Exoskeleton for Spinal Cord Injury
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.12345
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.26789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Device Fitting and Training
Participants undergo device fitting and five training sessions to learn basic skills with the exoskeleton, concluding with a competency evaluation.
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.
Follow-up
Participants are monitored for safety and effectiveness after the main training and evaluation phases.
What Are the Treatments Tested in This Trial?
Interventions
- Hands-free exoskeleton
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wandercraft
Lead Sponsor
James J. Peters Veterans Affairs Medical Center
Collaborator