Pneumatic Technology for Powered Mobility Devices (PTPMD)
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|ClinicalTrials.gov Identifier: NCT03898362|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Disability||Other: pneumatically powered wheelchair or scooter Device: battery powered wheelchair or scooter||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||6 months using one device then crossover and 6 months using other device|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of Pneumatic Technology for Powered Mobility Devices|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Active Comparator: pneumatically powered wheelchair or scooter
participants will use pneumatic powered wheelchair or scooter
Other: pneumatically powered wheelchair or scooter
a wheelchair or scooter powered by compressed air will be used for 6 months. Compressed air is a novel power source and no batteries are used in these devices.
Active Comparator: battery powered wheelchair or scooter
participants will use battery powered wheelchair or scooter
Device: battery powered wheelchair or scooter
a wheelchair or scooter powered by a battery will be used for 6 months. These are conventional mobility devices that the participants are using or in the process of obtaining
- Change in Functional Mobility Assessment [ Time Frame: Month 1, 3 and 6 within the first 6 months and repeated in the second 6 months." ]Functional measure of mobility; change of 10 points is considered clinically significant. The FMA contains 10 items that measure the extent to which a mobility device aids a user in completing functional tasks like reaching, personal care tasks, indoor mobility, outdoor mobility and transferring. Ten items are scored individually on a 7- point Likert scale (6 = completely agree, 5 = mostly agree, 4 = slightly agree, 3 = slightly disagree, 2 = mostly disagree, 1 = completely disagree and 0 = does not apply to me). A total mobility score is then calculated from summing the individual item scores and an adjusted total score is expressed as a percentage of total score divided by sum of relevant items. The FMA is the most widely used measure to assess function in mobility device users. The change in FMA will be assessed 3 times over a 6 month period in each arm of the trial. Assessments will occur in month 1, 3 and 6 within the first 6 months and repeated in the second 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898362
|Contact: Brad E Dicianno, MD MS||(412) 822-3700||Brad.Dicianno@va.gov|
|Contact: Rory A Cooper, PhD||(412) firstname.lastname@example.org|
|United States, Pennsylvania|
|VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15240|
|Contact: Stacy Eckstein, BS 412-822-3671 Stacy.Eckstein@va.gov|
|Contact: Andrea M Bagay (412) 822-3661 Andrea.Bagay@va.gov|
|Principal Investigator: Brad E. Dicianno, MD MS|
|Principal Investigator:||Brad E. Dicianno, MD MS||VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA|