The Effect of Cochlear Implant on Postural Control

NCT ID: NCT04404205

Last Updated: 2022-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-28

Study Completion Date

2020-08-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Cochlear Implant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Postural stability measurements by Biodex Balance System

Intervention Type 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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients who had cochlear implant surgery before

Exclusion Criteria

* Bilateral Cochlear implants
* Neurologic disease
* Communication problem
* Additional disability
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Fazıl Necdet Ardıç

Chief of Department Otolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fazıl N Ardıç, MD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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6

Identifier Type: -

Identifier Source: org_study_id

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