Movement Amplification Gait Training for Stroke

Recruiting at 1 trial location

Overseen By Keith E Gordon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Aphasia, Severe cardiovascular, others

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Stroke is a leading cause of disability in the United States, affecting approximately 795,000 people annually. The Veteran's Health Administration provides over 60,000 outpatient visits for stroke-related care annually at a cost of over $250 million. Among ambulatory people with chronic stroke (PwCS), impaired balance is a common health concern that substantially limits mobility (those with the worst balance walk the least). This project will explore adaptive strategies employed by PwCS in balance challenging environments and if a novel gait training intervention using a robotic device to amplify a person's self-generated movements can improve walking balance. The development of effective interventions to increase walking balance among PwCS will positively impact Veterans' health, quality of life, and ability to participate in walking activities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is Movement Amplification Gait Training generally safe for humans?

Movement Amplification Gait Training, also known as Robotic-Assisted Gait Training, has been associated with some adverse events like skin and tissue injuries, musculoskeletal issues, and blood pressure changes. These risks are often due to pressure and misalignments between the robot and the human body, but more detailed safety data is needed to improve safety measures. ^{1 2 3 4 5}

How is Movement Amplification Gait Training different from other treatments for stroke rehabilitation?

Movement Amplification Gait Training is unique because it uses robotic-assisted devices to provide powered assistance during walking, allowing for untethered and more natural movement. This approach can enhance active patient participation and improve gait patterns by combining robotic support with motor learning tasks, which is different from traditional physical therapy that may not offer the same level of precision and engagement. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment Movement Amplification Gait Training for Stroke?

Research shows that robotic-assisted gait training, which is part of Movement Amplification Gait Training, can significantly improve walking ability and muscle activation in stroke patients. Studies found that combining robotic training with motor learning tasks enhances active participation and leads to better gait and stair climbing abilities compared to traditional therapy alone. ^{2 6 10 11 12}

Who Is on the Research Team?

Keith Edward Gordon, PhD

Principal Investigator

Edward Hines Jr. VA Hospital, Hines, IL

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke at least 6 months ago, can walk 10 meters with or without support, and can stand for 10 minutes. It's not suitable for those in other gait/balance studies, with cognitive impairment, severe communication issues, excessive muscle stiffness in legs, serious heart/lung disease affecting walking balance, pregnancy, or use of certain braces.

Inclusion Criteria

I had a stroke over 6 months ago and still have weakness on one side.

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

I can stand for at least 10 minutes without issue.

Exclusion Criteria

Enrollment in concurrent physical therapy or research involving gait or balance training

Presence of cognitive impairment (score of 22/30 on the Montreal Cognitive Assessment scale (MoCA))

Known pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Biomechanical Response Assessment

Participants undergo a single-session cross-sectional study to assess gait patterns during and immediately following walking in balance-challenging environments.

1 day

1 visit (in-person)

High-Intensity Gait Training

Participants engage in two high-intensity gait training sessions, one in a natural environment and the other in a Movement Amplification Environment (MAE).

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in gait patterns and cardiovascular response after training sessions.

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Movement Amplification Gait Training

Trial Overview The study tests whether high-intensity gait training using a robotic device to enhance self-generated movements improves walking balance in people post-stroke. Participants will train on treadmills and in various environments to see if this novel approach helps.

How Is the Trial Designed?

Group I: Heart Rate Response to Balance Challenging Environments Experimental Treatment 1 Intervention

Aim 2 is a feasibility study to determine if high intensity gait training can be achieved within a MAE. For Aim 2, the investigators will employ a two-way cross over study design consisting of two gait training sessions (one in a natural unmodified environment and the other in a MAE). The investigators will examine cardiovascular response, perceived exertion, and gait characteristics (speed, number of steps) to quantify if the MAE impacts training intensity. All enrolled participants will undergo clinical outcome measure assessments. In addition, all participants for Aim 2, heart rate (HR), rate of perceived exertion (RPE), number of steps taken during the training sessions, and walking speeds will be recorded.

Group II: Biomechanical Response to Balance Challenging Environments Experimental Treatment 1 Intervention

Aim 1 will determine how people with chronic stroke (PwCS) adapt their gait in response to different balance challenging environments. For Aim 1, the investigators will conduct a single-session cross sectional study to assess gait patterns during and immediately following walking practiced in balance challenging environments. PwCS will perform treadmill walking in a natural unmodified environment, and in two balance-challenging environments that will include a Movement Amplification Environment (MAE), and an unpredictable lateral perturbation environment. All enrolled participants will undergo clinical outcome measure assessments to identify baseline function. In addition, all participants in Aim 1 will undergo biomechanical testing while walking in each of the three environments to assess changes in their walking patterns.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

Combining robot-aided gait therapy with a motor learning task significantly improves active participation and motor performance in individuals, as shown in a pilot study with six healthy adults and three chronic stroke survivors.

Participants demonstrated reduced tracking errors and increased muscle activation during the combined training, suggesting that this approach may enhance rehabilitation outcomes for those with neurological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study on the feasibility of robot-aided leg motor training to facilitate active participation. Krishnan, C., Ranganathan, R., Dhaher, YY., et al.[2022]

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]

Robotic-assisted gait training (RAGT) combined with conventional physical therapy showed potential benefits in improving hip joint function in patients with chronic hemiparetic stroke, particularly in the hip flexion phase, after an average of 86 sessions over 8 weeks.

Both subacute and chronic stroke patients experienced significant improvements in clinical function measures, such as the Functional Ambulation Category and modified Rankin scale, indicating that RAGT may enhance rehabilitation outcomes for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effects of robotic-assisted gait training combined with conventional physical therapy on paretic hip joint stiffness and kinematics between subacute and chronic hemiparetic stroke. Park, JH., Shin, YI., You, JSH., et al.[2018]

In a study of 63 participants with subacute stroke, conventional gait training resulted in significantly greater improvements in walking speed and distance compared to robotic-assisted training with the Lokomat, with these benefits lasting for at least 3 months after training.

While both training methods showed similar outcomes in secondary measures like balance and mobility, conventional training led to a two-fold greater improvement in walking cadence, suggesting its effectiveness in enhancing overall gait performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Hidler, J., Nichols, D., Pelliccio, M., et al.[2022]

In a study involving 50 stroke survivors, both the Stride Management Assist (SMA®) robotic device and functional task specific training (FTST) led to significant improvements in gait parameters, such as increased walking speed and stride length, after 6-8 weeks of training.

The SMA® device showed additional benefits, including greater improvements in step length on the impaired side and reduced spatial asymmetry during fast walking, suggesting it may enhance functional mobility more effectively than FTST alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a wearable exoskeleton stride management assist system (SMA®) on spatiotemporal gait characteristics in individuals after stroke: a randomized controlled trial. Buesing, C., Fisch, G., O'Donnell, M., et al.[2018]

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 of 28 patients with neurological deficits, overground robot-assisted gait training (RAGT) significantly improved muscle strength, balance, and gait function after more than ten sessions, indicating its effectiveness in rehabilitation.

The training was found to be safe, with only two mild adverse events reported, suggesting that RAGT can be a reliable option for patients recovering from neurological injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and Safety of Wearable Exoskeleton for Robot-Assisted Gait Training: A Retrospective Preliminary Study. Park, GM., Cho, SH., Hong, JT., et al.[2023]

Gait training using the Gait Exercise Assist Robot (GEAR) significantly reduced abnormal gait patterns in stroke patients, particularly in areas like insufficient knee flexion and excessive lateral trunk shift.

Patients using the GEAR also showed improved comfortable overground gait velocity and stride length compared to those receiving conventional gait training, indicating enhanced rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of using Gait Exercise Assist Robot (GEAR) on gait pattern in stroke patients: a cross-sectional pilot study. Katoh, D., Tanikawa, H., Hirano, S., et al.[2020]

Robot-assisted gait training, especially when combined with motivational instructions from a therapist, significantly increases muscle activity in children with motor impairments compared to training without instructions.

The study found that robotic-assisted gait training can produce more physiological muscle activation patterns than unassisted treadmill walking, suggesting it may promote restorative mechanisms in movement rather than just compensatory ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leg surface electromyography patterns in children with neuro-orthopedic disorders walking on a treadmill unassisted and assisted by a robot with and without encouragement. Aurich Schuler, T., Müller, R., van Hedel, HJ.[2021]

A new robotic walking aid (NF-Walker®) was successfully used to enable an 11-year-old child with spastic tetraplegic cerebral palsy to move independently, achieving measurable distances in walking tests.

The device showed potential for improving gait training in non-ambulatory children, although the energy cost of locomotion was higher than normal, indicating that further research is needed to optimize its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applicability of a new robotic walking aid in a patient with cerebral palsy. Case report. Smania, N., Gandolfi, M., Marconi, V., et al.[2012]

The study involved three ambulatory adult stroke survivors who used a new wearable robotic knee orthosis (RKO) during 18 sessions over six weeks, leading to significant improvements in balance, gait, and functional performance.

All participants showed positive outcomes, with average improvements of 12.6% in the Berg Balance Scale, 12.0% in the six-minute walk test, and 16.7% in the Emory Functional Ambulation Profile, and importantly, no adverse events were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. Wong, CK., Bishop, L., Stein, J.[2016]

Robotic orthoses for gait training in neurologically impaired patients have shown promising results, providing systematic training while reducing the workload for physical therapists.

Recent advancements in the design and control strategies of these robotic devices allow for customized training based on individual patient needs, but further clinical trials are necessary to confirm their efficacy and ensure safe human-robot interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State-of-the-art robotic gait rehabilitation orthoses: design and control aspects. Hussain, S.[2018]

Citations

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

A pilot study on the feasibility of robot-aided leg motor training to facilitate active participation. [2022]

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

Comparative effects of robotic-assisted gait training combined with conventional physical therapy on paretic hip joint stiffness and kinematics between subacute and chronic hemiparetic stroke. [2018]

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

Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of a wearable exoskeleton stride management assist system (SMA®) on spatiotemporal gait characteristics in individuals after stroke: a randomized controlled trial. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Effects and Safety of Wearable Exoskeleton for Robot-Assisted Gait Training: A Retrospective Preliminary Study. [2023]

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

The effect of using Gait Exercise Assist Robot (GEAR) on gait pattern in stroke patients: a cross-sectional pilot study. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Leg surface electromyography patterns in children with neuro-orthopedic disorders walking on a treadmill unassisted and assisted by a robot with and without encouragement. [2021]

10. Italy pubmed.ncbi.nlm.nih.gov

Applicability of a new robotic walking aid in a patient with cerebral palsy. Case report. [2012]

11. France pubmed.ncbi.nlm.nih.gov

A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. [2016]

12. Netherlands pubmed.ncbi.nlm.nih.gov

State-of-the-art robotic gait rehabilitation orthoses: design and control aspects. [2018]