Exoskeleton Technology for Spinal Cord Injury

Overseen By Nick Evans, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgia Institute of Technology

Disqualifiers: Skin lesions, Spasticity, Fractures, Pregnancy, others

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

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of wearable exoskeletons, Ekso Indego Therapy and Wandercraft Atalante X, to evaluate their effectiveness in improving walking for people with spinal cord injuries and to assess user satisfaction. One exoskeleton assists users in maintaining balance, while the other balances itself. Participants will use both devices over several walking sessions. The study seeks individuals with spinal cord injuries between the T3 and T10 vertebrae, who have been injured for at least three months and can use walkers or crutches.

As an unphased trial, this study offers participants the opportunity to explore innovative technology that could enhance mobility and improve quality of life.

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 these exoskeletons are safe for people with spinal cord injury?

Research has shown that both the Ekso Indego Therapy and the Wandercraft Atalante X are generally safe for people with spinal cord injuries. Studies on the Ekso Indego Therapy found no serious side effects. Many users felt comfortable and confident using the device, with some experiencing reduced muscle tightness and more regular bowel movements.

For the Wandercraft Atalante X, research suggests it is safe and aids in walking. In trials, participants walked without major issues. Both devices appear promising for improving mobility without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exoskeleton technologies for spinal cord injury because they offer unique features not seen in traditional rehabilitation methods like physical therapy or stationary robotic devices. The Ekso Indego Therapy and Wandercraft Atalante X both provide dynamic, user- or self-balancing support, allowing participants to engage in more natural walking movements. This could enhance user independence and mobility in a way that current options don't. These exoskeletons aim to improve walking ability more efficiently, potentially leading to quicker, more effective rehabilitation outcomes for individuals with spinal cord injuries.

What evidence suggests that these exoskeletons are effective for spinal cord injury?

This trial will compare two exoskeleton technologies for spinal cord injury rehabilitation. Research has shown that the Ekso Indego Therapy exoskeleton, used by participants in one arm of this trial, could benefit people with spinal cord injuries. Studies have found it can improve lower body movement, reduce fatigue, and enhance overall quality of life. Many users also report feeling comfortable and confident with the device.

In another arm of this trial, participants will use the Wandercraft Atalante X exoskeleton. Research suggests it is safe and effective. In one study, participants successfully completed important mobility tasks 100% of the time after just five training sessions. The exoskeleton also helps users walk efficiently, even those with complete spinal cord injuries. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for non-ambulatory individuals with spinal cord injury who want to participate in testing two different lower-limb exoskeleton technologies designed to assist with walking.

Inclusion Criteria

Height between 5'1" and 6'1"

I am between 18 and 70 years old.

I weigh less than 200 lbs (90 kg).

Exclusion Criteria

I have a heart or blood vessel condition.

Uncontrolled autonomic dysreflexia

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 5 walking sessions and 2 test sessions with two different exoskeleton devices in a randomized order

8 weeks

7 visits (in-person)

Follow-up

Participants are monitored for physiological and psychological effects of exoskeleton use

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Ekso Indego Therapy
• Wandercraft Atalante X

Trial Overview The study compares the Wandercraft Atalante X, a self-balancing exoskeleton, and the Ekso Indego Therapy, a user-balanced exoskeleton, to evaluate their impact on walking physiology and user experience in people with spinal cord injuries.

How Is the Trial Designed?

Group I: User-balancing lower limb exoskeleton Experimental Treatment 1 Intervention

Participants will use the user-balancing lower limb exoskeleton for 5 walking sessions and then complete a test session.

Group II: Self-balancing lower limb exoskeleton Experimental Treatment 1 Intervention

Participants will use the self-balancing lower limb exoskeleton for 5 walking sessions and then complete a test session.

Who Is Running the Clinical Trial?

Georgia Institute of Technology

Lead Sponsor

Trials

53

Recruited

5,600+

Shepherd Center, Atlanta GA

Collaborator

Trials

30

Recruited

4,000+

Citations

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

Clinical effectiveness and safety of powered exoskeleton ... Improvements in spasticity and bowel movement regularity were reported in 38% and 61% of patients, respectively. No serious adverse events ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875024001906

Exoskeleton-Assisted Rehabilitation and Neuroplasticity in ... The results revealed substantial improvements in lower extremity motor function, along with positive changes in fatigue levels, quality of life, and mood trends ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.689751/full

Outcomes of a Multicenter Safety and Efficacy Study of the ... All participants reported moderate to high levels of comfort and confidence using the device. All patients were able to achieve FIM of >4 on ...

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

Outcomes of Using EksoNR in Inpatient Rehab Almost 60% of the patients are stroke patients. They found that the EksoNR does such a good job, that typically they're ambulatory at the end of their ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-022-01003-9

Overground robotic training effects on walking and secondary ... Results showed that individuals with SCI, walk at a significantly lower speed and with a wider support surface, in comparison to ABs walking in ...

6. blueshieldca.com blueshieldca.com/content/dam/bsca/en/provider/docs/2023/May/PRV_PwrdExoskel_AmbPts_LowLimbDisablilities.pdf

1.03.04 Powered Exoskeleton for Ambulation in Patients ... Initial Outcomes from a Multicenter Study Utilizing the. Indego Powered Exoskeleton in Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2018 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29434463/

Initial Outcomes from a Multicenter Study Utilizing the ... Conclusion: The Indego was shown to be safe for providing upright mobility to 32 individuals with SCIs who were nonambulatory. Improvements in speed and ...