Wearable lower-limb exoskeleton to stretch legs and improve walking
Leg Stretching Using a Controllable Wearable Exoskeleton on Demand for People With Spasticity
This research will test a portable wearable exoskeleton to help people with spasticity from spinal cord injury increase leg range of motion and improve walking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Syracuse, New York) |
| Trial ID | NCT05926596 on ClinicalTrials.gov |
What this trial studies
The project develops a protocol using a fully wearable, portable lower‑limb exoskeleton and body sensors to support leg motion and stretching. Participants will perform guided leg‑stretching, treadmill walking, and overground walking while researchers record muscle activity, joint motion, and gait performance. The study enrolls people with neurological movement deficits, primarily veterans with spinal cord injury who are neurologically stable at least six months after injury. The overall aim is to refine an effective assistance strategy that can restore range of motion and gait ability and reduce caregiver burden.
Who should consider this trial
Good fit: Ideal candidates are veterans with spasticity from spinal cord injury at least six months post‑injury who are neurologically stable, can wear the device and sensors, and can provide informed consent.
Not a fit: People with other active neurological disorders, recent hip/knee pain or injuries that limit mobility, pregnancy, weight over 300 lbs, or unresolved surgical recovery are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could increase leg range of motion, reduce spasticity‑related gait problems, and improve independence and quality of life.
How similar studies have performed: Robotic and exoskeleton‑assisted gait training has shown promise for improving mobility in some populations, but fully wearable on‑demand exoskeleton approaches for spasticity are still emerging and less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veteran individuals with spasticity due to spinal cord injury (SCI) at least 6 months post SCI * Capable of providing informed consent and reporting age, gender, and neurological condition * Neurologically stable (\>6 months post-SCI) and can wear the device and the sensors, provide written informed consent, and follow instruction Exclusion Criteria: * Participants should not experience another neurological disorder except their primary diagnosed neurological condition (spinal cord injury) * Participants should not be pregnant * Participants should weigh less than 300 lbs * Participants should not have experienced signs of hip/knee pain during the past 2-3 weeks that limits mobility (i.e., reaching, walking, lifting, etc.) * Participants should be recovered from any previous surgical interventions, joint injuries, muscle strain, or extreme muscle soreness following surgery * Participants should not take medications known to affect bone metabolism, muscle strength or cardiovascular performance or have any ailments causing high fever, high blood pressure, or high heart rate
Where this trial is running
Syracuse, New York
- Syracuse VA Medical Center, Syracuse, NY — Syracuse, New York, United States (Recruiting)
Study contacts
- Principal investigator: Steven W Brose — Syracuse VA Medical Center, Syracuse, NY
- Study coordinator: Steven W Brose
- Email: steven.brose@va.gov
- Phone: (315) 425-4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.