Behavioral Intervention and Guided Stepping Training Early Post-Stroke

ClinicalTrials.gov ID

NCT07702643

Lead Sponsor

University of AlbertaOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

150Estimated

Last Update Posted

Sep 4, 2026Actual

Start Date

Aug 3, 2026Actual

Primary Completion Date

Jun 30, 2030Estimated

Completion Date

Jun 30, 2031Estimated

Official Title

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.

Brief Summary

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.

• Stroke

• Behavior and guided stepping training intervention (BIG STEPS)
• DELAYED Behavior and guided stepping training intervention

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

Single

Lead Sponsor

University of AlbertaOTHER

Collaborators

Canadian Institutes of Health Research (CIHR)OTHER_GOV

ezeugwu@ualberta.ca780 492 5108

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