Neuromechanical Gait Assist for Stroke Recovery

Overseen By Lisa M Lombardo, MPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Severe knee tone, Cardiac arrhythmias, Parkinson's, others

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

Compensation: Varies

Number of Visits: 33

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device called the Neuromechanical Gait Assist, which helps people walk better after a stroke. The device coordinates muscle stimulation and knee movement to assist those with muscle weakness or poor coordination. It may benefit stroke survivors who have difficulty walking, such as dragging or catching their toes, but can still walk at least 10 feet with some help. The researchers hope this device will improve walking speed, distance, and stability, making daily activities safer and easier. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance mobility for stroke survivors.

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

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 neuro-mechanical gait assist device is safe for stroke recovery?

Research has shown that powered exoskeletons, such as the Neuromechanical Gait Assist (NMGA), have received approval from health authorities, indicating general safety. However, users should be aware of some risks. Some have experienced skin irritation and other minor issues, suggesting that while the device is mostly safe, it can cause small side effects.

Previous studies have also shown that devices like the NMGA improve walking after a stroke. Although these devices are cutting-edge, ongoing studies aim to ensure their safety and effectiveness for everyone. Overall, the NMGA has been well-received, but awareness of potential minor side effects remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Neuromechanical Gait Assist is unique because it directly integrates assistance with a person's walking ability, offering a personalized approach to stroke recovery. Unlike standard physical therapy, which often relies on repetitive exercises, this device uses advanced controllers to sync with the user's natural gait, potentially enhancing rehabilitation outcomes. Researchers are excited about this technology because it allows for real-time adjustments, making therapy sessions more effective and tailored to each individual's progress.

What evidence suggests that the Neuromechanical Gait Assist device is effective for stroke recovery?

Research has shown that devices aiding movement, such as the Neuromechanical Gait Assist used in this trial, can significantly enhance walking in stroke survivors. One study found that powered hip exoskeletons increased walking speed by up to 17.6% for these individuals. Other studies indicate that robotic assistance can improve walking quality and speed while enhancing balance. These devices can make walking safer and more efficient, potentially enabling stroke survivors to engage more in daily activities and reduce their risk of falling. ^{2 3 4 6 7}

Who Is on the Research Team?

Ronald Triolo, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

This trial is for Veterans with hemiparesis after a stroke, who can walk at least 10ft with some help and have enough upper body function to use a cane. They should be over 6 months post-stroke and have specific ranges of motion in their hips and ankles. People with severe muscle tone issues, joint contractures, infections, pregnancy, certain heart conditions or severe cognitive impairments cannot participate.

Inclusion Criteria

I can use a cane with my arms.

I can move my ankle up to a neutral position without help when my leg is straight.

I can lift my knee toward my chest at least halfway.

Exclusion Criteria

My knee is very stiff, needing a lot of force to bend.

I have stiffness in my ankles and hips that limits their movement.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Testing

Initial testing to determine participants' impairment level and walking ability prior to controller development and training with the device

2 weeks

2 visits (in-person)

NMGA Fitting and Tuning

Participants are fitted with the NMGA device and appropriate stimulation patterns are determined to assist walking

2 weeks

2 sessions (in-person)

Controller Development

Development and optimization of the controller to coordinate NMGA assistance with walking ability

8 weeks

Up to 16 sessions (in-person)

Gait Training

Training sessions to use the device for walking, stair climbing, and sit-to-stand transitions

6 weeks

6 sessions (in-person)

Post-Training Assessment

Assessments repeated to test the hypothesis that walking with the NMGA enhances walking speed, endurance, metabolic consumption, and gait symmetry

2 weeks

Up to 6 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after training

up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Neuromechanical Gait Assist

Trial Overview The study tests a new device called NMGA that helps correct walking problems caused by strokes. It combines leg braces with motorized knee joints and electrical muscle stimulation. The goal is to improve walking speed, distance covered, energy used when walking, safety and stability.

How Is the Trial Designed?

Group I: Neuromechanical Gait Assist Experimental Treatment 1 Intervention

All participants will participate in developing controllers to coordinate device assistance with walking ability. Walking will be compared before gait training and after gait training. Walking will be evaluated both with and without device assistance.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Powered hip exoskeletons significantly improved walking speed in stroke patients, with a 17.6% increase using bilateral assistance and an 11.1% increase with unilateral assistance, compared to walking without a device.

Both assistance strategies also enhanced step length for both the affected and unaffected legs, indicating that exoskeletons can effectively improve gait biomechanics and overall mobility post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Bilateral Assistance for Hemiparetic Gait Post-Stroke Using a Powered Hip Exoskeleton. Pan, YT., Kang, I., Joh, J., et al.[2023]

The use of an electromechanical gait trainer combined with functional electrical stimulation (FES) in a 4-week program led to significant improvements in gait performance and functional activities for two patients with acute ischemic stroke.

Both patients maintained their improvements in various measures of mobility and balance, such as the Barthel Index and Berg Balance Scale, even 6 months after the intervention, indicating long-term benefits of this rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait training of patients after stroke using an electromechanical gait trainer combined with simultaneous functional electrical stimulation. Tong, RK., Ng, MF., Li, LS., et al.[2016]

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]

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12250684/

Effectiveness of Robot-Assisted Gait Training in Stroke ... The pooled results demonstrated significant improvements in gait function (SMD = 0.51), gait speed (SMD = 0.47), balance (MD = 4.58), and ...

2. withpower.com withpower.com/trial/phase-paresis-3-2020-8bd18

Neuromechanical Gait Assist for Stroke Recovery Powered hip exoskeletons significantly improved walking speed in stroke patients, with a 17.6% increase using bilateral assistance and an 11.1% increase with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3261106/

Rehabilitation of gait after stroke: a review towards a top-down ... This document provides a review of the techniques and therapies used in gait rehabilitation after stroke.

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

Current Trends in Gait Rehabilitation for Stroke Survivors Results show that the Spine Balance 3D system enhanced trunk muscle strength and walking ability in chronic stroke patients more effectively ...

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

Current Evidence for Walking Recovery After Stroke, Future ... Gait speed, lower extremity strength, and self-efficacy at 1- to 3-months poststroke are predictive of self-reported walking performance at >6- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07218094

Neuromechanical Mechanisms of Exosuit-assisted Gait ... This study aims to identify patient-specific neuromechanical locomotor control strategies, link them to biomechanical gait impairments, and ...

7. nature.com nature.com/articles/s41598-022-21271-8

Neuromechanical control of impact absorption during ... Thus, motor recovery evaluation and limb loading training for both limbs should be considered in the post-stroke rehabilitation program.