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

62 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.

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 data supports the effectiveness of the treatment Exoskeleton mediated gait training for neurologic gait disorders?

Research shows that exoskeleton-based gait training can improve walking speed and functional measures in stroke patients, suggesting it helps with motor recovery and functional ambulation. Preliminary findings indicate that this type of training is as effective as traditional therapy for chronic stroke patients and may offer additional benefits for those in the sub-acute phase. ^{1 2 3 4 5}

Is exoskeleton gait training generally safe for humans?

Exoskeleton gait training is generally considered safe, but there are some risks. Common issues include skin and tissue discomfort, musculoskeletal problems, and changes in blood pressure. More structured reporting and risk management are needed to improve safety. ^{2 5 6 7 8}

How does exoskeleton gait training differ from other treatments for neurologic gait disorders?

Exoskeleton gait training is unique because it uses a robotic device to assist with walking, allowing for high-intensity, repetitive, and task-specific practice, which can enhance motor recovery and improve walking speed and balance. This approach is different from traditional therapy as it provides consistent, controlled support and can be adjusted to the individual's needs, potentially offering more significant benefits, especially in the early stages of recovery after a stroke. ^{2 5 9 10 11}

Research Team

Soo Yeon Sun, PhD

Principal Investigator

Alvernia University

Kelley Limbauan, PT, DPT, NCS

Principal Investigator

Good Shepherd Rehabilitation Network

Eligibility Criteria

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 am 18 years old or older.

I speak English or Spanish.

Exclusion Criteria

Pregnancy

Resting blood pressure >180/110 mmHg

Resting heart rate > 120 bpm

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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 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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Gait training using a stationary, one-leg gait exercise assist robot for chronic stroke hemiplegia: a case report. [2020]

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

Intensity Modulated Exoskeleton Gait Training Post Stroke. [2023]

3. 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]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Exoskeleton-assisted Gait Training in Spinal Disease With Gait Disturbance. [2022]

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

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. [2023]

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. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. [2020]

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

The Effects on Kinematics and Muscle Activity of Walking in a Robotic Gait Trainer During Zero-Force Control. [2022]

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

Efficacy and safety of EXOWALK® on electromechanical-assisted gait training: study protocol for randomized controlled trial. [2022]

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

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

11. England pubmed.ncbi.nlm.nih.gov

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