Balance in Children With Cochlear Implants

Official Title: “Balance in Children With Cochlear Implants”

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.

Intervention(s) in this Clinical Trial

• Behavioral: Evaluation of motor proficiency skills.
  • The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
• Behavioral: Evaluation of motor proficiency
  • The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
• Behavioral: Evaluation of motor proficiency
  • The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
• Behavioral: Evaluation of motor proficiency.
  • The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Children with severe to profound deafness that have not received any intervention.
• Active Comparator: 2
  • Children with an unilateral cochlear implant.
• Active Comparator: 3
  • Children with bilateral cochlear implants.
• Active Comparator: 4
  • Children who receive their second implant during the duration of the study.

Primary Measures

• 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
    Safety Issue?: Yes

Secondary Measures

• 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
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Oklahoma Other

Overall Clinical Trial Officials and Contacts

Wayne Berryhill, MD Principal Investigator University of Oklahoma  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642343

Study ID Number: BALANCE W/COCHLEAR_BERRYHILL

ClinicalTrials.gov Identifier: NCT00642343

Health Authority: United States: Institutional Review Board