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NCT Number: NCT07649135

Feasibility of a Remotely Delivered Step Count Intervention in 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).

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Ischemic Stroke Motor Activity Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Activity Chats after Stroke (PA-ChatS)

Behavioral

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.

Primary outcomes

  1. Adherence to step count

    Time frame: 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.

Secondary outcomes

  1. Adherence to PA-ChatS sessions

    Time frame: 6-weeks

    Percentage of participants who complete 6 out of 6 (100%) of PA-ChatS sessions. Session completion will be documented by the study intervention therapist and total count of sessions completed will be computed after the last intervention session is delivered.

  2. Acceptability of PA-ChatS Intervention

    Time frame: Week 7

    The Client Satisfaction Questionnaire-8 will be used to measure acceptability of the intervention. This is an 8-item measure with each item rated on a 1 to 4-point Likert-type scale, and then averaged across all 8 items. A mean score of 3 or more indicates that the intervention is generally acceptable.

  3. Safety of the PA-ChatS Intervention

    Time frame: 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.

  4. Adherence to step count

    Time frame: 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.

  5. Change in step count

    Time frame: Weeks 1 to 12

    The activPAL micro4 will be used to measure step count, following a 24-hour, 7-day wear protocol.

  6. Change in sedentary time

    Time frame: 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.

  7. Change in sedentary time

    Time frame: Weeks 1 to 12

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Karli Jahnke

CONTACT

[email protected]

612-626-4046

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Acronym: PA-ChatS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 16, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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