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

131 Participants Needed

Trial Summary

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 High-Intensity Locomotor Training Program treatment for stroke?

Research shows that high-intensity locomotor training can significantly improve walking speed and balance in stroke patients compared to usual care. This type of training involves practicing walking at higher intensities, which helps enhance recovery and functional outcomes. ^{1 2 3 4 5}

Is high-intensity locomotor training safe for humans?

The studies reviewed do not provide specific safety data for high-intensity locomotor training, but they do suggest that it is being actively researched and used in clinical settings for stroke rehabilitation, indicating a level of acceptance in the medical community. However, the relative benefits and risks compared to moderate-intensity training are not well understood, so it's important to consult with healthcare providers for personalized advice. ^{1 2 6 7 8}

How does the High-Intensity Locomotor Training Program treatment differ from other treatments for stroke?

The High-Intensity Locomotor Training Program is unique because it focuses on high-intensity exercise, which means working at a level that significantly raises the heart rate. This approach is thought to improve walking ability more effectively by targeting specific movement deficits and enhancing the function of the affected limb, compared to lower-intensity or less targeted therapies. ^{1 3 5 7 9}

What is the purpose of this trial?

The purpose of this study is to elucidate optimal dosing for High Intensity Gait Training (HIGT) to reduce locomotor disability for those undergoing inpatient rehabilitation (IR) in the subacute phase of stroke recovery. This is a randomized controlled trial conducted at a single IR facility. Investigators will randomize patients to receive one of two distinct HIGT interventions or a high step count intervention during standard care.

Research Team

Susan Camillieri

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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

Potential contributions of training intensity on locomotor performance in individuals with chronic stroke. [2016]

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

Moderate to Vigorous Intensity Locomotor Training After Stroke: A Systematic Review and Meta-analysis of Mean Effects and Response Variability. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Importance of specificity, amount, and intensity of locomotor training to improve ambulatory function in patients poststroke. [2022]

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

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

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

Limb-loaded cycling program for locomotor intervention following stroke. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Moderate-intensity exercise versus high-intensity interval training to recover walking post-stroke: protocol for a randomized controlled trial. [2021]

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

Locomotor Kinematics and Kinetics Following High-Intensity Stepping Training in Variable Contexts Poststroke. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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

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

The Value of High Intensity Locomotor Training Applied to Patients With Acute-Onset Neurologic Injury. [2023]