The Effect of Cochlear Implant on Postural Control

Some patients are having balance problems after cochlear implant surgery. There are contradictory reports about the effect of the implant on postural control. While the cochlear implant is working, an electrical current is continuously stimulating the cochlear nerve which is in close proximity with vestibular ganglion and nerve. This stimulation may contribute to vestibular signals to the central system. The aim of the study is to investigate if this stimulation has any effect on postural control.

Study Overview

• Status: Completed
• Conditions: Cochlear Implant
• Intervention / Treatment: Diagnostic test: Postural stability measurements by Biodex Balance System

Detailed Description

Adult patients who had unilateral cochlear implantation will be included. Postural stability measurements will be done by the Biodex Balance System. Three preprogrammed main tests and their 9 subtests will be applied. Postural stability, fall index, sensory integration will be calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant on music on(3), and implant off again(4).

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20070
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who had cochlear implantation in our hospital will be invited to join the study.

Description

Inclusion Criteria:

• Patients who had cochlear implant surgery before

Exclusion Criteria:

• Bilateral Cochlear implants
• Neurologic disease
• Communication problem
• Additional disability

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patient with cochlear implant; Adult patients who had cochlear implant surgery before will be included. We will call patients from our cochlear implant list.	Diagnostic test: Postural stability measurements by Biodex Balance System; Postural stability measurements will be done by Biodex Balance System. Three preprogrammed main tests will be applied. Postural stability, fall index, sensory integration will be calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant on music on(3), and implant off again(4).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deviation of center of gravity(angle)	Deviation of center of gravity(angle) test assesses a patient's ability to maintain a center of balance. It measures how much the patient's position deviates from center and reports the average deviation as the stability index. Therefore, a low score is more desirable than a high score. Postural stability is a calculated value of difference in center of gravity when the subjects tested eyes open/closed, hard and soft surface test conditions. Postural stability will be measured in four conditions: İmplant on, implant off, implant on+music on, implant of again	3-6 months
postural sway velocity(angle/sec)	A high sway velocity when a patient is attempting to stand motionless suggests a deficit in postural control and assessment for lower extremity strength, proprioception, and vestibular or visual deficiencies. Postural sway velocity will be measured in four conditions: İmplant on, implant off, implant on+music on, implant of again	3-6 months
Sensory Integration Test(the mean absolute deviation of the patient's average position during a test)	The Clinical Test of Sensory Interaction of Balance (CTSIB) is a standard test for balance assessment on a static surface. The test assesses how well a patient can integrate sensory information to maintain balance. The result of the CTSIB test is the patient's sway index, which represents the mean absolute deviation of the patient's average position during a test. The higher the sway index, the more unsteady the person was during the test. Sensory Integration Test will be measured in four conditions: İmplant on, implant off, implant on+music on, implant of again	3-6 months

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: May 17, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 11, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be available University depository

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No