Cortical Visual Impairment and Visual Attentiveness

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00342108
First received: June 20, 2006
Last updated: November 2, 2010
Last verified: November 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other behavioural responses [ Time Frame: within the testing session ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Amichai Brezner, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00342108     History of Changes
Other Study ID Numbers: SHEBA-06-4162-AB-CTIL
Study First Received: June 20, 2006
Last Updated: November 2, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on April 17, 2014