Powered Exoskeleton for Spinal Cord Injury

(EKSO Trial)

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: 22

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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 population. The device can currently stand from a seated position, walk, and turn and sit down. Our hypothesis are as follows: * Hypothesis 1: We hypothesize that the Ekso subject will significantly improve balance while wearing the device as noted by subject's ability to safely achieve standing balance for 30 sec without loss of balance. * Hypothesis 2: We hypothesize that the Ekso subject will display improved ability to safely ambulate 10 meters to be assessed using the 10 meter walk test. * Hypothesis 3: We hypothesize that the Ekso subject will display improved weight shift in both static and dynamic activities as determined by a trained physical therapist. * Hypothesis 4: We hypothesize that the Ekso subject will verbalize improved success with training of the device as noted by subjective questionnaires that will be assessed following each training session.

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 Ekso exoskeleton for spinal cord injury?

Research shows that powered exoskeletons like Ekso can help people with spinal cord injuries improve their ability to walk and increase their physical activity. Studies have found that these devices are effective and safe for helping people with lower-body paralysis or weakened legs regain mobility. ^{1 2 3 4 5}

Is the powered exoskeleton safe for people with spinal cord injuries?

Research shows that powered exoskeletons, like the Ekso and Indego, are generally safe for people with spinal cord injuries. Some studies reported minor issues like low blood pressure, but these did not stop the training. Overall, the devices were used safely in both indoor and outdoor settings. ^{1 2 5 6 7}

How is the Ekso exoskeleton treatment different from other treatments for spinal cord injury?

The Ekso exoskeleton is unique because it is a wearable robotic device that helps people with spinal cord injuries walk by providing mechanical support and movement to the legs, unlike traditional therapies that may focus on physical therapy or medication. This treatment can improve mobility and physical activity, offering potential health benefits across various body systems. ^{1 2 3 5 8}

Research Team

Arun Jayaraman, PhD

Principal Investigator

RIC/Northwestern

Eligibility Criteria

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

You must be between 18 and 65 years old.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of robotic exoskeleton ambulation in a C4 person with incomplete spinal cord injury: a case report. [2022]

2. New Zealand 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. [2022]

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

Powered exoskeletons for bipedal locomotion after spinal cord injury. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. [2022]

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

The Safety and Feasibility of Exoskeletal-Assisted Walking in Acute Rehabilitation After Spinal Cord Injury. [2020]

6. England 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. [2021]

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

Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury. [2019]

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

Preliminary design of an energy storing orthosis for providing gait to people with spinal cord injury. [2020]