Balance in Children With Cochlear Implants
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|ClinicalTrials.gov Identifier: NCT03620500|
Recruitment Status : Enrolling by invitation
First Posted : August 8, 2018
Last Update Posted : September 12, 2019
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).
|Condition or disease||Intervention/treatment|
|Cochlear Implants Sensory-Neural Hearing Loss Balance Disorder||Behavioral: Gross motor and developmental balance testing|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Balance and Vestibular Impairments in Children With Cochlear Implantation|
|Actual Study Start Date :||August 3, 2018|
|Estimated Primary Completion Date :||August 3, 2020|
|Estimated Study Completion Date :||August 3, 2020|
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
Behavioral: 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).
- Change in the Peabody Developmental Motor Scales [ Time Frame: Baseline to 1 year ]The Peabody Development Motor Scale measures balance in children compared to peers. A percentile score compared to typically developing peers is measured. A percentile score based on developmental age from birth to 5 years, 11 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620500
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Cathey Norton, DPT||Vanderbilt University Medical Center|