Exoskeleton Mobility Training for Stroke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Joint contractures, Severe osteoporosis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 28

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a robotic exoskeleton in helping people regain their ability to walk after a severe stroke. Researchers aim to determine if this exoskeleton improves walking and balance, particularly when used at various stages post-stroke and among individuals with different mobility levels. The trial compares exoskeleton training to traditional rehab programs to assess which method better enhances walking and balance. Individuals who have experienced a severe stroke and face walking difficulties may find this trial suitable. As an unphased trial, it provides a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation options for stroke survivors.

Will I have to stop taking my current medications?

The trial protocol 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 the Ekso exoskeleton is safe for stroke patients?

Research has shown that the Ekso robotic exoskeleton is generally well-tolerated by people recovering from strokes. Studies have explored its use in helping patients walk again. One study found that using the exoskeleton improved walking speed and endurance, suggesting it can aid stroke recovery.

Safety data from these studies indicate that most users manage the treatment well, with no major reports of harmful side effects. This suggests the exoskeleton is safe for rehabilitation after a stroke. However, like any treatment, some people might experience minor discomfort or issues, though these are uncommon.

Overall, the findings suggest that the Ekso exoskeleton is a safe option to help improve walking ability during stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional stroke rehabilitation methods that often rely on physical therapy and assistive devices like canes or walkers, the Ekso exoskeleton offers a high-tech approach to mobility training. This robotic suit is designed to help stroke patients relearn walking by providing powered assistance and support, which can lead to improved gait and muscle activation. Researchers are excited about the Ekso exoskeleton because it allows for more intensive and repetitive walking exercises, which are crucial in promoting neuroplasticity and recovery after a stroke. Additionally, the exoskeleton can adjust to the user's individual needs, offering a personalized rehabilitation experience that traditional methods can't match.

What evidence suggests that the Ekso exoskeleton is effective for stroke recovery?

Research has shown that the Ekso robotic exoskeleton, used by participants in this trial, can help stroke patients walk better. Studies have found that this device enhances overall walking recovery and function. Patients using the EksoNR exoskeleton in rehab reported better mobility outcomes compared to those receiving regular therapy. The exoskeleton enables users to take more steps during therapy sessions, which links to greater mobility improvements. These findings suggest that the Ekso exoskeleton can be an effective tool for stroke recovery, particularly in improving walking speed and balance. ^{1 3 6 7 8}

Who Is on the Research Team?

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-85 who have had a severe stroke. They must be able to stand for 30 minutes, fit into the exoskeleton device, and have enough upper body strength to use it. Walking speed should be less than 0.4m/s. Participants need a mental status score above 17, medical clearance, and the ability to follow study procedures.

Inclusion Criteria

I can stand upright for 30 minutes without assistance.

I had a stroke or similar condition, and it's been between 2 weeks to 6 months or more since.

I can walk using a device thanks to my arm strength and balance.

Exclusion Criteria

You must be between 5 feet and 6 feet 2 inches tall.

I weigh 220 lbs or less.

I have stiff joints in my hip, knee, or ankle that affect my walking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment Phase 1

Participants undergo initial gait training sessions focusing on postural alignment and weight shifting strategies using the Ekso device.

4.5 weeks

9 sessions (in-person)

Treatment Phase 2

Continued gait training with progression towards non-tethered walking in the Ekso device.

4.5 weeks

9 sessions (in-person)

Treatment Phase 3

Participants with different walking speeds receive either continued Ekso device training or traditional physical therapy.

4 weeks

8 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up assessment 3 months post-treatment.

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ekso exoskeleton

Trial Overview The study tests if high-dose training with an Ekso robotic exoskeleton helps people recover walking abilities after a severe stroke better than traditional rehab programs. It looks at how timing and severity of strokes affect recovery and whether improvements last with continued training or traditional rehab.

How Is the Trial Designed?

Group I: Ekso Training Safety and Efficacy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

U.S. Department of Education

Collaborator

Trials

87

Recruited

54,500+

Published Research Related to This Trial

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]

The study involving 46 subacute stroke patients demonstrated that overground exoskeleton-assisted gait training (OEAGT) significantly improved clinical and gait outcomes, with many patients regaining the ability to walk after treatment.

Patients reported a positive acceptance of the OEAGT, indicating its potential as an innovative rehabilitation strategy, although further randomized studies with larger samples are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. Goffredo, M., Guanziroli, E., Pournajaf, 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]

Robotic-assisted gait training (RAGT) using the EksoNR exoskeleton significantly improved gait and functional status in 19 stroke patients over a 4-week rehabilitation program, with notable enhancements in walking ability and mobility.

The study showed statistically significant improvements in various functional categories, including a substantial increase in the number of steps taken and walking time, indicating that RAGT is both effective and well-tolerated for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Rehabilitation Outcomes of Robotic-Assisted Gait Training with EksoNR Lower Extremity Exoskeleton in 19 Stroke Patients. Wiśniowska-Szurlej, A., Wołoszyn, N., Brożonowicz, J., et al.[2023]

In a study of 44 patients aged 55-85 who had ischemic strokes, using the Ekso GT exoskeleton for rehabilitation showed improvements in balance and functional status compared to traditional rehabilitation methods over 4 weeks.

While both rehabilitation methods led to functional improvements, the exoskeleton group demonstrated greater benefits in multiple categories, suggesting it may be a more effective tool for enhancing recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exoskeleton Gait Training on Balance, Load Distribution, and Functional Status in Stroke: A Randomized Controlled Trial. Rojek, A., Mika, A., Oleksy, Ł., et al.[2020]

Integrating the Ekso Gait Training device into inpatient rehabilitation for patients with stroke or spinal cord injury is feasible, although it faced initial challenges that required administrative support and clinician persistence over several months.

Patients using the Ekso reported improved mobility and tolerated the sessions well, with no complications or adverse incidents, indicating a positive experience with the robotic exoskeleton.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. Swank, C., Sikka, S., Driver, S., et al.[2021]

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]

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/PMC9980569/

Efficacy of robotic exoskeleton for gait rehabilitation in patients ... These present findings suggest that the use of RAGT associated with CT is effective on gait recovery in subacute stroke patients, albeit not superior at only ...

2. eksobionics.com eksobionics.com/outcomes-of-using-eksonr-in-inpatient-rehab/

Outcomes of Using EksoNR in Inpatient Rehab The following data represents the “average” scoring of all of their 310 stroke patients. It is provided so that anyone may look over and compare this data with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10355131/

Enhanced Rehabilitation Outcomes of Robotic-Assisted ... This study supports previous findings, demonstrating that RAGT using the EksoNR lower extremity exoskeleton improves gait and functional status in stroke ...

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01536-1

Overground robotic exoskeleton vs conventional therapy in ... As compared to the 800–1200 steps/ session typically reported in clinical trials that demonstrated superior mobility outcomes in non-ambulatory ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02128152

Mobility Training Using Exoskeletons for Functional ... The purpose of this study is to assess the safety and effectiveness of the Ekso robotic exoskeleton in persons affected by a severe stroke. ... post stroke ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6988257/

Exoskeleton for post-stroke recovery of ambulation (ExStRA) This study will be the first mixed-methods study examining the adoptability of exoskeleton-based rehabilitation for individuals with stroke.

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-016-0162-5

Powered robotic exoskeletons in post-stroke rehabilitation of gait Main walking outcome measures were gait speed, Timed Up and Go, 6-min Walk Test, and the Functional Ambulation Category. Meaningful improvement ...

8. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2019.01344/full

Effects of Exoskeleton Gait Training on Balance, Load ... The aim of this study was to evaluate the effectiveness of rehabilitation with Ekso GT exoskeleton in patients after ischemic stroke and to ...