ACTIVE_NOT_RECRUITING

Mobile Manual Standing Wheelchair for 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

People with spinal cord injuries (SCI) are particularly prone to complications from excessive sitting, because many are not able to stand without support. Excessive sitting after SCI is believed to contribute to pressure injuries, pain, osteoporosis, joint stiffness, spasticity, and worsening bowel and bladder function. The VA has developed, patented, and licensed a mobile manual standing wheelchair (MMSW), and the investigators believe the key feature of being able to wheel around while in a standing position will dramatically change how paralyzed Veterans function in their home and community. If this expanded utility is realized, persons with SCI may naturally spend more time standing and less time sitting. To test these ideas, Veterans with SCI will be randomized to using one of two manual standing wheelchairs at home and in the community for two months.

Official Title

Impact of Mobile Manual Standing Wheelchair on Standing Dosage and Utility

Quick Facts

Study Start:2023-05-01
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04668326

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. * United States Veteran
  2. * SCI or stable disorder/dysfunction of the spinal cord
  3. * Tolerates manual wheelchair use on a regular basis
  4. * Sufficient hand \& arm function to operate manual standing wheelchair
  5. * Unable to stand independently without support
  6. * Greater than 6 months post-injury (SCI), or 6 months post diagnosis (disorder/dysfunction)
  7. * Weight less than 125 kg (275 lbs)
  8. * Age 18 or older
  9. * Decisional competency to provide consent and cognitive ability to participate fully in study procedures
  10. * Body size appropriate to fit the devices
  11. * Not involved in another study related to mobility
  12. * Identify an appropriate location for use of the study wheelchair
  1. * Contraindication for standing including lower limb contractures, uncontrolled hypertension, uncontrolled spasticity, etc.
  2. * Unhealed lower-limb fractures
  3. * Unstable lower-limb joints
  4. * An active grade 2 or greater pressure injury that can be worsened by standing in the device
  5. * Flap procedure to address pressure injury less than one year earlier
  6. * Not able to propel a manual wheelchair or operate the sit-to-stand mechanism (e.g. weakness, or discomfort)
  7. * Low bone mineral density (BMD), defined by total hip DXA more than 3.5 SD below peak and/or distal femur/proximal tibia BMD below 0.6 g/cm2. (Low BMD at any site will be ineligible).
  8. * Unable to obtain clinically acceptable seating system for study wheelchairs
  9. * Unable to build up standing tolerance within the first eight visits
  10. * Individual deemed not appropriate for participation in the study as determined by study team

Contacts and Locations

Principal Investigator

Andrew H Hansen, PhD
PRINCIPAL_INVESTIGATOR
Minneapolis VA Health Care System, Minneapolis, MN
B. Jenny Kiratli, PhD
PRINCIPAL_INVESTIGATOR
VA Palo Alto Health Care System, Palo Alto, CA

Study Locations (Sites)

VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Andrew H Hansen, PhD, PRINCIPAL_INVESTIGATOR, Minneapolis VA Health Care System, Minneapolis, MN
  • B. Jenny Kiratli, PhD, PRINCIPAL_INVESTIGATOR, VA Palo Alto Health Care System, Palo Alto, CA

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 Date2023-05-01
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2023-05-01
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • Paraplegia
  • Mobility
  • Standing
  • Spinal Cord Injury

Additional Relevant MeSH Terms

  • Spinal Cord Injuries and Disorders