30 Participants Needed

Movement Amplification Gait Training for Stroke

Recruiting at 1 trial location
KE
Overseen ByKeith E Gordon, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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. Please consult with the trial coordinators for more details.

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.12345

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.56789

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.18101112

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.

Research Team

KE

Keith Edward Gordon, PhD

Principal Investigator

Edward Hines Jr. VA Hospital, Hines, IL

Eligibility Criteria

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
See 8 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Heart Rate Response to Balance Challenging EnvironmentsExperimental Treatment1 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 EnvironmentsExperimental Treatment1 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.

Find a Clinic Near You

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+

Findings from Research

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.
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.
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.
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]

References

A pilot study on the feasibility of robot-aided leg motor training to facilitate active participation. [2022]
Robot-assisted practice of gait and stair climbing in nonambulatory stroke patients. [2019]
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]
Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. [2022]
Effects of a wearable exoskeleton stride management assist system (SMA®) on spatiotemporal gait characteristics in individuals after stroke: a randomized controlled trial. [2018]
Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]
Effects and Safety of Wearable Exoskeleton for Robot-Assisted Gait Training: A Retrospective Preliminary Study. [2023]
The effect of using Gait Exercise Assist Robot (GEAR) on gait pattern in stroke patients: a cross-sectional pilot study. [2020]
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]
Applicability of a new robotic walking aid in a patient with cerebral palsy. Case report. [2012]
A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. [2016]
State-of-the-art robotic gait rehabilitation orthoses: design and control aspects. [2018]
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