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.
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
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 group | Role | What they receive |
|---|---|---|
| pneumatically powered wheelchair or scooter | Active comparator | participants will use pneumatic powered wheelchair or scooter Receives: Other: pneumatically powered wheelchair or scooter |
| battery powered wheelchair or scooter | Active comparator | participants 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.
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.
- First posted2 Apr 2019
- Study start1 Oct 2019
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: COVID 19 made completion of clinical trial portion impossible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DisabilityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Brad E. Dicianno, MD MS, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Pneumatic Technology for Powered Mobility Devices
- ClinicalTrials.gov ID
- NCT03898362
- Acronym / sponsor ID
- PTPMD / A2753-R
- Conditions
- Disability
- Keywords
- wheelchair, scooter
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID 19 made completion of clinical trial portion impossible
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Posted 20 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 6 months using one device then crossover and 6 months using other device
| Arm | Type | Receives |
|---|---|---|
| pneumatically powered wheelchair or scooter | Active comparator | Other: pneumatically powered wheelchair or scooterparticipants will use pneumatic powered wheelchair or scooter |
| battery powered wheelchair or scooter | Active comparator | Device: battery powered wheelchair or scooterparticipants will use battery powered wheelchair or scooter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (2 listed)
- Open pressure injuries of skin on sitting surface that could worsen with prolonged sitting
- There are no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pneumatically powered wheelchair or scootera 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. | Other | pneumatically powered wheelchair or scooter |
| battery powered wheelchair or scootera 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 | Device | battery powered wheelchair or scooter |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad E. Dicianno, MD MS principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 site in 1 country: see every site and its status.
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.