TerminatedNot Applicable

Pneumatic Technology for Powered Mobility Devices

Stopped: COVID 19 made completion of clinical trial portion impossible

United States20 participantsStarted 2019-10-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Functional Mobility Assessment

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

Trial details

NCT IDNCT03898362

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-07-31

Results submitted2025-07-07

View on ClinicalTrials.gov More Disability trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.