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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. |
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| 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. |
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| 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. |
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| 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:
Exclusion Criteria:
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| 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 † |
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| Information Provided By | University of Oklahoma | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | March 19, 2008 | ||||
| Last Updated Date | March 24, 2008 | ||||
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