The Whole Day Matters After Stroke (BIG-STEPS)

NCT ID: NCT05753761

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2026-12-31

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. 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.

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 7 days of ischemic 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Within 7 days of ischemic 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor Ezeugwu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Victor Ezeugwu, PhD

Role: CONTACT

ezeugwu@ualberta.ca

7804925108

Facility Contacts

Victor Ezeugwu, PT, PhD

Role: primary

ezeugwu@ualberta.ca

7804925108

References

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.

Reference Type: DERIVED

PMID: 38060584 (View on PubMed)

Other Identifiers

Pro00127990

Identifier Type: -

Identifier Source: org_study_id