Clinical trial NCT03620500: Balance in Children With Cochlear Implants
Official title: Balance and Vestibular Impairments in Children With Cochlear Implantation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cochlear Implants
Sensory-Neural Hearing Loss
Balance Disorder
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with sensory neural hearing loss who are candidates for 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).


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) -

Primary outcomes:
measure: Change in the Peabody Developmental Motor Scales
timeFrame: Baseline to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Cathey Norton, DPT
role: PRINCIPAL_INVESTIGATOR
References: