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Cortical Visual Impairment and Visual Attentiveness

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.
 
ClinicalTrials.gov Identifier: NCT00342108
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : November 3, 2010
Sponsor:
Information provided by:
Sheba Medical Center

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Cerebral Palsy Cortical Visual Impairment Behavioral: cross-modal sensory stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : September 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : October 2010

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Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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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:

  • N/A
Contacts and Locations
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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
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Israel
Sheba_Medical_Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Amichai Brezner, MD Dept. of Pediatric Rehabilitation Sheba Medical Center Israel
More Information
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Responsible Party: Amichai Brezner, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00342108    
Other Study ID Numbers: SHEBA-06-4162-AB-CTIL
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: November 3, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Cerebral Palsy
Vision Disorders
Vision, Low
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Sensation Disorders
Neurologic Manifestations
Eye Diseases