RECRUITING

Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation

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 understand how standing and sitting balance control is altered after spinal cord injury and how a new type of robotic assistive device may be used with spinal stimulation to improve muscle function. The investigators will be testing a device called the Tethered Pelvic Asist Device (or "TPAD") in this study. The TPAD may be helpful in two ways. It can be used to help control and support of the trunk, pelvis, and knees during stand training. Also, the TPAD can be used as a training tool by providing controlled "pushes" or "perturbations" that must be corrected by the person with spinal cord injury in order to maintain proper posture and upright balance. This could be helpful for improving muscle function after spinal cord injury. Participants will be placed into one of two groups based on availability and preference. Group 1 will receive TPAD training with stimulation and assessments with and without stimulation. Participation in this group lasts approximately 4 months. Group 2 will only receive assessments with and without stimulation. Participation in this group last approximately 3 weeks.

Official Title

Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation

Quick Facts

Study Start:2024-11-01
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06650202

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years old
  2. * Stable medical condition.
  3. * Has a spinal cord injury caused by trauma (fall, car accident, etc.) for at least one year that is not getting worse over time
  4. * Has an implanted spinal cord epidural stimulation unit that is eligible for software upgrade as part of a previous study.
  5. * Unable to stand independently with epidural stimulation turned off.
  1. * unwilling to discontinue from anti-spasticity medications
  2. * Untreated painful problems with joints, muscles or bones.
  3. * Unhealed fracture.
  4. * Pressure sore or urinary tract infection.
  5. * History of bone disease (except for decreased bone mineral density due to spinal cord injury).
  6. * Ongoing drug abuse.
  7. * Untreated psychiatric disorders or clinical depression.
  8. * Received Botox injections in the lower extremities in the prior six months.
  9. * Heart or lung disease that may interfere with assessments.
  10. * Untreated severe and persistent problems regulating blood pressure, heart rate, body temperature or other automatic functions.

Contacts and Locations

Study Contact

Research Manager
CONTACT
9733243557
LMartinez@KesslerFoundation.Org

Principal Investigator

Principal Investigator
PRINCIPAL_INVESTIGATOR
Kessler Foundation

Study Locations (Sites)

Kessler Foundation
West Orange, New Jersey, 07052
United States

Collaborators and Investigators

Sponsor: Kessler Foundation

  • Principal Investigator, PRINCIPAL_INVESTIGATOR, Kessler Foundation

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 Date2024-11-01
Study Completion Date2028-01

Study Record Updates

Study Start Date2024-11-01
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • TPAD

Additional Relevant MeSH Terms

  • SCI - Spinal Cord Injury