The Whole Day Matters After Stroke (BIG-STEPS)

NCT05753761 | Completed

• 1 other identifier: Pro00127990
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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. 1.Test the effect of reducing sedentary behaviour early after stroke on functional mobility and global disability outcomes.
2. 2.Determine the impact of neuroimaging biomarkers (e.g. leukoaraiosis) on response to rehabilitation.
3. 3.Explore the predictive value of accelerometry as an adjunct to the subjective modified Rankin Scale (mRS) to assess functional disability after stroke.

Conditions

Stroke

Keywords

Stroke; Movement Behaviors; Leukoaraiosis; Whole Day

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change from Baseline ActivPAL-derived movement behaviors at 6 and 12 weeks

  6 and 12 weeks

• Change from Baseline 10-meter walk test at 6 and 12 weeks

  6 and 12 weeks

• Change from Baseline 6-minute walk test at 6 and 12 weeks

  6 and 12 weeks

• Change from Baseline Montreal Cognitive Assessment (MoCA) at 6 and 12 weeks

  6 and 12 weeks

• Change from Baseline EuroQol (EQ)-5D at 6 and 12 weeks

  6 and 12 weeks

Study Arms (2)

Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS)

EXPERIMENTAL

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

Usual care:

ACTIVE COMPARATOR

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

Interventions

Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention BEHAVIORAL

Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed.

Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS); Usual care:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (1)

• 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.

  PMID: 38060584 DERIVED

MeSH Terms

Conditions

Stroke; Leukoaraiosis

Interventions

Methods

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Victor Ezeugwu, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 3, 2023
• Study Start: July 10, 2023
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)