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

69 Participants Needed

Trial Summary

What is the purpose of this trial?

The focus of this study is to optimize the delivery of a combined strength and aerobic training regimen to individuals with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. This study proposes to use 1) split-belt treadmill and 2) single belt treadmill walking using split belt simulation software for enhancing symmetrical walking patterns for people with stroke.

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 treatment Split-belt treadmill training for post-stroke paresis?

Research shows that split-belt treadmill training helps improve walking symmetry in stroke patients by reducing step length differences between legs, and these improvements last for at least a month after training. This therapy also enhances muscle activity and joint movement, making it a promising option for long-term recovery. ^{1 2 3 4 5}

Is split-belt treadmill training safe for humans?

Research on split-belt treadmill training, including studies with healthy adults and stroke patients, does not report any significant safety concerns. The training appears to be safe, with no negative effects observed on muscle function after repeated sessions. ^{1 2 4 6 7}

How is split-belt treadmill training different from other treatments for post-stroke paresis?

Split-belt treadmill training is unique because it uses a treadmill with two belts moving at different speeds to help retrain walking patterns, promoting better symmetry and balance in people who have had a stroke. This approach specifically targets the differences in muscle activation and gait deviations, which are not addressed by traditional overground walking or other treadmill therapies. ^{1 2 5 8 9}

Research Team

Mansoo Ko, Ph.D.

Principal Investigator

University of Texas

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

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

Improved hemiparetic muscle activation in treadmill versus overground walking. [2007]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy of Aquatic Treadmill Training on Gait Symmetry and Balance in Subacute Stroke Patients. [2020]

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

The influence of treadmill inclination on the gait of ambulatory hemiparetic subjects. [2016]

4. England 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. [2021]

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

Treadmill training with partial body weight support after stroke. [2019]

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

Treadmill training and body weight support for walking after stroke. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Limping on split-belt treadmills implies opposite kinematic and dynamic lower limb asymmetries. [2019]

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

Treadmill training and body weight support for walking after stroke. [2018]

9. England 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. [2022]