Feasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke

Официальное название

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

Обзор

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).

Вмешательства

• Поведенческое 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 (in

Первичные конечные точки

• Adherence to step count [Срок оценки: Week 7]

Вторичные конечные точки (7)

• Adherence to PA-ChatS sessions [Срок оценки: 6-weeks]
• Acceptability of PA-ChatS Intervention [Срок оценки: Week 7]
• Safety of the PA-ChatS Intervention [Срок оценки: Week 7]
• Adherence to step count [Срок оценки: Week 12]
• Change in step count [Срок оценки: Weeks 1 to 12]
• Change in sedentary time [Срок оценки: Weeks 1 to 7]
• Change in sedentary time [Срок оценки: Weeks 1 to 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Minnesota — Minneapolis

Идентификаторы

NCT: NCT07649135 · STUDY00028280

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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