150 Participants NeededMy employer runs this trial

BIG STEPS for Stroke

(BIG STEPS Trial)

Recruiting at 5 trial locations
VE
Overseen ByVictor Ezeugwu, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help stroke survivors improve daily movement and reduce sitting time, potentially enhancing recovery and quality of life. Participants will replace sitting with more steps, and researchers will track their progress over a year. The trial is suitable for individuals aged 50 and older who have had a stroke in the past three months, have recently left the hospital, and can walk five meters, even with assistance. Researchers will compare two groups: one begins the movement program immediately, while the other waits six months. The goal is to determine the optimal timing for interventions to maximize recovery benefits. As an unphased trial, this study offers participants the chance to contribute to valuable research that could improve recovery strategies for future stroke survivors.

What prior data suggests that the BIG STEPS intervention is safe for stroke patients?

A previous study, the BIG STEPS program, combined behavior change with stepping exercises and proved both practical and safe for stroke patients. Participants in that study demonstrated promising early results without major safety concerns. This suggests the program is well-tolerated and poses no significant risks to participants.

These findings encourage prospective participants, showing that increasing daily steps and reducing sitting time can be achieved safely and effectively.12345

Why are researchers excited about this trial?

Researchers are excited about the BIG STEPS intervention for stroke recovery because it focuses on transforming sedentary behaviors into active stepping, tailored to each individual's baseline activity. Unlike traditional rehabilitation methods that might not prioritize everyday movement changes or are often standardized, this approach personalizes goals using accelerometry data to encourage consistent and specific increases in physical activity. By starting this intervention within three months post-stroke, the aim is to harness the critical early recovery period, potentially leading to better long-term mobility and health outcomes.

What evidence suggests that the BIG STEPS intervention is effective for improving outcomes after stroke?

Research has shown that walking more each day and sitting less can aid recovery after a stroke. Studies have found that taking more steps can increase walking speed and duration, enhancing overall mobility. For instance, one study found that more intense walking training improved walking distance and speed. Another study demonstrated that more intensive rehabilitation could enhance the quality of life for stroke survivors. In this trial, participants will engage in the BIG STEPS intervention, which focuses on behavior and guided stepping training. The trial includes two arms: the Early BIG STEPS group, where participants start the intervention within 3 months of stroke onset, and the Delayed BIG STEPS group, where participants begin after 6 months. Overall, walking exercises appear to help stroke patients move better and improve their daily activities.678910

Are You a Good Fit for This Trial?

This trial is for people aged 50 or older who have had a stroke within the past three months, are returning home from the hospital, and can walk at least five meters (with or without a walking aid).

Inclusion Criteria

I can walk at least 5 meters, with or without assistance.
I am 50 years old or older.
Have recently returned or are returning home from hospital
See 1 more

Exclusion Criteria

I have a heart condition or very high blood pressure.
Are without access to an internet-enabled computer or mobile device
Are enrolled in another interventional trial such as exercise or neuroprotection trials
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental arm receive the BIG STEPS intervention for 3 months, focusing on increasing daily step counts and reducing sedentary time.

3 months
Regular assessments every 90 days

Waitlist Control

Participants in the control group wait for 6 months before starting the BIG STEPS intervention.

6 months

Follow-up

Participants are monitored for changes in step counts, sedentary time, and other secondary outcomes every 90 days for 12 months.

12 months
Assessments every 90 days

What Are the Treatments Tested in This Trial?

Interventions

  • Behavior and guided stepping training intervention (BIG STEPS)

Trial Overview

The study compares starting a behavior and guided stepping program (BIG STEPS) soon after stroke versus waiting six months to start. The goal is to see if early intervention helps increase daily steps and improve recovery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Early BIG STEPSExperimental Treatment1 Intervention
Group II: Delayed BIG STEPSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Citations

Strategy training shows promise for addressing disability in ...

Conclusion. Strategy training shows promise for addressing disability and executive cognitive impairments within the first 6 months of stroke. Valuable lessons ...

NCT07661849 | Efficacy of Tele-CPASS Compared to In- ...

The results of this study will help determine whether telerehabilitation can improve access to effective stroke recovery interventions. While rehabilitation ...

Guidelines in Action: #STROKE rehabilitation ...

The evidence suggests more intensive rehab improves quality of life, and feedback from stroke survivors and families played a key role in this ...

Scoping review: The trajectory of recovery of participation ...

This scoping review aimed to critically review the evidence regarding patterns of recovery of participation outcomes among stroke survivors

Moving towards precision post-stroke rehabilitation: A systematic ...

Outcomes assessed were daily steps, gait speed (comfortable and fastest), and endurance (6-minute walk test). Meta-analyses using random-effects models (STATA ...

Feasibility of Behavioral Intervention and Guided Stepping ...

A behavioral intervention combined with guided stepping training early after stroke was feasible and safe, with promising preliminary effects.

Behavioral Intervention and Guided Stepping Training ...

Low daily steps and prolonged sedentary behavior are associated with reduced functional outcomes and quality of life in patients with stroke.

Implementation of High-intensity Stepping Training during ...

patients receiving inpatient stroke rehabilitation performed ~1500 steps/day and achieved higher intensities (~40% of sessions), with substantial gains

Increasing Activity After Stroke: A Randomized Controlled ...

The data demonstrate that gains in walking activity in those with chronic stroke occur following a targeted behavioral intervention integrating ...

Building a Data-Driven Stroke Rehabilitation Exercise Program

Explore stroke rehab exercises and data-driven protocols that boost patient outcomes, streamline clinic workflow, and support reimbursement.