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中风远程康复的认知启动

2026年5月18日 更新者:Stephanie Aghamoosa、Medical University of South Carolina

认知启动可提高中风远程康复效果

这项试点研究的目的是调查在现有的职业治疗 (OT) 中风远程康复计划中添加认知康复是否会改善中风幸存者的功能。 它旨在回答的主要问题是这种干预是否可以改善认知、参与、现实世界活动中的上肢使用以及情绪/生活质量。 参与者将被要求参加为期 8 周的中风远程康复计划(13 个疗程),其中包括认知康复和手臂/手功能的 OT,并在干预前后完成评估。

研究概览

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Medical University of South Carolina

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准:

  • 至少 30 天前曾经历过缺血性或出血性中风并导致一只手臂/手部麻痹
  • 21 岁或以上的成年人
  • 能够说和读英语
  • 视力矫正,能够阅读屏幕上的文字
  • 拥有可进行远程康复就诊的设备(即手机、平板电脑或笔记本电脑)以及 Wi-Fi 连接或蜂窝服务
  • 能够根据有执照、经验丰富的中风远程康复职业治疗师的判断参加研究的评估会议。

排除标准:

  • 患有中度至重度或重度失语症。
  • 根据评估提供知情同意能力的标准协议确定,决策能力受损。

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:认知康复+职业治疗(远程康复)

训练有素的 OT 将提供为期 8 周的中风远程康复计划。 总共 13 节课,前 5 周每周 2 节课,后 3 周每周 1 节课。 认知康复和 OT 部分将按如下方式调整:

  • 第 1-4 节将重点关注认知康复。
  • 第 5-10 节将审查/提供额外的认知康复并提供加班。
  • 第 11-13 节可能会简要回顾认知康复,但主要关注 OT。
认知康复将是 OT 主导的一对一课程,重点是教授认知策略及其在广泛的活动/环境中的应用。 目标是通过将新的认知策略应用于参与者的家庭和社区活动(通过干预的后续 OT 部分进行教授)的表现来促进认知技能的学习和概括。
OT 上肢康复将包含两个组成部分:任务练习和元认知策略训练。 任务练习涉及患者在功能性任务的背景下重复练习中风受损的运动技能,以促进受损技能的恢复。 任务练习课程将由治疗师通过元认知策略培训过程进行辅导/指导,该过程基于职业绩效认知导向(CO-OP)方法,旨在增强家庭和社区生活任务中的自我管理。

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 Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA)
大体时间:From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
Montreal Cognitive Assessment (MoCA) is a 16-item objective cognitive screening measure. Total scores range from 0-30 points, with higher scores indicating better cognition.
From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Patient Specific Functional Scale (PSFS)
大体时间:From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
The Patient Specific Functional Scale (PSFS) is a patient-reported measure of task-goal identification and difficulty performing the task on a 0-10-point ordinal scale with higher ratings indicating greater satisfaction with task performance.
From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
Change From Baseline Psychosocial Function (Depression), as Measured by the Patient Health Questionnaire (PHQ-9)
大体时间:From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
The Patient Health Questionnaire (PHQ-9) is a 9-item self-report measure of depression. Items query mood (feeling down, lack of interest), thoughts (guilt, suicidality), and physical symptoms (appetite, sleep, fatigue, concentration, restlessness). Each item is scored on a 4-point scale reflecting how often the symptom has occurred over the last 2 weeks (0=not at all, 3=nearly every day). Scores are summed (out of 27), with higher scores indicating more symptoms of depression.
From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline Subjective Cognition, as Measured by the NeuroQoL-Cognitive Function
大体时间:From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
The NeuroQoL-Cognitive Function Short Form v.2.0 is a 29-item subjective measure of cognitive function. This patient-reported outcome assesses perceived abilities in memory, attention, decision making, or in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering, and learning) on a 5-item rating scale (1=cannot do to 5=no difficulty). The summed raw score is converted into a normed T-score (mean=50, SD=10). Higher T-scores reflect better perceived cognitive function.
From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Performance Quality Rating Scale (PQRS)
大体时间:From intervention session #5 to intervention session #13 (approximately 5 weeks)
The Performance Quality Rating Scale (PQRS) is a therapist-rated measure. The OT observes the participant's performance of a specific task and rates it on a 0-10-point ordinal scale, with higher ratings indicating greater task performance skill.
From intervention session #5 to intervention session #13 (approximately 5 weeks)
Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Stroke Self Efficacy Questionnaire (SSEQ)
大体时间:From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
The Stroke Self Efficacy Questionnaire (SSEQ) is a 13-item self-report measure of confidence (0-10-point Likert scale with higher numbers indicating greater confidence) doing at-home tasks such as using both hands to eat food or prepare a meal for oneself. Item scores are summed and total range from 0-130, with higher scores indicating greater self-efficacy.
From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
Change From Baseline Psychosocial Function (Sleep), as Measured by the PROMIS Sleep Disturbance
大体时间:From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
PROMIS Sleep Disturbance is an 8-item self-report measure of perceived difficulties falling and/or staying asleep. Items are rated on a 5-point rating scale (1=no problem, 5=very much a problem). The summed raw score is converted into a normed T-score (mean=50, SD=10). Higher T-scores reflect more sleep disturbance.
From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
Change From Baseline Psychosocial Function (Global), as Measured by the Inventory of Psychosocial Functioning (IPF)
大体时间:From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure of impairment in 7 psychosocial domains within the last 30 days: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care. Participants rate the frequency of difficulty on each item on a 7-point scale (0=never, 6=always). Scores are averaged by domain (if ≥80% of items are complete) and multiplied by 100; an overall score (grand mean, range: 0-100) is the average of completed domain scores; higher scores indicate greater impairment in psychosocial function.
From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks

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。

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 (实际的)

2024年8月20日

初级完成 (实际的)

2025年4月9日

研究完成 (实际的)

2025年4月9日

研究注册日期

首次提交

2024年8月12日

首先提交符合 QC 标准的

2024年8月14日

首次发布 (实际的)

2024年8月15日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月18日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

去识别化数据将在 NIH 资助的尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 数据和样本中心 (DASH) 中共享。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

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