Cochlear ImplantsNCT03620500
Balance in Children With Cochlear Implants
An observational study of Cochlear Implants and Sensory-Neural Hearing Loss, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 71 months
- Conditions the study is for
- Cochlear Implants, Sensory-Neural Hearing Loss, Balance Disorder
- What is being tested?
- Gross motor and developmental balance testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2018to 3 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 71 months
- All sexes
- No healthy volunteers
- Child
Study population: Children with sensory neural hearing loss who are candidates for cochlear implantation
Who may be able to join
- 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.
Who cannot join
- 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) -
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Balance and Vestibular Impairments in Children With Cochlear Implantation
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).
- Being tested
- Gross motor and developmental balance testing
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gross motor and developmental balance testingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Gross motor and developmental balance testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start3 Aug 2018
- Primary completion3 Aug 2023 (estimated)
- Study completion3 Aug 2023
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathey Norton, Vanderbilt University Medical Center
- Investigators
- Cathey Norton, DPT, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620500
- Sponsor's protocol ID
- 171127
- Status last verified
- Mar 2024
- First submitted
- 3 Aug 2018
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance and Vestibular Impairments in Children With Cochlear Implantation
- ClinicalTrials.gov ID
- NCT03620500
- Acronym / sponsor ID
- 171127
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 3 Aug 2023 (estimated)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Cochlear Implants | – | Behavioral: Gross motor and developmental balance testingChildren with sensory neural hearing loss who undergo cochlear implantation will be monitored to see if balance develops normally in this population |
Who may qualify
- Ages
- 12 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with sensory neural hearing loss who are candidates for cochlear implantation
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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) -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gross motor and developmental balance testingBalance (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). | Behavioural | Children with Cochlear Implants |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cochlear Implants
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
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Recruiting
Pitch Perception and Memory: Deficits and Training
Cochlear Implants
Not yet recruiting
Patient-Oriented Research to Optimize Cochlear Implant Outcomes
Cochlear Implant, Cochlear Implant Users
RecruitingObservational study
Middle East MED-EL Observatory Study
Cochlear Implants
Recruiting
Assessment of a Method to Improve Cochlear Implant Users' Speech Perception in Noisy Environments While Maintaining Their Ability to Determine Where a Sound Originates From
Cochlear Implant Users
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathey Norton, DPT principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implants and Sensory-Neural Hearing Loss, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Peabody Developmental Motor Scales (time frame: Baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025; AzTrials last refreshed its copy on 28 Oct 2026.