RECRUITING

A Neuroprosthesis for Seated Posture and Balance

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 stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.

Official Title

A Neuroprosthesis for Seated Posture and Balance

Quick Facts

Study Start:2011-11-30
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01474148

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * C4-T12
  2. * ASIA Scale A through C
  3. * Time post injury greater than 6 months
  4. * Innervated and excitable trunk and pelvis musculature
  5. * Absence of acute or chronic psychological problems or chemical dependency
  6. * Range of motion within normal limits
  7. * Controlled spasticity and absence of hip flexion and adduction spasm
  8. * Height and weight within normal limits
  9. * No history of balance problems or spontaneous falls
  10. * No history of spontaneous fracture or evidence low bone density
  11. * No acute orthopaedic problems
  12. * No acute medical complications
  13. * Adequate social support and stability
  14. * Able to speak and read English
  1. * Pregnancy
  2. * Non-English speaking

Contacts and Locations

Study Contact

Lisa M Lombardo, MPT
CONTACT
(216) 791-3800
Lisa.Lombardo2@va.gov
Emily C Johnson, BA
CONTACT
(216) 791-3800
emily.johnson17@va.gov

Principal Investigator

Ronald Triolo, PhD
PRINCIPAL_INVESTIGATOR
Louis Stokes VA Medical Center, Cleveland, OH

Study Locations (Sites)

Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Ronald Triolo, PhD, PRINCIPAL_INVESTIGATOR, Louis Stokes VA Medical Center, Cleveland, OH

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 Date2011-11-30
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2011-11-30
Study Completion Date2027-01-31

Terms related to this study

Keywords Provided by Researchers

  • paraplegia
  • tetraplegia
  • Spinal cord injured
  • FES

Additional Relevant MeSH Terms

  • Spinal Cord Injury
  • Paralysis
  • Tetraplegia
  • Paraplegia