High-Intensity Gait Training for Stroke

Overseen By Soo Yeon Sun, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alvernia University

Disqualifiers: Severe cardiac disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 20

Duration: 7-10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether vigorous walking practice, known as high-intensity gait training, can improve walking ability and mental health in stroke survivors. Participants will undergo 20 sessions of this training. The study will also examine how mental health, social support, and understanding of health information might influence attendance at therapy sessions. This trial suits adults diagnosed with a stroke who can take a few steps with assistance and are referred to outpatient neurologic rehab. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance rehabilitation strategies 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 high-intensity gait training is safe for stroke patients?

Research has shown that high-intensity gait training is generally safe for people recovering from a stroke. This training involves practicing walking at a vigorous pace and improves walking ability and balance. Importantly, studies have not reported any significant negative effects, indicating that patients handle this treatment well.

For example, one study found that patients who engaged in high-intensity walking exercises during recovery achieved better results in walking and balance. Another study demonstrated that increasing the intensity of gait training was feasible and led to noticeable improvements in walking without major safety concerns.

Overall, the evidence supports high-intensity gait training as a safe way to help stroke patients improve their mobility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-intensity gait training for stroke recovery because it focuses on vigorous walking practice, which is different from the more traditional, lower-intensity rehabilitation exercises usually offered. This method aims to maximize the intensity and frequency of walking sessions, occurring 2-3 times a week, which could enhance recovery speed and effectiveness. By pushing the limits of conventional therapy, this approach has the potential to significantly improve mobility and independence in stroke survivors.

What evidence suggests that high-intensity gait training might be an effective treatment for stroke?

Research shows that high-intensity walking exercises can greatly improve walking ability in stroke patients. Studies have found that this type of training helps patients take more steps and increases their heart rates during sessions, both crucial for better walking recovery. In this trial, participants will undergo high-intensity gait training, which includes 20 sessions of vigorous walking practice. One study found that stroke patients who engaged in high-intensity walking exercises could walk longer distances. This training method also links to better success in practicing steps, essential for regaining independent walking ability. While not everyone may fully regain their walking ability, high-intensity walking exercises offer a promising chance for improved movement after a stroke. ^{1 4 6 7 8}

Who Is on the Research Team?

Soo Yeon Sun, PhD

Principal Investigator

Alvernia University

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke and are experiencing depression. Participants should be able to undergo vigorous walking exercises aimed at improving their gait and balance. The study seeks people willing to attend 20 physical therapy sessions where their heart rate will be elevated.

Inclusion Criteria

I have had a stroke.

I have been referred to outpatient physical therapy for neurological rehabilitation.

Exclusion Criteria

I cannot walk even with help.

My balance score is 50 or more out of 56.

I am shorter than 5'0" or taller than 6'4".

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-intensity gait training with 20 sessions of vigorous walking practice, 2-3 times a week

7-10 weeks

20 sessions (in-person)

Follow-up

Participants are monitored for improvements in walking function and mental health after the intervention

2 weeks

Post-intervention assessments

What Are the Treatments Tested in This Trial?

Interventions

• High-intensity Gait Training

Trial Overview The trial is testing the effectiveness of high-intensity gait training on improving walking function, balance, and mental health in post-stroke patients. It also examines how mental health, social support, and health literacy influence attendance at these sessions.

How Is the Trial Designed?

Group I: High intensity gait training Experimental Treatment 1 Intervention

Participants will receive 20 sessions of vigorous walking practice. These sessions are 2-3 times a week.

Who Is Running the Clinical Trial?

Alvernia University

Lead Sponsor

Trials

5

Recruited

170+

Lehigh Valley Health Network

Collaborator

Trials

4

Recruited

8,100+

Lehigh Valley Health Network

Collaborator

Published Research Related to This Trial

In a study involving 55 individuals with chronic stroke, high-intensity interval training (HIIT) led to greater improvements in walking capacity compared to moderate-intensity aerobic training (MAT), primarily due to faster training speeds and improvements in neuromotor gait function.

While HIIT resulted in higher heart rates and lactate levels, these factors did not correlate with improvements in walking distance; instead, prioritizing training speed and step count was found to be crucial for enhancing walking capacity post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training parameters and longitudinal adaptations that most strongly mediate walking capacity gains from high-intensity interval training post-stroke. Boyne, P., Miller, A., Schwab, SM., et al.[2023]

A high-intensity task-oriented training program significantly improved gait speed and walking capacity in patients with subacute stroke compared to a low-intensity physiotherapy program, as shown by results from the 10-metre timed walking test and the six-minute walk test.

The study involved 44 stroke patients and demonstrated that while the high-intensity training was feasible and effective for improving gait, it did not show significant differences in balance measures, suggesting that future research should also assess physical fitness and energy expenditure during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. Outermans, JC., van Peppen, RP., Wittink, H., et al.[2022]

In a pilot study involving four post-stroke individuals, high-intensity gait training with soft robotic exosuits (REAL training) significantly improved walking distance and speed compared to training without the exosuit, with large effect sizes observed (d=1.41 for distance and d=1.14 for speed).

75% of participants surpassed the minimal clinically-important difference (MCID) in walking improvements after REAL training, while only 25% did so after conventional training, indicating that robotic exosuits may enhance rehabilitation outcomes after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity gait training with and without soft robotic exosuits in people post-stroke: a development-of-concept pilot crossover trial. Porciuncula, F., Arumukhom Revi, D., Baker, TC., et al.[2023]

A pilot study involving 10 stroke participants showed that combined overground and treadmill high-intensity interval training (HIIT) significantly improved gait function, with overground speed changes averaging 61% of those seen on the treadmill after a 4-week treatment phase.

The study highlighted the importance of considering baseline gait speed and including measures of cognition, fatigue, and brain volume in future HIIT research for stroke rehabilitation, as these factors can influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Outcomes of Combined Treadmill and Overground High-Intensity Interval Training in Ambulatory Chronic Stroke. Boyne, P., Doren, S., Scholl, V., et al.[2022]

A 4-week high intensity speed-based treadmill training program was feasible for 16 chronic stroke survivors, with no serious adverse events reported during the training.

Participants showed significant improvements in walking speed (up to 19%) and endurance (up to 12%), and these gains were maintained for 3 months after the training, suggesting the program's effectiveness for gait training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high intensity speed-based treadmill training on ambulatory function in people with chronic stroke: A preliminary study with long-term follow-up. Madhavan, S., Lim, H., Sivaramakrishnan, A., et al.[2020]

Intensive gait training for chronic stroke survivors (44 participants) over 12 weeks significantly improved life role participation, as measured by the Craig Handicap Assessment & Reporting Technique (CHART) and the Stroke Impact Scale Subscale of Life Role Participation (SISpart).

The training, which included various methods like body weight supported treadmill training and functional electrical stimulation, also led to substantial improvements in gait and functional independence, indicating that enhanced mobility can positively impact overall life participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced life-role participation in response to comprehensive gait training in chronic stroke survivors. Pundik, S., Holcomb, J., McCabe, J., et al.[2016]

A study involving 30 acute post-stroke patients showed that early, intense supplemental gait training, whether through Lokomat® or conventional methods, was feasible and well-tolerated, leading to significant functional improvements.

Patients receiving Lokomat® training completed fewer sessions than those in conventional gait training but showed a trend towards greater efficiency in gait retraining, suggesting it may provide a more optimal therapy 'dose' despite the lower number of sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of supplemental gait training by robotic and conventional means in acute stroke rehabilitation. Talaty, M., Esquenazi, A.[2023]

A multicomponent implementation plan was successfully developed and executed to integrate high-intensity gait training into stroke rehabilitation practices across two inpatient facilities, involving 9 physical therapists.

The implementation addressed various barriers such as knowledge and resource limitations, leading to significant improvements in the adoption of high-intensity gait training and its sustained use over a 2-year period, positively impacting both clinicians and the health system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Results of an Implementation Plan for High-Intensity Gait Training. Moore, JL., Bø, E., Erichsen, A., et al.[2023]

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]

In a study of 22 stroke patients who began intensive gait-oriented rehabilitation an average of 8 days post-stroke, 16 patients were able to walk unassisted after 3 weeks, demonstrating significant improvements in mobility.

The rehabilitation program was well tolerated, with only three patients dropping out, and resulted in measurable enhancements in walking speed, muscle strength, and overall motor function, indicating its efficacy in early post-stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intensive gait-oriented physiotherapy during early acute phase of stroke. Peurala, SH., Airaksinen, O., Jäkälä, P., et al.[2019]

High-intensity exercise (HIE) significantly improves lower limb function in acute and subacute stroke patients, particularly enhancing performance in the 6-minute walk test and gait speed, based on a systematic review of seven randomized controlled trials.

The review found no major adverse events associated with HIE, suggesting it is a safe intervention for stroke rehabilitation, and supports its implementation over lower intensity exercises for better functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence of High-Intensity Exercise on Lower Limb Functional Outcomes and Safety in Acute and Subacute Stroke Population: A Systematic Review. Mah, SM., Goodwill, AM., Seow, HC., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11984070/

High‐Intensity Gait Training for Patients After Stroke Mounting evidence suggests that gait training provided at high cardiovascular intensity with a focus on stepping practice improves gait function after stroke.

2. 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 ...

3. mdpi.com mdpi.com/2077-0383/14/15/5409

Implementing High-Intensity Gait Training in Stroke ... Results: HIT was delivered with improved fidelity during the implementation and competency phases, reflected by increased stepping and heart rate metrics. A ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1565118/full

Effects of high-intensity exercise on rehabilitation ... Conclusion: High-intensity exercise significantly improves 6MWT and BBS in stroke patients, but does not significantly affect TUG, VO2peak, ...

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.122.038956

Current Evidence for Walking Recovery After Stroke, Future ... Approximately one-quarter of stroke survivors, however, do not achieve independent walking by 3-months poststroke. For those who do achieve ...

6. 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.

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

Increasing the Amount and Intensity of Stepping Training ... Increasing the amount and cardiovascular intensity of gait training during inpatient stroke rehabilitation was feasible and led to significant improvements in ...

8. obrienphysicaltherapy.net obrienphysicaltherapy.net/blog/post-stroke-rehabilitation-outcomes-statistics-on-physical-therapy-effectiveness

Post-Stroke Rehabilitation Outcomes: Statistics on Physical ... Task-oriented exercises and gait training, including treadmill and overground walking, have demonstrated significant improvements in walking ...