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Balance in Children With Cochlear Implants

Balance in Children With Cochlear Implants

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00642343
Enrollment
66
Registered
2008-03-25
Start date
2008-03-31
Completion date
2010-06-30
Last updated
2010-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe, Profound Deafness

Keywords

Balance, Severe, Profound deafness, Children, unilateral/bilateral cochlear implants, unilateral cochlear implant, bilateral 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.

Interventions

BEHAVIORALEvaluation of motor proficiency skills.

The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.

BEHAVIORALEvaluation of motor proficiency

The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.

BEHAVIORALEvaluation of motor proficiency.

The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.

Sponsors

American Academy of Otolaryngology-Head and Neck Surgery Foundation
CollaboratorOTHER
University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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

Secondary

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026