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临床试验/NCT06400147
NCT06400147已完成不适用

Examining Metacognitive Strategy Training for Individuals With Unilateral Spatial Neglect

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年8月16日最近更新:
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
45
试验地点
2
主要终点
Change in online self-awareness

研究概览

简要总结

It is common for individuals after stroke to have a cognitive perceptual impairment called unilateral spatial neglect (neglect). Individuals with neglect have difficulty paying attention to one side of their body or one side of the environment and therefore experience difficulty performing daily activities. There are a lack of effective treatments for neglect and new interventions are needed to help reduce disability for these individuals. Metacognitive strategy training (strategy training) is an intervention that has the potential to reduce neglect-related disability and improve individuals' awareness of their neglect. This study seeks to examine the effects of strategy training on self-awareness, disability, and neglect.

详细描述

Unilateral spatial neglect (neglect) post stroke is characterized by a lack of attention to one side of the body or one side of the environment. Individuals with neglect experience significant disability and are often unaware of their neglect symptoms which can make it even more difficult to treat. There are a lack of effective treatments for neglect and new interventions are needed to help reduce disability for these individuals. Metacognitive strategy training (strategy training) is an intervention that has the potential to reduce neglect-related disability and improve individuals' awareness of their neglect. Strategy training teaches individuals to develop personalized goals, self-assess their performance of daily activities, and develop and evaluate strategies designed to overcome barriers and improve their performance of daily activities. While strategy training shows promise for individuals with neglect, no studies have tailored the intervention for this group of individuals or examined the effects of strategy training for individuals with neglect. This study examines whether strategy training facilitates reductions in disability and neglect and improves self-awareness after acute stroke.

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

入选标准

  • •primary diagnosis of stroke
  • •admission to inpatient rehabilitation facility
  • •≥18 years old
  • •presence of neglect as determined by score of <18 on the Virtual Reality Lateralized Attention Test (VRLAT) or score below established cutoff for neglect on one of the six subtests of the Behavioral Inattention Test (BIT)

排除标准

  • •Boston Diagnostic Aphasia Examination (BDAE) Severity Scale score of 0 (severe global aphasia)
  • •diagnosis of dementia indicated in medical record
  • •diagnosis of active major depressive disorder/bipolar/psychotic disorder indicated in medical record
  • •anticipated length of stay <10 days

研究组 & 干预措施

Strategy Training

Experimental

The strategy training intervention teaches individuals to develop personalized goals, self-assess their performance of daily activities, and develop and evaluate strategies designed to overcome barriers and improve their performance of daily activities. Participants use a workbook to support their application of the strategy training.

干预措施: Strategy Training (Behavioral)

Attention Control

Active Comparator

The attention control intervention controls for the non-specific effects of strategy training. The study team will administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.

干预措施: Attention Control (Behavioral)

结局指标

主要结局

Change in online self-awareness

时间窗: Baseline to Post-intervention (up to 3 weeks)

Change in online self-awareness measured with the Catherine Bergego Scale. The Catherine Bergego Scale includes a therapist-rated assessment and client-rated (self) assessment. Total scores on the Catherine Bergego Scale therapist-rated assessment and client-rated (self) assessment each range from 0-30 (higher=greater neglect). The difference in client-rated total Catherine Bergego Scale scores and assessor-rated total Catherine Bergego Scale scores will be used as a measure of online self-awareness (smaller difference=better awareness). The a priori criterion for change was a medium effect size of change (Cohen's d≥0.5)

次要结局

  • Client Satisfaction with Strategy Training(Post-intervention (up to 3 weeks))

研究者

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

Emily Grattan

Assistant Professor

University of Pittsburgh

研究点 (2)

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