NCT00342108

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. 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. 2.Systematic, repetitive, visual stimulation over time, improves the visual attentiveness and/or visual-motor responses of CP-CVI children.
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 3, 2010

Status Verified

November 1, 2010

Enrollment Period

1.8 years

First QC Date

June 20, 2006

Last Update Submit

November 2, 2010

Conditions

Cerebral PalsyCortical Visual Impairment

Outcome Measures

Primary Outcomes (1)

  • Eye Movements

    within the testing session

Secondary Outcomes (1)

  • Other behavioural responses

    within the testing session

Study Arms (2)

1

EXPERIMENTAL

Diagnosis: CP, moderate to severe MR and CVI

Behavioral: cross-modal sensory stimulation

2

EXPERIMENTAL

Diagnosis: CP, Moderate to severe MR, no visual impairment

Behavioral: cross-modal sensory stimulation

Interventions

cross-modal sensory stimulationBEHAVIORAL

comparison of participant response to unimodal visual stimulation and to bimodal sensory stimulation

12

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • two to twelve years of age
  • diagnosis of: CP, mental retardation (MR) and CVI (Control group participants without visual disability)

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba_Medical_Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Cerebral PalsyBlindness, Cortical

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBlindnessVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amichai Brezner, MD

    Dept. of Pediatric Rehabilitation Sheba Medical Center Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 20, 2006

First Posted

June 21, 2006

Study Start

September 1, 2007

Primary Completion

July 1, 2009

Study Completion

October 1, 2010

Last Updated

November 3, 2010

Record last verified: 2010-11

Locations

IL(1)