Powered Exoskeleton for Spinal Cord Injury

(EKSO Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Height, Weight, Joint contractures, others

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

Compensation: Varies

Number of Visits: 22

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a powered exoskeleton called Ekso, designed to help individuals with spinal cord injuries (SCI) or similar conditions improve balance and walking ability. The study will observe whether using the device enables participants to stand, walk, and shift weight more effectively. Ideal candidates for this trial have an SCI between C7-S1, can stand upright for at least 30 minutes, and possess sufficient upper body strength to use a walker with the exoskeleton. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance mobility solutions for SCI patients.

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 the Ekso exoskeleton is safe for individuals with spinal cord injury?

Research shows that powered exoskeletons, like the Ekso, are generally safe for people with spinal cord injuries (SCI). Studies have found that these devices enable users to walk safely in everyday situations. This capability allows for longer use, indicating their safety and usefulness.

Data from training sessions with the Ekso device ensures that patients can use it comfortably. Although detailed safety results are not always available, the regular collection of this data indicates that any possible side effects are monitored.

Overall, evidence supports the safety of the Ekso exoskeleton, particularly in improving users' walking ability. This makes it a promising option for those with SCI seeking to enhance their mobility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for spinal cord injury, which often rely on physical therapy and medication, the Ekso exoskeleton offers a cutting-edge approach by using a robotic suit to aid mobility. This exoskeleton is unique because it physically supports the body, allowing individuals with spinal cord injuries to stand and walk, potentially improving muscle strength and circulation. Researchers are excited about the Ekso exoskeleton because it not only offers a new way to enhance rehabilitation outcomes but also provides real-time feedback and adjustable support tailored to each user's needs.

What evidence suggests that the Ekso exoskeleton is effective for improving mobility in spinal cord injury patients?

Research has shown that powered exoskeletons can help people with spinal cord injuries (SCI) walk safely in everyday situations. Studies have found that these devices enable ongoing physical activity, which is crucial for recovery. In one study, 12 weeks of exoskeleton training improved walking ability in individuals with long-term SCI who could already take steps independently. Another study demonstrated that robotic exoskeletons are more effective for rehabilitation than traditional methods. This trial will evaluate the Ekso exoskeleton, and these findings suggest it could enhance balance, walking, and weight shifting for individuals with SCI. ^{1 3 6 7 8}

Who Is on the Research Team?

Arun Jayaraman, PhD

Principal Investigator

RIC/Northwestern

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with spinal cord injury (SCI) levels C7-S1 or similar neurological weakness, who can fit into and tolerate the Ekso exoskeleton. They must stand for 30 minutes and have upper body strength to use a walker. Excluded are those with skin issues, cognitive impairments, extreme height/weight, joint contractures limiting movement, severe osteoporosis without physician approval.

Inclusion Criteria

Participants must be able to physically fit into the exoskeletal device.

You must be able to stand upright for at least 30 minutes without any problems.

You must have a spinal cord injury between the C7 and S1 vertebrae.

Exclusion Criteria

You are shorter than 62 inches or taller than 74 inches.

You weigh more than 220 pounds.

You have stiff joints that make it difficult to move normally with help from devices like crutches or walkers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phase 1

Determine if participant is compatible with device use

1-3 sessions

1-3 visits (in-person)

Phase 2

Assessment and training of participant with device to determine safety and efficacy

4-10 sessions

4-10 visits (in-person)

Phase 3

Continued training to determine functional ability of patient to use device

11-40 sessions

11-40 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up testing at Week 6 and Week 12

What Are the Treatments Tested in This Trial?

Interventions

• Ekso exoskeleton

Trial Overview

The EKSO Trial tests the safety and effectiveness of an Ekso powered exoskeleton in helping individuals with SCI walk again. It evaluates balance improvement while standing, ability to walk 10 meters safely, better weight shifting during movement as assessed by therapists, and user feedback on device training success.

How Is the Trial Designed?

Group I: Ekso Safety and Efficacy Experimental Treatment 1 Intervention

Observational study on the first time use of a robotic exoskeleton.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A systematic review of 22 studies on powered exoskeletons for individuals with spinal cord injury (SCI) found that most research focuses on patients with thoracic level injuries, particularly T10, and emphasizes gait and ambulation as primary outcome measures.

While powered exoskeletons show promise in improving mobility and health for people with lower-body paralysis, the variability in outcome measures across studies complicates comparisons, highlighting the need for standardized metrics and better patient selection criteria in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Powered exoskeletons for bipedal locomotion after spinal cord injury. Contreras-Vidal, JL., A Bhagat, N., Brantley, J., et al.[2017]

A study involving 12 participants with acute/sub-acute spinal cord injuries showed that using powered exoskeletons for locomotor training is generally safe, although symptomatic hypotension was the most common adverse event reported.

The feasibility of using exoskeletons was demonstrated, with 54% protocol compliance and 58% of participants achieving at least minimal assistance during walking sessions, indicating potential for effective rehabilitation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exoskeleton-assisted walking during acute/sub-acute SCI in an inpatient rehabilitation facility: A single-group preliminary study. Delgado, AD., Escalon, MX., Bryce, TN., et al.[2021]

The Indego powered exoskeleton was found to be safe for use in 32 nonambulatory individuals with spinal cord injuries, with limited device-related adverse events and no interruptions in training over an 8-week period.

Participants showed significant improvements in walking speed and endurance in both indoor and outdoor conditions, as well as increased independence in donning and doffing the exoskeleton after the training program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury. Tefertiller, C., Hays, K., Jones, J., et al.[2019]

The study involving 11 participants with acute spinal cord injuries demonstrated that exoskeletal-assisted walking is safe, with no serious adverse events reported during up to 25 training sessions.

Participants showed significant improvements in walking distance and speed, indicating that this intervention is feasible and effective for enhancing mobility in individuals less than 6 months post-injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety and Feasibility of Exoskeletal-Assisted Walking in Acute Rehabilitation After Spinal Cord Injury. McIntosh, K., Charbonneau, R., Bensaada, Y., et al.[2020]

Powered exoskeletons have been shown to enable 76% of patients with spinal cord injury to walk independently after training, with sessions typically lasting 60-120 minutes, three times a week for up to 24 weeks.

The training was safe, with a low incidence of falls (4.4%) and fractures (3.4%), and no serious adverse events reported, indicating that newer exoskeleton designs have improved safety features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis. Miller, LE., Zimmermann, AK., Herbert, WG.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4809334/

Clinical effectiveness and safety of powered exoskeleton ...

Powered exoskeletons allow patients with SCI to safely ambulate in real-world settings at a physical activity intensity conducive to prolonged use and known to ...

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eksobionics.com

eksobionics.com/how-effective-is-exoskeleton-rehabilitation/

How Effective Is Exoskeleton Rehabilitation?

In this article, we will explore the current state of research on exoskeleton rehabilitation in physical therapy and consider the potential benefits.

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EKSO Trial: Powered Exoskeleton for Ambulation in ...

This study seeks to test the safety and efficacy of the Esko device in SCI population and in populations with similar neurological weakness to the SCI ...

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jneuroengrehab.biomedcentral.com

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This meta-analysis aims to explore the effectiveness of lower limb robotic exoskeletons in rehabilitation training for patients with SCI. Our ...

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nature.com

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Walking improvement in chronic incomplete spinal cord ...

Twelve weeks of exoskeleton robotic training in chronic SCI participants with independent stepping ability at baseline can improve clinical ambulatory status.

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Data on the safety and tolerability of the EKSO-GT training are recorded at the beginning and at the end of each session, however a synthesis of safety outcomes ...

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frontiersin.org

frontiersin.org/journals/neurorobotics/articles/10.3389/fnbot.2022.848443/full

Frontiers | Safety and Feasibility of a Novel Exoskeleton for ...

The advent of exoskeletal robotic technology can benefit the spinal cord injury population in three ways: (1) extensive repetitions of walking ...

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jneuroengrehab.biomedcentral.com

jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01158-z

Exoskeleton-based training improves walking ...

Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial.