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Not Yet Recruiting NCT05753761

The Whole Day Matters After Stroke (BIG-STEPS)

Conditions: Stroke

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 50
Sponsor: University of Alberta

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:Test the effect of reducing sedentary behaviour early after stroke on functional mobility and global disability outcomes.Determine the impact of neuroimaging biomarkers (e.g. leukoaraiosis) on response to rehabilitation.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.

Eligibility Criteria

Inclusion Criteria:Within 7 days of ischemic stroke onsetAged ≥ 18 yearsMedically stable as deemed by physiciansAble to walk at least 5 meters with/without gait aidOngoing walking goals (walk speed <1.0 meter/sec)Exclusion Criteria:Have another condition such as multiple sclerosis or Parkinson's disease, or active cancerUncontrolled high blood pressureUnstable cardiovascular conditionUnable to understand or follow instructions.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05753761). StuddyBuddy aggregates publicly available trial information.