Actively Recruiting

Phase Not Applicable
Age: 21Years - 75Years
All Genders
NCT00623389

Evaluation of an Advanced Lower Extremity Neuroprostheses

Led by Case Western Reserve University · Updated on 2025-06-15

10

Participants Needed

2

Research Sites

500 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.

CONDITIONS

Official Title

Evaluation of an Advanced Lower Extremity Neuroprostheses

Who Can Participate

Age: 21Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Skeletal maturity and ability to sign informed consent (over 18 years old)
  • Non-ventilator dependent paralysis from mid cervical/thoracic spinal cord injury (C4 or below), poststroke hemiparesis, traumatic brain injury, or multiple sclerosis affecting trunk and/or lower limbs
  • Innervated and excitable muscles in lower extremities and trunk
  • Adequate social support and stability
  • Willingness to comply with follow-up procedures
Not Eligible

You will not qualify if you...

  • Non-English speaking
  • Pregnant females
  • Current pressure injuries that could worsen with study activities
  • Severe contractures or uncontrolled spasticity causing fixed deformities interfering with activities
  • History of spontaneous fractures or very low bone density
  • History of vestibular dysfunction, balance problems, or spontaneous falls
  • Acute or untreated orthopedic problems preventing weight bearing or exercise such as dislocation or fracture

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

2

MetroHealth System

Cleveland, Ohio, United States, 44109

Actively Recruiting

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Research Team

L

Lisa M Lombardo, MPT

CONTACT

M

Maura Malenchek, PTA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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