Leg Stretching Using an Exoskeleton for Spasticity

This study is testing a wearable robotic exoskeleton designed to help people with spasticity (muscle stiffness) due to spinal cord injury. The goal is to improve leg movement and walking ability by using the exoskeleton for leg stretching, treadmill walking, and regular walking. Researchers will measure how well the exoskeleton helps with joint movement and muscle activity. To join, you must be an adult veteran with spasticity from a spinal cord injury that happened at least six months ago, and be able to wear the device and follow instructions. The study aims to enroll 10 participants. Success will be measured by changes in 3D body postures, joint angles, and joint angular velocities over approximately 24 weeks.

Study design
This is an interventional study with a planned enrollment of 10 participants. The phase of the study is not specified.
What's involved
Participants will undergo preparation, sensor placement, and device fitting. They will then follow a leg stretching protocol using the wearable robotic exoskeleton for 40-60 minutes.
Compensation
Not stated in the trial record.
Follow-up
Primary endpoints, such as 3D postures and joint angles, will be measured through study completion, an average of 24 weeks.

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NCT05926596

Leg Stretching Using an Exoskeleton on Demand for People With Spasticity

Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~10 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:Wearable Robotic Exoskeleton

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
3D postures
Measured over Through study completion, an average of 24 weeks
+2 more outcomes measured
Spasticity
Movement Disorders
Spinal Cord Injury
1 sites across 1 states
New York1
  • Steven W Brose · PRINCIPAL_INVESTIGATOR · Syracuse VA Medical Center, Syracuse, NY

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Eligibility criteria

Inclusion

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

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
  • 3D posturesThrough study completion, an average of 24 weeks

    3D postures will be assessed using the device, combining measurements of multiple joints in space

  • Joint anglesThrough study completion, an average of 24 weeks

    Hip and knee joint angles measured in degrees will be assessed using the device

  • Joint angular velocitiesThrough study completion, an average of 24 weeks

    Hip and knee joint velocities measured in radians per second or degrees per second will be assessed using the device