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Balance in Children With Cochlear Implants

This study is enrolling participants by invitation only.
Study NCT00642343.   Last updated on March 24, 2008.   Information provided by University of Oklahoma

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Descriptive Information Fields
Brief Title  Balance in Children With Cochlear Implants
Official Title  Balance in Children With Cochlear Implants
Brief Summary

The purpose is to test the balance of children with unilateral,bilateral cochlear implants and patients having unilateral implants before,bilateral implants after surgery,using the Bruininks-Oseretsky Test 2nd ed. to find out if the cochlear implants have an effect.

Detailed Description

Hearing impairment has a significant impact on individual quality of life and stresses community resources. In the last two decades cochlear implantation has developed into the new standard of care for severe to profound haring loss. Recent studies have shown bilateral implantation improves sound localization and understanding of speech in noise. For children, this is seen as a significant benefit. As we begin to offer bilateral cochlear implants to a growing number of children it would be in our patient's best interest to evaluate whether or not this may cause balance impairment. We will evaluate the balance scores of children with bilateral cochlear implants, and compare their results to unilaterally implanted children and a hearing impaired population, with the Bruininks-Oseretsky Test 2nd ed (BOT2). In addition we will take a small group of unilaterally implanted patients and test them before and after a contralateral cochlear implant as a prospective study group.

Study Phase Phase 0
Study Type  Interventional
Study Design  Treatment, Open Label, Parallel Assignment, Safety Study
Primary Outcome Measure  The specific aim will be to compare the balance of children with cochlear implants to profoundly deaf children using the BOT2. [ Time Frame: no earlier than 2 weeks following activation of implants ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  To evaluate the differences in balance function between children with bilateral cochlear implants compared to children with unilateral cochlear using implants the BOT2. [ Time Frame: no earlier than 2 weeks after implant activation ] [ Designated as safety issue: Yes ]
Condition  Severe, Profound Deafness
Intervention  Behavioral: Evaluation of motor proficiency skills.
Behavioral: Evaluation of motor proficiency
Behavioral: Evaluation of motor proficiency.
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status  Enrolling by invitation
Enrollment  150
Start Date  March 2008
Completion Date February 2012
Eligibility Criteria 

Inclusion Criteria:

  • Children with cochlear implant(s) activated for at least two weeks before participation.
  • Children with severe to profound deafness that have not received intervention.

Exclusion Criteria:

  • Children with mental retardation, associated physical handicaps, or chronic sedative use prohibiting completion of the balance tests.
Gender Both
Ages 4 Years to 18 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00642343
Organization ID BALANCE W/COCHLEAR_BERRYHILL
Secondary IDs ††
Study Sponsor  University of Oklahoma
Collaborators †† American Academy of Otolaryngology-Head and Neck Surgery Foundation
Investigators 
Principal Investigator:     Wayne Berryhill, MD     University of Oklahoma    
Information Provided By University of Oklahoma
Verification Date March 2008
First Received Date  March 19, 2008
Last Updated Date March 24, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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