Actively Recruiting

Phase Not Applicable
Age: 21Years - 75Years
All Genders
ID00623389

Evaluation of Advanced Lower Extremity Neuroprostheses to Assist Standing and Mobility in Paralysis

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

10

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a surgically implanted functional electrical stimulation (FES) system designed to assist people with various degrees of paralysis in exercising, standing, stepping, and maintaining balance. This study focuses on individuals with conditions such as spinal cord injuries, stroke, tetraplegia, and paraplegia who experience paralysis affecting the trunk and lower limbs. The purpose is to assess the system's technical performance and its impact on functional abilities. Participants undergo surgery to implant electrodes into muscles of the trunk and legs, which are connected to a stimulator/telemeter device. After implantation, patients receive training in standing, transfers, and advanced mobility skills using the FES system. The study includes a prescribed course of exercise, functional training, rehabilitation, and laboratory assessments of strength, balance, and functional abilities both with and without the system. Following this, patients complete home-based training before discharge for continued home use of the device. During the study, participants are monitored with follow-up visits at 6 and 12 months after discharge and annually thereafter. Researchers evaluate device reliability and technical performance by measuring changes in standing duration, standing loads, walking distance, and walking duration from baseline at discharge to 12 months later. They also assess changes in daily functional activities. The total study participation includes surgical intervention, rehabilitation, home training, and long-term follow-up over multiple years.

CONDITIONS

Brief 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)
  • Non-ventilator dependent paralysis caused by mid cervical/thoracic spinal cord injuries (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
  • Females who are pregnant
  • Current pressure injuries that could worsen with study activities
  • Severe contractures or uncontrolled spasticity causing fixed deformities in major upper or lower joints that interfere with study activities
  • History of spontaneous fractures or very low bone density
  • History of vestibular dysfunction, balance problems, or spontaneous falls
  • Untreated or acute orthopedic problems preventing weight bearing or exercise such as dislocation or fracture

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo surgery to implant electrodes into muscles of the trunk and legs, connected to an implanted stimulator-telemeter device.

1 surgery visit and immediate post-operative monitoring

Treatment

Duration - Several weeks post-surgery until discharge

Participants receive prescribed exercise, functional training, and rehabilitation using the implanted stimulation system, including laboratory assessments of strength, balance, and functional abilities.

Multiple in-person visits during rehabilitation and training period

Post-operative Follow-up

Duration - Up to 12 months after discharge and annually thereafter

Participants continue home-based training with the implanted system and attend follow-up visits to assess device performance and functional outcomes.

Visits at 6 months, 12 months, and annually after discharge

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

M

Maura Malenchek, PTA

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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Published Research Related To This Trial

Long-term user perceptions of an implanted neuroprosthesis for exercise, standing, and transfers after spinal cord injury.

Sanjeev Agarwal, Ronald J Triolo, Rudi Kobetic...

https://pubmed.ncbi.nlm.nih.gov/14582528

Preliminary evaluation of a neural prosthesis for standing after spinal cord injury with four contact nerve-cuff electrodes for quadriceps stimulation.

Lee E Fisher, Michael E Miller, Stephanie J Nogan...

https://pubmed.ncbi.nlm.nih.gov/17947042

Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up.

Ronald J Triolo, Stephanie Nogan Bailey, Kevin M Foglyano...

https://pubmed.ncbi.nlm.nih.gov/28899825