Exoskeleton vs High-Intensity Gait Training for Neurologic Gait Disorders

Overseen By Soo Yeon Sun, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alvernia University

Disqualifiers: Severe cardiac disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 20

Duration: 10 weeks

3 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to improve walking after a stroke: using a robotic suit (exoskeleton-mediated gait training) or engaging in high-energy walking exercises (high-intensity gait training). Researchers aim to determine which method more effectively enhances walking ability and mental health after 20 sessions. They are also examining whether factors like mental health and support from friends and family influence therapy attendance. Individuals who have had a stroke and are referred for physical therapy at Good Shepherd Rehabilitation may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance stroke rehabilitation techniques.

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 prior data suggests that these gait training methods are safe for neurologic gait disorders?

A previous study found that using robotic exoskeletons for walking training is safe for people with nerve injuries. Participants showed improvements in muscle strength, balance, and walking ability without major issues. Another study demonstrated that people recovering from a stroke who used robotic exoskeletons improved their walking and daily living skills.

Research on high-intensity walking training has shown it to be effective and safe for increasing walking speed and balance, particularly after a stroke. Participants in this type of training achieved better results in walking and balance compared to other methods. Both treatments have been well-tolerated in past studies, suggesting they are safe options to consider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative approaches to improving mobility for neurologic gait disorders. The exoskeleton-mediated gait training uses a robotic suit to assist and enhance leg movement, providing a unique, high-tech way to promote walking ability and muscle engagement. This is quite different from traditional rehabilitation methods, which rely on manual exercises and physical therapy. On the other hand, high-intensity gait training focuses on pushing the limits of physical exertion more than conventional neurorehabilitation, offering a more rigorous workout to potentially accelerate recovery and improve outcomes. Both methods aim to enhance the effectiveness and efficiency of gait rehabilitation, potentially leading to faster and better recovery for patients.

What evidence suggests that this trial's treatments could be effective for neurologic gait disorders?

This trial will compare Exoskeleton-mediated gait training with High-Intensity Gait Training for individuals with neurologic gait disorders. Studies have shown that robotic exoskeletons for walking training can significantly improve balance, leg strength, and walking speed in stroke survivors. Research also indicates that this method benefits children with cerebral palsy by enhancing their walking patterns. Conversely, high-intensity walking training, which involves vigorous walking practice, has proven effective in improving walking ability, distance, and balance, particularly for stroke survivors. This training emphasizes practicing steps with high effort, boosting walking skills and endurance. Both treatments have strong evidence supporting their effectiveness in aiding those with walking difficulties due to neurological conditions. ^{6 7 8 9 10}

Who Is on the Research Team?

Soo Yeon Sun, PhD

Principal Investigator

Alvernia University

Kelley Limbauan, PT, DPT, NCS

Principal Investigator

Good Shepherd Rehabilitation Network

Are You a Good Fit for This Trial?

This trial is for adults who've had a stroke and are referred to Good Shepherd Rehabilitation Outpatient Physical Therapy Clinic. They must be able to speak English or Spanish. People won't qualify if they don't meet these criteria.

Inclusion Criteria

I am referred to Good Shepherd for outpatient physical therapy.

I have been diagnosed with a stroke.

Exclusion Criteria

Pregnancy

Resting blood pressure >180/110 mmHg

Resting heart rate > 120 bpm

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 20 interventions of either exoskeleton-mediated gait training or high-intensity gait training

10 weeks

20 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exoskeleton mediated gait training
• High intensity gait training

Trial Overview Researchers are testing two types of physical therapy: one uses a robotic exoskeleton for walking practice, while the other involves high-intensity training aimed at keeping heart rates up. The goal is to see which method better improves walking function and mental health after 20 sessions.

How Is the Trial Designed?

Group I: Exoskeleton mediated gait training Experimental Treatment 1 Intervention

Two sessions of High-Intensity Gait Training

Group II: High intensity gait training Active Control 1 Intervention

One session of conventional neurorehabilitation intervention per week One session of Forward Walking with EksoGT per week

Exoskeleton mediated gait training is already approved in United States, European Union for the following indications:

Approved in United States as Robotic Exoskeleton Gait Training for:

• Stroke rehabilitation
• Spinal cord injury rehabilitation
• Neurological impairments

Approved in European Union as Exoskeleton Assisted Gait Training for:

• Stroke rehabilitation
• Spinal cord injury rehabilitation
• Neurological impairments

Who Is Running the Clinical Trial?

Alvernia University

Lead Sponsor

Trials

5

Recruited

170+

Good Shepherd Rehabilitation Network

Collaborator

Trials

2

Recruited

260+

Published Research Related to This Trial

A case study of a 66-year-old male stroke survivor showed that 14 days of gait training with the Gait Exercise Assist Robot (GEAR) combined with physical therapy improved hip extension and gait speed.

The training helped the participant transfer body weight more smoothly onto the affected limb, indicating that GEAR can be an effective rehabilitation tool for chronic stroke hemiplegia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait training using a stationary, one-leg gait exercise assist robot for chronic stroke hemiplegia: a case report. Itoh, N., Imoto, D., Kubo, S., et al.[2020]

Overground exoskeleton-assisted gait training (OEGT) was found to be a feasible rehabilitation method for patients with gait disorders due to spinal stenosis, with positive changes observed in gait performance, balance, muscle strength, and psychological well-being among the five participants studied.

Despite the improvements in various aspects of rehabilitation, there was no significant change in neurological deficits, indicating that while OEGT can enhance certain functional outcomes, it may not address underlying neurological issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exoskeleton-assisted Gait Training in Spinal Disease With Gait Disturbance. Jang, TG., Choi, SH., Yu, SH., et al.[2022]

Powered robotic exoskeletons are a safe intervention for gait rehabilitation in stroke patients, showing meaningful improvements in walking outcomes, especially in those who are in the sub-acute phase of recovery.

While exoskeleton training is equivalent to traditional therapy for chronic stroke patients, sub-acute patients may benefit more from this technology, indicating a need for further rigorous trials to establish its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. Louie, DR., Eng, JJ.[2023]

This multicenter clinical trial will involve 144 stroke patients to compare the effectiveness of electromechanical-assisted gait training against conventional gait training over 4 weeks, with a focus on improving independent walking as measured by the Functional Ambulation Category (FAC).

The study aims to provide robust data on the safety and efficacy of electromechanical-assisted gait training, addressing gaps in previous research and potentially establishing it as a beneficial rehabilitation option for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of EXOWALK® on electromechanical-assisted gait training: study protocol for randomized controlled trial. Lim, CY., Ko, MJ., Lee, JW., 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]

The Ekso GTTM exoskeleton was successfully implemented in a rehabilitation setting for 26 patients with subacute stroke, showing significant improvements in gait-related measures and overall functional independence after 3 weeks of training.

Patients reported high satisfaction and low perceived exertion during training sessions, indicating that exoskeleton-assisted gait training is a feasible and well-received option for enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing the exoskeleton Ekso GTTM for gait rehabilitation in a stroke unit - feasibility, functional benefits and patient experiences. Høyer, E., Opheim, A., Jørgensen, V.[2022]

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]

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]

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]

The LOPES gait trainer, an advanced exoskeleton, allows for a free walking mode that closely resembles natural walking, with only minor changes in gait parameters and muscle activity compared to walking on a treadmill.

While using the LOPES, there was a slight decrease in knee angle range and changes in muscle activity, indicating that the device's inertia affects movement; however, these adaptations suggest that it can effectively support 'Assist as Needed' training for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects on Kinematics and Muscle Activity of Walking in a Robotic Gait Trainer During Zero-Force Control. van Asseldonk, EH., Veneman, JF., Ekkelenkamp, R., et al.[2022]

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]

Citations

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Robotic exoskeleton-assisted gait training in patients with .. ... Gait training with robotic exoskeleton-assisted rehabilitation systems can lead to a significant improvement in gait endurance, speed, balance, and functional ...