Behavioural intervention and guided stepping training early post-stroke (BIG STEPS): protocol for a multicentre randomised controlled trial.

INTRODUCTION

Physical inactivity and prolonged sedentary time are associated with lower functional and quality of life outcomes after stroke, and may increase the risk of stroke recurrence. Yet, the best way to manage these movement behaviours after stroke remains uncertain. This study aims to test the effects of a 3-month behavioural intervention and guided stepping training early post-stroke (BIG STEPS) programme on daily step counts, sedentary time, timed walking outcomes and patient-reported fatigue, cognitive function and quality of life.

METHODS AND ANALYSIS: This is a multicentre, assessor-blinded, waitlist-controlled, randomised controlled trial to be completed within 60 months from August 2026 to July 2031. A total of 150 participants in the early subacute stroke recovery phase (<3 months post-stroke), 50 years and older, who are able to walk at least 5 m will be recruited from six centres in Canada. Participants will be randomly assigned (1:1) to an early BIG STEPS intervention group or delayed BIG STEPS waitlist control group. Blinded assessors will complete in-person assessments at baseline and at 3, 6, 9 and 12 months post-baseline. BIG STEPS will be delivered by trained interventionists in a blended format (1 initial in-person +11 virtual sessions). The primary outcome will be daily step counts at 3 months post-baseline, measured with an activPAL accelerometer and inclinometer. In addition, changes over time in 24-hour movement behaviours, timed-walking tests and patient-reported outcomes will be evaluated.

ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the Health Research Ethics Board at the University of Alberta, Edmonton, Canada (Approval Number: Pro00140017). The results will be disseminated through peer-reviewed open-access publications, scientific conferences, participating clinical sites and knowledge translation activities to contribute to the evidence base for behaviour change interventions after stroke.

TRIAL REGISTRATION NUMBER: NCT07702643.