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Search / Trial NCT05926596

Leg Stretching Using an Exoskeleton on Demand for People With Spasticity

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 22, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Exoskeleton Spasticity

ClinConnect Summary

This clinical trial is studying the use of a special device called an exoskeleton, which is a wearable robotic suit designed to help improve leg and walking function for people with movement disorders, particularly those who have spasticity due to spinal cord injuries. The researchers want to see how this device can help stretch the legs, assist with walking on a treadmill, and aid in walking on ground surfaces. The ultimate goal is to find effective ways to help individuals regain their ability to move their legs and walk better, which can lead to a better quality of life.

To participate in this study, you need to be a veteran who has experienced spasticity from a spinal cord injury for at least six months and is in stable condition. You should be able to wear the device and follow instructions during the trial. However, there are some important exclusions: you cannot be pregnant, weigh less than 300 pounds, or have recent hip or knee pain that limits your movement. If you qualify and choose to participate, you’ll take part in experiments that track how your muscles and joints respond while using the exoskeleton. This could be a great opportunity to help researchers understand how to enhance mobility for people with similar conditions.

Gender

ALL

Eligibility 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

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Syracuse, New York, United States

Patients applied

0 patients applied

Trial Officials

Steven W Brose

Principal Investigator

Syracuse VA Medical Center, Syracuse, NY

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported