Stroke Clinical Trial
— BIG-STEPSOfficial 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: 1. Test the effect of reducing sedentary behaviour early after stroke on functional mobility and global disability outcomes. 2. Determine the impact of neuroimaging biomarkers (e.g. leukoaraiosis) on response to rehabilitation. 3. 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 1 week of ischemic 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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Within 7 days of ischemic 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) Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta Hospital | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Change from Baseline 10-meter walk test at 6 and 12 weeks | Measure of gait speed | 6 and 12 weeks | |
Secondary | Change from Baseline 6-minute walk test at 6 and 12 weeks | 6-minute walk test of endurance | 6 and 12 weeks | |
Secondary | Change from Baseline Montreal Cognitive Assessment (MoCA) at 6 and 12 weeks | Montreal Cognitive Assessment (MoCA) test of cognition | 6 and 12 weeks | |
Secondary | Change from Baseline EuroQol (EQ)-5D at 6 and 12 weeks | EQ-5D to assess quality of life | 6 and 12 weeks | |
Secondary | Change from Baseline National Institute of Health Stroke Scale (NIHSS) at 6 and 12 weeks | NIHSS to classify stroke severity | 6 and 12 weeks | |
Secondary | Leukoraiosis staging/severity at Baseline | White matter disease on imaging | Baseline |
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