Locomotor Training for Stroke

Overseen By Melissa Chung

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Weightbearing restrictions, uncontrolled disorders, others

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

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the most effective use of the High-Intensity Locomotor Training Program to improve walking abilities in stroke recovery. Participants will be randomly assigned to one of three groups: two different types of High-Intensity Gait Training (HIGT) or a program focused on taking many steps. The goal is to identify which method best reduces walking difficulties. The trial seeks participants who have had a stroke and are in inpatient rehabilitation, provided they can walk more than 50 meters and do not have major health issues that prevent exercise. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance stroke recovery methods.

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 this High-Intensity Gait Training is safe for stroke patients?

Earlier studies have shown that High-Intensity Locomotor Training (HILT) helps stroke patients walk faster and improve balance. Research indicates that this training is usually well-tolerated and leads to significant improvements without major safety concerns.

Similarly, studies have found that Moderate-Intensity Locomotor Training (MILT) improves walking ability in stroke patients. A review of the research highlighted that this training carries a low risk of serious harm.

Both training programs appear safe and effective for enhancing mobility in stroke patients. Participants in these studies generally handled the exercises well, with no severe adverse events reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the High-Intensity and Moderate-Intensity Locomotor Training Programs for stroke rehabilitation because these methods aim to enhance recovery by focusing on intensity and step count, potentially leading to faster and more significant improvements in walking ability. Unlike traditional stroke rehabilitation, which often involves low to moderate intensity exercise, these programs concentrate on increasing the cardiovascular demand and engagement through high-intensity, repetitive stepping exercises. This approach could lead to better outcomes in a shorter time frame, providing a promising alternative to current rehabilitation practices.

What evidence suggests that this trial's treatments could be effective for reducing locomotor disability after stroke?

Research has shown that high-intensity walking exercises, like those in the High-Intensity Locomotor Training Program studied in this trial, can significantly enhance walking and balance for stroke recovery patients. Patients who engaged in these exercises during rehabilitation walked faster and longer than those receiving standard care. Some studies even found that these improvements enabled patients to progress from walking only at home to walking outside.

The trial also includes a Moderate-Intensity Locomotor Training Program, which helps increase walking distance and strength. However, moderate-intensity exercises may not enhance walking ability as much as high-intensity exercises. Both exercise types show promise in aiding stroke survivors to walk better and regain mobility. ^{1 2 6 7 8}

Who Is on the Research Team?

Susan Camillieri

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for stroke patients in the early recovery phase who are currently undergoing inpatient rehabilitation. Participants should be able to handle a certain level of physical activity but specifics on inclusion and exclusion criteria were not provided.

Inclusion Criteria

I have been diagnosed with a stroke.

Exclusion Criteria

I don't have any health issues that would stop me from doing exercises involving walking or running.

Estimated length of stay of less than 14 days

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three distinct locomotor training protocols for 10 consecutive 1-hour sessions over a 10-day period

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-Intensity Locomotor Training Program

Trial Overview

The study is testing three different walking programs: moderate-intensity, high-intensity, and one focused on achieving a high number of steps. Patients will be randomly assigned to one of these programs to see which is most effective at improving walking after a stroke.

How Is the Trial Designed?

Group I: Moderate-Intensity Locomotor Training Program Experimental Treatment 1 Intervention

Treatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care.

Group II: High-Intensity Locomotor Training Program Experimental Treatment 1 Intervention

Treatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care.

Group III: High-Step Count Locomotor Training Program Active Control 1 Intervention

Treatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

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 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]

This study involves 50 chronic stroke survivors and compares the effects of high-intensity interval training (HIIT) versus moderate-intensity aerobic training on walking capacity over 36 sessions, aiming to determine which method is more effective for improving mobility post-stroke.

The results will provide crucial insights into the optimal intensity and duration of exercise for stroke rehabilitation, potentially influencing future guidelines to enhance walking capacity and overall recovery in stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate-intensity exercise versus high-intensity interval training to recover walking post-stroke: protocol for a randomized controlled trial. Miller, A., Reisman, DS., Billinger, SA., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7034641/

Implementation of High-intensity Stepping Training during ...

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

2.

ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.119.027450

Implementation of High-Intensity Stepping Training During ...

Provision of high-intensity stepping training applied during inpatient rehabilitation resulted in significantly greater walking and balance outcomes.

3.

digitalscholar.lsuhsc.edu

digitalscholar.lsuhsc.edu/ahrd/2024/2024/29/

The Effect of Power Training and High-Intensity Gait ...

Results: The patient improved in functional mobility and decreased fall risk. Gait speed increased, which elevated ambulation status from household to limited ...

4.

tandfonline.com

tandfonline.com/doi/full/10.1080/09593985.2024.2424354?af=R

Full article: A retrospective analysis of a clinician-initiated ...

Compared to usual care, high-intensity locomotor training during inpatient rehabilitation is associated with improved outcomes in gait speed and endurance ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10189784/

Increasing the Amount and Intensity of Stepping Training ...

Implementation of high-intensity stepping training during inpatient stroke rehabilitation improves functional outcomes. Stroke 2020;51(2):563–570. doi ...

6.

neuropt.org

neuropt.org/docs/default-source/stroke-sig/value-of-higt-in-acute-care.pdf?sfvrsn=3d0f5d43_2

The Value of High Intensity Locomotor Training in Acute ...

The purpose of this review is to delineate some of the evidence regarding the effects of exercise intensity during locomotor training in ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06637839

Optimal Dosing of High-Intensity Locomotor Training for ...

The purpose of this study is to elucidate optimal dosing for High Intensity Gait Training (HIGT) to reduce locomotor disability for those undergoing ...

8.

tandfonline.com

tandfonline.com/doi/full/10.1080/09593985.2024.2424354?scroll=top&needAccess=true

Full article: A retrospective analysis of a clinician-initiated ...

Compared to usual care, high-intensity locomotor training during inpatient rehabilitation is associated with improved outcomes in gait speed ...