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

NCT06067607 | Unknown

• 1 other identifier: 2021-09
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cortical/Cerebral Visual Impairment; Cerebral Palsy

Keywords

Cortical/Cerebral Visual Impairment; Vision; Occupational Performance; Sensory Processing

Outcome Measures

Primary Outcomes (3)

• 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.

Other Outcomes (2)

• Sensory Processing Checklist for Children with Visual Impairment (SPCCVI)

  Test given at baseline.

• Sensory Profile-Short Form (SPSF)

  Test given at baseline.

Study Arms (1)

Eye gaze technology intervention

EXPERIMENTAL

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

Other: eye gaze technology

Interventions

eye gaze technology OTHER

eye gaze technology and software activities

Eye gaze technology intervention

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with Cortical/Cerebral Visual Impairment by Physician
• years of age
• Parent or Caregiver available for interview

You may not qualify if:

• Only ocular visual impairment,
• Age above 10 years of age.
• No parent or caregiver available for interview

Sponsors & Collaborators

• Rockhurst University: lead

Study Sites (1)

The Children's Center for the Visually Impaired

Kansas City, Missouri, 64108, United States

RECRUITING

Related Publications (17)

• 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.

  PMID: 34813110 BACKGROUND

• 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.

  PMID: 29505103 BACKGROUND

• 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.

  PMID: 35363793 BACKGROUND

• 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.

  PMID: 31267521 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 35892617 BACKGROUND

• 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.

  PMID: 34619456 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 36010014 BACKGROUND

• 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.

  PMID: 35308614 BACKGROUND

• 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.

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  PMID: 30798014 BACKGROUND

• 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.

  PMID: 33230032 BACKGROUND

• 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.

  PMID: 32199940 BACKGROUND

• 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.

  PMID: 31548020 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Blindness, Cortical; Cerebral Palsy

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Tammy Bruegger

  Rockhurst University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tammy Bruegger, OTD

CONTACT

816-501-4342; Tammy.Bruegger@rockhurst.edu

Sunni Alford, OTD

CONTACT

816-501-3269; sunni.alford@rockhurst.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Occupational Therapy

Model Details: Mixed Design, Pre/Post Pre-Experimental Design

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: October 5, 2023
• Study Start: February 1, 2023
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)