An interventional study of Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention in Stroke, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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:
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.
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:
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 55 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Additional to usual care, the experimental arm will undergo a theory-based behaviour change intervention to improve stepping time relative to reducing sedentary behaviour.
Behavioral: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention
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.
Behavioral: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention
Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed.
Change from Baseline modified Rankin Scale (mRS) at 6 and 12 weeks
Measure of global disability using the mRS score \[grade 0-2 vs ≥3\]
Time frame: 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
Time frame: 6 and 12 weeks
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)
Time frame: 6 and 12 weeks
Change from Baseline 10-meter walk test at 6 and 12 weeks
Measure of gait speed
Time frame: 6 and 12 weeks
Change from Baseline 6-minute walk test at 6 and 12 weeks
6-minute walk test of endurance
Time frame: 6 and 12 weeks
Change from Baseline Montreal Cognitive Assessment (MoCA) at 6 and 12 weeks
Montreal Cognitive Assessment (MoCA) test of cognition
Time frame: 6 and 12 weeks
Change from Baseline EuroQol (EQ)-5D at 6 and 12 weeks
EQ-5D to assess quality of life
Time frame: 6 and 12 weeks
Change from Baseline National Institute of Health Stroke Scale (NIHSS) at 6 and 12 weeks
NIHSS to classify stroke severity
Time frame: 6 and 12 weeks
Leukoraiosis staging/severity at Baseline
White matter disease on imaging
Time frame: Baseline
Plan to share: No — Study team will have access to individual participant data.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
University of Alberta