StrokeBIG-STEPSNCT05753761
The Whole Day Matters After Stroke (BIG-STEPS)
A study testing Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention in people with Stroke, run by University of Alberta at 1 site in Canada.
Trial summary
Goal of research program: To understand person-specific factors, such as imaging markers and activity patterns early after stroke, that may guide precision rehabilitation to optimize function and improve recovery. Objectives: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jul 2023to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Within 3 months of stroke onset
- Aged ≥ 18 years
- Medically stable as deemed by physicians
- Able to walk at least 5 meters with/without gait aid
- Ongoing walking goals (walk speed <1.0 meter/sec)
Who cannot join
- Have another condition such as multiple sclerosis or Parkinson's disease, or active cancer
- Uncontrolled high blood pressure
- Unstable cardiovascular condition
- Unable to understand or follow instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Whole Day Matters After Stroke: Moving Towards Precision Rehabilitation Guided by Behavioural and Imaging Markers
Goal of research program: To understand person-specific factors, such as imaging markers and activity patterns early after stroke, that may guide precision rehabilitation to optimize function and improve recovery.
Objectives:
Read more
- Test the effect of reducing sedentary behaviour early after stroke on functional mobility and global disability outcomes.
- Determine the impact of neuroimaging biomarkers (e.g. leukoaraiosis) on response to rehabilitation.
- Explore the predictive value of accelerometry as an adjunct to the subjective modified Rankin Scale (mRS) to assess functional disability after stroke.
Experimental approach/Research Plan/Use of Funds: The investigators aim to recruit 50 participants within 3 months of stroke onset, aged ≥ 18 years, medically stable as deemed by their physicians, able to walk at least 5 meters with/without gait aid and with ongoing walking or balance goals. Demographic and stroke characteristics, including stroke risk factors, infarct location and volume, leukoaraiosis on routine MRI, and acute stroke treatments (e.g., thrombectomy) will be determined and documented. A battery of impairment, psychosocial, and functional measures, including the mRS and Timed-Up and Go test (primary outcomes) will be completed. Subsequently, participants will be set up to wear activPAL accelerometer, validated in stroke, for 1 week. Following randomization, a sedentary behaviour change intervention will span 6 weeks, with final follow-up assessments at 90 days.
Read the detailed description
Background Prolonged sedentary behaviour is associated with worse functional outcomes poststroke. The effect of reducing sedentary behaviour early after stroke remains unknown. Leukoaraiosis or cerebral white matter disease, recognizable on magnetic resonance imaging (MRI) as areas of hyperintensities, has gained significance as a potential moderator of stroke recovery. No specific rehabilitation intervention has been developed for survivors of stroke with leukoaraiosis.
The goals of this research project are to:
- Test the effect of reducing sedentary behaviour early after stroke on functional mobility and global disability outcomes.
- Determine the impact of leukoaraiosis on response to poststroke rehabilitation.
- Explore the associations of accelerometry metrics with functional mobility and global disability outcomes poststroke.
Methods The investigators aim to recruit 50 participants, within 3 months of stroke onset, aged ≥ 18 years, medically stable as deemed by physicians, able to walk at least 5 meters with/without gait aid, and ongoing walking goals (walk speed <1.0 meter/second). Demographic and stroke characteristics, including stroke risk factors, infarct location and volume, leukoaraiosis on MRI, and acute stroke treatments (e.g. thrombectomy) will be determined and documented. Subsequently, participants will be set up to wear activPAL accelerometer, validated in stroke,5 for one week. Following randomization, a behaviour change intervention will span 6 weeks with final follow-up assessments at 90 days.
Primary outcomes: modified Rankin Scale and Timed-Up and Go (TUG) score.
Plan for Data Analysis Compositional data analysis and generalized estimating equations with R software will be used to model the effect of reducing sedentary behaviour and impact of leukoaraiosis on response to rehabilitation. The correlation, responsiveness, and predictive value of the activPAL outcomes as adjunct to the mRS and TUG measures will be evaluated using machine learning, logistic regression, and receiver operating curves.
Significance and Expected Results The first 90 days after stroke represents a critical window of neuroplasticity. Frequent interruptions in sedentary behaviour, using a whole-day approach, may improve function and recovery, especially for poor responders. If the investigators find this rehabilitation approach to be effective for survivors of stroke with leukoaraiosis, then it could be useful for improving decision-making. Accelerometry as an adjunct to the MRS will increase the granularity of outcome measurement poststroke.
- Conditions
- Stroke
- Being tested
- Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention
- Keywords
- Stroke, Movement Behaviors, Leukoaraiosis, Whole Day
- Medical subject headings
- Stroke, Leukoaraiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) interventionBehavioural
Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed.
| Study group | Role | What they receive |
|---|---|---|
| Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) | Experimental | Additional to usual care, the experimental arm will undergo a theory-based behaviour change intervention to improve stepping time relative to reducing sedentary behaviour. Receives: Behavioral: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention |
| Usual care: | Active comparator | The control arm program will consist of usual inpatient care including therapeutic mobilization by the physical therapy team and general mobilization, as tolerated, by the nursing team. Receives: Behavioral: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline modified Rankin Scale (mRS) at 6 and 12 weeks
Measure of global disability using the mRS score [grade 0-2 vs ≥3]
Measured: 6 and 12 weeks
Change from Baseline Timed-Up and Go (TUG) test at 6 and 12 weeks
Functional mobility will be assessed using the TUG test
Measured: 6 and 12 weeks
Secondary outcomes (7)
Change from Baseline ActivPAL-derived movement behaviors at 6 and 12 weeks
Whole-day movement behaviours (time spent stepping, sedentary, sleeping, number of steps, and sit-to-stand transitions)
Measured: 6 and 12 weeks
Change from Baseline 10-meter walk test at 6 and 12 weeks
Measure of gait speed
Measured: 6 and 12 weeks
Change from Baseline 6-minute walk test at 6 and 12 weeks
6-minute walk test of endurance
Measured: 6 and 12 weeks
Change from Baseline Montreal Cognitive Assessment (MoCA) at 6 and 12 weeks
Montreal Cognitive Assessment (MoCA) test of cognition
Measured: 6 and 12 weeks
Change from Baseline EuroQol (EQ)-5D at 6 and 12 weeks
EQ-5D to assess quality of life
Measured: 6 and 12 weeks
Change from Baseline National Institute of Health Stroke Scale (NIHSS) at 6 and 12 weeks
NIHSS to classify stroke severity
Measured: 6 and 12 weeks
Leukoraiosis staging/severity at Baseline
White matter disease on imaging
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start10 Jul 2023
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor Ezeugwu, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753761
- Sponsor's protocol ID
- Pro00127990
- Acronym
- BIG-STEPS
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study team will have access to individual participant data.
Publications
Okusanya D, Ezeugwa JC, Khan A, Buck B, Jickling GC, Ezeugwu VE. The whole day matters after stroke: Study protocol for a randomized controlled trial investigating the effect of a 'sit less, move more, sleep better' program early after stroke. PLoS One. 2023 Dec 7;18(12):e0290515. doi: 10.1371/journal.pone.0290515. eCollection 2023.
PubMed 38060584
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Whole Day Matters After Stroke: Moving Towards Precision Rehabilitation Guided by Behavioural and Imaging Markers
- ClinicalTrials.gov ID
- NCT05753761
- Acronym / sponsor ID
- BIG-STEPS / Pro00127990
- Conditions
- Stroke
- Keywords
- Stroke, Movement Behaviors, Leukoaraiosis, Whole Day
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 3 Mar 2023 (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.
Goal of research program: To understand person-specific factors, such as imaging markers and activity patterns early after stroke, that may guide precision rehabilitation to optimize function and improve recovery.
Objectives:
- Test the effect of reducing sedentary behaviour early after stroke on functional mobility and global disability outcomes.
- Determine the impact of neuroimaging biomarkers (e.g. leukoaraiosis) on response to rehabilitation.
- Explore the predictive value of accelerometry as an adjunct to the subjective modified Rankin Scale (mRS) to assess functional disability after stroke.
Experimental approach/Research Plan/Use of Funds: The investigators aim to recruit 50 participants within 3 months of stroke onset, aged ≥ 18 years, medically stable as deemed by their physicians, able to walk at least 5 meters with/without gait aid and with ongoing walking or balance goals. Demographic and stroke characteristics, including stroke risk factors, infarct location and volume, leukoaraiosis on routine MRI, and acute stroke treatments (e.g., thrombectomy) will be determined and documented. A battery of impairment, psychosocial, and functional measures, including the mRS and Timed-Up and Go test (primary outcomes) will be completed. Subsequently, participants will be set up to wear activPAL accelerometer, validated in stroke, for 1 week. Following randomization, a sedentary behaviour change intervention will span 6 weeks, with final follow-up assessments at 90 days.
Detailed description
Background Prolonged sedentary behaviour is associated with worse functional outcomes poststroke. The effect of reducing sedentary behaviour early after stroke remains unknown. Leukoaraiosis or cerebral white matter disease, recognizable on magnetic resonance imaging (MRI) as areas of hyperintensities, has gained significance as a potential moderator of stroke recovery. No specific rehabilitation intervention has been developed for survivors of stroke with leukoaraiosis.
The goals of this research project are to:
- Test the effect of reducing sedentary behaviour early after stroke on functional mobility and global disability outcomes.
- Determine the impact of leukoaraiosis on response to poststroke rehabilitation.
- Explore the associations of accelerometry metrics with functional mobility and global disability outcomes poststroke.
Methods The investigators aim to recruit 50 participants, within 3 months of stroke onset, aged ≥ 18 years, medically stable as deemed by physicians, able to walk at least 5 meters with/without gait aid, and ongoing walking goals (walk speed <1.0 meter/second). Demographic and stroke characteristics, including stroke risk factors, infarct location and volume, leukoaraiosis on MRI, and acute stroke treatments (e.g. thrombectomy) will be determined and documented. Subsequently, participants will be set up to wear activPAL accelerometer, validated in stroke,5 for one week. Following randomization, a behaviour change intervention will span 6 weeks with final follow-up assessments at 90 days.
Primary outcomes: modified Rankin Scale and Timed-Up and Go (TUG) score.
Plan for Data Analysis Compositional data analysis and generalized estimating equations with R software will be used to model the effect of reducing sedentary behaviour and impact of leukoaraiosis on response to rehabilitation. The correlation, responsiveness, and predictive value of the activPAL outcomes as adjunct to the mRS and TUG measures will be evaluated using machine learning, logistic regression, and receiver operating curves.
Significance and Expected Results The first 90 days after stroke represents a critical window of neuroplasticity. Frequent interruptions in sedentary behaviour, using a whole-day approach, may improve function and recovery, especially for poor responders. If the investigators find this rehabilitation approach to be effective for survivors of stroke with leukoaraiosis, then it could be useful for improving decision-making. Accelerometry as an adjunct to the MRS will increase the granularity of outcome measurement poststroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) | Experimental | Behavioral: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) interventionAdditional to usual care, the experimental arm will undergo a theory-based behaviour change intervention to improve stepping time relative to reducing sedentary behaviour. |
| Usual care: | Active comparator | Behavioral: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) interventionThe control arm program will consist of usual inpatient care including therapeutic mobilization by the physical therapy team and general mobilization, as tolerated, by the nursing team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Within 3 months of stroke onset
- Aged ≥ 18 years
- Medically stable as deemed by physicians
- Able to walk at least 5 meters with/without gait aid
- Ongoing walking goals (walk speed <1.0 meter/sec)
Key exclusion criteria (4 listed)
- Have another condition such as multiple sclerosis or Parkinson's disease, or active cancer
- Uncontrolled high blood pressure
- Unstable cardiovascular condition
- Unable to understand or follow instructions.
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 |
|---|---|---|
| Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) interventionUsing baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed. | Behavioural | Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS), Usual care: |
Primary outcome
Change from Baseline modified Rankin Scale (mRS) at 6 and 12 weeks
Time frame: 6 and 12 weeks
Measure of global disability using the mRS score [grade 0-2 vs ≥3]
Change from Baseline Timed-Up and Go (TUG) test at 6 and 12 weeks
Time frame: 6 and 12 weeks
Functional mobility will be assessed using the TUG test
7 secondary outcomes
Change from Baseline ActivPAL-derived movement behaviors at 6 and 12 weeks
Time frame: 6 and 12 weeks
Change from Baseline 10-meter walk test at 6 and 12 weeks
Time frame: 6 and 12 weeks
Change from Baseline 6-minute walk test at 6 and 12 weeks
Time frame: 6 and 12 weeks
Change from Baseline Montreal Cognitive Assessment (MoCA) at 6 and 12 weeks
Time frame: 6 and 12 weeks
Change from Baseline EuroQol (EQ)-5D at 6 and 12 weeks
Time frame: 6 and 12 weeks
Change from Baseline National Institute of Health Stroke Scale (NIHSS) at 6 and 12 weeks
Time frame: 6 and 12 weeks
Leukoraiosis staging/severity at Baseline
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 38060584Okusanya D, Ezeugwa JC, Khan A, Buck B, Jickling GC, Ezeugwu VE. The whole day matters after stroke: Study protocol for a randomized controlled trial investigating the effect of a 'sit less, move more, sleep better' program early after stroke. PLoS One. 2023 Dec 7;18(12):e0290515. doi: 10.1371/journal.pone.0290515. eCollection 2023.
- Individual participant dataSharing planned: No. Study team will have access to individual participant data.
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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. This study is not recruiting at the moment.
Victor Ezeugwu, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention in people with Stroke, run by University of Alberta at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 13 Apr 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline modified Rankin Scale (mRS) at 6 and 12 weeks (time frame: 6 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05753761, which also lists 1 linked publication.
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 13 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.