An interventional study of Smart Power Assistance Module (SPAM) and Smart Wheelchair Component System (SWCS) in Blindness and Spinal Cord Injury, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-03.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Prevention
The goal of this project is to evaluate the Smart Wheelchair Component System (SWCS) for power wheelchairs and the Smart Power Assistance Module (SPAM) for manual wheelchairs in realistic indoor environments with target users performing realistic tasks. We will combine group trials involving individuals who have a visual impairment (but do not have a mobility impairment) with several single-case studio involving individuals who have a visual and mobility impairment. Our long-term objective is to provide independent mobility to veterans with mobility and sensory impairments.
There are currently very few mobility options for veterans who have a mobility impairment and visual impairment, and this population will grow as the number of older veteran's increases. The goal of this project is to evaluate the Smart Wheelchair Component System (SWCS) for power wheelchairs and the Smart Power Assistance Module (SPAM) for manual wheelchairs in realistic indoor environments with target users performing realistic tasks. We will combine group trials involving individuals who have a visual impairment (and may or may not have a mobility impairment) with several single-case studies involving individuals who have a visual and mobility impairment.
The key questions that will be addresses by the proposed research are:
Can smart wheelchair technology improve performance on realistic navigation tasks for individuals with visual and mobility impairments?
Will smart wheelchair technology increase the amount of independent travel by individuals with visual and mobility impairments?
Will using a smart wheelchair for an extended period of time diminish a person's ability to operate a "traditional" wheeled mobility aid?
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 4 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Smart Power Assistance Module (SPAM) Smart Wheelchair Component System (SWCS)
Device: Smart Power Assistance Module (SPAM) · Device: Smart Wheelchair Component System (SWCS)
Experimental Power wheelchair utilized to traverse prescribed course
Experimental power wheelchair utilized to traverse prescribed course
Time to Complete Trial Wheelchair Course
Time to complete the course was recorded. The indoor course was set up in the research laboratory to include a straight path and 90 degree turns that included obstacles such as a cardboard box, a large orange cone, and a desk chair. The location of these obstacles were randomly placed in order to test whether or not the SPAM or SWCS was able to detect objects.
Time frame: Two years
| Milestone | Arm 1: SWCS and SPAM |
|---|---|
| Started | 4 |
| Completed | 0 |
| Not completed | 4 |
Time to complete the course was recorded. The indoor course was set up in the research laboratory to include a straight path and 90 degree turns that included obstacles such as a cardboard box, a large orange cone, and a desk chair. The location of these obstacles were randomly placed in order to test whether or not the SPAM or SWCS was able to detect objects.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: SWCS and SPAM | — | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Arm 1: SWCS and SPAM |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Arm 1: SWCS and SPAM |
|---|---|
| Female | 0 |
| Male | 4 |
| Region of Enrollment(participants) | Arm 1: SWCS and SPAM |
|---|---|
| United States | 4 |
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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VA Office of Research and Development