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临床试验/NCT07649135
NCT07649135招募中不适用

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

University of Minnesota1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Adherence to step count

研究概览

简要总结

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

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

PA-ChatS Intervention

Experimental

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.

干预措施: Physical Activity Chats after Stroke (PA-ChatS) (Behavioral)

结局指标

主要结局

Adherence to step count

时间窗: 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.

次要结局

  • Adherence to PA-ChatS sessions(6-weeks)
  • Acceptability of PA-ChatS Intervention(Week 7)
  • Adherence to step count(Week 12)
  • Change in step count(Weeks 1 to 12)
  • Change in sedentary time(Weeks 1 to 7)
  • Change in sedentary time(Weeks 1 to 12)
  • Safety of the PA-ChatS Intervention(Week 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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