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临床试验/NCT04404205
NCT04404205已完成不适用

The Effect of Cochlear Implant on Postural Control

Pamukkale University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Deviation of center of gravity(angle)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who had cochlear implant surgery before

排除标准

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

结局指标

主要结局

Deviation of center of gravity(angle)

时间窗: 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

Sensory Integration Test(the mean absolute deviation of the patient's average position during a test)

时间窗: 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

postural sway velocity(angle/sec)

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fazıl Necdet Ardıç

Chief of Department Otolaryngology

Pamukkale University

研究点 (1)

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