CClinicalTrials.gg
RecruitingNCT07649135PA-ChatSUpdated Jul 10, 2026

Feasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke

An interventional study of Physical Activity Chats after Stroke (PA-ChatS) in Stroke, Ischemic Stroke and Hemorrhagic Stroke, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Stroke
  • Ischemic Stroke
  • Hemorrhagic Stroke

Keywords

  • physical activity
  • behavior change
  • rehabilitation
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 24 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    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.

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

Interventions

  • BehavioralPhysical 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.

06

What researchers measure

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.

    Time frame: Week 7

Secondary outcomes

  1. Adherence to PA-ChatS sessions

    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.

    Time frame: 6-weeks

  2. Acceptability of PA-ChatS Intervention

    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.

    Time frame: Week 7

  3. Safety of the PA-ChatS Intervention

    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.

    Time frame: Week 7

  4. 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.

    Time frame: Week 12

  5. Change in step count

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

    Time frame: Weeks 1 to 12

  6. Change in sedentary time

    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.

    Time frame: Weeks 1 to 7

  7. Change in sedentary time

    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.

    Time frame: Weeks 1 to 12

07

Study locations

1 of 1 sites recruiting
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07649135
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Jul 8, 2026
Primary completion
Nov 30, 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jul 10, 2026

Study contacts

Karli Jahnke
Contact
dwell@umn.edu
612-626-4046
Emily Kringle, PhD, OTR/L
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion