Walking Balance Training for Stroke

Overseen By Shamali Dusane, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University Feinberg School of Medicine

Disqualifiers: Cognitive impairment, Aphasia, Excessive spasticity, 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: 12

Duration: 5 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Stroke is one of the leading causes of disability in the United States, affecting \~795,000 people annually. Among ambulatory people with chronic stroke, impaired balance is common and substantially limits mobility (those with the poorest balance walk the least). This project will explore if a novel gait training intervention using a robotic device to amplify a person's self-generated movements can improve walking balance in people with chronic stroke. The development of effective interventions to increase walking balance among people with chronic stroke will positively impact quality of life and ability to participate in walking activities.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Walking Balance Training for Stroke?

Research shows that robot-assisted gait training, which is part of the Walking Balance Training, can improve walking ability and balance in stroke patients. Studies have found that high-intensity gait training and robotic exoskeletons help increase walking speed and functional recovery, suggesting these methods are effective for stroke rehabilitation. ^{1 2 3 4 5}

Is robotic-assisted gait training safe for stroke patients?

Robotic-assisted gait training is generally safe for stroke patients, but some adverse events like skin discomfort, musculoskeletal issues, and blood pressure changes have been reported. These issues are often related to the interaction between the robot and the human body, such as pressure from harnesses or misalignments. ^{4 5 6 7 8}

How is the High intensity gait training in a balance challenging Movement amplification environment treatment different from other stroke rehabilitation treatments?

This treatment is unique because it combines high-intensity gait training with a balance-challenging environment, often using robotic assistance, to enhance walking and balance in stroke patients. Unlike traditional therapies, it focuses on task-specific, repetitive movements at high intensity, which can lead to improved walking speed and functional recovery. ^{2 4 5 9 10}

Research Team

Keith Gordon, PhD

Principal Investigator

Assistant Professor, Northwestern University

Eligibility Criteria

This trial is for adults aged 18-80 who had a stroke at least 6 months ago and can walk 10 meters with or without help. It's not for pregnant individuals, those with significant cognitive issues, severe speech impairments, extreme muscle stiffness in the legs, inability to stand for short periods, or if they have other serious health conditions affecting walking.

Inclusion Criteria

I can walk 10 meters with or without help from a cane or ankle support.

It has been over 6 months since my stroke.

I am between 18 and 80 years old.

Exclusion Criteria

You are currently receiving physical therapy at the same time as the study.

My legs are very stiff, scoring over 3 on a stiffness scale.

I cannot stand for 10 minutes straight.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Baseline assessments including Berg Balance Scale, Chedoke-McMaster Stroke Assessment, and other functional tests

1 week

1 visit (in-person)

Treatment

Participants undergo 10 sessions of high-intensity gait training in a Movement Amplification Environment over 5 weeks

5 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in walking balance and daily stepping activity post-treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• High intensity gait training in a balance challenging Movement amplification environment

Trial Overview The study tests a new way of improving walking balance using high-intensity gait training with a robotic device that amplifies movements. This method could potentially enhance mobility and quality of life for people who've had strokes.

Participant Groups

Group I: Control of lateral COM motion during and after walking practiced in the MAE Experimental Treatment 1 Intervention

For Aim 1a, participant's preferred and fast treadmill walking speeds will be determined followed by 2-min of baseline walking. Each participant will perform eight 2-min trials of treadmill walking 1) Null Environment: no forces, 2) MAE Low Gain: 25 Nsm-1, 3) MAE Medium Gain: 35 Nsm-1, 4) MAE High Gain: 45 Nsm-1, that will be repeated at both treadmill walking speeds. The trial order will be randomized. For Aim 1b, we will assess participant's maximum ability to control their lateral COM motion with no forces applied, using three 21-meter walking trials with visual projections on the treadmill to provide feedback used to challenge their lateral COM motion control. Five 2-min trials in a Null environment will be followed by COM control assessment. Participants will rest and repeat the above sequence in a MAE. The order of the external environments will be randomized across participants. Participants may participate in more than one aim (1a, 1b and 2).

High intensity gait training in a balance challenging Movement amplification environment is already approved in United States, European Union, Switzerland for the following indications:

Approved in United States as High intensity gait training for:

• Rehabilitation post-stroke
• Improvement of walking balance in chronic stroke patients

Approved in European Union as Robotic-assisted gait training for:

• Neurological rehabilitation
• Gait training post-stroke

Approved in Switzerland as Balance challenging Movement amplification environment for:

• Rehabilitation of balance disorders post-stroke
• Gait training for chronic stroke patients

Who Is Running the Clinical Trial?

Northwestern University Feinberg School of Medicine

Lead Sponsor

Trials

42

Recruited

15,500+

Findings from Research

High-intensity robot-assisted gait training (RAGT) at 70% of heart rate reserve (HRR) significantly improved dynamic balance and aerobic capacity in chronic stroke patients compared to RAGT based on a perceived exertion (RPE) of 15, with both groups showing improvements after 6 weeks of training.

The study involved 34 participants divided into two groups, and no adverse effects were reported, indicating that high-intensity RAGT at 70% HRR is a safe and effective intervention for enhancing rehabilitation outcomes in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects on dynamic balance and aerobic capacity between objective and subjective methods of high-intensity robot-assisted gait training in chronic stroke patients: a randomized controlled trial. Bae, YH., Lee, SM., Ko, M.[2019]

Exoskeleton-assisted Body Weight Supported Treadmill Training (BWSTT) shows promise in improving gait function in patients with chronic stroke, with 10 out of 11 studies indicating positive outcomes for walking ability among 309 participants.

While exoskeleton-assisted BWSTT appears effective, it may primarily serve as an assistive tool rather than providing significant advantages over traditional therapist-assisted training, highlighting the need for further research to clarify its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exoskeleton-assisted Body Weight-Supported Treadmill Training on gait function for patients with chronic stroke: a scoping review. Yamamoto, R., Sasaki, S., Kuwahara, W., et al.[2023]

A novel gait robot significantly improved gait and stair climbing abilities in nonambulatory patients with subacute stroke, with the experimental group showing a mean Functional Ambulation Categories (FAC) score increase of 2.4 compared to 1.2 in the control group after 4 weeks of training.

The improvements in the experimental group were attributed to higher training intensity, and these gains in mobility persisted even at follow-up, suggesting lasting benefits from the robotic training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted practice of gait and stair climbing in nonambulatory stroke patients. Hesse, S., Tomelleri, C., Bardeleben, A., et al.[2019]

In a study involving 30 patients recovering from acute stroke, the Gait Trainer GT1, a robot-assisted device, showed significant improvements in balance and walking ability, although no major differences were found compared to a control group of 20 patients receiving standard rehabilitation.

The use of the Gait Trainer GT1 led to notable improvements in muscle tone and sensitivity, indicating its potential to enhance rehabilitation outcomes for patients with varying degrees of neurological deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of a robot-assisted Gait Trainer GT1 in patients in the acute period of cerebral stroke: a pilot study]. Skvortsova, VI., Ivanova, GE., Kovrazhkina, EA., et al.[2016]

Intensity modulated robotic exoskeleton gait training significantly improved walking speed and functional mobility in stroke survivors over a 10-week period, with participants training at 75-85% of their maximum heart rates during 30 sessions.

These preliminary results suggest that using robotic exoskeletons for gait training can enhance motor recovery and functional ambulation in post-stroke rehabilitation, although further research is needed to fully understand the benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity Modulated Exoskeleton Gait Training Post Stroke. Nolan, KJ., Ames, GR., Dandola, CM., et al.[2023]

Robot-assisted gait training (RAGT) has been shown to improve balance in stroke patients, with significant effect sizes observed across various balance assessment tests, including the Berg Balance Scale and Timed Up and Go test.

Despite the improvements in balance, the review found no significant differences in balance outcomes between RAGT and other gait rehabilitation methods, indicating that while RAGT is beneficial, its superiority over traditional methods remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does robot-assisted gait rehabilitation improve balance in stroke patients? A systematic review. Swinnen, E., Beckwée, D., Meeusen, R., et al.[2022]

A systematic review of 50 studies involving 985 subjects revealed that adverse events (AEs) occurred in 18 studies, with over 169 device-related AEs reported, primarily soft tissue injuries and musculoskeletal issues, particularly in end-effector and exoskeleton devices.

The most common risks associated with stationary robot-assisted gait training include excessive pressure and shear at the interface between the device and the user, as well as misalignments that increase forces on the musculoskeletal system, highlighting the need for improved reporting and safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. Bessler, J., Prange-Lasonder, GB., Schulte, RV., et al.[2021]

In a study involving 44 participants with acute stroke, those using robotic exoskeletons (RE) for gait training walked twice the distance compared to those receiving standard care, indicating enhanced rehabilitation potential.

The RE group also showed a greater improvement in functional independence, as measured by the Functional Independence Measure (FIM), suggesting that increased dosing of gait training through RE may lead to better motor function recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic Exoskeleton Gait Training During Acute Stroke Inpatient Rehabilitation. Nolan, KJ., Karunakaran, KK., Chervin, K., et al.[2020]

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]

Gait training assisted by an endpoint robot led to significant improvements in walking speed and stride characteristics among six chronic stroke survivors, indicating enhanced mobility.

The training also improved balance during both standing and walking, and reduced reliance on compensatory strategies from the non-affected side, suggesting a more effective rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional evaluation of robot end-point assisted gait re-education in chronic stroke survivors. De Luca, A., Lentino, C., Vernetti, H., et al.[2016]

References

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

Comparison of the effects on dynamic balance and aerobic capacity between objective and subjective methods of high-intensity robot-assisted gait training in chronic stroke patients: a randomized controlled trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effect of exoskeleton-assisted Body Weight-Supported Treadmill Training on gait function for patients with chronic stroke: a scoping review. [2023]

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

Robot-assisted practice of gait and stair climbing in nonambulatory stroke patients. [2019]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use of a robot-assisted Gait Trainer GT1 in patients in the acute period of cerebral stroke: a pilot study]. [2016]

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

Intensity Modulated Exoskeleton Gait Training Post Stroke. [2023]

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

Does robot-assisted gait rehabilitation improve balance in stroke patients? A systematic review. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Robotic Exoskeleton Gait Training During Acute Stroke Inpatient Rehabilitation. [2020]

9. 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]

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

Functional evaluation of robot end-point assisted gait re-education in chronic stroke survivors. [2016]