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

October 2, 2023 updated by: Tammy Bruegger, Rockhurst University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • The Children's Center for the Visually Impaired
        • Contact:
        • Principal Investigator:
          • Tammy Bruegger, OTD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measurement (COPM)
Time Frame: Measure change from baseline and after 4 weeks of intervention.
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
Time Frame: Measure change from baseline and after 4 weeks of intervention.
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)
Time Frame: Measure change from baseline and after 4 weeks of intervention.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory Processing Checklist for Children with Visual Impairment (SPCCVI)
Time Frame: Test given at baseline.
Caregiver checklist of observed behaviors of sensory processing.SPCCVI scores on 0-5 scale with 0 indicating sensory behavior not seen and 5 indicating behavior "always observed". Higher scores relate to increased sensory processing behaviors.
Test given at baseline.
Sensory Profile-Short Form (SPSF)
Time Frame: Test given at baseline.
Caregiver Test of sensory processing. The rating scale on the Sensory Profile ranges from 1 (Almost Never) to 5 (Almost Always), with higher scores indicating a higher frequency of specific sensory responses.
Test given at baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rockhurst University

Investigators

  • Principal Investigator: Tammy Bruegger, Rockhurst University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

April 5, 2024

Study Completion (Estimated)

April 5, 2024

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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