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Feasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke (PA-ChatS)

2026年7月8日 更新者：University of Minnesota

Feasibility of Engaging Stroke Survivors in a Brief Step Count Intervention During Chronic Stroke

The goal of this study is to explore the feasibility of a new approach to rehabilitation that focuses on step count. Participants will complete 6 telephone or Zoom-based sessions with an occupational therapist over 6 weeks and use a step count tracker during that time. They will also complete questionnaires, assessments, surveys, and physical activity measurements during study weeks 0 (baseline), 3 (mid-point), 7 (post-intervention) and 12 (follow-up).

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

24

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。

学习联系方式

  • 姓名：Karli Jahnke
  • 电话号码：612-626-4046
  • 邮箱：dwell@umn.edu

学习地点

  • 美国
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • 招聘中
        • University of Minnesota

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

Inclusion Criteria:

  • Stroke diagnosis confirmed by imaging
  • Stroke occurred 6 or more months before study enrollment
  • Meet criteria for "inactive" on the International Physical Activity Questionnaire-Short Form
  • Able to identify a support person that they interact with in-person at least once per week
  • Able and willing to participate fully in the study and provide informed consent or proxy consent with participant assent

Exclusion Criteria:

  • Currently receiving care in a transitional care unit, skilled nursing facility, or other institutional care setting
  • Currently receiving outpatient neurorehabilitation services (e.g., physical therapy, occupational therapy, speech therapy)
  • Severe cognitive or communication impairments (inability to respond accurately to complete study screening questions or to provide informed consent or assent)
  • Currently pregnant or expecting to become pregnant in the next 8 weeks Comorbid neurological disorder (Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma, spinal cord injury, cerebral palsy)
  • Comorbid cancer, currently undergoing chemotherapy or radiation treatment
  • Received inpatient treatment or was hospitalized for a psychiatric condition and/or alcohol or substance abuse within the past 12 months
  • Current diagnosis of a terminal illness and/or currently receiving hospice care
  • History of allergic reaction to adhesives that precludes the use of an adhesive necessary for adherence to activPAL measurement
  • Uses wheelchair as primary mobility aid outside of home setting
  • Inability to speak, read, or understand English
  • Concurrent participation in another rehabilitation intervention research study
  • Resides more than 50 miles outside of the Twin Cities, Minnesota metropolitan area
  • Investigator discretion for safety or adherence reasons

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：PA-ChatS Intervention
Participants will receive 6, 20-30 minute intervention sessions delivered over the telephone or using Zoom by an occupational therapist over 6 weeks (1 session/week). They will also complete self-monitoring of step counts using a pedometer.
行为的：Physical Activity Chats after Stroke (PA-ChatS)

PA-ChatS consists of (1) self-monitoring step count using a pedometer, and (2) behavioral activation for stepping activity delivered via the telephone or Zoom and guided by the PA-ChatS workbook.

Participants will receive education regarding physical activity after stroke, American Heart Association guidelines for post-stroke physical activity levels, and an overview of the intervention activities. They will then use a pedometer to monitor average daily step counts, set new step count goals (increasing by 5 to 10% of the daily average step count from the prior week), and create a specific plan for achieving the new step count goal. The interventionist will collaboratively problem solve with the participant to identify strategies to overcome barriers to stepping activity and maintain safety.

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
Adherence to step count
大体时间：Week 7
The activPAL micro4 (24/7 wear protocol) will used to measure step count. The proportion of participants achieving 7500 or more steps per day will be reported.
Week 7

次要结果测量

结果测量
措施说明
大体时间
遵守 PA-ChatS 会话
大体时间：6周
完成 6 次 PA-ChatS 会话中的 6 次 (100%) 的参与者的百分比。 课程完成情况将由研究干预治疗师记录，完成的课程总数将在最后一次干预课程结束后计算。
6周
PA-ChatS 干预的可接受性
大体时间：第 7 周
客户满意度调查问卷 8 将用于衡量干预措施的可接受性。 这是一个包含 8 个项目的衡量标准，每个项目均按 1 至 4 分的李克特量表进行评分，然后对所有 8 个项目进行平均。 平均分 3 分或以上表明干预措施总体上是可以接受的。
第 7 周
步数变化
大体时间：第 1 周至第 12 周
ActivPAL micro4 将用于按照 24 小时、7 天的佩戴方案测量步数。
第 1 周至第 12 周
改变久坐时间
大体时间：第 1 周至第 12 周
ActivPAL micro4 将用于测量久坐时间，遵循 24 小时、7 天的佩戴方案。 参与者将完成每日日记，注明睡眠时间。 睡眠将按照日记通知的方法消除。
第 1 周至第 12 周
Adherence to step count
大体时间：Week 12
The activPAL micro4 (24/7 wear protocol) will used to measure step count. The proportion of participants achieving 7500 or more steps per day will be reported.
Week 12
Change in sedentary time
大体时间：Weeks 1 to 7
The activPAL micro4 will be used to measure sedentary time, following a 24-hour, 7-day wear protocol. Participants will complete a daily diary indicating the sleep time. Sleep will be removed following a diary-informed method.
Weeks 1 to 7
Safety of the PA-ChatS Intervention
大体时间：Week 7
All participants will be queried regarding possible adverse events during the study at one time-point using an adverse events questionnaire previously administered in physical activity studies after stroke. The total count of adverse events that are possibly or definitely related to this intervention will be reported.
Week 7

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。

赞助

University of Minnesota

调查人员

  • 首席研究员：Emily Kringle, PhD, OTR/L、University of Minnesota

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)

2026年7月8日

初级完成 (估计的)

2026年11月30日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY00028280

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

Data related to demographics, medical and stroke history, cognitive function, mobility, self-reported psychosocial and social support measures, and physical activity data may be requested

IPD 共享时间框架

Deidentified data and supporting documents will be made available upon reasonable request after the main results are published in a peer-reviewed journal.

IPD 共享访问标准

Requests for data sharing may be directed to the Principal Investigator. Deidentified IPD and supporting documents will be provided upon reasonable request through appropriate channels (Data Use Agreement).

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

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

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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