The Whole Day Matters After Stroke (BIG-STEPS) (BIG-STEPS)

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 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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention

Detailed Description

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:

1. Test the effect of reducing sedentary behaviour early after stroke on functional mobility and global disability outcomes.
2. Determine the impact of leukoaraiosis on response to poststroke rehabilitation.
3. Explore the associations of accelerometry metrics with functional mobility and global disability outcomes poststroke.

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS); Additional to usual care, the experimental arm will undergo a theory-based behaviour change intervention to improve stepping time relative to reducing sedentary behaviour.	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.
Active Comparator: Usual care: The control arm program will consist of usual inpatient care including therapeutic mobilization by the physical therapy team and general mobilization, as tolerated, by the nursing team.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change from Baseline 10-meter walk test at 6 and 12 weeks	Measure of gait speed	6 and 12 weeks
Change from Baseline 6-minute walk test at 6 and 12 weeks	6-minute walk test of endurance	6 and 12 weeks
Change from Baseline Montreal Cognitive Assessment (MoCA) at 6 and 12 weeks	Montreal Cognitive Assessment (MoCA) test of cognition	6 and 12 weeks
Change from Baseline EuroQol (EQ)-5D at 6 and 12 weeks	EQ-5D to assess quality of life	6 and 12 weeks
Change from Baseline National Institute of Health Stroke Scale (NIHSS) at 6 and 12 weeks	NIHSS to classify stroke severity	6 and 12 weeks
Leukoraiosis staging/severity at Baseline	White matter disease on imaging	Baseline

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Victor Ezeugwu, PhD, University of Alberta

Publications and helpful links

General Publications

• Okusanya D, Ezeugwa JC, Khan A, Buck B, Jickling GC, Ezeugwu VE. The whole day matters after stroke: Study protocol for a randomized controlled trial investigating the effect of a 'sit less, move more, sleep better' program early after stroke. PLoS One. 2023 Dec 7;18(12):e0290515. doi: 10.1371/journal.pone.0290515. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): November 26, 2025
• Study Completion (Actual): November 26, 2025

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Leukoaraiosis; Movement Behaviors; Whole Day
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Leukoaraiosis; Investigative Techniques; Methods
• Other Study ID Numbers: Pro00127990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study team will have access to individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No