Walking Exercise Program for Stroke Survivors

Overseen By Wen Liu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Severe depression, Musculoskeletal disorders, 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: Unknown

Duration: 8 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new walking exercise program for individuals who had a stroke and cannot walk independently. Researchers aim to determine if walking on a treadmill with special support (Gait Training) improves heart health more effectively than using a stationary bike (Leg Cycling Exercise). Participants will either walk on a treadmill or use a bike while researchers monitor their heart rate and blood pressure. Ideal candidates for this trial are those who experienced their first stroke over six months ago, cannot currently walk independently, and were able to walk before their stroke. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance rehabilitation options 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 gait training program is safe for stroke survivors?

Research has shown that using a treadmill for walking is generally safe for stroke recovery. It can help individuals walk longer distances, though it may not significantly increase walking speed or balance. Most participants can perform this exercise without major issues.

Conversely, studies on leg cycling exercises have demonstrated their safety and effectiveness. Cycling can enhance both balance and walking skills in stroke survivors, while also benefiting heart health, which is crucial for overall recovery.

Both treadmill walking and leg cycling have been researched and found safe for stroke rehabilitation. During these exercises, researchers closely monitor participants' heart rates and blood pressure to ensure safety. This careful oversight helps prevent problems, making these exercises reliable options for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial for stroke survivors because it explores innovative exercise methods to improve walking ability. The gait training uses a treadmill with a partial body-weight support system, which could offer a safer way for participants to practice walking without the full weight burden on their legs. This approach allows for gradual speed increases while carefully monitoring heart rate, which might enhance rehabilitation outcomes compared to standard physical therapy alone. Meanwhile, the leg cycling exercise offers a complementary approach, focusing on cardiovascular fitness and endurance, tailored to each participant's abilities. By comparing these two methods, researchers hope to identify more effective ways to improve mobility and overall recovery for stroke survivors.

What evidence suggests that this trial's treatments could be effective for stroke survivors?

Research has shown that gait training, which involves walking on a treadmill with support, can significantly help stroke survivors walk longer distances. Many regain some walking ability after a stroke with this training. In this trial, some participants will receive gait training. Others will engage in leg cycling exercises, which studies indicate can improve balance and heart health in stroke survivors. These exercises enhance walking ability and overall fitness. Both treatments in this trial offer promising ways to help stroke survivors improve their health and movement. ^{3 4 6 7 8}

Who Is on the Research Team?

Wen Liu, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for chronic stroke survivors who currently cannot walk. It's designed to help them develop a walking exercise program. To join, participants must have had a stroke that resulted in limited mobility and difficulty with walking.

Inclusion Criteria

Able to understand and follow verbal commands in English

Be in a stable medical condition

I was able to walk on my own before having a stroke.

Exclusion Criteria

Blood pressure higher than 200/110 mm Hg

Unable to speak or understand English

Currently participate in other walking training using treadmill with or without a body-weight support system

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week gait training program using a treadmill with body-weight support or an 8-week sitting leg cycling exercise program

8 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in cardiovascular, pulmonary, and sensorimotor functions after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gait Training
• Leg Cycling Exercise

Trial Overview The study is testing whether gait training using a treadmill and partial body-weight support can improve cardiovascular health more effectively than leg cycling exercises. Researchers will measure heart rate, blood pressure, and A1c levels to assess improvements.

How Is the Trial Designed?

Group I: Gait Training Experimental Treatment 1 Intervention

The gait training in the experimental group will use a treadmill with a partial body-weight support system and our gait training device. A gait training session will include 2-minute warming up at the beginning and 2-minute cooling down at the end, at a treadmill speed of 0.6 mph. After the warming up, the treadmill speed will increase at every two minutes by an increment of 0.2 mph. Participant's heart rate will be monitored throughout the training session by using a Polar OH1 optical HR sensor placed in the participant's left forearm. Reseachers will stop the increase and maintain the same treadmill speed after the HR reaching the target heart rate zone of 50% - 60% of age-predicted heart rate reserve.

Group II: Leg Cycling Exercise Active Control 1 Intervention

The leg cycling exercise will use a stationary bicycle and the similar protocol as in the experimental group. The cycling exercise will include 2-minute warming up in the beginning and 2-minute cooling down at the end with a speed of 10 rpm and resistance of level 1 of 4. After warming up, the speed will increase at every two minutes by an increment of 5 rpm until reaching the target heart rate zone of 50% - 60% of age-predicted maximum heart rate. If the participant cannot tolerate any more increase in cycling speed before reaching the target heart rate, the resistance will be increased. The training duration will be individualized at the beginning and increase weekly by 5 minutes, depending on the tolerance of the participant, up to the maximum of 30 minutes. Both heart rate and blood pressure will be monitored before, during, and after each session to ensure safety. Each session including setting up will be about one hour.

Gait Training is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Gait Training for:

• Spinal Cord Injury
• Cerebral Palsy
• Stroke Rehabilitation

Approved in European Union as Gait Training for:

• Spinal Cord Injury
• Neurological Rehabilitation

Approved in Canada as Gait Training for:

• Spinal Cord Injury
• Stroke Rehabilitation

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

In a study involving 155 non-ambulatory stroke patients, those who received 20 minutes of locomotor training combined with 25 minutes of physiotherapy showed significantly better outcomes in walking ability and daily living skills compared to those who only received 45 minutes of physiotherapy.

At the end of the treatment, 41 patients in the locomotor training group were able to walk independently, and 44 achieved a high level of daily living competence, demonstrating the effectiveness of this combined approach in improving recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Pohl, M., Werner, C., Holzgraefe, M., et al.[2022]

Treadmill training with partial body weight support is as effective as traditional floor walking for restoring gait in stroke patients, allowing for repetitive practice with therapist assistance.

Using gait machines like the Gait Trainer GTI has shown superior results in improving walking ability and speed in acute stroke patients compared to other methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training with partial body weight support after stroke: a review. Hesse, S.[2022]

In a study of 408 stroke survivors, locomotor training using body-weight support on a treadmill did not show superior effectiveness compared to a home-exercise program managed by a physical therapist, with similar improvements in walking ability and quality of life across all groups after one year.

While locomotor training was generally safe, it was associated with a higher incidence of dizziness and falls, particularly in those with severe walking impairments, indicating the need for careful monitoring during such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body-weight-supported treadmill rehabilitation after stroke. Duncan, PW., Sullivan, KJ., Behrman, AL., et al.[2022]

This study will evaluate the effectiveness of an 8-week community-based exercise training program for 120 stroke patients after hospital discharge, focusing on improvements in muscle strength, cardiorespiratory fitness, and overall physical performance.

The trial aims to provide insights into how such exercise programs can enhance the quality of life and daily living activities for stroke survivors, potentially leading to better rehabilitation protocols in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for Community-Based Exercise Training after Discharge from Hospital-Based Stroke Rehabilitation: A Multicenter, Randomized, Parallel-Group, Double-Blind Controlled Pilot and Feasibility Trial. Kang, D., Park, J., Eun, SD.[2023]

The LEAPS trial aims to assess the effectiveness of specialized locomotor training programs (LTP) versus a home-based exercise program (HEP) in improving walking ability in 400 adults with moderate to severe walking limitations post-stroke, with outcomes measured at one year.

The trial will evaluate whether the timing of LTP delivery (2 or 6 months post-stroke) and the severity of initial impairment affect gait speed recovery, with a goal to detect a 20% difference in recovery rates and a 0.1 m/s difference in gait speed between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. Duncan, PW., Sullivan, KJ., Behrman, AL., et al.[2023]

Supported treadmill ambulation training (STAT) is a safe and feasible intervention for acute stroke survivors, showing promising results in improving gait outcomes.

Although the small sample size (13 participants) limited the ability to detect significant differences, medium to large effect sizes were observed for gait energy cost and walking distance, suggesting potential benefits of STAT over regular rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait outcomes after acute stroke rehabilitation with supported treadmill ambulation training: a randomized controlled pilot study. da Cunha, IT., Lim, PA., Qureshy, H., et al.[2019]

A new rehabilitation tool significantly improved step length symmetry in a 47-year-old male stroke patient, with a 72% improvement observed after a 5-minute training session and rest period.

Gait velocity also increased by 5.5% following the 5-minute training, suggesting that this tool may enhance both spatial and temporal aspects of gait in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The immediate effects of a novel auditory and proprioceptive training device on gait after stroke. Johnson, EG., Lohman, EB., Rendon, A., et al.[2021]

Eighteen randomized controlled trials were reviewed, revealing that interventions like aerobic and resistance training, electrical stimulation during walking, and robot-assisted arm therapy significantly increased physical activity in stroke patients.

Despite some effective interventions, the overall quality of evidence was low, and many studies showed no significant differences in physical activity, highlighting the need for more robust research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of interventions aimed at improving physical activity in individuals with stroke: a systematic review. Aguiar, LT., Nadeau, S., Martins, JC., et al.[2021]

Treadmill walking training significantly improves balance and motor functions in individuals with chronic stroke, with a standardized mean difference of 0.70 for balance and 0.56 for motor functions, based on a meta-analysis of 15 randomized controlled trials involving 6476 screened articles.

Overground walking training enhances walking endurance, speed, participation, and quality of life, with significant improvements noted in walking endurance (SMD = 0.38) and quality of life (SMD = 0.46), suggesting that both training methods are effective rehabilitation strategies for chronic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of walking training on balance, motor functions, activity, participation and quality of life in people with chronic stroke: a systematic review with meta-analysis and meta-regression of recent randomized controlled trials. Nindorera, F., Nduwimana, I., Thonnard, JL., et al.[2022]

Improving walking ability is crucial for stroke survivors, as it not only enhances their mobility but also helps prevent secondary health issues like heart disease and osteoporosis.

The paper reviews various gait training strategies, including neurodevelopmental techniques and treadmill training, and discusses their effectiveness based on randomized controlled trials, suggesting that these methods can significantly aid in recovery and maintenance of walking ability post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait training strategies to optimize walking ability in people with stroke: a synthesis of the evidence. Eng, JJ., Tang, PF.[2022]

A randomized controlled trial with 33 chronic stroke patients showed that a 4-week treadmill training program significantly improved gait velocity and dynamic balance ability compared to traditional training, indicating its effectiveness for rehabilitation.

The study found no adverse effects from the training, suggesting that challenging treadmill speed-dependent gait and balance training is a safe and feasible option for stroke patients with low ambulation ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of challenging treadmill speed-dependent gait and perturbation-induced balance training in chronic stroke patients with low ambulation ability: a randomized controlled trial. Hu, J., Jin, L., Wang, Y., et al.[2023]

In a study of 63 chronic stroke survivors, improvements in walking capacity were significantly linked to increases in paretic leg muscle strength and peak oxygen consumption after 19 weeks of therapeutic exercise.

The study highlights that while enhancing muscle strength and cardiorespiratory fitness are important for walking improvement, other unmeasured factors may also play a role, as indicated by the relatively weak relationship in the analysis (R2 = 0.229).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of improvement in walking capacity among individuals with chronic stroke following a multi-dimensional exercise program. Pang, MY., Eng, JJ.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10106590/

Comparative efficacy of gait training for balance outcomes ... Growing evidence suggests that gait training can improve stroke patients' balance outcomes. However, it remains unclear which type of gait training is more ...

2. 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 ...

3. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.120.032041?doi=10.1161/STROKEAHA.120.032041

Gait Rehabilitation After Stroke Stroke is a leading cause of long-term disability. Of the individuals who survive, more than 80% have gait impairment that recovers with some extent in the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590113319300124

Effectiveness of treadmill assisted gait training in stroke ... Treadmill training following stroke offers improvement in walking distance. However, it has no significant advantage in improving walking speed and balance ...

5. mdpi.com mdpi.com/2077-0383/13/5/1358

Current Trends in Gait Rehabilitation for Stroke Survivors Results revealed that combining functional electrical stimulation with conventional rehabilitation was more effective in improving walking speed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10216461/

A Comprehensive Review of Physical Therapy Interventions ... The study found that VR training was equally as effective as CT in improving upper extremity function during the subacute phase after a stroke.

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

Current Evidence for Walking Recovery After Stroke, Future ... Reduced gait speed is a predictor of all-cause mortality and is associated with lower survival rate, increased risk of falls and reduced quality ...

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01243-3

Feasibility and outcomes of supplemental gait training by ... Preliminary evidence exists that patients with stroke can improve their walking recovery and quality of life when higher doses of aerobic ...