Balance in Children With Cochlear Implants

Cochlear Implants Clinical Trial

Official title:

Balance and Vestibular Impairments in Children With Cochlear Implantation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03620500
• Other study ID #: 171127
• Status: Withdrawn
• Start date: August 3, 2018
• Est. completion date: August 3, 2023

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 3, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 71 Months

Eligibility

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) -

Related Conditions & MeSH terms

• Balance Disorder
• Cochlear Implants
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensory-Neural Hearing Loss

Intervention

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).

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Peabody Developmental Motor Scales	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.	Baseline to 1 year