Balance in Children With Cochlear Implants

Early Phase 1

Completed

• Conditions: Severe, Profound Deafness
• Interventions: Behavioral: Evaluation of motor proficiency.; Behavioral: Evaluation of motor proficiency skills.; Behavioral: Evaluation of motor proficiency

• Registration Number: NCT00642343
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-25
• Status Verified: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-14
• Last Update Posted: 2010-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Evaluation of motor proficiency.	Children with severe to profound deafness that have not received any intervention.
2	Evaluation of motor proficiency skills.	Children with an unilateral cochlear implant.
3	Evaluation of motor proficiency	Children with bilateral cochlear implants.
4	Evaluation of motor proficiency	Children who receive their second implant during the duration of the study.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States