StrokeBIG STEPSNCT07702643
Behavioral Intervention and Guided Stepping Training Early Post-Stroke
A study testing Behavior and guided stepping training intervention (BIG STEPS) and DELAYED Behavior and guided stepping training intervention in people with Stroke, run by University of Alberta at 6 sites in Canada.
Trial summary
Low daily steps and prolonged sedentary behavior are associated with reduced functional outcomes and quality of life in patients with stroke. The goal of this research project is to test the effect of increasing daily step counts and reducing sedentary time early after stroke, on functional mobility and global… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Behavior and guided stepping training intervention (BIG STEPS) and DELAYED Behavior and guided stepping training intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesCanada
- Study dates
- 3 Aug 2026to 30 Jun 2031
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50 - or older
- Had an ischemic or hemorrhagic stroke within the last 3 months
- Have recently returned or are returning home from hospital
- Able to walk 5 meters with or without a gait aid
Who cannot join
- Previously diagnosed with a mobility limiting musculoskeletal condition
- Previously diagnosed with a mobility limiting neurological condition
- Have cardiac conditions (e.g. blood pressure ≥180/100 mmHg)
- Are without access to an internet-enabled computer or mobile device
- Are enrolled in another interventional trial such as exercise or neuroprotection trials
- Have aphasia or are unable to provide consent in English.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Not yet recruiting
Carewest Dr Vernon Fanning Centre
Calgary, Alberta, T2E 6V7
Victor Ezeugwu, PhD, 780 492 5108, ezeugwu@ualberta.ca
Charmaine van Eeden, PhD, 780 248 2059, vaneeden@ualberta.ca
- Not yet recruiting
Foothills Medical Center
Calgary, Alberta, T2N 2T9
Victor Ezeugwu, PhD, 780 492 5108, ezeugwu@ualberta.ca
Charmaine van Eeden, PhD, 780 248 2059, vaneeden@ualberta.ca
- Recruiting
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
Victor Ezeugwu, PhD, 780 492 5108, ezeugwu@ualberta.ca
Charmaine van Eeden, PhD, 780 248 2059, vaneeden@ualberta.ca
- Recruiting
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Victor Ezeugwu, PhD, 780 492 5108, ezeugwu@ualberta.ca
Charmaine van Eeden, PhD, 780 248 2059, vaneeden@ualberta.ca
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Victor Ezeugwu, PhD, 780 492 5108, ezeugwu@ualberta.ca
Charmaine van Eeden, PhD, 780 248 2059, vaneeden@ualberta.ca
- Recruiting
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8
Victor Ezeugwu, PhD, 780 492 5108, ezeugwu@ualberta.ca
Charmaine van Eeden, PhD, 780 248 2059, vaneeden@ualberta.ca
About this study
Official title: Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS): A Randomized Controlled Trial Investigating the Effect of a 3-month Behavioral Intervention and Guided Stepping Training in Early Post-stroke Patients.
Low daily steps and prolonged sedentary behavior are associated with reduced functional outcomes and quality of life in patients with stroke. The goal of this research project is to test the effect of increasing daily step counts and reducing sedentary time early after stroke, on functional mobility and global disability outcomes.
The investigators aim to recruit 150 participants, aged 50 years and over, within three months of stroke onset, whom have recently returned or are returning home from hospital and are able to walk 5 meters with or without a gait aid. At baseline, demographic and stroke characteristics will be determined and documented. A battery of impairment, psychosocial, and functional measures will be completed. Step counts (primary outcome) and sedentary time will be determined from activPAL accelerometry.
Read more
Following randomization, a sedentary behaviour change and guided stepping intervention (BIG STEPS) will be extended to the experimental arm (early BIG STEPS), the intervention will span 3 months, with final follow-up assessments every 90 days, until the final assessment at 12 months. The waitlist control group (delayed BIG STEPS) will receive the BIG STEPS intervention after a 6 month wait period.
The primary outcome of this study is change in step counts from baseline to 3 months, measured with an activPAL accelerometer. Secondary outcomes include sedentary time, functional mobility, and walking endurance measured every 90 days for 12 months. Patient-reported mood, fatigue, and quality of life outcomes will also be assessed.
The BIG STEPS program will allow individuals with stroke to take an active role in their recovery, encouraging engagement, autonomy and sustained health outcomes. The implementation of a waitlist RCT design allows for the evaluation the critical period for intervention delivery. The results of this trial will help inform future changes in best practice, reducing disability after stroke and improving patient quality of life.
- Conditions
- Stroke
- Being tested
- Behavior and guided stepping training intervention (BIG STEPS), DELAYED Behavior and guided stepping training intervention
- Keywords
- stroke, daily steps, sedentary time, self efficacy
- Medical subject headings
- Stroke, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior and guided stepping training intervention (BIG STEPS)Behavioural
The BIG STEPS intervention comprises a home-based behavioral intervention aimed at reducing and frequently interrupting prolonged sedentary periods, along with guided stepping training to gradually increase daily steps. Participants will wear an accelerometer throughout the whole day for four consecutive days during each assessment. Using baseline accelerometer data, prolonged periods of sedentary time or minimal activity levels will be identified and used to inform personalized activity and behavior-change recommendations.
DELAYED Behavior and guided stepping training interventionBehavioural
The waitlist control group will complete the BIG STEPS intervention after 6 months. During the waiting period they will receive usual care and educational materials.
| Study group | Role | What they receive |
|---|---|---|
| Early BIG STEPS | Experimental | Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed. Participants will start the BIG STEP intervention within 3 months of stroke onset. Receives: Behavioral: Behavior and guided stepping training intervention (BIG STEPS) |
| Delayed BIG STEPS | Other | The waitlist control group will complete the BIG STEPS intervention after 6 months. Receives: Behavioral: DELAYED Behavior and guided stepping training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functioning: Step Counts
activPAL derived step counts
Measured: Difference in changes from baseline to 3 months (post intervention/post waiting)
Secondary outcomes (6)
Sedentary time
activPAL-derived sedentary time.
Measured: Change from baseline at 3, 6, 9 and 12 months.
Global Disability
Modified Rankin Scale (mRS) 0-5, higher scores mean worse outcome.
Measured: Change from baseline at 3, 6, 9 and 12 months.
Functional mobility
Timed Up and Go Test (TUG)
Measured: Change from baseline at 3, 6, 9 and 12 months.
Gait Speed
10-meter walk test (10MWT)
Measured: Change from baseline at 3, 6, 9 and 12 months.
Walking Endurance
6-Minute walk test (6MWT)
Measured: Change from baseline at 3, 6, 9 and 12 months.
Self efficacy
Stroke Self Efficacy Questionnaire is a 13-item questionnaire. Higher scores in each subscale indicate higher confidence levels and better self-efficacy.
Measured: Change from baseline at 3, 6, 9 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start3 Aug 2026
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2031 (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.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Behavioral: Behavior and guided stepping training
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702643
- Sponsor's protocol ID
- Pro00140017
- Acronym
- BIG STEPS
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets that will be generated and/or analysed during the current study will not be publicly available due to the sensitivity of personal health information and privacy requirements. After publication of the primary study results, de-identified data sets may be made available on reasonable request to the corresponding author, subject to approval by regulatory authorities
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS): A Randomized Controlled Trial Investigating the Effect of a 3-month Behavioral Intervention and Guided Stepping Training in Early Post-stroke Patients.
- ClinicalTrials.gov ID
- NCT07702643
- Acronym / sponsor ID
- BIG STEPS / Pro00140017
- Conditions
- Stroke
- Keywords
- stroke, daily steps, sedentary time, self efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 14 Jul 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.
Low daily steps and prolonged sedentary behavior are associated with reduced functional outcomes and quality of life in patients with stroke. The goal of this research project is to test the effect of increasing daily step counts and reducing sedentary time early after stroke, on functional mobility and global disability outcomes.
The investigators aim to recruit 150 participants, aged 50 years and over, within three months of stroke onset, whom have recently returned or are returning home from hospital and are able to walk 5 meters with or without a gait aid. At baseline, demographic and stroke characteristics will be determined and documented. A battery of impairment, psychosocial, and functional measures will be completed. Step counts (primary outcome) and sedentary time will be determined from activPAL accelerometry.
Following randomization, a sedentary behaviour change and guided stepping intervention (BIG STEPS) will be extended to the experimental arm (early BIG STEPS), the intervention will span 3 months, with final follow-up assessments every 90 days, until the final assessment at 12 months. The waitlist control group (delayed BIG STEPS) will receive the BIG STEPS intervention after a 6 month wait period.
The primary outcome of this study is change in step counts from baseline to 3 months, measured with an activPAL accelerometer. Secondary outcomes include sedentary time, functional mobility, and walking endurance measured every 90 days for 12 months. Patient-reported mood, fatigue, and quality of life outcomes will also be assessed.
The BIG STEPS program will allow individuals with stroke to take an active role in their recovery, encouraging engagement, autonomy and sustained health outcomes. The implementation of a waitlist RCT design allows for the evaluation the critical period for intervention delivery. The results of this trial will help inform future changes in best practice, reducing disability after stroke and improving patient quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Behavioral: Behavior and guided stepping training
| Arm | Type | Receives |
|---|---|---|
| Early BIG STEPS | Experimental | Behavioral: Behavior and guided stepping training intervention (BIG STEPS)Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed. Participants will start the BIG STEP intervention within 3 months of stroke onset. |
| Delayed BIG STEPS | Other | Behavioral: DELAYED Behavior and guided stepping training interventionThe waitlist control group will complete the BIG STEPS intervention after 6 months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 50 - or older
- Had an ischemic or hemorrhagic stroke within the last 3 months
- Have recently returned or are returning home from hospital
- Able to walk 5 meters with or without a gait aid
Key exclusion criteria (6 listed)
- Previously diagnosed with a mobility limiting musculoskeletal condition
- Previously diagnosed with a mobility limiting neurological condition
- Have cardiac conditions (e.g. blood pressure ≥180/100 mmHg)
- Are without access to an internet-enabled computer or mobile device
- Are enrolled in another interventional trial such as exercise or neuroprotection trials
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 |
|---|---|---|
| Behavior and guided stepping training intervention (BIG STEPS)The BIG STEPS intervention comprises a home-based behavioral intervention aimed at reducing and frequently interrupting prolonged sedentary periods, along with guided stepping training to gradually increase daily steps. Participants will wear an accelerometer throughout the whole day for four consecutive days during each assessment. Using baseline accelerometer data, prolonged periods of sedentary time or minimal activity levels will be identified and used to inform personalized activity and behavior-change recommendations. | Behavioural | Early BIG STEPS |
| DELAYED Behavior and guided stepping training interventionThe waitlist control group will complete the BIG STEPS intervention after 6 months. During the waiting period they will receive usual care and educational materials. | Behavioural | Delayed BIG STEPS |
Primary outcome
Physical functioning: Step Counts
Time frame: Difference in changes from baseline to 3 months (post intervention/post waiting)
activPAL derived step counts
6 secondary outcomes
Sedentary time
Time frame: Change from baseline at 3, 6, 9 and 12 months.
Global Disability
Time frame: Change from baseline at 3, 6, 9 and 12 months.
Functional mobility
Time frame: Change from baseline at 3, 6, 9 and 12 months.
Gait Speed
Time frame: Change from baseline at 3, 6, 9 and 12 months.
Walking Endurance
Time frame: Change from baseline at 3, 6, 9 and 12 months.
Self efficacy
Time frame: Change from baseline at 3, 6, 9 and 12 months.
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 23 Oct 2026.
- Individual participant dataSharing planned: No. The datasets that will be generated and/or analysed during the current study will not be publicly available due to the sensitivity of personal health information and privacy requirements. After publication of the primary study results, de-identified data sets may be made available on reasonable request to the corresponding author, subject to approval by regulatory authorities
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior and guided stepping training intervention (BIG STEPS) and DELAYED Behavior and guided stepping training intervention in people with Stroke, run by University of Alberta at 6 sites in Canada.
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 4 inclusion and 6 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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 Victor Ezeugwu, PhD (780 492 5108, ezeugwu@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical functioning: Step Counts (time frame: Difference in changes from baseline to 3 months (post intervention/post waiting)). 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 23 Oct 2026.