Brief Title
Balance in Children With Cochlear Implants
Official Title
Balance and Vestibular Impairments in Children With Cochlear Implantation
Brief Summary
Cochlear implantation is performed in children with sensorineural hearing loss to restore
hearing. Fifty percent of children with sensory neural hearing loss, who are candidates for
cochlear implant, have vestibular (inner ear) dysfunction prior to surgery. Anatomically, the
cochlea, semicircular canals, and otolith organs are located in close proximity in the inner
ear and any procedure in the cochlea may affect the vestibular system, resulting in
subsequent balance impairment. In addition, the process of implantation often results in
further suppression of vestibular function necessary to develop normal balance. Vestibular
dysfunction predisposes these children to balance impairments that can affect the normal
development of gross motor skills such as sitting, standing, and walking. These balance and
gross motor deficits may predispose the child to difficulties with safe community
participation resulting in lower quality of life for the child and family.
Evidence in the literature suggests that children with vestibular loss do not recover to the
same levels as their peers, especially in the area of activities requiring vestibular input
for balance.
The purpose of this descriptive study is to examine balance, vestibular function, and gross
motor skills in children following cochlear implantation over a period of one year. Children,
ages 1 year to 5 years will be tested post cochlear implant , and at 6 and 12 months
subsequent to initial testing, using clinically based tests of vestibular impairment (head
impulse test, post rotary nystagmus or head shake nystagmus), balance (Pediatric Balance
Scale) and gross motor skill development (Peabody Developmental Motor Scales, 2nd edition).
Quality of life will be assessed using the Life-H (Assessment of Life Habits).
Study Type
Observational
Primary Outcome
Change in the Peabody Developmental Motor Scales
Condition
Cochlear Implants
Intervention
Gross motor and developmental balance testing
Study Arms / Comparison Groups
Children with Cochlear Implants
Description: Children with sensory neural hearing loss who undergo cochlear implantation will be monitored to see if balance develops normally in this population
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
20
Start Date
August 3, 2018
Completion Date
August 3, 2022
Primary Completion Date
August 3, 2022
Eligibility Criteria
Inclusion Criteria:
1. The Child must be a child between 12 months and 71 months of age.
2. The child should have received a cochlear implant within the previous year.
3. The child should be able to stand unsupported for 4 seconds.
4. Follow simple one step directions.
Exclusion Criteria:
1. Uncontrolled seizures
2. Any physician-recommended activity limitations that would preclude performing
activities in the testing protocol.
3. Testing will not occur when the child is or has been acutely ill (i.e. fever, ear
infection, etc.) within the previous week.
4. The participant must not have a known medical or developmental diagnosis that impacts
his or her motor skills (i.e.
cerebral palsy, Down Syndrome) -
Gender
All
Ages
12 Months - 71 Months
Accepts Healthy Volunteers
No
Contacts
Cathey Norton, DPT, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03620500
Organization ID
171127
Responsible Party
Principal Investigator
Study Sponsor
Vanderbilt University Medical Center
Study Sponsor
Cathey Norton, DPT, Principal Investigator, Vanderbilt University Medical Center
Verification Date
October 2020