Pneumatic Technology for Powered Mobility Devices

NCT03898362 | Terminated Results FDA Device

• 1 other identifier: A2753-R
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Disability

Keywords

wheelchair; scooter

Outcome Measures

Primary Outcomes (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.

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

Study Arms (2)

pneumatically powered wheelchair or scooter

ACTIVE COMPARATOR

participants will use pneumatic powered wheelchair or scooter

Other: pneumatically powered wheelchair or scooter

battery powered wheelchair or scooter

ACTIVE COMPARATOR

participants will use battery powered wheelchair or scooter

Device: battery powered wheelchair or scooter

Interventions

pneumatically powered wheelchair or scooter OTHER

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.

pneumatically powered wheelchair or scooter

battery powered wheelchair or scooter DEVICE

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

battery powered wheelchair or scooter

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Limitations and Caveats

No participants were randomized into the cross-over sequences and the planned cross-over study was not conducted because of COVID-19. All participants reported participated in one focus group. Each participant's duration of participation was one day, and no adverse events occurred during the day of their participation.

Results Point of Contact

• Title: Dr. Brad Dicianno
• Organization: VA Pittsburgh Healthcare System

brad.dicianno@va.gov

412-822-3700

Study Officials

• Brad E. Dicianno, MD MS

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 6 months using one device then crossover and 6 months using other device

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: April 2, 2019
• Study Start: October 1, 2019
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)