Cortical Visual Impairment and Visual Attentiveness
This study has been completed.
Sponsor:
Sheba Medical Center
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00342108
First received: June 20, 2006
Last updated: November 2, 2010
Last verified: November 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
- 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.
| 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 May 16, 2013