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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention | Behavioral | Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed. |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | 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 | 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 and 12 weeks |
| Change from Baseline 10-meter walk test at 6 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Ezeugwu, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38060584 | Derived | 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. |
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Study team will have access to individual participant data.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D049292 | Leukoaraiosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Measure of gait speed |
| 6 and 12 weeks |
| Change from Baseline 6-minute walk test at 6 and 12 weeks | 6-minute walk test of endurance | 6 and 12 weeks |
| Change from Baseline Montreal Cognitive Assessment (MoCA) at 6 and 12 weeks | Montreal Cognitive Assessment (MoCA) test of cognition | 6 and 12 weeks |
| Change from Baseline EuroQol (EQ)-5D at 6 and 12 weeks | EQ-5D to assess quality of life | 6 and 12 weeks |
| Change from Baseline National Institute of Health Stroke Scale (NIHSS) at 6 and 12 weeks | NIHSS to classify stroke severity | 6 and 12 weeks |
| Leukoraiosis staging/severity at Baseline | White matter disease on imaging | Baseline |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |