Clinical trial NCT06067607: Examining the Effect of Eye Gaze Technology on Children With Cortical Visual Impairment
Official title: Examining the Effect of Eye Gaze Technology on Children With Cortical Visual Impairment and Its Impact on Occupational Performance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cortical/Cerebral Visual Impairment
Cerebral Palsy
Keywords: Cortical/Cerebral Visual Impairment
Vision
Occupational Performance
Sensory Processing
Lead sponsor: Rockhurst University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mixed Design, Pre/Post Pre-Experimental Design
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Canadian Occupational Performance Measurement (COPM)
timeFrame: Measure change from baseline and after 4 weeks of intervention.
measure: Eye Gaze Technology Software Scoring: Insight Software
timeFrame: Measure change from baseline and after 4 weeks of intervention.
measure: Cortical Visual Impairment Range (CVI)
timeFrame: Measure change from baseline and after 4 weeks of intervention.
Secondary outcomes:
Other outcomes:
measure: Sensory Processing Checklist for Children with Visual Impairment (SPCCVI)
timeFrame: Test given at baseline.
measure: Sensory Profile-Short Form (SPSF)
timeFrame: Test given at baseline.
Locations:
city: Kansas City
country: United States
facility: The Children's Center for the Visually Impaired
state: Missouri
Study officials:
affiliation: Rockhurst University
name: Tammy Bruegger
role: PRINCIPAL_INVESTIGATOR
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