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临床试验/NCT03950648
NCT03950648撤回不适用

Spatial Cognitive Training for Chronic Vestibular Disorders

University of Pittsburgh0 个研究点开始时间: 2020年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Change from baseline in Dizziness Handicap Inventory

研究概览

简要总结

In this study the investigators propose to apply cognitive training, which has been largely used in the realm of age-related cognitive decline, dementia, and Alzheimer's disease, in a novel clinical context to individuals with vestibular impairment. In prior work the investigators observed that individuals with vestibular loss have evidence of spatial cognitive impairment. The investigators plan to evaluate the preliminary efficacy and feasibility of a cognitive training program in a sample of participants with chronic vestibular impairment who display deficits in spatial ability. The cognitive training program will focus on visuospatial skills and will be used as an adjunct to traditional vestibular physical therapy (VPT).

详细描述

Patients with chronic vestibular dysfunction with report symptoms of spatial cognitive impairment will be offered cognitive training. The intervention will consist of a well-validated cognitive training protocol that specifically targets spatial navigation skills. The protocol was developed by Willis et al. for the Adult Development and Enrichment Trial (ADEPT) trial, which trains map reading and route-learning skills through mental rotation training tasks over the course of 5 weeks. Patients will be assessed by study staff pre-intervention, immediately post-intervention and at 3 months post-intervention using spatial cognitive outcomes, quality of life measures, and gait and balance outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Diagnosis of chronic vestibular disorder (>6months & diagnosis from laboratory testing by neuro-otologist)

排除标准

  • Participants with dementia, or with blindness or deafness who cannot participate in cognitive training procedures.

研究组 & 干预措施

Spatial Cognitive Training

Experimental

map reading and route-learning skills

干预措施: Spatial Cognitive Training (Behavioral)

结局指标

主要结局

Change from baseline in Dizziness Handicap Inventory

时间窗: Baseline vs immediately post-training

Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100

Change from immediate post-training to 3-months post-training in Dizziness Handicap Inventory

时间窗: Immediately post-training to 3 months post-training

Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100

Change from baseline in Four Square Step Test

时间窗: Baseline vs immediately post-training

Assesses dynamic balance, spatial, \& sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)

Change from immediate post-training to 3-months post-training in Four Square Step Test

时间窗: Immediately post-training to 3 months post-training

Assesses dynamic balance, spatial, \& sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)

Change from baseline in Dynamic Gait Index

时间窗: Baseline vs immediately post-training

Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.

Change from immediate post-training to 3-months post-training in Dynamic Gait Index

时间窗: Immediately post-training to 3 months post-training

Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.

次要结局

  • Change from baseline in Money Road Map Test(Baseline vs immediately post-training)
  • Change from baseline in Santa Barbara Sense of Direction Scale(Baseline vs immediately post-training)
  • Change from immediate post-training to 3-months post-training in Santa Barbara Sense of Direction Scale(Immediately post-training to 3 months post-training)
  • Change from immediate post-training to 3-months post-training in Money Road Map Test(Immediately post-training to 3 months post-training)
  • Change from baseline in Benton Visual Retention Test(Baseline vs immediately post-training)
  • Change from baseline in modified Clinical Test of Sensory Organization and Balance(Baseline vs immediately post-training)
  • Change from baseline in Activities-specific Balance Confidence Scale(Baseline vs immediately post-training)
  • Change from immediate post-training to 3-months post-training in Activities-specific Balance Confidence Scale(Immediately post-training to 3 months post-training)
  • Change from immediate post-training to 3-months post-training in modified Clinical Test of Sensory Organization and Balance(Immediately post-training to 3 months post-training)
  • Change from immediate post-training to 3-months post-training in Benton Visual Retention Test(Immediately post-training to 3 months post-training)

研究者

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

Brooke Klatt

Postdoctoral Research Fellow

University of Pittsburgh

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