Mobile Manual Standing Wheelchair for SCI

Spinal Cord Injuries Clinical Trial

— MMSW-SCI  

Official title:

Impact of Mobile Manual Standing Wheelchair on Standing Dosage and Utility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04668326
• Other study ID #: F3505-R
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Andrew H Hansen, PhD
• Phone: (612) 467-2910
• Email: andrew.hansen2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background - The investigators contend that for Veterans with SCI to stand enough to impact health outcomes, the standing device must enhance utility while integrating into their everyday life; at home, at work, and in the community. For this integration to occur, the investigators believe the standing device must fulfill the following criteria: 1. Easy access, 2. Straightforward standing mechanism, 3. Mobility in both seated and standing positions, 4. Natural intuitive propulsion, 5. Stability, and 6. Independent operability. The Minneapolis Adaptive Design & Engineering (MADE) Program has recently developed a mobile manual standing wheelchair (MMSW) with all these features. Based on initial in-lab pilot testing, Veterans who trialed the device demonstrated excellent functional mobility and stability in both seated and standing postures. User feedback received during this initial testing also indicated these unique mobility and stability features offer potential new utility for Veterans with SCI.

Research Questions (Objectives) - The purpose of this project is to extend testing of the MMSW to home and community environments of 48 Veterans with SCI to see if mobility in standing affects utility and standing time.

Relevance to VA - There is a mounting body of literature showing significant adverse health consequences associated with excessive time spent in a seated position. Any person who has an underlying condition which impairs their ability to stand or walk is at increased risk for seating related adverse health consequences. There are an estimated 1.7 million people in the United States who have enough impairment that they use seated mobility devices (wheelchairs and scooters). Specifically, people with spinal cord injuries (SCI) are particularly prone to complications from excessive sitting, because many are unable to stand without some type of support. According to the VA's Corporate Data Warehouse, the VA provides care to 17,886 Veterans with SCI/D each year and estimate that over 7,000 of these Veterans have paraplegia. Excessive sitting after SCI is believed to contribute to pressure injuries, worsening pain, osteoporosis, joint stiffness, spasticity, and worsening bowel and bladder function. Until recently, there have been few practical options for safely supporting these individuals while standing or walking. Although there is now a growing list of assistive devices available to support standing and walking in SCI, relatively little attention has been given to determining how often such devices are used or how often they would need to be used to optimally promote the various potential health-related outcomes, nor which devices are most likely to achieve these changes.

Number of Research Participants (Sample Size) - Forty-eight participants (24/group) will be randomized. Each of the two study sites will be expected to screen up to 390 participants to reach the target of 48 randomized over both sites.

Participating Sites - Minneapolis VA Health Care System, VA Palo Alto Health Care System

Duration of Participant Intake (Study Duration) - This project is projected to be a total of four years. The two study sites will have a start-up period of between three to six months and will recruit for approximately three years. The remaining six to nine months will be used for dissemination of study results and study close-out.

Treatment (follow-up) - The intervention being tested is two months of home and community use of a manual standing wheelchair (mobile or non-mobile in standing).

Endpoints - The primary outcomes for this study are utility and standing dose.

Utility - The utility of the study wheelchairs and the current standing device (when applicable) will be assessed using the Wheelchair Outcome Measure (WhOM). The WhOM focuses on ICF constructs of participation and body function. It 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. These rankings allow a quantitative score to be calculated for comparison.

Standing dose - Acceleration data from data loggers will be downloaded and placed on a secure server for further analysis. These data will be visually inspected to determine a threshold for distinguishing sitting and standing postures. These values may vary depending on the mounting on each standing device. After mounting with each system, the participant will go through a sit-to-stand movement and data will be uploaded to ensure the system is detecting movement. This initial movement will also be used to determine an appropriate threshold for standing/sitting. In addition to overall standing time, the investigators will examine frequency of standing bouts and time per standing bout as these are relevant for future pressure injury prevention. The investigators will also monitor movement of the wheelchair during both sitting and standing to understand how often the mobility feature of the MMSW is used during the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Veterans with spinal cord injury between C7 and T12 (AIS A-C)

• Unable to stand independently without support

• Greater than 6 months post-injury

• Mass less than 275 lb (125 kg)

• Manual wheelchair as primary means of mobility

• 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

Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• Manual Standing Wheelchair
Mobile in seated position; Not mobile in standing position
• Mobile Manual Standing Wheelchair
Mobile in BOTH seated and standing positions

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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