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:
- 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.