Spatial Cognitive Training for Chronic Vestibular Disorders
2020年9月8日 更新者：Brooke Klatt、University of Pittsburgh
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).
研究概览
详细说明
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.
研究类型
介入性
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosis of chronic vestibular disorder (>6months & diagnosis from laboratory testing by neuro-otologist)
Exclusion Criteria:
- Participants with dementia, or with blindness or deafness who cannot participate in cognitive training procedures.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Spatial Cognitive Training
map reading and route-learning skills
|
map reading and route-learning skills
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in Dizziness Handicap Inventory
大体时间：Baseline vs immediately post-training
|
Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100
|
Baseline vs immediately post-training
|
|
Change from immediate post-training to 3-months post-training in Dizziness Handicap Inventory
大体时间：Immediately post-training to 3 months post-training
|
Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100
|
Immediately post-training to 3 months post-training
|
|
Change from baseline in Dynamic Gait Index
大体时间：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.
|
Baseline vs immediately post-training
|
|
Change from immediate post-training to 3-months post-training in Dynamic Gait Index
大体时间：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.
|
Immediately post-training to 3 months post-training
|
|
Change from baseline in Four Square Step Test
大体时间：Baseline vs immediately post-training
|
Assesses dynamic balance, spatial, & sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)
|
Baseline vs immediately post-training
|
|
Change from immediate post-training to 3-months post-training in Four Square Step Test
大体时间：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)
|
Immediately post-training to 3 months post-training
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in Money Road Map Test
大体时间：Baseline vs immediately post-training
|
Assessment of egocentric mental rotation in space by recording total number of errors in right-left discrimination mental rotation tasks.
|
Baseline vs immediately post-training
|
|
Change from immediate post-training to 3-months post-training in Money Road Map Test
大体时间：Immediately post-training to 3 months post-training
|
Assessment of egocentric mental rotation in space by recording total number of errors in right-left discrimination mental rotation tasks.
|
Immediately post-training to 3 months post-training
|
|
Change from baseline in Benton Visual Retention Test
大体时间：Baseline vs immediately post-training
|
visual perception and visual memory assessment by asking participant to reproduce 10 designs following a 10-second exposure and scored 0-10 based on correct drawing reconstruction.
|
Baseline vs immediately post-training
|
|
Change from immediate post-training to 3-months post-training in Benton Visual Retention Test
大体时间：Immediately post-training to 3 months post-training
|
visual perception and visual memory assessment by asking participant to reproduce 10 designs following a 10-second exposure and scored 0-10 based on correct drawing reconstruction.
|
Immediately post-training to 3 months post-training
|
|
Change from baseline in modified Clinical Test of Sensory Organization and Balance
大体时间：Baseline vs immediately post-training
|
Static standing balance during 4 conditions where sensory inputs are altered (eyes open/eyes closed on firm/foam surface) and each condition is timed for max of 30 seconds.
|
Baseline vs immediately post-training
|
|
Change from immediate post-training to 3-months post-training in modified Clinical Test of Sensory Organization and Balance
大体时间：Immediately post-training to 3 months post-training
|
Static standing balance during 4 conditions where sensory inputs are altered (eyes open/eyes closed on firm/foam surface) and each condition is timed for max of 30 seconds.
|
Immediately post-training to 3 months post-training
|
|
Change from baseline in Activities-specific Balance Confidence Scale
大体时间：Baseline vs immediately post-training
|
Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)
|
Baseline vs immediately post-training
|
|
Change from immediate post-training to 3-months post-training in Activities-specific Balance Confidence Scale
大体时间：Immediately post-training to 3 months post-training
|
Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)
|
Immediately post-training to 3 months post-training
|
|
Change from baseline in Santa Barbara Sense of Direction Scale
大体时间：Baseline vs immediately post-training
|
15 question related to subjective sense of direction adeptness (ranging 1-7 for each item); cumulative score is divided by number of responses answered to yield a 1-7 total score.
|
Baseline vs immediately post-training
|
|
Change from immediate post-training to 3-months post-training in Santa Barbara Sense of Direction Scale
大体时间：Immediately post-training to 3 months post-training
|
15 question related to subjective sense of direction adeptness (ranging 1-7 for each item); cumulative score is divided by number of responses answered to yield a 1-7 total score.
|
Immediately post-training to 3 months post-training
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Brooke Klatt, PhD, PT、University of Pittsburgh
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年6月1日
初级完成 (预期的)
2020年6月30日
研究完成 (预期的)
2020年8月31日
研究注册日期
首次提交
2019年5月11日
首先提交符合 QC 标准的
2019年5月11日
首次发布 (实际的)
2019年5月15日
研究记录更新
最后更新发布 (实际的)
2020年9月10日
上次提交的符合 QC 标准的更新
2020年9月8日
最后验证
2020年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Spatial Cognitive Training的临床试验
-
Karolinska InstitutetMinistry of Health and Social Affairs, Sweden完全的
-
Mental Health Services in the Capital Region, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention Research; Center for Clinical Intervention...完全的