Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS)

Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS): A Randomized Controlled Trial Investigating the Effect of a 3-month Behavioral Intervention and Guided Stepping Training in Early Post-stroke Patients.

Low daily steps and prolonged sedentary behavior are associated with reduced functional outcomes and quality of life in patients with stroke. The goal of this research project is to test the effect of increasing daily step counts and reducing sedentary time early after stroke, on functional mobility and global disability outcomes.

The investigators aim to recruit 150 participants, aged 50 years and over, within three months of stroke onset, whom have recently returned or are returning home from hospital and are able to walk 5 meters with or without a gait aid. At baseline, demographic and stroke characteristics will be determined and documented. A battery of impairment, psychosocial, and functional measures will be completed. Step counts (primary outcome) and sedentary time will be determined from activPAL accelerometry.

Following randomization, a sedentary behaviour change and guided stepping intervention (BIG STEPS) will be extended to the experimental arm (early BIG STEPS), the intervention will span 3 months, with final follow-up assessments every 90 days, until the final assessment at 12 months. The waitlist control group (delayed BIG STEPS) will receive the BIG STEPS intervention after a 6 month wait period.

The primary outcome of this study is change in step counts from baseline to 3 months, measured with an activPAL accelerometer. Secondary outcomes include sedentary time, functional mobility, and walking endurance measured every 90 days for 12 months. Patient-reported mood, fatigue, and quality of life outcomes will also be assessed.

The BIG STEPS program will allow individuals with stroke to take an active role in their recovery, encouraging engagement, autonomy and sustained health outcomes. The implementation of a waitlist RCT design allows for the evaluation the critical period for intervention delivery. The results of this trial will help inform future changes in best practice, reducing disability after stroke and improving patient quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Behavior and guided stepping training intervention (BIG STEPS); Behavioral: DELAYED Behavior and guided stepping training intervention

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victor Ezeugwu, PhD; Phone Number: 780 492 5108; Email: ezeugwu@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Center
      • Contact: Victor Ezeugwu, PhD; Phone Number: 780 492 5108; Email: ezeugwu@ualberta.ca
      • Contact: Charmaine van Eeden, PhD; Phone Number: 780 248 2059; Email: vaneeden@ualberta.ca
      • Principal Investigator: Victor Ezeugwu, PhD
    • Calgary, Alberta, Canada, T2E 6V7
      • Carewest Dr Vernon Fanning Centre
      • Contact: Victor Ezeugwu, PhD; Phone Number: 780 492 5108; Email: ezeugwu@ualberta.ca
      • Contact: Charmaine van Eeden, PhD; Phone Number: 780 248 2059; Email: vaneeden@ualberta.ca
      • Principal Investigator: Victor Ezeugwu, PhD
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
      • Contact: Victor Ezeugwu, PhD; Phone Number: 780 492 5108; Email: ezeugwu@ualberta.ca
      • Contact: Charmaine van Eeden, PhD; Phone Number: 780 248 2059; Email: vaneeden@ualberta.ca
      • Principal Investigator: Victor Ezeugwu, PhD
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
      • Contact: Victor Ezeugwu, PhD; Phone Number: 780 492 5108; Email: ezeugwu@ualberta.ca
      • Contact: Charmaine van Eeden, PhD; Phone Number: 780 248 2059; Email: vaneeden@ualberta.ca
      • Principal Investigator: Victor Ezeugwu, PhD
    • Edmonton, Alberta, Canada, T5G 0B7
      • Glenrose Rehabilitation Hospital
      • Contact: Victor Ezeugwu, PhD; Phone Number: 780 492 5108; Email: ezeugwu@ualberta.ca
      • Contact: Charmaine van Eeden, PhD; Phone Number: 780 248 2059; Email: vaneeden@ualberta.ca
      • Principal Investigator: Victor Ezeugwu, PhD
    • Edmonton, Alberta, Canada, T6L 5X8
      • Grey Nuns Community Hospital
      • Contact: Victor Ezeugwu, PhD; Phone Number: 780 492 5108; Email: ezeugwu@ualberta.ca
      • Contact: Charmaine van Eeden, PhD; Phone Number: 780 248 2059; Email: vaneeden@ualberta.ca
      • Principal Investigator: Victor Ezeugwu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 50 - or older
• Had an ischemic or hemorrhagic stroke within the last 3 months
• Have recently returned or are returning home from hospital
• Able to walk 5 meters with or without a gait aid

Exclusion Criteria:

• Previously diagnosed with a mobility limiting musculoskeletal condition
• Previously diagnosed with a mobility limiting neurological condition
• Have cardiac conditions (e.g. blood pressure ≥180/100 mmHg)
• Are without access to an internet-enabled computer or mobile device
• Are enrolled in another interventional trial such as exercise or neuroprotection trials
• Have aphasia or are unable to provide consent in English.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early BIG STEPS; Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed. Participants will start the BIG STEP intervention within 3 months of stroke onset.	Behavioral: Behavior and guided stepping training intervention (BIG STEPS); The BIG STEPS intervention comprises a home-based behavioral intervention aimed at reducing and frequently interrupting prolonged sedentary periods, along with guided stepping training to gradually increase daily steps. Participants will wear an accelerometer throughout the whole day for four consecutive days during each assessment. Using baseline accelerometer data, prolonged periods of sedentary time or minimal activity levels will be identified and used to inform personalized activity and behavior-change recommendations.
Other: Delayed BIG STEPS; The waitlist control group will complete the BIG STEPS intervention after 6 months.	Behavioral: DELAYED Behavior and guided stepping training intervention; The waitlist control group will complete the BIG STEPS intervention after 6 months. During the waiting period they will receive usual care and educational materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical functioning: Step Counts	activPAL derived step counts	Difference in changes from baseline to 3 months (post intervention/post waiting)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedentary time	activPAL-derived sedentary time.	Change from baseline at 3, 6, 9 and 12 months.
Global Disability	Modified Rankin Scale (mRS) 0-5, higher scores mean worse outcome.	Change from baseline at 3, 6, 9 and 12 months.
Functional mobility	Timed Up and Go Test (TUG)	Change from baseline at 3, 6, 9 and 12 months.
Gait Speed	10-meter walk test (10MWT)	Change from baseline at 3, 6, 9 and 12 months.
Walking Endurance	6-Minute walk test (6MWT)	Change from baseline at 3, 6, 9 and 12 months.
Self efficacy	Stroke Self Efficacy Questionnaire is a 13-item questionnaire. Higher scores in each subscale indicate higher confidence levels and better self-efficacy.	Change from baseline at 3, 6, 9 and 12 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stanford Gender-Related Variables for Health Research scale	The Stanford Gender-Related Variables for Health Research scale is a 25-item self-report survey that measures how specific gender-related behaviors and roles impact physical and mental well-being.	Change from baseline at 3, 6, 9 and 12 months.
Cognition	5-minute Montreal Cognitive Assessment (5-min MoCA)	Change from baseline at 3, 6, 9 and 12 months.
Memory	Multifactorial Memory Questionnaire 9 (MMQ-9). T scores will be derived. T scores between 40 and 60 are generally interpreted as average.	Change from baseline at 3, 6, 9 and 12 months.
EuroQol-5 Dimension 5-Level (EQ-5D-5L)	The 5-level EQ-5D version (EQ-5D-5L) is a patient-reported quality of life measure. Country-specific valuation set will be used. The EQ-5D VAS score rates perceived health on a scale of 0-100, where higher scores are better.	Change from baseline at 3, 6, 9 and 12 months.
Depression	Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire where higher scores represent worse outcome.	Change from baseline at 3, 6, 9 and 12 months.
Fatigue Severity Scale (FSS)	Fatigue Severity Scale (FSS) is a 9-item questionnaire with higher scores indicating worse outcome	Change from baseline at 3, 6, 9 and 12 months.
Pittsburgh Sleep Quality Index (PSQI)	Pittsburgh Sleep Quality Index (PSQI) scores range from 0 to 21 where higher scores are worse.	Change from baseline at 3, 6, 9 and 12 months.
Modified Caregiver Stress Index	Modified Caregiver Stress Index is a 13-item questionnaire with higher scores indicating greater caregiver burden.	Change from baseline at 3, 6, 9 and 12 months.

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Canadian Institutes of Health Research (CIHR)

Study record dates

Study Major Dates

• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: stroke; sedentary time; self efficacy; daily steps
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Stroke; Sedentary Behavior
• Other Study ID Numbers: Pro00140017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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