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

Primary Purpose

Cortical/Cerebral Visual Impairment, Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eye gaze technology
Sponsored by
Rockhurst University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cortical/Cerebral Visual Impairment focused on measuring Cortical/Cerebral Visual Impairment, Vision, Occupational Performance, Sensory Processing

Eligibility Criteria

2 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Children's Center for the Visually ImpairedRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eye gaze technology intervention

Arm Description

Participants will use eye gaze technology and software activities as an intervention to improve visual abilities.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 27, 2023
Last Updated
October 2, 2023
Sponsor
Rockhurst University
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1. Study Identification

Unique Protocol Identification Number
NCT06067607
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
April 5, 2024 (Anticipated)
Study Completion Date
April 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rockhurst University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cortical/Cerebral Visual Impairment, Cerebral Palsy
Keywords
Cortical/Cerebral Visual Impairment, Vision, Occupational Performance, Sensory Processing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Mixed Design, Pre/Post Pre-Experimental Design
Masking
None (Open Label)
Masking Description
Masking is not used as this is not a randomized control study and because eye gaze software will objectively document improvements in visual abilities. Scoring on COPM will be conducted by separate investigator from the CVI Range.
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eye gaze technology intervention
Arm Type
Experimental
Arm Description
Participants will use eye gaze technology and software activities as an intervention to improve visual abilities.
Intervention Type
Other
Intervention Name(s)
eye gaze technology
Intervention Description
eye gaze technology and software activities
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measurement (COPM)
Description
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.
Time Frame
Measure change from baseline and after 4 weeks of intervention.
Title
Eye Gaze Technology Software Scoring: Insight Software
Description
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.
Time Frame
Measure change from baseline and after 4 weeks of intervention.
Title
Cortical Visual Impairment Range (CVI)
Description
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.
Time Frame
Measure change from baseline and after 4 weeks of intervention.
Other Pre-specified Outcome Measures:
Title
Sensory Processing Checklist for Children with Visual Impairment (SPCCVI)
Description
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.
Time Frame
Test given at baseline.
Title
Sensory Profile-Short Form (SPSF)
Description
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.
Time Frame
Test given at baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tammy Bruegger, OTD
Phone
816-501-4342
Email
Tammy.Bruegger@rockhurst.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sunni Alford, OTD
Phone
816-501-3269
Email
sunni.alford@rockhurst.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy Bruegger
Organizational Affiliation
Rockhurst University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Center for the Visually Impaired
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Schulte, PT
Phone
816-841-2284
Email
dschulte@ccvi.org
First Name & Middle Initial & Last Name & Degree
Tammy Bruegger, OTD

12. IPD Sharing Statement

Plan to Share IPD
No
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Examining the Effect of Eye Gaze Technology on Children With Cortical Visual Impairment

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