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

Trial Summary

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 Gait Training, Locomotor Training, Walking Therapy, Gait Rehabilitation, Leg Cycling Exercise, Stationary Cycling, Leg Ergometry, Cycle Ergometer Exercise for stroke survivors?

Research shows that walking training and repetitive locomotor training can improve walking ability and daily activities in stroke survivors. Treadmill training, which is part of gait rehabilitation, is also beneficial for improving balance and motor functions in these patients. ^{1 2 3 4 5}

Is walking exercise safe for stroke survivors?

Walking exercise programs, including gait training and treadmill training, are generally considered safe for stroke survivors and can improve physical activity and walking ability, which are important for overall health. ^{1 6 7 8 9}

How is the Gait Training treatment different from other treatments for stroke survivors?

Gait Training, which involves treadmill walking with body-weight support, is unique because it allows stroke survivors to practice walking in a controlled environment, helping them improve their walking ability and speed. This method is different from traditional therapies as it focuses on repetitive, complex gait cycles and can be adjusted for intensity, making it more effective for improving walking efficiency and endurance. ^{1 4 10 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to test a gait (walking) training program in non-ambulatory (unable to walk) chronic stroke survivors. The main question it aims to answer is: • Will gait training improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise? Participants will walk on a treadmill with a partial body-weight support system and the gait training device. Researchers will compare with a leg-cycling exercise to see if there are significant differences in resting heart rate, systolic blood pressure (SBP), and A1c levels in the blood.

Research Team

Wen Liu, PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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

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

Be in a stable medical condition

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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 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]

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]

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]

References

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

Gait outcomes after acute stroke rehabilitation with supported treadmill ambulation training: a randomized controlled pilot study. [2019]

2. Sweden pubmed.ncbi.nlm.nih.gov

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

3. England 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). [2022]

4. England 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. [2022]

5. Switzerland 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. [2023]

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

Efficacy of interventions aimed at improving physical activity in individuals with stroke: a systematic review. [2021]

7. Switzerland 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. [2023]

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

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

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

The immediate effects of a novel auditory and proprioceptive training device on gait after stroke. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Body-weight-supported treadmill rehabilitation after stroke. [2022]