Treadmill Training for Post-Stroke Paresis

Overseen By Mansoo Ko, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Orthopedic, Psychiatric, Neurological, Diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests treadmill training to help stroke survivors improve their walking. It examines how to balance strength and cardio exercises to enhance walking efficiency, with a focus on using both legs evenly. The study will evaluate two treadmill techniques, including split-belt treadmill training, to determine which better improves walking symmetry. Individuals who had a stroke over six months ago and can walk 10 meters with or without assistance may qualify. Healthy individuals who can walk 10 meters unaided are also needed for comparison. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance rehabilitation techniques for stroke survivors.

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 treadmill training is safe for post-stroke individuals?

Research shows that split-belt treadmill training is safe for people recovering from a stroke. This training helps make steps more even, improving walking. Studies have not reported any major side effects or safety problems. Most participants managed the training well and often saw improvements in walking without slowing down or taking shorter steps. This indicates the training is both effective and easy to handle. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about split-belt treadmill training for post-stroke paresis because it offers a new approach to improving gait and balance in stroke survivors. Unlike traditional physical therapy, which often focuses on general mobility exercises, this technique specifically targets asymmetries in walking patterns by using a treadmill with two belts that can move at different speeds. This method aims to retrain the brain and body to develop more balanced and efficient walking, potentially leading to faster and more significant improvements in gait compared to standard rehabilitation methods.

What evidence suggests that split-belt treadmill training is effective for post-stroke hemiparesis?

Research has shown that split-belt treadmill training, which participants in this trial may receive, can greatly improve walking for people who have had a stroke. This training helps balance walking between the two legs. One study found that the difference in step length between the legs improved by 27.3%, allowing patients to walk more evenly without slowing down. These improvements were noticeable not just immediately after training but also lasted for at least a month. This method helps the brain learn new walking patterns, aiding recovery and enhancing movement control. ^{1 2 3 5 6}

Who Is on the Research Team?

Mansoo Ko, Ph.D.

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

This trial is for healthy individuals and stroke survivors over 20 years old. Healthy participants must walk independently without aids, while those with a history of stroke should be able to walk with or without assistance and have had their first unilateral stroke at least 6 months prior without major complications.

Inclusion Criteria

People who are 20 years old or older and in good health.

You can walk at least 10 meters without any help, at a speed that feels good for you.

Healthy participants will be required to be medically stable

Exclusion Criteria

You have unstable chest pain.

You have peripheral vascular disease.

Your diabetes is not well controlled, for example, if you have foot ulcers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline assessment of spatiotemporal patterns and kinematic representation before treadmill walking

1 day

1 visit (in-person)

Gait Training

Participants undergo gait training using split-belt and single belt treadmill walking with neuromechanical and biobehavioral approaches

20-30 minutes per session

Multiple sessions over the study period

Follow-up

Participants are monitored for safety and effectiveness after gait training

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Split-belt treadmill training

Trial Overview

The study tests two types of treadmill training: split-belt and single belt using simulation software. It aims to improve walking symmetry in people who have experienced a stroke by combining strength and aerobic exercises.

How Is the Trial Designed?

Group I: Gait training for stroke Experimental Treatment 1 Intervention

Group II: Gait training for healthy Active Control 1 Intervention

Split-belt treadmill training is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Split-belt treadmill training for:

• Rehabilitation of gait asymmetry in post-stroke hemiparesis

Approved in European Union as Split-belt treadmill therapy for:

• Gait rehabilitation in stroke survivors
• Improvement of step length symmetry in post-stroke hemiparesis

Approved in Canada as Split-belt treadmill training for:

• Rehabilitation of gait disorders in post-stroke patients

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Ko, Mansoo

Lead Sponsor

Trials

1

Recruited

100+

Mansoo Ko

Lead Sponsor

Trials

1

Recruited

100+

Published Research Related to This Trial

Repeated split-belt treadmill (SBT) walking training significantly reduced step length (SL) asymmetry in 12 individuals post-stroke, with improvements retained for at least one month after training.

The training led to increased muscle activity and joint moments in the trained leg, particularly in plantarflexors, knee flexors, and hip extensors, without negative effects on the paretic plantarflexors, suggesting SBT is a safe and effective method for enhancing recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower limb joint moments on the fast belt contribute to a reduction of step length asymmetry over ground after split-belt treadmill training in stroke: A pilot study. Betschart, M., McFayden, BJ., Nadeau, S.[2021]

Treadmill training leads to earlier activation of the vastus lateralis muscle in the paretic leg of stroke patients, which may help improve gait symmetry during walking.

In contrast, the nonparetic vastus lateralis shows delayed activation and reduced muscle activity during treadmill walking compared to overground walking, indicating that treadmill training alters muscle activation patterns beneficially for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved hemiparetic muscle activation in treadmill versus overground walking. Harris-Love, ML., Macko, RF., Whitall, J., et al.[2007]

A systematic review of 15 trials involving 622 participants found no statistically significant differences in walking speed or dependence between treadmill training with or without body weight support and other interventions for stroke rehabilitation.

While some individual studies suggested potential benefits of treadmill training with body weight support for dependent walkers, the overall evidence is limited, and adverse events were more common in treadmill training groups but not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training and body weight support for walking after stroke. Moseley, AM., Stark, A., Cameron, ID., et al.[2018]

Aquatic treadmill training (ATT) significantly improved gait function, balance, and confidence in stroke patients after 15 sessions, as evidenced by notable increases in the Comfortable 10-Meter Walk Test, Berg Balance Scale, and Activities-specific Balance Confidence scale scores.

While ATT showed improvements in step-length and temporal symmetry, these changes were not statistically significant, indicating that while ATT is beneficial, further research is needed to fully understand its impact compared to other rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Aquatic Treadmill Training on Gait Symmetry and Balance in Subacute Stroke Patients. Lee, ME., Jo, GY., Do, HK., et al.[2020]

In a study involving 10 healthy adults, walking on a split-belt treadmill revealed significant asymmetries in lower limb dynamics, particularly at the ankle joint, where the faster leg provided much more propulsion than the slower leg.

The findings suggest that the split-belt treadmill may not be an effective therapeutic exercise for rehabilitation, as the dynamics observed differ from those seen in patients with hemiplegia, potentially complicating the expected benefits of this training method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limping on split-belt treadmills implies opposite kinematic and dynamic lower limb asymmetries. Tesio, L., Malloggi, C., Malfitano, C., et al.[2019]

Treadmill therapy with partial body weight support (BWS) significantly improves gait ability in nonambulatory stroke patients by allowing them to practice complex walking patterns, leading to more symmetrical walking and reduced spasticity.

Clinical studies indicate that treadmill training is as effective as traditional physiotherapy methods for improving gait in both chronic and acute stroke patients, with upcoming multicenter trials expected to further validate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training with partial body weight support after stroke. Hesse, S., Werner, C., von Frankenberg, S., et al.[2019]

Treadmill training at inclinations of up to 8% is safe for ambulatory patients with hemiparetic stroke, as it did not exceed critical heart rate levels while improving walking symmetry.

At higher inclinations (6% and 8%), patients showed increased stride length and improved swing symmetry, indicating potential benefits for gait rehabilitation in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of treadmill inclination on the gait of ambulatory hemiparetic subjects. Werner, C., Lindquist, AR., Bardeleben, A., et al.[2016]

Treadmill training with harness support can effectively improve gait deviations in individuals with post-stroke hemiparesis, as shown in a study with six hemiparetic subjects.

Adjusting training parameters like body weight support, treadmill speed, and support stiffness can lead to significant improvements in gait patterns, such as increased single limb support time and reduced energy costs during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait deviations associated with post-stroke hemiparesis: improvement during treadmill walking using weight support, speed, support stiffness, and handrail hold. Chen, G., Patten, C., Kothari, DH., et al.[2022]

A systematic review of 11 trials involving 458 participants found no statistically significant differences in walking speed or dependency between treadmill training with or without body weight support and other interventions for stroke rehabilitation.

There was a slight trend suggesting that treadmill training with body weight support may improve walking speed in individuals who can walk independently, but this finding was not strong enough to be conclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training and body weight support for walking after stroke. Moseley, AM., Stark, A., Cameron, ID., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3394680/

SPLIT-BELT TREADMILL TRAINING POST-STROKE

Improvements in step length asymmetry were observed following training and these improvements were maintained 1 month later. Concomitant changes in clinical ...

2.

nature.com

nature.com/articles/s41598-025-98322-3

Split-belt treadmill training improves gait symmetry and ...

Split-belt treadmill training (SBTT) enhances gait symmetry in patients with stroke (PwS) by improving sensorimotor adaptation, However, ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01646216?term=stroke%20belt&viewType=Table&rank=2

Long Term Split Belt Treadmill Training for Stroke Recovery

The purpose of this study is to determine whether split belt or conventional treadmill training can be used to treat walking pattern deficits from stroke and to ...

4.

frontiersin.org

frontiersin.org/journals/physiology/articles/10.3389/fphys.2024.1409304/full

Single-belt vs. split-belt treadmill symmetry training: is there ...

Split-belt treadmill training was more effective at improving step length symmetry (improved by 27.3%) without sacrificing gait velocity or step length.

5.

physio-pedia.com

physio-pedia.com/Split-Belt_Treadmill_Training_for_Asymmetric_Walking_Patterns

Split-Belt Treadmill Training for Asymmetric Walking Patterns

A study in humans walking on a split-belt treadmill identified that there are independent, functional control networks for forward and backward walking, ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/21084921/

Split-belt Treadmill Training Poststroke: A Case Study - PubMed

Improvements in step length symmetry were observed following training and these improvements were maintained 1 month later. Concomitant changes in clinical ...