Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03898362 |
| Other study ID # |
A2753-R |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
VA Office of Research and Development |
| Contact |
Brad E Dicianno, MD MS |
| Phone |
(412) 822-3700 |
| Email |
Brad.Dicianno[@]va.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Over 240,000 Veterans with disabilities use mobility devices such as manual and power
wheelchairs and scooters, and this number continues to grow. Mobility devices have been
described as the most enabling technology a clinician can provide to a person with a
disability. Yet, the batteries used to power scooters and wheelchairs have many drawbacks.
Batteries are hazardous to humans and the environment, heavy (which limits transportability),
and incompatible with wet or highly humid environments. Repairs to electrical systems and
replacement of batteries are frequently needed. These are costly and adversely affect the
Veteran. Compressed air is a power source that overcomes many of these disadvantages. The
investigators have developed a scooter and a wheelchair that are powered solely by compressed
air. The purpose of this study is to clinically evaluate the impact of these new devices on
Veterans living in long-term care facilities, and to obtain feedback from nurses, therapists,
and engineers regarding their design and feasibility of use in long-term care.
Description:
Over 240,000 Veterans with disabilities use mobility devices such as manual and power
wheelchairs and scooters, and this number continues to grow. Mobility devices have been
described as the most enabling technology a clinician can provide to a person with a
disability. Appropriate mobility devices improve function, independence, home and community
integration; activity and participation; comfort; and quality of life. Yet, battery-powered
mobility devices (BPMDs) have many drawbacks. Despite advances in technology, batteries are
still hazardous to humans and the environment, heavy (which limits transportability), and
incompatible with wet or highly humid environments. Repairs to electrical systems and
replacement of batteries are frequently needed. These are costly and result in being
stranded, missing medical appointments, missing work or school, injury, increased pain, lower
self-perceived health, skin breakdown, higher hospitalization rates, and reduced community
participation. Surveys conducted by the VA Center on Wheelchairs and Associated
Rehabilitation Engineering (WARE) identified alternative power sources as a top research
priority of Veterans and providers.
Compressed air is a power source that has many advantages over batteries, including safety to
both humans and the environment, lighter weight, waterproof nature, and lack of any
electrical components which can reduce the frequency of repairs. Two novel
pneumatically-powered mobility devices (PPMDs), a scooter and wheelchair, were developed and
tested for feasibility with 107 users. The devices were lighter and had sufficient driving
range per charge for the average user. There were no safety or repair issues encountered in
the 11-week field test. Filling air tanks was also much faster than charging a typical
battery. With pilot funds, the investigators then built two new scooters and two new power
wheelchairs with longer driving ranges. The investigators also developed a portable backup
tank system that allows us to refill or replace the tanks easily in the community.
The purpose of this study is to clinically evaluate the impact of PPMDs on Veterans living in
long-term care facilities, and to obtain feedback from key stakeholders regarding the design
and feasibility of use of PPMDs in long-term care. Long-term care was chosen because it is an
ideal setting for technology that is water-proof (e.g., compatible with inclement weather,
ease of cleaning, and resistant to incontinence and requires less maintenance and upkeep. In
Phase 1 (Technical), the investigators will build 8 pneumatically-powered scooters, 8
pneumatically-powered wheelchairs, 2 air filling stations with flow switches that measure air
filling time, 20 dataloggers that will measure battery charging time, and 20 dataloggers that
will monitor activity levels. Phase 2 (clinical evaluation) will comprise two aims. First,
the investigators will enroll 50 Veterans into a cross-over trial in which they use a BPMD
provided to them that is the same make and model as their own BPMD, and its PPMD counterpart
in random order, each for 6 months. The investigators will compare pneumatically-powered and
battery-powered scooters and wheelchairs with respect to functional mobility, satisfaction,
psychosocial impact, "charging time," maintenance and repairs. The investigators hypothesize
that Veterans will have higher levels of mobility, satisfaction, and psychosocial impact when
using PPMDs compared to when using BPMDs. The investigators also hypothesize that PPMDs will
be faster to "charge" and have fewer maintenance and repair issues than BPMDs. Second, the
investigators will conduct qualitative interviews of the 50 participants in the clinical
evaluation and an additional 54 key stakeholders involved in PPMD and BPMD use (e.g., family
members/caregivers, clinicians, and technical support personnel). The investigators will
assess patient, facility, VA healthcare system, and other factors that may be barriers or
facilitators to use of PPMDs and identify modifiable factors that may further improve the
design.
Results of the proposed study will pave the way for potential adoption of this technology
within the VA. Such adoption could have a direct and positive impact on Veterans' lives. This
research has the potential for national impact on the wheelchair provision process and
services within the VA.
