Balance in Children With Cochlear Implants

NCT ID: NCT00642343

Last Updated: 2010-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Severe, Profound Deafness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Children with severe to profound deafness that have not received any intervention.

Group Type PLACEBO_COMPARATOR

Evaluation of motor proficiency.

Intervention Type BEHAVIORAL

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

2

Children with an unilateral cochlear implant.

Group Type ACTIVE_COMPARATOR

Evaluation of motor proficiency skills.

Intervention Type BEHAVIORAL

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

3

Children with bilateral cochlear implants.

Group Type ACTIVE_COMPARATOR

Evaluation of motor proficiency

Intervention Type BEHAVIORAL

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

4

Children who receive their second implant during the duration of the study.

Group Type ACTIVE_COMPARATOR

Evaluation of motor proficiency

Intervention Type BEHAVIORAL

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

Interventions

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Evaluation of motor proficiency skills.

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

Intervention Type BEHAVIORAL

Evaluation of motor proficiency

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

Intervention Type BEHAVIORAL

Evaluation of motor proficiency

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

Intervention Type BEHAVIORAL

Evaluation of motor proficiency.

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

Intervention Type BEHAVIORAL

Other Intervention Names

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deaf children, balance, unilateral cochlear implants, bilateral cochlear implants balance,unilateral/bilateral cochlear implants, deaf children balance, unilateral/bilateral cochlear implants, deaf children deaf children, unilateral/bilateral cochlear implants, balance

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Academy of Otolaryngology-Head and Neck Surgery Foundation

OTHER

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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University of Oklahoma Health Sciences Center

Principal Investigators

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Wayne Berryhill, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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BALANCE W/COCHLEAR_BERRYHILL

Identifier Type: -

Identifier Source: org_study_id

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