iVision - Development of a Game-based Therapy for Children With Cerebral Visual Impairment

NCT04051983 | Completed

• 1 other identifier: S61226
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present study is to develop a therapeutic, adaptive, and enjoyable game that will be used by children with CVI between the mental age of 3 and 12 years. Such a game will be easy to use and implement by the children, their parents, and therapists.

Conditions

Visual Perceptual Weakness (Disorder); Cerebral Visual Impairment

Outcome Measures

Primary Outcomes (9)

• L94 Visual Perceptual Battery

  L94 is an object recognition battery for children aged 3-6 years. The test is composed of 5 computer tasks, \[visual matching (VISM), overlapping line drawings (OVERL), line drawings occluded by noise (NOISE), De Vos task (DE VOS), unconventional object views (VIEW). (Ortibus et al., 2009)

  25 minutes.

• Test of Visual Perceptual Skills (TVPS)

  TVPS-3 is a standardized and norm-referenced task for children age 4-13 years that uses a response format suitable for all children, including those with disabilities. It includes subtasks of visual discrimination, visual memory, visual-spatial relationships, form constancy, visual sequential memory, figure ground, and visual closure (Martin et al., 2006).

  30 minutes.

• Developmental Test of Visual - Motor Integration (Beery VMI)

  Beery a standardized and norm-referenced screening tool for visual-motor deficits. It includes updated norms for ages 2 through 18. The VMI helps assess to what extent children can integrate their visual and motor abilities. In addition to a copying task, the child also performs a visual perception matching task of the same constructs seen before in the copy task, and a motor coordination task, developed to assess the supplementary motor deficits. (Beery et al., 2010).

  20 minutes.

• Developmental Neuropsychological Assessment (NEPSY-II-NL)

  NEPSY-II-NL is a customizable cognitive assessment tool for children aged 5 to 16 years. It assesses six domains with one integrated instrument, composed of different normed subtests. Among those, visual attention and visuospatial functions, are routinely performed in the diagnostic work up of children with (a suspicion of) CVI. (Korkman, 1998).

  Subtests geometric puzzles and arrows, 20 minutes.

• Revisie Amsterdamse Kinderintelligentie Test (RAKIT)

  RAKIT is a paediatric intelligence test, with reference values from a Dutch population of children 4-12.5 years of age. From this test, the subtest "Vertelplaat" is used to evaluate the ability to tell a logic story from a crowded scene, thereby evaluating object recognition, figure ground perception and scene perception (Bleichroth et al., 1987).

  Subtests Hidden figures and Figure recogntion, 20 minutes.

• Relative Enjoyment Scale for Primary School Children adapted for cerebral visual impairment (RESC-CVI)

  The RES-C measures enjoyment by relating it subjectively to a series of other activities which are part of the 'experience horizon' of a child using visual analogue scales (Van Looy et al., 2016)

  10 minutes

• Preschool judgment of line orientation (PJLO)

  The PJLO is an extension of the Benton judgment of line orientation task and is administered to children between the age of 3.25 and 6 years. This test includes 24 items where the orientation of one or two target lines needs to be matched to 2, 4, or 11 choices (Stiers et al., 2005).

  10 minutes.

• Motion perception tasks

  Motion perception tasks measure motion-defined form, global motion coherence, motion speed, and biological motion, and can be administered to children between the age of 4 and 6 years. In motion-defined form, an object is concealed in a random dot kinematogram and the child is required to identify the image seen. In global motion coherence, the child indicates in which half of the display, left or right, a coherently moving strip forming a horizontal bar is located. In motion speed, two contours of a car are shown next to each other with moving dots inside, and the child indicates in which car the dots are moving at the highest speed. In biological motion, two dot matrices are shown, one is a human-point light walker (walking man) and the other one is a phasescrambled point-light figure, and the child should indicate the walking man (Van der Zee et al., 2019).

  20 minutes.

• The Flemish cerebral visual impairment questionnaire (FCVIQ)

  The FCVIQ is a 46-item screening tool for CVI filled out by caregivers using a binary response format (yes or no). This tool screens for visual perceptual difficulties in daily life (Ortibus et al., 2011).

  10 minutes.

Secondary Outcomes (2)

• Snijders-Oomen Non-verbal intelligence test (SON-R 6-40)

  60 minutes.

• Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III-NL)

  Non-verbal subtests, 45 minutes.

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Fifty children will be recruited from the consultations at the CVI clinic at the Centre For Developmental Disabilities Leuven, from Centrum Ganspoel, and the CP reference Centre of the UZ Leuven.

You may qualify if:

• Visual perceptual deficits or diagnosed with CVI
• Gross Motor Function Classification (GMFCS) level I-IV
• Two age groups; 3-7 and 8-12 years of mental age

You may not qualify if:

• mental age below 3 and above 12 years of mental age
• severely limited motor abilities (cerebral palsy with a gross motor function classification level V)
• severely limited or unable to express their experiences with the game due to serious speech disorders, deafness, autism
• visual acuity of ≤ 3/10

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Research Foundation Flanders: collaborator
• KU Leuven: collaborator
• Free University of Brussels: collaborator
• University Ghent: collaborator
• Ganspoel: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaams-brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Blindness, Cortical

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Els Ortibus, Professor

  UZ Leuven

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 9, 2019
• Study Start: January 2, 2018
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)