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Cortical Visual Impairment and Visual Attentiveness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00342108
First Posted: June 21, 2006
Last Update Posted: November 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose

This study will investigate the effect of enhanced visual and cross-modal environments upon the visual attentiveness of multiply handicapped children diagnosed with Cerebral Palsy (CP) and Cortical Visual Impairment (CVI).

Research Hypothesis

  1. Adapted visual environments which present controlled auditory, tactile, proprioceptive or contrasting visual background stimulation will enhance the visual attentiveness to a given visual stimulus of children diagnosed with CP and CVI.
  2. Systematic, repetitive, visual stimulation over time, improves the visual attentiveness and/or visual-motor responses of CP-CVI children.
  3. The analysis of additional behavioral responses to visual stimuli is a critical component in evaluating the perceptual development of visual attention in CP-CVI children.

Use of Noldus: The Observer, an advanced objective computerized observation program, will enable precise detection of the neurobehavioral responses of the participants. Both overt and covert responses will be observed, analyzed and correlated to identify the level of attention of each participant.


Condition Intervention
Cerebral Palsy Cortical Visual Impairment Behavioral: cross-modal sensory stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cortical Visual Impairment and Visual Attentiveness: The Effect of Visual and Cross-Modal Environments on Children Diagnosed With Cerebral Palsy and Cortical Visual Impairment

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Eye Movements [ Time Frame: within the testing session ]

Secondary Outcome Measures:
  • Other behavioural responses [ Time Frame: within the testing session ]

Enrollment: 60
Study Start Date: September 2007
Study Completion Date: October 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Diagnosis: CP, moderate to severe MR and CVI
Behavioral: cross-modal sensory stimulation
comparison of participant response to unimodal visual stimulation and to bimodal sensory stimulation
Experimental: 2
Diagnosis: CP, Moderate to severe MR, no visual impairment
Behavioral: cross-modal sensory stimulation
comparison of participant response to unimodal visual stimulation and to bimodal sensory stimulation

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • two to twelve years of age
  • diagnosis of: CP, mental retardation (MR) and CVI (Control group participants without visual disability)

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00342108


Locations
Israel
Sheba_Medical_Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Amichai Brezner, MD Dept. of Pediatric Rehabilitation Sheba Medical Center Israel
  More Information

Responsible Party: Amichai Brezner, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00342108     History of Changes
Other Study ID Numbers: SHEBA-06-4162-AB-CTIL
First Submitted: June 20, 2006
First Posted: June 21, 2006
Last Update Posted: November 3, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Cerebral Palsy
Vision Disorders
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms