The Effect of Cochlear Implant on Postural Control

NCT04404205 | Completed

• 1 other identifier: 6
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cochlear Implant

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Postural stability measurements by Biodex Balance System DIAGNOSTIC_TEST

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).

Adult patient with cochlear implant

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients who had cochlear implant surgery before

You may not qualify if:

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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

Study Officials

• Fazıl N Ardıç, MD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department Otolaryngology

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: May 27, 2020
• Study Start: April 28, 2020
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)