Actively Recruiting
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
Eligibility Criteria
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
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
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
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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