Exoskeleton Mobility Training for Stroke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

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

Compensation: Varies

Number of Visits: 28

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the safety and effectiveness of the Ekso robotic exoskeleton in persons affected by a severe stroke. * Primary Objectives: * To determine if a structured high-dosage exoskeleton training program (EXTP) results in clinically significant gains in walking recovery in individuals affected by severe stroke. * To determine whether timing of EXTP delivery (i.e., sub-acute vs. chronic) and severity (non-ambulators vs. limited house-hold ambulators) affects the improvement in gait speed and overall function following the EXTP training protocol. * To determine whether maintenance or further improvement in gait speed can be achieved by an intensive follow-up program of either a traditional rehabilitation program (TRP) or extended EXTP. * Secondary Objectives: * To determine the effect on functional walking endurance as assessed by the 6 minute walk test and 10 meter walk test, in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting for post stroke individuals. * To determine the effect on functional balance, as assessed by the Berg Balance Scale, Functional Gait Assessment and Five times sit to stand measure as assessed by the 6 minute walk test, in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting for post stroke individuals. * To determine the effect on stroke recovery, as assessed by the step counter of task specific training in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting

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 data supports the effectiveness of the treatment Ekso exoskeleton for stroke patients?

Research shows that using the Ekso exoskeleton for stroke rehabilitation can improve balance, walking ability, and overall functional status. Patients using the exoskeleton experienced significant improvements in mobility and were able to take more steps and walk for longer periods, suggesting it may be more beneficial than traditional therapy for some stroke patients. ^{1 2 3 4 5}

Is the Ekso exoskeleton safe for use in humans?

Research shows that the Ekso exoskeleton is generally safe for use in humans, with no reported complications or adverse incidents during sessions. Patients have tolerated the device well, and it has been integrated into rehabilitation settings with positive feedback from both patients and therapists. ^{1 2 3 6 7}

How does the Ekso exoskeleton treatment differ from other stroke rehabilitation treatments?

The Ekso exoskeleton treatment is unique because it uses a robotic device to assist with walking, providing precise, task-specific training that can be adjusted for intensity. This approach allows for progressive, repetitive movements that help improve walking speed and functional mobility, which is different from traditional physical therapy methods. ^{5 8 9 10 11}

Research Team

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. [2020]

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

Enhanced Rehabilitation Outcomes of Robotic-Assisted Gait Training with EksoNR Lower Extremity Exoskeleton in 19 Stroke Patients. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Immediate kinematic and muscle activity changes after a single robotic exoskeleton walking session post-stroke. [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

Intensity Modulated Exoskeleton Gait Training Post Stroke. [2023]

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

Adapted Assistance and Resistance Training With a Knee Exoskeleton After Stroke. [2023]

10. 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]

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

Exoskeletal wearable robot on ambulatory function in patients with stroke: a protocol for an international, multicentre, randomised controlled study. [2023]