Examining the Effect of Eye Gaze Technology on Children With Cortical Visual Impairment

Study Overview
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Brief Summary
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The goal of this study is to learn about eye gaze technology's use as an assessment and intervention of visual skills and the impact on occupational performance in children with cortical/cerebral visual impairment. The main questions the study aims to answer are: Does the use of eye gaze technology with graded visual activities improve visual abilities: Does an improvement in visual abilities improve occupational performance? - What are the factors that correlate with improved visual abilities? Participants will complete the Pre-test with Canadian Occupational Performance Measurement, Cortical Visual Impairment Range, Sensory Profile and Sensory Processing Checklist for Children with Visual Impairment. Then will participate in eye gaze technology activities using eye gaze software with graded visual games for 20 minutes per day for 4 weeks. Observations of positioning, head/eye position, sensory processing, and types of eye gaze activities used during the session. Pre test, daily and post test percentage scores on the eye gaze activities will be recorded. Then the child will complete post testing with the Canadian Occupational Performance Measurement and Cortical Visual Impairment Range.

Detailed Description
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Approval to perform this study was granted by the Rockhurst University Institutional Review Board (IRB) and the Rockhurst University (RU) Occupational Therapy Department prior to participant recruitment. Written informed consent was obtained from the parents of the participants and physical assent was obtained from the children older than 8 years of age. Researchers were trained by the primary investigator following an established written protocol for eye gaze technology administration. The protocal involved set up of the eye gaze camera and laptop computer with calibration of the camera to the child's eyes using Gaze Point software by Tobii. If the camera is unable to be calibrated to the child's eyes it will be calibrated with the therapists eyes in the same position as the child with eyes centered in the middle of the calibration screen. The child will be positioned 15-18 inches from the screen with a black trifold board behind the screen and lights turned off in a quiet room to decrease distractions. Teachers and therapists involved with data collection were trained in eye gaze technology administration following the protocal. Data was collected by the Insight and Learning Curve eye gaze software using percentage scoring and a heat map/line plot pictures. Eye gaze technology sessions will last 20 minutes, three to five days per week, for four weeks. Images presented during the eye gaze sessions include the following characteristics: single colors, reduced complexity, movement of the image, reduced surrounding auditory and visual clutter, and reduced inclusion of multiple colors. Demographic information, Canadian Occupational Performance Measurement (COPM,) Cortical Visual Impairment (CVI) Range, Sensory Profile Short Form (SP), and Sensory Processing Checklist for Children with Visual Impairment (SPCCVI) scores were collected by the researchers prior to administration of the eye gaze intervention. A baseline score was obtained from the Insight software using a mean of the subtests completed and then a mean of the subtests 4 weeks later. Scores for all of the measures except for the Sensory Profile and SPCCVI were then re-collected 4 weeks later at the conclusion of the study. Data was compiled and stored on a file on a password protected computer.

Official Title
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Examining the Effect of Eye Gaze Technology on Children With Cortical Visual Impairment and Its Impact on Occupational Performance

Conditions
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Cerebral Palsy, Cortical/Cerebral Visual Impairment

Intervention / Treatment
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* Other: eye gaze technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Cortical/Cerebral Visual Impairment by Physician 2-10 years of age Parent or Caregiver available for interview Exclusion Criteria: Only ocular visual impairment, Age above 10 years of age. No parent or caregiver available for interview

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Mixed Design, Pre/Post Pre-Experimental Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eye gaze technology intervention<br>Participants will use eye gaze technology and software activities as an intervention to improve visual abilities. | Other: eye gaze technology<br>* eye gaze technology and software activities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measurement (COPM) | semi structured interview of daily function and occupational performance using score for importance, performance and satisfaction of occupational performance skills. Minimum score of 0-10, 10 being maximum score. Increased score shows higher performance, and satisfaction. | Measure change from baseline and after 4 weeks of intervention. | 
| Eye Gaze Technology Software Scoring: Insight Software | Computerized score of visual abilities conducted by software and eye gaze camera. Scale of 0-100%. Increased percentage score shows improvement in eye gaze skill. | Measure change from baseline and after 4 weeks of intervention. | 
| Cortical Visual Impairment Range (CVI) | Test of functional vision and visual processing. Scale of 0-10 on CVI Range scores range from 0 to 10, with 10 indicating the best functional vision. The scores are further divided into three phases (phase I: 0-3, phase II: 4-7 and phase III: 8-10. Severity of each visual behavior is rated on 0-1 scale. 1 means that behavior has resolved and is no longer observed. | Measure change from baseline and after 4 weeks of intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cortical/Cerebral Visual Impairment, Vision, Occupational Performance, Sensory Processing