Exoskeleton for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By David Kim

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: 10

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 exoskeleton aims to help individuals with SCI regain mobility and improve their quality of life. Ideal participants have had an SCI for at least six months, with injuries at or above the T6 vertebra, and can attend multiple sessions at the research center. Participants should live in the U.S. and understand English. The trial aims to offer new hope for better mobility and independence to those living with spinal cord injuries. As an unphased trial, it provides participants the opportunity to contribute to groundbreaking research that could significantly 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 study team 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 and easy to use. In one study with 50 patients, this exoskeleton helped people walk again after spinal cord injuries. Another study found it safe and well-tolerated for people recovering from strokes. These studies reported no serious side effects, suggesting that the exoskeleton is a promising tool for rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for spinal cord injury, which often includes physical therapy and rehabilitation, the hands-free exoskeleton offers a new approach by physically supporting and enhancing mobility. This exoskeleton allows individuals with spinal cord injuries to walk without the need for crutches or walkers, providing a more natural and autonomous movement experience. Researchers are excited because this technology could significantly improve the quality of life and independence for patients, making everyday activities more accessible and less reliant on assistance.

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

Research has shown that robotic exoskeletons can help people with spinal cord injuries walk better and become stronger. A review of several studies found that these devices improve leg function and overall movement. In this trial, participants will use a hands-free exoskeleton to assess its effectiveness. Other research indicates that exoskeletons not only aid in movement but may also provide long-term health benefits. Additionally, studies have examined the cost of exoskeletons compared to traditional rehab methods, suggesting they could improve the quality of life for those with spinal cord injuries. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 living in the US with spinal cord injuries at or above T6, who are at least 6 months post-injury. Participants must be able to attend multiple training sessions and operate the device using a hand-control interface. Exclusions include severe medical conditions, pregnancy, leg discrepancies over 2 cm, untreated severe spasticity or hypertension, unstable fractures, and those with open skin sores.

Inclusion Criteria

I can attend 9-10 visits at the center for training and assessments.

Able to read, understand, and provide informed consent

It has been over 6 months since my spinal cord injury.

Exclusion Criteria

Morphological contraindications to the use of the device

My legs are different lengths by more than 2 cm.

I cannot use devices controlled by hand.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Device Fitting and Training

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

2-3 weeks

6 visits (in-person)

Effectiveness Evaluation

Participants are evaluated on the effectiveness of the exoskeleton through various tests, including the 10-Meter Walk Test and Timed Up and Go.

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 exoskeleton's safety and effectiveness for individuals with spinal cord injury. It involves attending several visits for training and assessments to see how well participants can use this personal mobility device.

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+

James J. Peters Veterans Affairs Medical Center

Collaborator

Trials

59

Recruited

2,900+

Published Research Related to This Trial

The study introduced an innovative intraoral tongue-computer interface (ITCI) that allows individuals with tetraplegia to control a five-degree-of-freedom upper-limb exoskeleton, enabling them to perform tasks like drinking with minimal training (only 2 hours).

Participants, including a clinical case study, demonstrated the ability to control the exoskeleton effectively, achieving performance speeds that were only slightly slower than able-bodied individuals, even without visual feedback, showcasing the potential for independence in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eyes-Free Tongue Gesture and Tongue Joystick Control of a Five DOF Upper-Limb Exoskeleton for Severely Disabled Individuals. Mohammadi, M., Knoche, H., Thøgersen, M., et al.[2022]

The FLEXotendon Glove-III, a soft robotic hand exoskeleton, was evaluated in a case study with two individuals with cervical spinal cord injury, using standardized tests to measure hand function improvements.

Design enhancements, such as fingertip force sensors and a redesigned smartphone app, were implemented to improve user experience and safety during rehabilitation, indicating a focus on both efficacy and user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the FLEXotendon glove-III through a human subject case study. Tran, P., Elliott, D., Herrin, K., et al.[2023]

A novel controller that monitors head position to control hand movements in three-dimensional space was tested, showing effectiveness in helping individuals with upper limb disabilities perform tracking tasks.

Out of 18 subjects, including 13 with spinal cord injuries, most were able to use the controller effectively after minimal training, suggesting its potential for aiding those with upper limb amputation or paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel five degree of freedom user command controller in people with spinal cord injury and non-injured for full upper extremity neuroprostheses, wearable powered orthoses and prosthetics. Scott, TR., Vare, VA.[2021]

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]

A feasibility study involving 10 individuals with chronic spinal cord injury showed that while exoskeleton training improved walking speeds and distances, only 5 out of 10 participants completed the program due to challenges like ineligibility and lack of interest.

Participants experienced some skin issues (grade I/II aberrations), highlighting the need for careful monitoring of medical complications when using exoskeletons for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower-limb exoskeletons for individuals with chronic spinal cord injury: findings from a feasibility study. Benson, I., Hart, K., Tussler, D., et al.[2018]

The motor-augmented wrist-driven orthosis (MWDO) enhances grasping ability for individuals with C6-C7 spinal cord injuries by combining both body-powered and motorized actuation, allowing for more flexible and dexterous hand movements.

The MWDO features a control scheme that decouples wrist and finger movements, along with a magnetic latch at the finger joint, improving the ability to perform daily activities like pinching and grasping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor-Augmented Wrist-Driven Orthosis: Flexible Grasp Assistance for People with Spinal Cord Injury. McPherson, AIW., Patel, VV., Downey, PR., et al.[2020]

This study developed a musculoskeletal model to analyze upper extremity biomechanics in individuals with complete spinal cord injury using a powered exoskeleton and crutches, revealing that these users experience significantly higher joint loads compared to those with incomplete SCI.

The findings suggest that prolonged crutch use during exoskeleton walking leads to increased upper extremity joint impulses, which could raise the risk of overuse injuries; thus, improving device design and training methods is crucial for reducing these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating upper extremity joint loads of persons with spinal cord injury walking with a lower extremity powered exoskeleton and forearm crutches. Smith, AJJ., Fournier, BN., Nantel, J., et al.[2021]

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]

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]

Powered robotic exoskeletons enable non-ambulatory individuals with spinal cord injuries (SCI) to walk, achieving a mean gait speed of 0.26 m/s, particularly among those with thoracic-level motor-complete injuries.

Factors such as age, injury level, and the number of training sessions positively influence gait speed, indicating that more training can lead to better walking outcomes for users of powered exoskeletons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait speed using powered robotic exoskeletons after spinal cord injury: a systematic review and correlational study. Louie, DR., Eng, JJ., Lam, T.[2018]

A concordance table was developed to estimate Spinal Cord Injury Functional Index Assistive Technology (SCI-FI/AT) scores from FIM motor item scores, allowing researchers to combine data from both assessments for better analysis of functional outcomes in individuals with spinal cord injuries.

The study found that while the estimated SCI-FI/AT scores correlated well with actual scores (Pearson correlation of 0.79), caution is advised when interpreting scores for individuals with cervical-level injuries, as greater discrepancies were noted in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Concordance Table to Convert FIM Basic Mobility and Self-Care Scale Scores to SCI-FI/AT Scores. Ni, P., Spellman, K., Zafonte, R., et al.[2022]

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/PMC9611825/

The Outcomes of Robotic Rehabilitation Assisted Devices ... Spinal cord injuries (SCIs) have a significant negative effect on patients' quality of life. Voluntary muscle paralysis caused by spinal cord damage affects the ...

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01649-1

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 ...

4. 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 ...

5. asia-spinalinjury.org asia-spinalinjury.org/wp-content/uploads/2025/05/Wandercraft_ASIApresentation_04.25.25.pdf

Robotic Exoskeletons Cost-effectiveness analysis of overground robotic training versus conventional locomotor training in people with spinal cord injury. J ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10274525/

Results of 50 patients - PMC - PubMed Central The purpose of this study was to determine the safety, feasibility, and functional effectiveness of HAL® locomotion training in the initial rehabilitation of ...

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01621-z

Hands-free Atalante exoskeleton in post-stroke gait and ... This study indicates that the hands-free Atalante exoskeleton is safe, feasible, and well-tolerated for gait and balance rehabilitation in post-stroke subjects.

8. 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.

9. sralab.org sralab.org/sites/default/files/downloads/2021-05/Clinician%20Perceptions%20of%20Robotic%20Exoskeletons%20for%20Locomotor%20Training%20Following%20Spinal%20Cord%20Injury%20A%20Qualitative%20Approach.pdf

Clinician Perceptions of Robotic Exoskeletons for ... This study aims to describe clinicians' preferences, clinical practices, training strategies, and clinical decisions on how robotic exoskeleton devices are used.