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临床试验/NCT02867683
NCT02867683已完成不适用

The Effects of Vibrotactile Feedback During Vestibular Rehabilitation

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2013年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
Change in Five Times Sit to Stand

研究概览

简要总结

This study evaluates the use of vibrotactile feedback to traditional vestibular treatment protocols. Half the patients will have vibrotactile feedback added to their treatment protocols while the other half will undergo traditional vestibular treatment without vibrotactile feedback.

详细描述

Vestibular and balance rehabilitation is an effective way to improve balance for individuals with balance impairments by using the strategies of adaptation, habituation, or substitution. Typical vestibular treatment is usually 3 sessions per week for 6 weeks. For people with uncompensated unilateral vestibular hypofunction or bilateral vestibular loss, recovery/adaptation is often incomplete and chronic balance impairments result.

Vibrotactile feedback (VTF) is a strategy of substitution, or augmentation, to replace disrupted or absent vestibular function. The sensory information replaces disrupted or absent vestibular function to give persons additional signals about their body position in space. Real-time VTF applied to the trunk has been shown to decrease postural sway but the long-term benefits of training with VTF on balance and function have not been examined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • unilateral peripheral vestibular hypofunction
  • bilateral peripheral vestibular hypofunction

排除标准

  • confounding neurologic or neuromuscular disorders
  • pregnancy
  • inability to stand for 3 minutes
  • recent lower extremity fracture/severe sprain within the last 6 months
  • previous lower extremity joint replacement
  • incapacitating back or lower extremity pain
  • body too large for equipment

研究组 & 干预措施

Vibrotactile Feedback

Experimental

Balance exercises completed while vibration was applied to the trunk (anterior, posterior, right, and left) if postural sway exceeded a pre-determined threshold during the exercise.

干预措施: Vibrotactile Feedback (Other)

Without Vibrotactile Feedback

No Intervention

Balance training without feedback

结局指标

主要结局

Change in Five Times Sit to Stand

时间窗: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks

A stopwatch is used to record the amount of time it takes the participant to move from a seated position to a standing position back to seated without using their hads for a total of 5 repetitions

Change in Sensory Organization Testing

时间窗: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks

Postural sway data will be collected during Computerized Dynamic Posturography using the NeuroCom Equitest.

Change in 10-meter walk test

时间窗: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks

Participants preferred gait velocity will be assessed while walking in a straight path by timing 10-meter walk.

Change in Dynamic Gait Index and Functional Gait Assessment

时间窗: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks

Measures that assess ability to modify walking in the presence of external demands. Includes tasks such walking with head turns, walking around obstacles, stepping over obstacles, and negotiating stairs. Each task is scored on a 4 point scale (0-3) and a total score is compiled.

次要结局

  • Change in Activities-specific Balance Confidence Scale(Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks)
  • Change in Short Form-12(Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks)
  • Change in Dizziness Handicap Inventory(Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks)

研究者

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

Susan Whitney

Professor

University of Pittsburgh

研究点 (2)

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