RECRUITING

TPAD for Recovery of Standing After Severe SCI

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 investigate how standing and sitting balance control is altered after spinal cord injury (SCI) and how a new type of robotic assistive device may be used to improve muscle function. This device is called the Tethered Pelvic Assist Device, or TPAD. The main aims are to: 1. Examine muscle activation patterns generated during different types of standing in spinal cord injured individuals using robotic assistance or self-assistance for balance 2 and 3. Examine the effectiveness of robotic-assisted stand training in the improvement of posture control during different types of standing and sitting in spinal cord injured individuals. Participants will be placed into one of 5 groups based on a physical classification of their spinal cord injury: Group 1: * Individuals with SCI that can stand independently * Will receive TPAD training * Will undergo standing, posture, sitting, and stepping assessments * Participation in this group will last about six months Group 2: * Individuals with SCI that cannot stand independently * Will receive TPAD training * Will undergo standing, posture, sitting, and stepping assessments * Participation in this group will last about 6 months Group 3: * Individuals with SCI that can stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks Group 4: * Individuals with SCI that cannot stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks Group 5: * Individuals without a SCI * Will undergo standing, posture, and sitting assessments * Participation in this group will last about 2 weeks

Official Title

Tethered Pelvic Assist Device for Recovery of Standing After Severe SCI

Quick Facts

Study Start:2024-10
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06643312

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. At least 18 years of age at the time of enrollment;
  2. 2. stable medical condition
  3. 3. at least one year post-spinal cord injury (Groups 1-4)
  4. 4. non-progressive, traumatic SCI above T10 (Groups 1-4)
  5. 5. Injury Grade A, B, C or D (Groups 1-4)
  6. 6. ability to stand independently for short periods of time, not exceeding 1 hour (Groups 1 and 3)
  7. 7. inability to stand independently (Groups 2 and 4)
  1. 1. unwillingness to wean from anti-spasticity medications;
  2. 2. untreated painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection
  3. 3. history of bone disease unassociated with decreased bone mineral density due to spinal cord injury
  4. 4. ongoing drug abuse
  5. 5. untreated psychiatric disorders or clinical depression
  6. 6. received botox injections in lower extremities in the prior six months
  7. 7. Cardiopulmonary disease that may interfere with assessments
  8. 8. Untreated severe and persistent dysautonomia
  9. 9. Neurological injury or disease (Group 5)
  10. 10. Orthopedic injury or condition (Group 5)

Contacts and Locations

Study Contact

Research Manager
CONTACT
9733243557
LMartinez@KesslerFoundation.Org
Gail F Forrest, PhD
CONTACT
9733243518

Principal Investigator

Gail F Forrest, PhD
PRINCIPAL_INVESTIGATOR
Kessler Foundation

Study Locations (Sites)

Kessler Foundation
West Orange, New Jersey, 07052
United States

Collaborators and Investigators

Sponsor: Kessler Foundation

  • Gail F Forrest, PhD, 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 Date2024-10
Study Completion Date2028-01

Study Record Updates

Study Start Date2024-10
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • TPAD

Additional Relevant MeSH Terms

  • SCI - Spinal Cord Injury