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DisabilityPTPMDNCT03898362

Pneumatic Technology for Powered Mobility Devices

A study testing pneumatically powered wheelchair or scooter and battery powered wheelchair or scooter in people with Disability, run by VA Office of Research and Development at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Disability
What is being tested?
pneumatically powered wheelchair or scooter and battery powered wheelchair or scooter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Oct 2019to 31 Jul 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • Open pressure injuries of skin on sitting surface that could worsen with prolonged sitting
  • There are no exclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

Official title: Clinical Evaluation of Pneumatic Technology for Powered Mobility Devices

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.

Read the 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.

Conditions
Disability
Being tested
pneumatically powered wheelchair or scooter, battery powered wheelchair or scooter
Keywords
wheelchair, scooter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pneumatically powered wheelchair or scooterOther

    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.

  • battery powered wheelchair or scooterDevice

    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

Study groups in NCT03898362
Study groupRoleWhat they receive
pneumatically powered wheelchair or scooterActive comparatorparticipants will use pneumatic powered wheelchair or scooter
Receives: Other: pneumatically powered wheelchair or scooter
battery powered wheelchair or scooterActive comparatorparticipants will use battery powered wheelchair or scooter
Receives: Device: battery powered wheelchair or scooter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Functional Mobility Assessment

    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.

    Measured: Month 1, 3 and 6 within the first 6 months and repeated in the second 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2019
  2. Study start1 Oct 2019
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

Why it stopped: COVID 19 made completion of clinical trial portion impossible

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Model description
6 months using one device then crossover and 6 months using other device
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03898362
Sponsor's protocol ID
A2753-R
Acronym
PTPMD
Status last verified
Jul 2025
First submitted
15 Mar 2019
Last updated
20 Aug 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing pneumatically powered wheelchair or scooter and battery powered wheelchair or scooter in people with Disability, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Functional Mobility Assessment (time frame: Month 1, 3 and 6 within the first 6 months and repeated in the second 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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