Balance in Children With Cochlear Implants

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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