Mobile Manual Standing Wheelchair for SCI

NCT04668326 | Completed FDA Device

• 1 other identifier: F3505-R
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Spinal Cord Injuries and Disorders

Keywords

Paraplegia; Mobility; Standing; Spinal Cord Injury

Outcome Measures

Primary Outcomes (3)

• Utility - Measured using the Wheelchair Outcome Measure

  The Wheelchair Outcome Measure (WhOM) will be slightly modified to ask users to provide participation goals in the home and community in the context of standing devices/wheelchairs as opposed to wheelchairs alone. The WhOM collects activities that are goals for participation and then has the participant rank the importance and satisfaction with each activity. The rankings allow a quantitative score to be calculated for comparison. The WhOM was chosen to represent the concept of "utility" because it captures what is meaningful and important to each participant, while also allowing a quantitative scoring. The investigators will specifically calculate Mean satisfaction x importance = the sum of the individual importance x satisfaction of all goals divided number of goals Higher scores indicate higher satisfaction with specific goals, using importance of the task to help scale the effect of each goal. Thus higher scores will be considered higher utility.

  Two months

• Standing Dose - Total time standing - Study Wheelchair

  An accelerometer will be placed on part of the study standing wheelchair that rotates upward during standing. The gravitational acceleration will indicate standing versus sitting. A custom algorithm will be used to determine when the wheelchair is in the standing position.

  Two months

• Standing Dose - Total time standing - Existing Standing Device

  An accelerometer will be placed on part of the existing standing device (when applicable) that rotates upward during standing. The gravitational acceleration will indicate standing versus sitting. A custom algorithm will be used to determine when the standing device is in the standing position.

  Two months

Study Arms (2)

Manual Standing Wheelchair

ACTIVE COMPARATOR

Mobile in seated position; Not mobile in standing position

Device: Manual Standing Wheelchair

Mobile Manual Standing Wheelchair

EXPERIMENTAL

Mobile in BOTH seated and standing positions

Device: Mobile Manual Standing Wheelchair

Interventions

Manual Standing Wheelchair DEVICE

Mobile in seated position; Not mobile in standing position

Also known as: Levo Summit Wheelchair

Manual Standing Wheelchair

Mobile Manual Standing Wheelchair DEVICE

Mobile in BOTH seated and standing positions

Also known as: Modified Levo Summit Wheelchair

Mobile Manual Standing Wheelchair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• United States Veteran
• SCI or stable disorder/dysfunction of the spinal cord
• Tolerates manual wheelchair use on a regular basis
• Sufficient hand \& arm function to operate manual standing wheelchair
• Unable to stand independently without support
• Greater than 6 months post-injury (SCI), or 6 months post diagnosis (disorder/dysfunction)
• Weight less than 125 kg (275 lbs)
• Age 18 or older
• Decisional competency to provide consent and cognitive ability to participate fully in study procedures
• Body size appropriate to fit the devices
• Not involved in another study related to mobility
• Identify an appropriate location for use of the study wheelchair

You may not qualify if:

• Contraindication for standing including lower limb contractures, uncontrolled hypertension, uncontrolled spasticity, etc.
• Unhealed lower-limb fractures
• Unstable lower-limb joints
• An active grade 2 or greater pressure injury that can be worsened by standing in the device
• Flap procedure to address pressure injury less than one year earlier
• Not able to propel a manual wheelchair or operate the sit-to-stand mechanism (e.g. weakness, or discomfort)
• 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).
• Unable to obtain clinically acceptable seating system for study wheelchairs
• Unable to build up standing tolerance within the first eight visits
• Individual deemed not appropriate for participation in the study as determined by study team

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Disease; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Paralysis; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Andrew H Hansen, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

• B. Jenny Kiratli, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Device Trial

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 16, 2020
• Study Start: May 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: March 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)