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The Whole Day Matters After Stroke (BIG-STEPS)

NCT05753761 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-04-13

No results posted yet for this study

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 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.

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.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Victor Ezeugwu, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2025-11-26
Completion
2025-11-26

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05753761 on ClinicalTrials.gov