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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067607
• Other study ID #: 2021-09
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: April 5, 2024

Study information

• Verified date: October 2023
• Source: Rockhurst University
• Contact: Tammy Bruegger, OTD
• Phone: 816-501-4342
• Email: Tammy.Bruegger[@]rockhurst.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 5, 2024
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Vision Disorders
• Vision, Low

Intervention

Other:
• eye gaze technology
eye gaze technology and software activities

Locations

Country	Name	City	State
United States	The Children's Center for the Visually Impaired	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Rockhurst University

Country where clinical trial is conducted

United States, 

References & Publications (17)

Ben Itzhak N, Kooiker MJG, van der Steen J, Pel JJM, Wagemans J, Ortibus E. The relation between visual orienting functions, daily visual behaviour and visuoperceptual performance in children with (suspected) cerebral visual impairment. Res Dev Disabil. 2021 Dec;119:104092. doi: 10.1016/j.ridd.2021.104092. Epub 2021 Oct 5. — View Citation

Bennett, C. R., Bailin, E. S., Gottlieb, T. K., Bauer, C. M., Bex, P. J., & Merabet, L. B. (2018). Virtual reality based assessment of static object visual search in ocular compared to cerebral visual impairment. In International Conference on Universal Access in Human-Computer Interaction (pp. 28-38). Springer, Cham. https://doi.org/10.1007/978-3-319-92052-8_3

Cemali M, Pekcetin S, Aki E. The Effectiveness of Sensory Integration Interventions on Motor and Sensory Functions in Infants with Cortical Vision Impairment and Cerebral Palsy: A Single Blind Randomized Controlled Trial. Children (Basel). 2022 Jul 27;9(8):1123. doi: 10.3390/children9081123. — View Citation

Chang MY, Borchert MS. Advances in the evaluation and management of cortical/cerebral visual impairment in children. Surv Ophthalmol. 2020 Nov-Dec;65(6):708-724. doi: 10.1016/j.survophthal.2020.03.001. Epub 2020 Mar 19. — View Citation

Chang MY, Borchert MS. Methods of visual assessment in children with cortical visual impairment. Curr Opin Neurol. 2021 Feb 1;34(1):89-96. doi: 10.1097/WCO.0000000000000877. — View Citation

Fazzi E, Micheletti S, Calza S, Merabet L, Rossi A, Galli J; Early Visual Intervention Study Group. Early visual training and environmental adaptation for infants with visual impairment. Dev Med Child Neurol. 2021 Oct;63(10):1180-1193. doi: 10.1111/dmcn.14865. Epub 2021 May 4. — View Citation

Ferziger, N. (2017). Assessment of gaze responses of children with Cerebral Palsy and cerebral visual impairment: Implementation of a computerized video coding system. The American Journal of Occupational Therapy, 71(4_Supplement_1). https://doi.org/10.5014/ajot.2017.71s1-po1138

Galli J, Loi E, Molinaro A, Calza S, Franzoni A, Micheletti S, Rossi A, Semeraro F, Fazzi E; CP Collaborative Group. Age-Related Effects on the Spectrum of Cerebral Visual Impairment in Children With Cerebral Palsy. Front Hum Neurosci. 2022 Mar 2;16:750464. doi: 10.3389/fnhum.2022.750464. eCollection 2022. — View Citation

Gartz, R., Dickerson, A., & Radloff, J. (2019). Effectiveness of visual scanning compensatory training after stroke. The American Journal of Occupational Therapy, 73(4_Supplement_1). https://doi.org/10.5014/ajot.2019.73s1-po2039

Kovarski K, Caetta F, Mermillod M, Peyrin C, Perez C, Granjon L, Delorme R, Cartigny A, Zalla T, Chokron S. Emotional face recognition in autism and in cerebral visual impairments: In search for specificity. J Neuropsychol. 2021 Jun;15(2):235-252. doi: 10.1111/jnp.12221. Epub 2020 Sep 13. — View Citation

Kran BS, Lawrence L, Mayer DL, Heidary G. Cerebral/Cortical Visual Impairment: A Need to Reassess Current Definitions of Visual Impairment and Blindness. Semin Pediatr Neurol. 2019 Oct;31:25-29. doi: 10.1016/j.spen.2019.05.005. Epub 2019 May 11. — View Citation

Lammers NA, Van den Berg NS, Lugtmeijer S, Smits AR, Pinto Y, de Haan EHF; visual brain group. Mid-range visual deficits after stroke: Prevalence and co-occurrence. PLoS One. 2022 Apr 1;17(4):e0262886. doi: 10.1371/journal.pone.0262886. eCollection 2022. — View Citation

Manley CE, Bennett CR, Merabet LB. Assessing Higher-Order Visual Processing in Cerebral Visual Impairment Using Naturalistic Virtual-Reality-Based Visual Search Tasks. Children (Basel). 2022 Jul 26;9(8):1114. doi: 10.3390/children9081114. — View Citation

Racey C, Franklin A, Bird CM. The processing of color preference in the brain. Neuroimage. 2019 May 1;191:529-536. doi: 10.1016/j.neuroimage.2019.02.041. Epub 2019 Feb 21. — View Citation

Rowe FJ, Hanna K, Evans JR, Noonan CP, Garcia-Finana M, Dodridge CS, Howard C, Jarvis KA, MacDiarmid SL, Maan T, North L, Rodgers H. Interventions for eye movement disorders due to acquired brain injury. Cochrane Database Syst Rev. 2018 Mar 5;3(3):CD011290. doi: 10.1002/14651858.CD011290.pub2. — View Citation

Vancleef K, Janssens E, Petre Y, Wagemans J, Ortibus E. Assessment tool for visual perception deficits in cerebral visual impairment: development and normative data of typically developing children. Dev Med Child Neurol. 2020 Jan;62(1):111-117. doi: 10.1111/dmcn.14303. Epub 2019 Jul 2. — View Citation

VerMaas-Hannan, J., Gehringer, J., Wilson, T., & Kurz, M. (2019). Visual motion perception is aberrant in children with cerebral palsy. The American Journal of Occupational Therapy, 73(4_Supplement_1). https://doi.org/10.5014/ajot.2019.73s1-rp302b

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensory Processing Checklist for Children with Visual Impairment (SPCCVI)	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.
Other	Sensory Profile-Short Form (SPSF)	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.
Primary	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.
Primary	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.
Primary	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.