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Cortical 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
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 20, 2006
Last Updated
November 2, 2010
Sponsor
Sheba Medical Center
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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

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Cortical Visual Impairment and Visual Attentiveness

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