Guided Stepping Training for Stroke Recovery

(BIG-STEPS Trial)

Overseen By Victor Ezeugwu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Multiple sclerosis, Parkinson's, active cancer, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if reducing sitting time soon after a stroke can improve walking and lessen disability. The study will also examine how brain scans and activity trackers can predict recovery and tailor rehabilitation. Participants will receive either usual care or an additional program focused on increasing stepping time, known as the Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention. Individuals who experienced an ischemic stroke within the past week, can walk at least 5 meters with assistance, and wish to improve their walking may be suitable candidates. The study targets those who are medically stable and free from conditions like Parkinson's disease or uncontrolled high blood pressure. As an unphased trial, this study provides a unique opportunity to contribute to innovative stroke recovery research and potentially enhance personal rehabilitation outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention is safe?

Research shows that high-intensity stepping exercises, such as the BIG STEPS program, are generally safe. Studies have incorporated this exercise type in stroke recovery programs without major safety issues. The goal is to reduce sitting time and encourage more movement, aiding recovery after a stroke. Although any new treatment carries some risks, evidence suggests this approach is well-tolerated. Participants in similar studies have not reported significant negative effects, supporting the idea that the BIG STEPS program is a safe option for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BIG STEPS intervention for stroke recovery because it combines behavior change techniques with imaging guidance to enhance stepping activity early after a stroke. Unlike standard treatments that focus primarily on general physical and therapeutic mobilization, BIG STEPS aims to specifically reduce sedentary behavior through targeted stepping exercises. This approach not only encourages more active recovery but could also lead to improved outcomes by addressing the early post-stroke phase when patients are most receptive to forming new habits.

What evidence suggests that the BIG STEPS intervention could be effective for stroke recovery?

Research shows that moving more and sitting less soon after a stroke can improve movement and reduce disability. Studies have found that encouraging early activity in patients leads to better recovery. In this trial, participants in the experimental arm will receive the BIG STEPS program, designed to help people walk more and sit less. Evidence suggests that starting rehabilitation soon after a stroke enhances abilities. By using imaging and activity data, the BIG STEPS program customizes to each person, potentially increasing its effectiveness. ^{1 2 4 6 7}

Who Is on the Research Team?

Victor Ezeugwu, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for adults who've had an ischemic stroke within the last week. They should be medically stable, able to walk at least 5 meters with or without help, and have goals to improve walking. People with other conditions like MS or Parkinson's, active cancer, uncontrolled high blood pressure, unstable heart issues, or difficulty understanding instructions can't join.

Inclusion Criteria

I can walk at least 5 meters, with or without help.

I walk slower than 1 meter per second.

Medically stable as deemed by physicians

Exclusion Criteria

I have multiple sclerosis, Parkinson's disease, or another active cancer.

My high blood pressure is not under control.

Unable to understand or follow instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including demographic and stroke characteristics, and are set up with an activPAL accelerometer for 1 week

1 week

1 visit (in-person)

Treatment

Participants undergo a sedentary behaviour change intervention for 6 weeks

6 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with final assessments at 90 days

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention

Trial Overview The BIG-STEPS intervention aims to reduce sedentary behavior after a stroke to enhance mobility and lessen disability. It involves tracking activity levels using an accelerometer and assessing how brain imaging markers influence rehab outcomes.

How Is the Trial Designed?

Group I: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) Experimental Treatment 1 Intervention

Additional to usual care, the experimental arm will undergo a theory-based behaviour change intervention to improve stepping time relative to reducing sedentary behaviour.

Group II: Usual care: Active Control 1 Intervention

The control arm program will consist of usual inpatient care including therapeutic mobilization by the physical therapy team and general mobilization, as tolerated, by the nursing team.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

High-intensity stepping training significantly improved walking speed and distance in individuals post-stroke compared to low-intensity training, with 90 participants completing over 10 sessions in a randomized clinical trial.

In addition to enhancing walking ability, high-intensity and variable stepping practice also led to better gait symmetry and increased balance confidence, particularly in those with severe impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Hornby, TG., Henderson, CE., Plawecki, A., et al.[2020]

The LEAPS trial aims to assess the effectiveness of specialized locomotor training programs (LTP) versus a home-based exercise program (HEP) in improving walking ability in 400 adults with moderate to severe walking limitations post-stroke, with outcomes measured at one year.

The trial will evaluate whether the timing of LTP delivery (2 or 6 months post-stroke) and the severity of initial impairment affect gait speed recovery, with a goal to detect a 20% difference in recovery rates and a 0.1 m/s difference in gait speed between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. Duncan, PW., Sullivan, KJ., Behrman, AL., et al.[2023]

In a study of 39 stroke survivors who underwent up to 40 rehabilitation sessions, specific biomechanical assessments were found to help differentiate changes in daily stepping activity, which is crucial for maintaining functional capacity and reducing mortality risk.

Participants who showed greater improvements in non-paretic (the unaffected side) walking kinematics were more likely to retain increased daily stepping activity over time, suggesting that focusing on both sides of the body during rehabilitation may enhance long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved walking function in laboratory does not guarantee increased community walking in stroke survivors: Potential role of gait biomechanics. Ardestani, MM., Henderson, CE., Hornby, TG.[2021]

In a study of 39 stroke survivors, physical activity intensity and duration significantly increased between 3 and 12 weeks post-stroke, indicating a positive trend in recovery during this period.

However, changes in physical activity were not strongly correlated with improvements in lower limb motor function, highlighting the complexity of recovery and the need for personalized rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity dimensions after stroke: patterns and relation with lower limb motor function. Braakhuis, HEM., Berger, MAM., Regterschot, RGRH., et al.[2022]

The DOSE trial demonstrated that higher therapeutic intensity in physical therapy can significantly improve long-term walking outcomes after stroke, with participants achieving over double the steps and aerobic minutes compared to usual care.

A model developed from data of 25 individuals in inpatient rehabilitation provides specific targets for prescribing exercise based on walking impairment, predicting increases of 73 steps and 0.56 minutes of aerobic activity per session, which can help tailor rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Step Number and Aerobic Minute Exercise Prescription and Progression in Stroke: A Roadmap. Peters, S., Klassen, T., Schneeberg, A., et al.[2022]

A focused stepping training program for patients early poststroke was feasible and resulted in a significant increase in daily stepping activity, averaging 1516 steps per day, which is 5 to 6 times more than typical levels during rehabilitation.

Increased stepping activity was positively correlated with improved mobility outcomes, including better performance on the 6-minute walk test and balance assessments, suggesting that more intensive stepping practice may enhance recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Focused Stepping Practice During Inpatient Rehabilitation Poststroke and Potential Contributions to Mobility Outcomes. Hornby, TG., Holleran, CL., Leddy, AL., et al.[2016]

High-intensity, variable stepping training significantly improved walking speed and distance in individuals 1 to 6 months post-stroke compared to conventional interventions, with experimental participants showing a walking speed increase of 0.27 m/s versus 0.09 m/s in controls.

Participants in the experimental group also experienced greater gains in gait symmetry and self-reported participation, suggesting that the intensity and variability of stepping practice are crucial for locomotor recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Hornby, TG., Holleran, CL., Hennessy, PW., et al.[2017]

In a study of 76 stroke survivors, only slow choice stepping reaction time was identified as a predictor of adherence to group-based exercise, with participants attending an average of 60% of classes over one year.

Better physical functioning and quality of life were linked to higher daily step counts, with a model including these factors explaining 33% of the variance in average steps taken per day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of adherence to a structured exercise program and physical activity participation in community dwellers after stroke. Tiedemann, A., Sherrington, C., Dean, CM., et al.[2021]

In a study involving 34 chronic stroke patients, both voluntary-induced stepping response training (VSR) and DynSTABLE perturbation training (DST) improved protective stepping parameters, with VSR showing a notable increase in the use of the affected leg for stepping.

DST training resulted in greater improvements in step length and center of mass control compared to VSR, suggesting that while both methods are effective, DST may offer superior benefits in certain aspects of protective stepping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate effect of voluntary-induced stepping response training on protective stepping in persons with chronic stroke: a randomized controlled trial. Chayasit, P., Hollands, K., Hollands, M., et al.[2022]

High-intensity stepping training significantly improved walking capacity and balance in stroke patients compared to usual care, with participants taking an average of 5777 steps per day versus 3917 steps in the usual care group.

The high-intensity intervention led to clinically meaningful improvements in self-selected and fastest gait speeds, as well as balance outcomes, suggesting that early, intensive rehabilitation can enhance recovery post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. Moore, JL., Nordvik, JE., Erichsen, A., et al.[2021]

The FALLS program, designed specifically for individuals who have had a stroke, was developed based on a proven-effective falls prevention exercise program and was tested with twelve community-dwelling stroke patients.

Participants and health care professionals found the FALLS program to be suitable and feasible, indicating its potential for implementation in clinical practice to help reduce fall risks after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Process Evaluation of a 5-Week Exercise Program to Prevent Falls in People after Stroke: The FALLS Program. van Duijnhoven, HJ., De Kam, D., Hellebrand, W., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05753761

The Whole Day Matters After Stroke (BIG-STEPS ... Goal of research program: To understand person-specific factors, such as imaging markers and activity patterns early after stroke, that may guide precision ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10703225/

The whole day matters after stroke: Study protocol for a ... This study aims to determine the feasibility and effect of a 'sit less, move more, sleep better' program early after stroke on functional mobility and global ...

3. withpower.com withpower.com/trial/guided-stepping-training-for-stroke-recovery-d9a20

Guided Stepping Training for Stroke Recovery Trial Overview The BIG-STEPS intervention aims to reduce sedentary behavior after a stroke to enhance mobility and lessen disability. It involves tracking ...

4. researchgate.net researchgate.net/publication/376311381_The_whole_day_matters_after_stroke_Study_protocol_for_a_randomized_controlled_trial_investigating_the_effect_of_a_'sit_less_move_more_sleep_better'_program_early_after_stroke

(PDF) The whole day matters after stroke: Study protocol ... Objective This study aims to determine the feasibility and effect of a 'sit less, move more, sleep better' program early after stroke on ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5802378/

Early Rehabilitation After Stroke: a Narrative Review - PMC The evidence is mounting that for at least some deficits, initiation of rehabilitative strategies within the first 2 weeks of stroke is beneficial.

6. researchgate.net researchgate.net/figure/Study-schedule-BIG-STEPS-Behaviour-and-Imaging-Guided-Stepping-Training-Early_fig1_376311381

Study schedule BIG STEPS, Behaviour and Imaging ... Addressing these co-dependent behaviours early after stroke may help to optimize recovery and improve overall quality of life for individuals with stroke.

7. pnas.org pnas.org/doi/10.1073/pnas.2026676118

Critical Period After Stroke Study (CPASS): A phase II ... We found a similar sensitive or optimal period 60 to 90 d after stroke, with lesser effects ≤30 d and no effect 6 mo or later after stroke.