University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
NCT Number: NCT05753761
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 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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Edmonton, Alberta, T6G 2B7, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed.
Time frame: 6 and 12 weeks
Measure of global disability using the mRS score [grade 0-2 vs ≥3]
Time frame: 6 and 12 weeks
Functional mobility will be assessed using the TUG test
Time frame: 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
Measure of gait speed
Time frame: 6 and 12 weeks
6-minute walk test of endurance
Time frame: 6 and 12 weeks
Montreal Cognitive Assessment (MoCA) test of cognition
Time frame: 6 and 12 weeks
EQ-5D to assess quality of life
Time frame: 6 and 12 weeks
NIHSS to classify stroke severity
Time frame: Baseline
White matter disease on imaging
University of Alberta
Other
The Whole Day Matters After Stroke: Moving Towards Precision Rehabilitation Guided by Behavioural and Imaging Markers
Acronym: BIG-STEPS
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