Balance in Children With Cochlear Implants

University of Oklahoma (OU)

Status and phase: Completed; Early Phase 1

Conditions: Severe, Profound Deafness

Treatments: Behavioral: Evaluation of motor proficiency skills.; Behavioral: Evaluation of motor proficiency.; Behavioral: Evaluation of motor proficiency

Study type: Interventional

Funder types: Other

Identifiers

NCT00642343

BALANCE W/COCHLEAR_BERRYHILL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Evaluation of motor proficiency.

2

Active Comparator group

Description:

Children with an unilateral cochlear implant.

Treatment:

Behavioral: Evaluation of motor proficiency skills.

3

Active Comparator group

Description:

Children with bilateral cochlear implants.

Treatment:

Behavioral: Evaluation of motor proficiency

Behavioral: Evaluation of motor proficiency

4

Active Comparator group

Description:

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

Treatment:

Behavioral: Evaluation of motor proficiency

Behavioral: Evaluation of motor proficiency