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RECRUITING
NCT05753761
NA

The Whole Day Matters After Stroke (BIG-STEPS)

Sponsor: University of Alberta

View on ClinicalTrials.gov

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. 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.

Official title: The Whole Day Matters After Stroke: Moving Towards Precision Rehabilitation Guided by Behavioural and Imaging Markers

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-07-10

Completion Date

2026-12

Last Updated

2025-04-16

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

University of Alberta Hospital

Edmonton, Alberta, Canada