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| Name | Class |
|---|---|
| American Academy of Otolaryngology-Head and Neck Surgery Foundation | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Children with severe to profound deafness that have not received any intervention. |
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| 2 | Active Comparator | Children with an unilateral cochlear implant. |
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| 3 | Active Comparator | Children with bilateral cochlear implants. |
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| 4 | Active Comparator | Children who receive their second implant during the duration of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of motor proficiency skills. | Behavioral | The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored. |
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| Measure | Description | Time Frame |
|---|---|---|
| The specific aim will be to compare the balance of children with cochlear implants to profoundly deaf children using the BOT2. | no earlier than 2 weeks following activation of implants |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the differences in balance function between children with bilateral cochlear implants compared to children with unilateral cochlear using implants the BOT2. | no earlier than 2 weeks after implant activation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne Berryhill, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
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| Evaluation of motor proficiency | Behavioral | The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored. |
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| Evaluation of motor proficiency | Behavioral | The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored. |
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| Evaluation of motor proficiency. | Behavioral | The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored. |
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