StrokePA-ChatSNCT07649135
Feasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke
A study testing Physical Activity Chats after Stroke (PA-ChatS) in people with Stroke and Ischemic Stroke, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
- What is being tested?
- Physical Activity Chats after Stroke (PA-ChatS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Feasibility of Engaging Stroke Survivors in a Brief Step Count Intervention During 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).
- Conditions
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
- Being tested
- Physical Activity Chats after Stroke (PA-ChatS)
- Keywords
- physical activity, behavior change, rehabilitation
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Chats after Stroke (PA-ChatS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical Activity Chats after Stroke (PA-ChatS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 7
Secondary outcomes (7)
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.
Measured: 6-weeks
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.
Measured: Week 7
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.
Measured: Week 7
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.
Measured: Week 12
Change in step count
The activPAL micro4 will be used to measure step count, following a 24-hour, 7-day wear protocol.
Measured: Weeks 1 to 12
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.
Measured: Weeks 1 to 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.
Measured: Weeks 1 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start8 Jul 2026
- Primary completion30 Nov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Kringle, PhD, OTR/L, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649135
- Sponsor's protocol ID
- STUDY00028280
- Acronym
- PA-ChatS
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Engaging Stroke Survivors in a Brief Step Count Intervention During Chronic Stroke
- ClinicalTrials.gov ID
- NCT07649135
- Acronym / sponsor ID
- PA-ChatS / STUDY00028280
- Conditions
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- physical activity, behavior change, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PA-ChatS Intervention | Experimental | Behavioral: Physical Activity Chats after Stroke (PA-ChatS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 (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. | Behavioural | PA-ChatS Intervention |
Primary outcome
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.
7 secondary outcomes
Adherence to PA-ChatS sessions
Time frame: 6-weeks
Acceptability of PA-ChatS Intervention
Time frame: Week 7
Safety of the PA-ChatS Intervention
Time frame: Week 7
Adherence to step count
Time frame: Week 12
Change in step count
Time frame: Weeks 1 to 12
Change in sedentary time
Time frame: Weeks 1 to 7
Change in sedentary time
Time frame: Weeks 1 to 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Kringle, PhD, OTR/L principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Chats after Stroke (PA-ChatS) in people with Stroke and Ischemic Stroke, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karli Jahnke (612-626-4046, dwell@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to step count (time frame: Week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.