Trial Outcomes & Findings for Pneumatic Technology for Powered Mobility Devices (NCT NCT03898362)
NCT ID: NCT03898362
Last Updated: 2025-08-20
Results Overview
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.
TERMINATED
NA
20 participants
Month 1, 3 and 6 within the first 6 months and repeated in the second 6 months.
2025-08-20
Participant Flow
No participants were randomized into the cross-over sequences and the planned cross-over study was not conducted
Participant milestones
| Measure |
Expert
healthcare professional
|
Veteran With Disability
Veteran with disability who has experience using wheelchairs or scooters
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
|
Overall Study
COMPLETED
|
14
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pneumatic Technology for Powered Mobility Devices
Baseline characteristics by cohort
| Measure |
Expert
n=14 Participants
healthcare professional
|
Veterans With Disability
n=6 Participants
Veterans with disability with experience using wheelchairs and scooters
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
70.4 years
STANDARD_DEVIATION 3.3 • n=107 Participants
|
52.3 years
STANDARD_DEVIATION 14.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Number of people with spinal cord injury
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 1, 3 and 6 within the first 6 months and repeated in the second 6 months.Population: This outcome measure could not be conducted, and data were not collected due to COVID-19
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.
Outcome measures
Outcome data not reported
Adverse Events
Expert
Veteran With Disability
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place