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Pneumatic Technology for Powered Mobility Devices (PTPMD)

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ClinicalTrials.gov Identifier: NCT03898362
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Disability Other: pneumatically powered wheelchair or scooter Device: battery powered wheelchair or scooter Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 6 months using one device then crossover and 6 months using other device
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Pneumatic Technology for Powered Mobility Devices
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Aim 2A

  • Participant must be 18 years or older
  • Participant must use or be in the process of obtaining a scooter or Group 2 power wheelchair without power seat functions
  • Participant must be able to speak and understand English in order to provide informed consent

Aim 2B Inclusion Criteria

  • Participants must be 18 years or older
  • Participants must be either a participant in Aim 2A, a family member/caregiver of a participant, or an employee of a participating long-term care facility
  • Participants who are employees must have some experience with charging, storing, transporting, cleaning, or maintaining BPMDs, e.g.:

    • nurse
    • physical therapist
    • occupational therapist
    • engineer, etc.
  • Participants who are employees must be willing to assist at least three Aim 1 participants in the charging, storing, transporting, cleaning, or maintaining of their PPMDs for at least 3 months
  • Participants must be able to speak and understand English in order to provide informed consent

Exclusion Criteria:

Exclusion Criteria for Aim 2A

  • Open pressure injuries of skin on sitting surface that could worsen with prolonged sitting

Exclusion Criteria for Aim 2B

  • There are no exclusion criteria

Information from the National Library of Medicine

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


Contacts
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Contact: Brad E Dicianno, PhD MD (412) 954-5287 Brad.Dicianno@va.gov
Contact: Rory A Cooper, PhD (412) 365-4850 rcooper@pitt.edu

Locations
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United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Not yet 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, PhD MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Brad E. Dicianno, PhD MD VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03898362     History of Changes
Other Study ID Numbers: A2753-R
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
wheelchair
scooter