- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04404205
The Effect of Cochlear Implant on Postural Control
June 11, 2022 updated by: Fazıl Necdet Ardıç, Pamukkale University
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Denizli, Turkey, 20070
- Pamukkale University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
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.
|
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)
Time Frame: 3-6 months
|
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)
Time Frame: 3-6 months
|
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)
Time Frame: 3-6 months
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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