Balance in Children With Cochlear Implants

NCT03620500 | Withdrawn

• 1 other identifier: 171127
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Cochlear Implants; Sensory-Neural Hearing Loss; Balance Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Gross motor and developmental balance testing 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).

Children with Cochlear Implants

Eligibility Criteria

• Age: 12 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with sensory neural hearing loss who are candidates for cochlear implantation

You may qualify if:

• The Child must be a child between 12 months and 71 months of age.
• The child should have received a cochlear implant within the previous year.
• The child should be able to stand unsupported for 4 seconds.
• Follow simple one step directions.

You may not qualify if:

• Uncontrolled seizures
• Any physician-recommended activity limitations that would preclude performing activities in the testing protocol.
• Testing will not occur when the child is or has been acutely ill (i.e. fever, ear infection, etc.) within the previous week.
• The participant must not have a known medical or developmental diagnosis that impacts his or her motor skills (i.e.
• cerebral palsy, Down Syndrome) -

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cathey Norton, DPT

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physical Therapist

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 8, 2018
• Study Start: August 3, 2018
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: June 10, 2025

Record last verified: 2024-03

Locations

US (1)