Viewing Strategy Training

Sponsor

Royal Dutch Visio (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05600140

Collaborator

Radboud University, Behavioural Science Institute, Nijmegen, The Netherlands (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vision Disorders Vision, Low	Behavioral: Viewing strategy training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

For the first phase of the study, we aim to include 48 children aged 5-12 years for each group (i.e. normal Vision, ocular visual impairment, cerebral visual impairment). For the second phase of the study 70 children with visual impairment aged 5-9 years will be included (ocular impairment: n=35, cerebral visual impairment: n=35). In the second phase of the project, 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.For the first phase of the study, we aim to include 48 children aged 5-12 years for each group (i.e. normal Vision, ocular visual impairment, cerebral visual impairment). For the second phase of the study 70 children with visual impairment aged 5-9 years will be included (ocular impairment: n=35, cerebral visual impairment: n=35). In the second phase of the project, 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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Viewing Strategy Training in Children With (Cerebral) Visual Impairment

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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)	Behavioral: Viewing strategy 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)	Behavioral: Viewing strategy 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.

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)

Behavioral: Viewing strategy 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)

Behavioral: Viewing strategy training

Outcome Measures

Primary Outcome Measures

Changes in reading accuracy after viewing strategy training [Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4]
Radner reading test
Changes in reading speed after viewing strategy training [Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4]
Radner reading test
Changes in visual search accuracy after training [Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4]
Accuracy during conjunction search
Changes in visual search speed after training [Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
Speed during conjunction search
Changes in saccade amplitudes during reading and visual search after training [Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
Saccade amplitudes measured using Radner reading test and conjunction search
Changes in fixation duration during reading and search after training [Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
Fixation durations measured using Radner reading test and conjunction search
Changes in average distance between fixation points during conjunction search (EB-VSA) after training [Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
Average distance between fixation points using Radner reading test and conjunction search

Secondary Outcome Measures

Changes in WISC-V visual processing speed index (VSI) after training [Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
WISC-IV visual processing speed index
Changes in local visual selective attention after training [Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
TEA-Ch Speurtocht (total number of symbols found in 1 minute)
Changes in global visual selective attention after training [Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
Gestalt Closure (Kaufman-ABC), number of correct answers
Changes in visual identification speed after training [Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4]
'DST-Plaatjes Benoemen', number of pictures correctly named within 1 minute

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.