Balance in Children With Cochlear Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-03

Study Completion Date

2023-08-03

Brief Summary

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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).

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Detailed Description

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Conditions

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Cochlear Implants Sensory-Neural Hearing Loss Balance Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with Cochlear Implants

Children with sensory neural hearing loss who undergo cochlear implantation will be monitored to see if balance develops normally in this population

Gross motor and developmental balance testing

Intervention Type BEHAVIORAL

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).

Interventions

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Gross motor and developmental balance testing

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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) -

Minimum Eligible Age

12 Months

Maximum Eligible Age

71 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No