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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvements in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions.

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 High-intensity Gait Training for stroke?

Research shows that high-intensity gait training can improve walking speed, distance, and balance in stroke patients. In one study, most patients who couldn't walk or needed assistance before the training were able to walk unassisted after completing the program. ^{1 2 3 4 5}

Is high-intensity gait training safe for stroke patients?

High-intensity gait training for stroke patients has been shown to be generally safe, with no major adverse events reported in studies. Some minor incidents were noted in one study, but overall, the training was well-tolerated by participants. ^{2 3 6 7 8}

How is high-intensity gait training different from other stroke treatments?

High-intensity gait training is unique because it focuses on high cardiovascular workload and a large number of repetitions to improve walking speed, distance, and balance after a stroke. This approach is more intense than traditional physiotherapy and can be combined with technologies like soft robotic exosuits to enhance outcomes. ^{2 3 9 10 11}

Research Team

Soo Yeon Sun, PhD

Principal Investigator

Alvernia University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Enhanced life-role participation in response to comprehensive gait training in chronic stroke survivors. [2016]

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

Development and Results of an Implementation Plan for High-Intensity Gait Training. [2023]

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

Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of supplemental gait training by robotic and conventional means in acute stroke rehabilitation. [2023]

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

Effects of intensive gait-oriented physiotherapy during early acute phase of stroke. [2019]

6. Switzerland 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. [2023]

7. England 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. [2020]

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Preliminary Outcomes of Combined Treadmill and Overground High-Intensity Interval Training in Ambulatory Chronic Stroke. [2022]

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

Training parameters and longitudinal adaptations that most strongly mediate walking capacity gains from high-intensity interval training post-stroke. [2023]

11. England 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. [2023]