Balance in Children With Cochlear Implants
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Mar 2008
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 19, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJune 15, 2010
June 1, 2010
2.3 years
March 19, 2008
June 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (4)
1
PLACEBO COMPARATORChildren with severe to profound deafness that have not received any intervention.
2
ACTIVE COMPARATORChildren with an unilateral cochlear implant.
3
ACTIVE COMPARATORChildren with bilateral cochlear implants.
4
ACTIVE COMPARATORChildren who receive their second implant during the duration of the study.
Interventions
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Eligibility Criteria
You may qualify if:
- Children with cochlear implant(s) activated for at least two weeks before participation.
- Children with severe to profound deafness that have not received intervention.
You may not qualify if:
- Children with mental retardation, associated physical handicaps, or chronic sedative use prohibiting completion of the balance tests.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Wayne Berryhill, MD
University of Oklahoma
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 19, 2008
First Posted
March 25, 2008
Study Start
March 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
June 15, 2010
Record last verified: 2010-06