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Balance in Children With Cochlear Implants

Primary Purpose

Severe, Profound Deafness

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Evaluation of motor proficiency skills.
Evaluation of motor proficiency
Evaluation of motor proficiency
Evaluation of motor proficiency.
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe, Profound Deafness focused on measuring Balance, Severe, Profound deafness, Children, unilateral/bilateral cochlear implants, unilateral cochlear implant, bilateral cochlear implants

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

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

Children with an unilateral cochlear implant.

Children with bilateral cochlear implants.

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

Outcomes

Primary Outcome Measures

The specific aim will be to compare the balance of children with cochlear implants to profoundly deaf children using the BOT2.

Secondary Outcome Measures

To evaluate the differences in balance function between children with bilateral cochlear implants compared to children with unilateral cochlear using implants the BOT2.

Full Information

First Posted
March 19, 2008
Last Updated
June 14, 2010
Sponsor
University of Oklahoma
Collaborators
American Academy of Otolaryngology-Head and Neck Surgery Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00642343
Brief Title
Balance in Children With Cochlear Implants
Official Title
Balance in Children With Cochlear Implants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oklahoma
Collaborators
American Academy of Otolaryngology-Head and Neck Surgery Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe, Profound Deafness
Keywords
Balance, Severe, Profound deafness, Children, unilateral/bilateral cochlear implants, unilateral cochlear implant, bilateral cochlear implants

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Children with severe to profound deafness that have not received any intervention.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Children with an unilateral cochlear implant.
Arm Title
3
Arm Type
Active Comparator
Arm Description
Children with bilateral cochlear implants.
Arm Title
4
Arm Type
Active Comparator
Arm Description
Children who receive their second implant during the duration of the study.
Intervention Type
Behavioral
Intervention Name(s)
Evaluation of motor proficiency skills.
Other Intervention Name(s)
deaf children, balance, unilateral cochlear implants,, bilateral cochlear implants
Intervention Description
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Intervention Type
Behavioral
Intervention Name(s)
Evaluation of motor proficiency
Other Intervention Name(s)
balance,unilateral/bilateral cochlear implants,, deaf children
Intervention Description
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Intervention Type
Behavioral
Intervention Name(s)
Evaluation of motor proficiency
Other Intervention Name(s)
balance, unilateral/bilateral cochlear implants,, deaf children
Intervention Description
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Intervention Type
Behavioral
Intervention Name(s)
Evaluation of motor proficiency.
Other Intervention Name(s)
deaf children, unilateral/bilateral cochlear implants,, balance
Intervention Description
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Berryhill, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

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Balance in Children With Cochlear Implants

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