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Search / Trial NCT01474148

A Neuroprosthesis for Seated Posture and Balance

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Nov 15, 2011

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Paraplegia Tetraplegia Spinal Cord Injured Fes

ClinConnect Summary

This clinical trial is studying a special device called a functional electrical stimulation (FES) system, which is surgically implanted to help people with spinal cord injuries improve their posture and balance while sitting. The FES system sends small electric signals to the nerves, causing muscles to contract and helping to stabilize the trunk and hips. This could make it easier for individuals to sit up straight, breathe better, and perform daily activities like reaching, pushing a wheelchair, or rolling in bed.

To participate in this study, volunteers should have a spinal cord injury at specific levels (between C4 and T12) and have been injured for more than six months. They also need to have good muscle control in their trunk and pelvis, be able to communicate in English, and not have serious psychological or medical issues. Participants will work with researchers to see how the FES system affects their ability to maintain stability and perform daily tasks, and they will receive support throughout the study. If you or someone you know might be interested in joining, it's a great opportunity to explore new ways to improve quality of life after a spinal cord injury.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • C4-T12
  • ASIA Scale A through C
  • Time post injury greater than 6 months
  • Innervated and excitable trunk and pelvis musculature
  • Absence of acute or chronic psychological problems or chemical dependency
  • Range of motion within normal limits
  • Controlled spasticity and absence of hip flexion and adduction spasm
  • Height and weight within normal limits
  • No history of balance problems or spontaneous falls
  • No history of spontaneous fracture or evidence low bone density
  • No acute orthopaedic problems
  • No acute medical complications
  • Adequate social support and stability
  • Able to speak and read English
  • Exclusion Criteria:
  • Pregnancy
  • Non-English speaking

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

Cleveland, Ohio, United States

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Ronald Triolo, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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