The Effect of Cochlear Implant on Postural Control

Cochlear Implant Clinical Trial

Official title:

The Effect of Cochlear Implant on Postural Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04404205
• Other study ID #: 6
• Status: Completed
• Start date: April 28, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: June 2022
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients who had cochlear implant surgery before

Exclusion Criteria:

• Bilateral Cochlear implants

• Neurologic disease

• Communication problem

• Additional disability

Related Conditions & MeSH terms

• Cochlear Implant

Intervention

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).

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Implant on, implant off, implant on+music on, implant of again	3-6 months
Primary	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: Implant on, implant off, implant on+music on, implant of again	3-6 months
Primary	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: Implant on, implant off, implant on+music on, implant of again	3-6 months