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
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