Balance in Children With Cochlear Implants

Study Overview
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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.

Official Title
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Balance in Children With Cochlear Implants

Conditions
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Severe, Profound Deafness

Intervention / Treatment
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* Behavioral: Evaluation of motor proficiency skills.
* Behavioral: Evaluation of motor proficiency
* Behavioral: Evaluation of motor proficiency
* Behavioral: Evaluation of motor proficiency.


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Children with severe to profound deafness that have not received any intervention. | Behavioral: Evaluation of motor proficiency.<br>* The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.<br>* Other names: balance;|
| Active Comparator: 2<br>Children with an unilateral cochlear implant. | Behavioral: Evaluation of motor proficiency skills.<br>* The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.<br>* Other names: bilateral cochlear implants;|
| Active Comparator: 3<br>Children with bilateral cochlear implants. | Behavioral: Evaluation of motor proficiency<br>* The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.<br>* Other names: deaf children;|
| Active Comparator: 4<br>Children who receive their second implant during the duration of the study. | Behavioral: Evaluation of motor proficiency<br>* The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.<br>* Other names: deaf children;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balance, Severe, Profound deafness, Children, unilateral/bilateral cochlear implants, unilateral cochlear implant, bilateral cochlear implants