Treadmill Oscillation Walking for Stroke Recovery

(TOW Trial)

Overseen By Hao-Yuan Hsiao, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Cardiac conditions, Neurological conditions, Joint problems, 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: 21

Duration: 6 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Treadmill Oscillation Walking (TOW) can help stroke survivors improve their walking. The researchers aim to determine if this exercise boosts muscle activity and enhances walking speed and quality. It suits individuals who had a stroke over six months ago, can walk at least 10 meters (about 30 feet) with or without a walking aid, and can stand unsupported for five minutes. As an unphased trial, this study provides a unique opportunity to contribute to innovative rehabilitation research and potentially enhance recovery outcomes.

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 treadmill oscillation walking is safe for stroke recovery?

Previous studies have shown that treadmill training, similar to treadmill oscillation walking (TOW), improves walking speed and endurance in stroke recovery. This suggests TOW might be safe for stroke rehabilitation. Research on treadmill exercises for stroke patients generally shows no serious side effects, and most people can perform this exercise without problems. Although specific safety data on TOW is limited, its similarity to other treadmill exercises suggests it is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Treadmill Oscillation Walking (TOW) for stroke recovery because it introduces a novel approach to rehabilitation. Unlike traditional stroke recovery methods that often focus on static exercises and passive therapies, TOW actively engages the patient's proprioceptive and motor systems through dynamic, oscillating movements on a treadmill. This innovative technique is designed to improve balance and coordination more effectively, potentially speeding up recovery and enhancing outcomes for stroke survivors. By offering a more immersive and interactive form of therapy, TOW has the potential to redefine how stroke rehabilitation is approached.

What evidence suggests that Treadmill Oscillation Walking is effective for stroke recovery?

Research has shown that using a treadmill can help stroke survivors walk faster and longer. This exercise might improve leg function and walking smoothness, both crucial for stroke recovery. Specifically, in this trial, participants will undergo Treadmill Oscillation Walking (TOW) training, which may boost activity in the hip and knee muscles, potentially leading to better walking. However, some studies suggest that treadmill training alone might not significantly increase the chances of walking independently. Overall, while TOW appears promising for recovery, its effectiveness can vary among individuals. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who had a stroke over 6 months ago, can stand unaided for 5 minutes, walk 10 meters with or without help, and have sufficient cognitive function. They must have more difficulty loading the affected limb during walking. Excluded are those with certain blood pressure or heart rate issues, joint replacements, severe bone/joint problems affecting gait beyond stroke effects, multiple strokes, cerebellar stroke or other major health conditions.

Inclusion Criteria

I have had partial paralysis on one side due to a stroke over 6 months ago.

My affected limb supports over 6% less weight than my unaffected limb when I walk.

I can walk 10 meters by myself or with help.

Exclusion Criteria

A resting blood pressure outside of the range of 90/60 to 170/90 mm Hg

Pregnancy by self-report

I don't have health issues preventing me from exercising, aside from my stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo baseline gait and neuromechanical assessments

1 day

1 visit (in-person)

Treatment

Participants undergo a 6-week Treadmill Oscillation Walking (TOW) intervention

6 weeks

18 sessions (in-person)

Post-training Evaluation

Participants undergo post-training gait and neuromechanical assessments

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in gait and neuromechanics 1 month after treatment

1 month

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Treadmill Oscillation Walking

Trial Overview The study tests treadmill oscillation walking (TOW) to see if it improves hip and knee muscle activity and torque production in post-stroke patients. It aims to determine whether TOW can increase limb loading and walking speeds immediately after use and following a six-week program.

How Is the Trial Designed?

Group I: TOW Experimental Treatment 1 Intervention

Treadmill Oscillation Walking training

Treadmill Oscillation Walking is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Treadmill Training for:

• Rehabilitation after stroke
• Improvement of gait function

Approved in European Union as Treadmill Walking for:

• Physical therapy for stroke survivors
• Enhancement of walking ability

Approved in Canada as Treadmill Oscillation Therapy for:

• Neurological rehabilitation
• Gait training post-stroke

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Texas State University

Collaborator

Trials

16

Recruited

1,400+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

Published Research Related to This Trial

Treadmill training with or without body weight support does not significantly improve the likelihood of independent walking in stroke patients compared to other physiotherapy interventions, based on a review of 44 trials with 2658 participants.

However, treadmill training does lead to significant improvements in walking speed and endurance, particularly in patients who are already able to walk, with some benefits in endurance lasting beyond the initial training period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training and body weight support for walking after stroke. Mehrholz, J., Pohl, M., Elsner, B.[2023]

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 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, with or without body weight support, does not significantly improve the likelihood of independent walking in stroke patients compared to other physiotherapy interventions, based on a review of 56 trials with 3105 participants.

However, treadmill training does lead to modest improvements in walking speed and endurance, particularly in stroke patients who are already able to walk, suggesting it may be more beneficial for those with some walking ability rather than those who are completely dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training and body weight support for walking after stroke. Mehrholz, J., Thomas, S., Elsner, B.[2023]

A randomized controlled trial involving 130 non-ambulatory stroke patients will assess the effectiveness of treadmill walking with partial weight support compared to routine overground walking in helping patients achieve independent walking.

The study aims to determine if the treadmill intervention leads to independent walking more often, earlier, and with better quality, which could enhance long-term health and community participation for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supported treadmill training to establish walking in non-ambulatory patients early after stroke. Ada, L., Dean, CM., Morris, ME.[2022]

In a study involving 21 newly ambulatory stroke patients, 10 minutes of treadmill walking led to greater knee extension at heel strike during subsequent overground walking compared to 10 minutes of overground walking, indicating a potential benefit of treadmill practice on walking mechanics.

The effects of treadmill walking were more pronounced in poorer walkers, who showed a greater increase in step length of the non-paretic limb, suggesting that treadmill training may be particularly beneficial for those with more significant walking difficulties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate effect of treadmill walking practice versus overground walking practice on overground walking pattern in ambulatory stroke patients: an experimental study. Kuys, SS., Brauer, SG., Ada, L., et al.[2016]

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 19 chronic stroke patients, those who underwent treadmill walking training with rhythmic auditory stimulation (TRAS) showed significant improvements in various gait parameters compared to those who trained with over ground walking (ORAS).

The TRAS group demonstrated enhanced walking speed, step cycle, step length of the unaffected limb, and overall gait ability, suggesting that treadmill training with rhythmic auditory feedback is an effective rehabilitation method for improving gait in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between treadmill training with rhythmic auditory stimulation and ground walking with rhythmic auditory stimulation on gait ability in chronic stroke patients: A pilot study. Park, J., Park, SY., Kim, YW., et al.[2018]

Whole-body vibration combined with treadmill training (WBV-TT) significantly improved walking performance in chronic stroke patients, enhancing metrics like walking speed, cadence, and step length over a 6-week intervention involving 30 participants.

WBV-TT was found to be more effective than traditional treadmill training alone, indicating that the addition of vibration therapy can lead to better rehabilitation outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Body Vibration Combined with Treadmill Training Improves Walking Performance in Post-Stroke Patients: A Randomized Controlled Trial. Choi, W., Han, D., Kim, J., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05541705?term=AREA%5BBasicSearch%5D(walking)&rank=10

Treadmill Oscillation Walking to Improve Weight Transfer ... This study aims to determine the immediate and short-term effects of treadmill oscillation walking (TOW) exercise on hip and knee neuromechanics and gait ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4200720/

Gait improvement after treadmill training in ischemic stroke ... These findings suggest that treadmill training likely improves ischemic stroke patients' lower limb functions and gait performance and promotes stroke recovery ...

3. trialx.com trialx.com/clinical-trials/listings/236133/treadmill-oscillation-walking-to-improve-weight-transfer-during-gait-following-stroke/

Treadmill Oscillation Walking to Improve Weight Transfer ... This study aims to determine the immediate and short-term effects of treadmill oscillation walking (TOW) exercise on hip and knee neuromechanics ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12063472/

Effectiveness of Treadmill Training Intervention for the ... Treadmill training, particularly when combined with BWSTT, effectively enhances walking speed and endurance in stroke survivors.

5. withpower.com withpower.com/trial/phase-treadmill-walking-9-2022-67215

Treadmill Oscillation Walking for Stroke Recovery (TOW Trial) Treadmill training with or without body weight support does not significantly improve the likelihood of independent walking in stroke patients compared to other ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05541705

Treadmill Oscillation Walking to Improve Weight Transfer ... This study aims to determine the immediate and short-term effects of treadmill oscillation walking (TOW) exercise on hip and knee neuromechanics and gait ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6483714/

Treadmill training and body weight support for walking after ... Overall, the use of treadmill training in walking rehabilitation for people after stroke increased the walking velocity and walking endurance significantly. The ...

8. mdpi.com mdpi.com/1424-8220/25/18/5834

Clinical Trials of a Stroke Rehabilitation Trainer Employing ... Among ten stroke subjects, all subjects' walking speeds and nine subjects' stride lengths were improved, while eight subjects showed improvement in the swing- ...