Feasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke

NCT07649135 | Recruiting

• 1 other identifier: STUDY00028280
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Keywords

physical activity; behavior change; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Adherence to step count

  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

Secondary Outcomes (7)

• Adherence to PA-ChatS sessions

  6-weeks

• Acceptability of PA-ChatS Intervention

  Week 7

• Safety of the PA-ChatS Intervention

  Week 7

• Adherence to step count

  Week 12

• Change in step count

  Weeks 1 to 12

Study Arms (1)

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.

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

Interventions

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.

PA-ChatS Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Emily Kringle, PhD, OTR/L

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karli Jahnke

CONTACT

612-626-4046; dwell@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 16, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deidentified data and supporting documents will be made available upon reasonable request after the main results are published in a peer-reviewed journal.
• Access Criteria: 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).

Locations

US (1)