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Cortical/Cerebral Visual ImpairmentNCT06067607

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

A study testing eye gaze technology in people with Cortical/Cerebral Visual Impairment and Cerebral Palsy, run by Rockhurst University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 2 to 10 yearsHealthy volunteers can take part
What is being tested?
eye gaze technology
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Feb 2023to 5 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Diagnosed with Cortical/Cerebral Visual Impairment by Physician
  • 2-10 years of age
  • Parent or Caregiver available for interview

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Tammy Bruegger, OTD contact

816-501-4342

Tammy.Bruegger@rockhurst.edu

Sunni Alford, OTD contact

816-501-3269

sunni.alford@rockhurst.edu

United States1 site, 1 recruiting

  • The Children's Center for the Visually Impaired

    Kansas City, Missouri, 64108

    Danielle Schulte, PT, 816-841-2284, dschulte@ccvi.org

    Tammy Bruegger, OTD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
eye gaze technology
Keywords
Cortical/Cerebral Visual Impairment, Vision, Occupational Performance, Sensory Processing
Medical subject headings
Blindness, Cortical, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eye gaze technologyOther

    eye gaze technology and software activities

Study groups in NCT06067607
Study groupRoleWhat they receive
Eye gaze technology interventionExperimentalParticipants will use eye gaze technology and software activities as an intervention to improve visual abilities.
Receives: Other: eye gaze technology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Measure change from baseline and after 4 weeks of intervention.

  2. 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.

    Measured: Measure change from baseline and after 4 weeks of intervention.

  3. 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.

    Measured: Measure change from baseline and after 4 weeks of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2023
  2. Study start1 Feb 2023
  3. Primary completion5 Apr 2024 (estimated)
  4. Study completion5 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Mixed Design, Pre/Post Pre-Experimental Design
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06067607
Sponsor's protocol ID
2021-09
Status last verified
Oct 2023
First submitted
27 Mar 2023
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34813110

  • 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.

    PubMed 29505103

  • 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.

    PubMed 35363793

  • 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.

    PubMed 31267521

  • 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

  • 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.

    PubMed 35892617

  • 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.

    PubMed 34619456

  • 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

  • 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

  • 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.

    PubMed 36010014

  • 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.

    PubMed 35308614

  • 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.

    PubMed 32920927

  • 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.

    PubMed 30798014

  • 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.

    PubMed 33230032

  • 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.

    PubMed 32199940

Questions about this trial

What is this clinical trial studying?

A study testing eye gaze technology in people with Cortical/Cerebral Visual Impairment and Cerebral Palsy, run by Rockhurst University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tammy Bruegger, OTD (816-501-4342, Tammy.Bruegger@rockhurst.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Canadian Occupational Performance Measurement (COPM) (time frame: Measure change from baseline and after 4 weeks of intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06067607, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.

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