Evaluation of an Advanced Lower Extremity Neuroprostheses

Description

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

Spinal Cord Injuries, Stroke, Paralysis, Tetraplegia, Paraplegia

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Study Overview

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Study Details

Study overview

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.

Evaluation of Advanced Lower Extremity Neuroprostheses

Evaluation of an Advanced Lower Extremity Neuroprostheses

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

Cleveland

Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio, United States, 44106

Cleveland

MetroHealth System, Cleveland, Ohio, United States, 44109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Low cervical or thoracic spinal cord injury (C6-T12) or other paralyzing condition
  • * Skeletal maturity
  • * Ability to understand and sign informed consents
  • * Disability equivalent to ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing) or C (motor and sensory sparing)
  • * Intact and electrically excitable lower motor neurons
  • * Greater than 6 months since injury or onset
  • * Range of motion within normal limits
  • * Pacemaker
  • * Cardiac arrythmia
  • * Pregnancy
  • * Contractures of any major joint of upper or lower extremities
  • * Uncontrolled seizure disorder
  • * Obesity
  • * Untreated substance abuse
  • * Immunodeficiency
  • * Frequent urinary tract infections
  • * Presence of decubitis ulcers
  • * Acute or chronic psychological problems
  • * Acute orthopaedic problems
  • * Pulmonary compromise
  • * Renal compromise
  • * Circulatory compromise
  • * History of spontaneous fractures or insulin dependent diabetes

Ages Eligible for Study

21 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Case Western Reserve University,

Ronald J Triolo, Ph.D., PRINCIPAL_INVESTIGATOR, Case Western Reserve University

Musa L Audu, Ph.D., PRINCIPAL_INVESTIGATOR, Louis Stokes Cleveland VA Medical Center

Study Record Dates

2025-05-31