RECRUITING

Evaluation of an Advanced Lower Extremity Neuroprostheses

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Evaluation of Advanced Lower Extremity Neuroprostheses

Quick Facts

Study Start:2018-06-01
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00623389

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.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Low cervical or thoracic spinal cord injury (C6-T12) or other paralyzing condition
  2. * Skeletal maturity
  3. * Ability to understand and sign informed consents
  4. * Disability equivalent to ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing) or C (motor and sensory sparing)
  5. * Intact and electrically excitable lower motor neurons
  6. * Greater than 6 months since injury or onset
  7. * Range of motion within normal limits
  1. * Pacemaker
  2. * Cardiac arrythmia
  3. * Pregnancy
  4. * Contractures of any major joint of upper or lower extremities
  5. * Uncontrolled seizure disorder
  6. * Obesity
  7. * Untreated substance abuse
  8. * Immunodeficiency
  9. * Frequent urinary tract infections
  10. * Presence of decubitis ulcers
  11. * Acute or chronic psychological problems
  12. * Acute orthopaedic problems
  13. * Pulmonary compromise
  14. * Renal compromise
  15. * Circulatory compromise
  16. * History of spontaneous fractures or insulin dependent diabetes

Contacts and Locations

Study Contact

Lisa M Lombardo, MPT
CONTACT
216-791-3800
lisa.lombardo2@va.gov
Maura Malenchek, PTA
CONTACT
216-791-3800
maura.malencheck@va.gov

Principal Investigator

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 Locations (Sites)

Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44106
United States
MetroHealth System
Cleveland, Ohio, 44109
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-01
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2018-06-01
Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

  • Neurologic disorders
  • Rare disease
  • Spinal cord injuries
  • Stroke
  • Paraplegia
  • Tetraplegia

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Stroke
  • Paralysis
  • Tetraplegia
  • Paraplegia