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临床试验/NCT03620500
NCT03620500撤回不适用

Balance and Vestibular Impairments in Children With Cochlear Implantation

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家开始时间: 2018年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Change in the Peabody Developmental Motor Scales

研究概览

简要总结

Cochlear implantation is performed in children with sensorineural hearing loss to restore hearing. Fifty percent of children with sensory neural hearing loss, who are candidates for cochlear implant, have vestibular (inner ear) dysfunction prior to surgery. Anatomically, the cochlea, semicircular canals, and otolith organs are located in close proximity in the inner ear and any procedure in the cochlea may affect the vestibular system, resulting in subsequent balance impairment. In addition, the process of implantation often results in further suppression of vestibular function necessary to develop normal balance. Vestibular dysfunction predisposes these children to balance impairments that can affect the normal development of gross motor skills such as sitting, standing, and walking. These balance and gross motor deficits may predispose the child to difficulties with safe community participation resulting in lower quality of life for the child and family.

Evidence in the literature suggests that children with vestibular loss do not recover to the same levels as their peers, especially in the area of activities requiring vestibular input for balance.

The purpose of this descriptive study is to examine balance, vestibular function, and gross motor skills in children following cochlear implantation over a period of one year. Children, ages 1 year to 5 years will be tested post cochlear implant , and at 6 and 12 months subsequent to initial testing, using clinically based tests of vestibular impairment (head impulse test, post rotary nystagmus or head shake nystagmus), balance (Pediatric Balance Scale) and gross motor skill development (Peabody Developmental Motor Scales, 2nd edition). Quality of life will be assessed using the Life-H (Assessment of Life Habits).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Months 至 71 Months(Child)
性别
All
接受健康志愿者

入选标准

  • The Child must be a child between 12 months and 71 months of age.
  • The child should have received a cochlear implant within the previous year.
  • The child should be able to stand unsupported for 4 seconds.
  • Follow simple one step directions.

排除标准

  • Uncontrolled seizures
  • Any physician-recommended activity limitations that would preclude performing activities in the testing protocol.
  • Testing will not occur when the child is or has been acutely ill (i.e. fever, ear infection, etc.) within the previous week.
  • The participant must not have a known medical or developmental diagnosis that impacts his or her motor skills (i.e.
  • cerebral palsy, Down Syndrome) -

结局指标

主要结局

Change in the Peabody Developmental Motor Scales

时间窗: Baseline to 1 year

The Peabody Development Motor Scale measures balance in children compared to peers. A percentile score compared to typically developing peers is measured. A percentile score based on developmental age from birth to 5 years, 11 months.

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

Cathey Norton

Staff Physical Therapist

Vanderbilt University Medical Center

研究点 (1)

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