Clinical trial Recruiting at 4 sites Interventional Ages 50 and up

Big Steps: Early Walking and Sedentary-Reduction After Stroke

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.

Run by University of Alberta · NCT07702643 · Data updated 2026-11-12

This trial tests whether a guided stepping program and strategies to cut sitting time can help people 50 and older who recently had a stroke improve daily walking and reduce disability.

Quick facts

Study typeInterventional
Ages50 Years and up
SexAll
Enrollment150 (estimated)
SponsorUniversity of Alberta
Academic / other
Locations6 sites (Calgary, Alberta and 5 other locations)
StatusRecruiting
StartedAugust 3, 2026
Main results expectedJune 30, 2030
Study endsJune 30, 2031
Registry record updatedOctober 23, 2026
Trial IDNCT07702643 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 50 and older who had an ischemic or hemorrhagic stroke within the last 3 months and can walk 5 meters with or without a gait aid, recently discharged or returning home from hospital.

Probably not a fit

Patients without access to internet-enabled devices or with conditions limiting mobility beyond stroke may see little or no benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will enroll about 150 stroke patients aged 50 and above within 3 months of onset who can walk at least 5 meters. After baseline assessments, participants will be randomized to receive a sedentary-behavior change plus guided stepping program (BIG STEPS) early after stroke, or a delayed version. The primary outcome is daily steps measured by activPAL, with sedentary time as a secondary outcome, to see if the intervention improves functional mobility and overall disability. The study will use at least one internet-enabled device for participation and will recruit from three Alberta centers. Results will inform whether early, structured activity and strategies to reduce sedentary time can enhance recovery after stroke.

Why it matters

Potential benefit: If successful, participants may experience greater daily activity and better functional recovery after stroke.

How similar studies have gone: Prior work in post-stroke rehabilitation supports activity- and sedentary-targeted approaches, though the specific BIG STEPS program is novel in its early post-stroke timing.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Glenrose Rehabilitation Hospital
    Edmonton, Alberta, Canada
    Recruiting
  • Royal Alexandra Hospital
    Edmonton, Alberta, Canada
    Recruiting
  • University of Alberta Hospital
    Edmonton, Alberta, Canada
    Recruiting
  • Grey Nuns Community Hospital
    Edmonton, Alberta, Canada
    Recruiting
  • Carewest Dr Vernon Fanning Centre
    Calgary, Alberta, Canada
    Not yet recruiting
  • Foothills Medical Center
    Calgary, Alberta, Canada
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.