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

Trial Summary

What is the purpose of this trial?

Goal of research program: To understand person-specific factors, such as imaging markers and activity patterns early after stroke, that may guide precision rehabilitation to optimize function and improve recovery. Objectives: 1. Test the effect of reducing sedentary behaviour early after stroke on functional mobility and global disability outcomes. 2. Determine the impact of neuroimaging biomarkers (e.g. leukoaraiosis) on response to rehabilitation. 3. Explore the predictive value of accelerometry as an adjunct to the subjective modified Rankin Scale (mRS) to assess functional disability after stroke. Experimental approach/Research Plan/Use of Funds: The investigators aim to recruit 50 participants within 1 week of ischemic stroke onset, aged ≥ 18 years, medically stable as deemed by their physicians, able to walk at least 5 meters with/without gait aid and with ongoing walking or balance goals. Demographic and stroke characteristics, including stroke risk factors, infarct location and volume, leukoaraiosis on routine MRI, and acute stroke treatments (e.g., thrombectomy) will be determined and documented. A battery of impairment, psychosocial, and functional measures, including the mRS and Timed-Up and Go test (primary outcomes) will be completed. Subsequently, participants will be set up to wear activPAL accelerometer, validated in stroke, for 1 week. Following randomization, a sedentary behaviour change intervention will span 6 weeks, with final follow-up assessments at 90 days.

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 data supports the effectiveness of the BIG STEPS treatment for stroke recovery?

Research shows that high-intensity stepping practice, which is part of the BIG STEPS treatment, can significantly improve walking speed, distance, and balance in stroke patients compared to traditional care. This suggests that the BIG STEPS treatment may be effective in enhancing mobility and recovery post-stroke. ^{1 2 3 4 5}

Is Guided Stepping Training for Stroke Recovery safe for humans?

The available research on high-intensity stepping training for stroke recovery suggests it is generally safe for humans, as it has been implemented in clinical trials without reported safety concerns. However, it is important to consult with healthcare providers to ensure it is appropriate for individual health conditions. ^{1 4 6 7 8}

How is the BIG STEPS treatment different from other stroke recovery treatments?

The BIG STEPS treatment is unique because it focuses on high-intensity and variable stepping practice early after a stroke, which is different from traditional rehabilitation that often discourages such strategies. This approach aims to maximize recovery by increasing the intensity and variability of stepping exercises, which has been shown to improve walking speed and balance more effectively than usual care. ^{1 4 9 10 11}

Research Team

Victor Ezeugwu, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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.

I had a stroke caused by a clot less than a week ago.

Exclusion Criteria

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

My high blood pressure is not under control.

My heart condition is not stable.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Focused Stepping Practice During Inpatient Rehabilitation Poststroke and Potential Contributions to Mobility Outcomes. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Improved walking function in laboratory does not guarantee increased community walking in stroke survivors: Potential role of gait biomechanics. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Physical activity dimensions after stroke: patterns and relation with lower limb motor function. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Step Number and Aerobic Minute Exercise Prescription and Progression in Stroke: A Roadmap. [2022]

7. United States 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Predictors of adherence to a structured exercise program and physical activity participation in community dwellers after stroke. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. [2017]

10. England 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. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. [2023]