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Balance in Children With Cochlear Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03620500
Recruitment Status : Enrolling by invitation
First Posted : August 8, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Cathey Norton, Vanderbilt University Medical Center

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).


Condition or disease Intervention/treatment
Cochlear Implants Sensory-Neural Hearing Loss Balance Disorder Behavioral: Gross motor and developmental balance testing

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with sensory neural hearing loss who are candidates for cochlear implantation
Criteria

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) -


Information from the National Library of Medicine

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


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Cathey Norton, DPT Vanderbilt University Medical Center

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Responsible Party: Cathey Norton, Staff Physical Therapist, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03620500    
Other Study ID Numbers: 171127
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms