment. In addition, viewing strategy training is often adopted in clinical practice, but till date there is no scientific evidence about effectiveness of this approach.
The current project has two goals: (1) to measure viewing strategies used by children with normal vision, children with ocular visual impairment and children with CVI, and (2) to evaluate whether training viewing strategies results in more efficiënt visual Information processing.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bianca Huurneman, PhD
- Phone Number: 0(031)646944002
- Email: biancahuurneman@visio.org
Study Locations
-
-
-
Nijmegen, Netherlands
- Recruiting
- Royal Dutch Visio
-
Contact:
- Hanna Romema, MSc
-
Contact:
- Email: hannarozema@visio.org
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Principal Investigator:
- Hanna Rozema, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria typically developing children with normal vision:
- Age 5-12 years
- linear distant visual acuity of 0.1 logMAR or better
- Verbal IQ above 70
- Absence of developmental disorders or psychiatric problems like ASS or AD(H)D
Inclusion criteria for children with ocular visual impairment:
- Age 5-12 years
- Children with linear distance visual acuity better <=1.3logMAR and >0.1 logMAR
- Intact central visual field (at least > 30 degrees)
- Children with a verbal IQ above 70
- Absence of developmental disorders or psychiatric problems like ASS or AD(H)D
Inclusion criteria for children with cerebral visual impairment:
- Age 5-12 years
- Linear distance visual acuity <=0.3 logMAR
- Having the diagnosis CVI (verified by ophthalmologists)
- Children with a verbal IQ above 70
- Absence of psychiatric problems like ASS or AD(H)D
Additional inclusion criterion for study 2 (evaluating training effectiveness): children with (cerebral) visual impairment should have an indication for viewing strategy training. Training should not be indicated if children have no problems performing academic tasks (i.e. when speed and accuracy of visual processing is within the normal range). The age range for study 2 is 5-9 years.
Exclusion criteria:
- Children with VI: linear near visual acuity >1.0 logMAR
- Children with visual field defect < 30 degrees
- Children with a verbal IQ below 70
- Children who attended a form of vision training in the past two years
- Children with psychiatric problems like ASS or AD(H)D
- Auditory impairment or language impairments
- Major life events during training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A) early training group
T0 = baseline measurement T1 = posttest (within two weeks after training) T2 = follow up measurement (6 months after training)
|
Children receive a visual training of viewing strategies (six weeks, 2 times a week, 30 minutes).
During the training, children are instructed to use specific viewing strategies (looking in a structured direction which fits the task at hand, zooming in and out / change of visual selective attentional field, visual discrimination).
The verbal instructions and exercises are protocol-based.
A textbook is used to describe the reactions of the children during training.
|
|
Experimental: Group B) late training group
T0 = baseline measurement T1 = test-retest reliability and natural development (over period 1 1/2-2 months after T0) T2 = posttest (within two weeks after training)
|
Children receive a visual training of viewing strategies (six weeks, 2 times a week, 30 minutes).
During the training, children are instructed to use specific viewing strategies (looking in a structured direction which fits the task at hand, zooming in and out / change of visual selective attentional field, visual discrimination).
The verbal instructions and exercises are protocol-based.
A textbook is used to describe the reactions of the children during training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in reading accuracy after viewing strategy training
Time Frame: Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
|
Radner reading test
|
Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
|
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Changes in reading speed after viewing strategy training
Time Frame: Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
|
Radner reading test
|
Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
|
|
Changes in visual search accuracy after training
Time Frame: Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
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Accuracy during conjunction search
|
Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
|
|
Changes in visual search speed after training
Time Frame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
|
Speed during conjunction search
|
Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
|
|
Changes in saccade amplitudes during reading and visual search after training
Time Frame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
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Saccade amplitudes measured using Radner reading test and conjunction search
|
Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
|
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Changes in fixation duration during reading and search after training
Time Frame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
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Fixation durations measured using Radner reading test and conjunction search
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Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
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Changes in average distance between fixation points during conjunction search (EB-VSA) after training
Time Frame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
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Average distance between fixation points using Radner reading test and conjunction search
|
Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in WISC-V visual processing speed index (VSI) after training
Time Frame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
|
WISC-IV visual processing speed index
|
Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
|
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Changes in local visual selective attention after training
Time Frame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
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TEA-Ch Speurtocht (total number of symbols found in 1 minute)
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Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
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Changes in global visual selective attention after training
Time Frame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
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Gestalt Closure (Kaufman-ABC), number of correct answers
|
Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
|
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Changes in visual identification speed after training
Time Frame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
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'DST-Plaatjes Benoemen', number of pictures correctly named within 1 minute
|
Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bianca Huurneman, PhD, Royal Dutch Visio
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL81584.091.22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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