Back to resultsCortical Visual Impairment and Visual Attentiveness
Primary Purpose
Cerebral Palsy, Cortical Visual Impairment
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
cross-modal sensory stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility 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
Sites / Locations
- Sheba_Medical_Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Diagnosis: CP, moderate to severe MR and CVI
Diagnosis: CP, Moderate to severe MR, no visual impairment
Outcomes
Primary Outcome Measures
Eye Movements
Secondary Outcome Measures
Other behavioural responses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00342108
Brief Title
Cortical Visual Impairment and Visual Attentiveness
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 Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
Systematic, repetitive, visual stimulation over time, improves the visual attentiveness and/or visual-motor responses of CP-CVI children.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Cortical Visual Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Diagnosis: CP, moderate to severe MR and CVI
Arm Title
2
Arm Type
Experimental
Arm Description
Diagnosis: CP, Moderate to severe MR, no visual impairment
Intervention Type
Behavioral
Intervention Name(s)
cross-modal sensory stimulation
Intervention Description
comparison of participant response to unimodal visual stimulation and to bimodal sensory stimulation
Primary Outcome Measure Information:
Title
Eye Movements
Time Frame
within the testing session
Secondary Outcome Measure Information:
Title
Other behavioural responses
Time Frame
within the testing session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amichai Brezner, MD
Organizational Affiliation
Dept. of Pediatric Rehabilitation Sheba Medical Center Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba_Medical_Center
City
Ramat Gan
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Cortical Visual Impairment and Visual Attentiveness
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