Evaluation of an Advanced Lower Extremity Neuroprostheses

Launched by CASE WESTERN RESERVE UNIVERSITY · Feb 15, 2008

Keywords

ClinConnect Summary

**Clinical Trial Summary: Evaluation of an Advanced Lower Extremity Neuroprostheses**

This clinical trial is looking at a special device that can be surgically implanted to help people with paralysis, which may come from conditions like spinal cord injuries or strokes. The device uses something called functional electrical stimulation (FES) to assist with movements such as standing, stepping, and maintaining balance. The goal is to see if this technology can improve physical activity and mobility for individuals who may have limited movement due to their condition.

To participate in this study, individuals must be between the ages of 16 and 75 and have a specific type of spinal cord injury or another condition that causes paralysis. They should have been stable for at least six months and have certain functioning nerves in their legs. However, there are some health conditions that would prevent someone from participating, such as having a pacemaker or pregnancy. If you join the study, you can expect to receive support and monitoring throughout the trial as you try out this new technology designed to help enhance movement and independence.

Gender

ALL

Eligibility criteria

• • Phase I Inclusion Criteria
• • 1. Skeletal maturity and ability to sign informed consent (\>18 years)
• • 2. Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
• • 3. Innervated and excitable lower extremity and trunk musculature
• • 4. Adequate social support and stability
• • 5. Willingness to comply with follow-up procedures
• • Phase I Exclusion Criteria
• • 1. Non-English speaking
• • 2. Females who are pregnant
• • 3. Current pressure injuries that would be exacerbated by study activities
• • 4. Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities
• • 5. History of spontaneous fractures or other evidence of excessively low bone density
• • 6. History of vestibular dysfunction, balance problems, or spontaneous falls
• • 7. Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.