Exoskeleton for Spinal Cord Injury

Overseen By Joshua Breighner, PT DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wandercraft

Disqualifiers: Neurological injury, Severe disease, Fractures, others

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

Compensation: Varies

Number of Visits: 9

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a hands-free exoskeleton to determine its safety and effectiveness for people with spinal cord injuries (SCI). The goal is to help those who have had an SCI for at least six months and have an injury at or above the middle of the back (T6) potentially improve mobility. Ideal participants are individuals living in the US who can attend multiple study sessions and have no other major health issues.

As an unphased trial, participants have the unique opportunity to contribute to groundbreaking research that could enhance mobility solutions for SCI patients.

Do I need to stop my current medications for the trial?

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 this exoskeleton is safe for individuals with spinal cord injury?

Research has shown that the hands-free exoskeleton is generally safe for people with spinal cord injuries. Earlier studies examined its safety, particularly in aiding walking after a stroke, and found the exoskeleton to be well-tolerated, with no major safety issues reported.

A detailed review also supports the safety of wearable exoskeletons for individuals with movement difficulties. While minor side effects like skin redness or discomfort may occur, serious problems are rare. Overall, evidence suggests that the exoskeleton is a safe option for those with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for spinal cord injury, which often involve physical therapy or assistive devices like wheelchairs, the hands-free exoskeleton offers a new, innovative approach. This exoskeleton is unique because it allows users to move independently without relying on hand controls, enhancing mobility and independence. Researchers are excited about this treatment because it could significantly improve the quality of life for individuals with spinal cord injuries by enabling more natural movement patterns and potentially aiding in rehabilitation.

What evidence suggests that this exoskeleton is effective for spinal cord injury?

Research has shown that hands-free exoskeletons, which participants in this trial will use, can assist people with spinal cord injuries. Studies have found that these devices improve balance and leg strength for walking and aid in everyday activities. Powered exoskeletons have enabled individuals with spinal cord injuries to walk at moderate speeds, with performance improving through practice. Additionally, exoskeletons might support the brain's ability to adapt and reorganize, potentially aiding recovery. Overall, exoskeletons are a promising tool for rehabilitation and enhancing movement in people with spinal cord injuries. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults in the US with spinal cord injuries at or above T6, who are at least 6 months post-injury. They must be able to attend multiple training sessions and assessments. Excluded are those with severe spasticity, uncontrolled hypertension, inability to use hand-controls, certain bone density issues, concurrent medical conditions that conflict with study objectives or participation in another interventional trial.

Inclusion Criteria

SCI user:

Able to read, understand, and provide informed consent

Companion:

Exclusion Criteria

Untreatable severe spasticity judged to be contraindicated by the site physician

Untreated/uncontrolled hypertension, as judged to be contraindicated by the site physician

Morphological contraindications to the use of the device

Timeline for a Trial Participant

Screening and Device Fitting

Participants are screened for eligibility to participate in the trial and fitted with the exoskeleton device

1 week

1 visit (in-person)

Training

Participants undergo five training sessions to learn basic skills with the exoskeleton, concluding with a competency evaluation

2 weeks

5 visits (in-person)

Effectiveness Evaluation

Participants are evaluated on the effectiveness of the exoskeleton through various tests and an additional practice session

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main training and evaluation phases

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Hands-free exoskeleton

Trial Overview The study tests a hands-free personal exoskeleton's safety and effectiveness for individuals with spinal cord injury. Participants will undergo training and assessment sessions to evaluate how well they can operate the device and its impact on their mobility.

How Is the Trial Designed?

Group I: Hands-free exoskeleton Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Wandercraft

Lead Sponsor

Trials

10

Recruited

310+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06777576

NCT06777576 | Self-balancing Personal Exoskeleton for SCI This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI). Detailed Description. This ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12121209/

Comparative efficacy of robotic exoskeleton and conventional ... This meta-analysis discovered the evidence that robotic exoskeleton gait training can improve the walking balance, strength of lower limbs, functional scores ...

3. nature.com nature.com/articles/s41393-025-01085-x

Evaluating therapeutic effects of exoskeletons and FES in ... Functional electrical stimulation and exoskeletons provide direct functional ability but may also have therapeutic effects that improve function ...

4. withpower.com withpower.com/trial/phase-spinal-cord-injuries-sci-1-2025-f1135

Hands-free Exoskeleton for Spinal Cord Injury Research shows that powered exoskeletons can help people with spinal cord injuries walk at modest speeds, and their effectiveness improves with more training ...

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

Exoskeleton-Assisted Rehabilitation and Neuroplasticity in ... Exoskeleton serves as an emerging and promising tool for rehabilitation, especially in promoting neuroplasticity and alleviating SCI-related complications.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11992748/

Hands-free Atalante exoskeleton in post-stroke gait and ... This study primarily aimed to assess the safety of hands-free Atalante exoskeleton training in post-stroke subjects, with a secondary aim to assess gait and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07222033

Self-balancing Personal Exoskeleton for SCI (WINY) This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI). Detailed Description. This ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823146

Exoskeletal-Assisted Walking in Veterans With Paralysis A systematic review of the effects of robotic exoskeleton training on energy expenditure and body composition in adults with spinal cord injury.

9. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00815-5

Systematic review on wearable lower-limb exoskeletons ... This systematic review provides a comprehensive overview on wearable lower-limb exoskeletons for people with neuromuscular impairments.