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临床试验/NCT04617548
NCT04617548已完成1 期

Feasibility Testing of tDCS and Metacognitive Strategy Training in Chronic Stroke

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
8
试验地点
2
主要终点
Semi-Structured Interview

研究概览

简要总结

This project seeks to evaluate the acceptability feasibility, practicality feasibility, and preliminary effect of combining transcranial direct current stimulation (tDCS) and metacognitive strategy training (MCST) in individuals with chronic stroke.

详细描述

Currently seven million people are living in the United States post stroke, making stroke the leading cause of long term disability. Almost half of the people living in the community following stroke have problems that challenge the activities that support their daily lives. This is in part due to the rehabilitation community's focus on short term stroke recovery and not on supporting survivors' need to actively manage their long-term disability and the environment around them so they can return to full participation in communities of their choice post-rehabilitation. The rehabilitation community is in need of evidence-based interventions for addressing post-stroke functional limitations. Metacognitive strategy training is a performance-based, problem-solving approach to task performance difficulties. Participants are taught to identify when to apply a cognitive strategy, how to apply it, and how to monitor and adapt usage of cognitive strategies within task performance. Metacognitive strategy training is recognized as a practice standard for addressing functional limitations post-stroke. Transcranial direct current stimulation is a method that has been used for over 15 years to modulate the excitability of targeted brain regions. While it does not directly stimulate neurons, it results in changes to polarity of neuronal membranes and is thought to facilitate or inhibit neuroplasticity. Combination of these approaches may result in an interaction of effects and a greater effect on function in individuals post-stroke than either approach used alone.

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
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 6 months post mild to moderate ischemic stroke
  • self-reported functional limitations
  • Age 30-80

排除标准

  • history of other neurological diagnoses
  • cognitive impairment (less than or equal to 21 on the Montreal Cognitive Assessment)
  • severe aphasia (greater than or equal to 2 on the NIHSS language item
  • non-English speaking
  • any additional condition where the PI deems participation unsafe
  • pregnancy, 7)
  • history of seizures
  • medications that influence cortical excitability
  • metallic implants above the chest
  • history of welding or metalwork
  • severe depressive symptoms (>21 on Patient Health Questionnaire)

结局指标

主要结局

Semi-Structured Interview

时间窗: after study completion, an average of 5 weeks

A brief interview to gather participant perceptions of the intervention, including their perceived benefit and practicality of the intervention and suggestions for improvement for the intervention.

Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure

时间窗: after study completion, an average of 5 weeks

A brief questionnaire to evaluate participant satisfaction regarding the intervention's acceptability, appropriateness, and feasibility

Client Satisfaction Questionnaire (CSQ-8)

时间窗: after study completion, an average of 5 weeks

Self-report, 8 item measures of intervention acceptability

次要结局

  • Performance Quality Rating Scale (PQRS)(Pre-intervention and post-intervention, typically an average of 5 weeks)
  • Canadian Occupational Performance Measure (COPM)(Pre-intervention and post-intervention, typically an average of 5 weeks)

研究者

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

Anna Boone

Anna E. Boone, MSOT, PhD, OTR/L

University of Missouri-Columbia

研究点 (2)

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tDCS and CO-OP in Chronic Stroke | 临床试验