Trial Outcomes & Findings for Virtual Reality Based Testing of Power Wheelchair Driving Skills (NCT NCT00951509)
NCT ID: NCT00951509
Last Updated: 2015-08-24
Results Overview
The computer-based and the virtual environments will be modeled after and scored similarly to the real world PMRT. The PMRT contains two domains: Structured Elements/Tasks and Unstructured Skilled Driving. The first domains contain 16 tasks that include activities such as passing through standard width doorways, and turning a ninety-degree turn, turning 180 degrees. In both domains, each task is scored from 1 to 4, depending on speed and the number of collisions that occur with obstacles. A total score for the entire test is calculated out of a possible 64 points, and the final score on the test reflects the percentage of total points acquired1. A passing score is a percentage of \> 95%.
COMPLETED
31 participants
Baseline in-lab testing
2015-08-24
Participant Flow
The Institutional Review Boards of the Veteran Affairs Pittsburgh Healthcare System and the University of Pittsburgh approved the protocol for this research study. Participants were recruited at the 31st National Veterans Wheelchair Games (NVWG), VA Wheelchair clinic, and the UPMC Center of Assistive Technology.
Participant milestones
| Measure |
Participants Who Qualified for the Study
All participants who qualified for the study, performed electric power wheelchair (EPW) driving under five driving conditions, while clinicians observed and assessed the EPW users' driving performance. The first four conditions were conducted in virtual environments (with different interfaces in each condition, as listed below) and condition 5 was conducted in the real world - Condition 1 - Desktop screens with no roller systems Condition 2- Desktop screens with roller systems Condition 3 - Immersive virtual reality screens with no roller systems Condition 4 - Immersive virtual reality screens with roller systems Condition 5 - Real world EPW driving
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|---|---|
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Overall Study
STARTED
|
31
|
|
Overall Study
Driving Condition 1
|
29
|
|
Overall Study
Driving Condition 2
|
29
|
|
Overall Study
Driving Condition 3
|
25
|
|
Overall Study
Driving Condition 4
|
28
|
|
Overall Study
Driving Condition 5
|
30
|
|
Overall Study
COMPLETED
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29
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Participants Who Qualified for the Study
All participants who qualified for the study, performed electric power wheelchair (EPW) driving under five driving conditions, while clinicians observed and assessed the EPW users' driving performance. The first four conditions were conducted in virtual environments (with different interfaces in each condition, as listed below) and condition 5 was conducted in the real world - Condition 1 - Desktop screens with no roller systems Condition 2- Desktop screens with roller systems Condition 3 - Immersive virtual reality screens with no roller systems Condition 4 - Immersive virtual reality screens with roller systems Condition 5 - Real world EPW driving
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|---|---|
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Overall Study
Withdrawal by Subject
|
2
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Baseline Characteristics
Virtual Reality Based Testing of Power Wheelchair Driving Skills
Baseline characteristics by cohort
| Measure |
All Subjects
n=31 Participants
Power Mobility Road Test (PMRT): All subjects were asked to complete the "real world" power mobility evaluation via the PMRT.
Computer-Based Test: All subjects were asked to complete the computer-based evaluation designed to simulate real world driving in a 2D environment.
Virtual Reality Test: All subjects were asked to complete the virtual-based evaluation designed to simulate real world driving in a 3D environment.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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31 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline in-lab testingPopulation: Majority of the participants (41%) had a spectrum of multiple disabilities ranging from stroke, spinal stenosis, osteoarthritis, emphysema, and cerebral degeneration, followed by 11 participants (35%) with spinal cord injury.
The computer-based and the virtual environments will be modeled after and scored similarly to the real world PMRT. The PMRT contains two domains: Structured Elements/Tasks and Unstructured Skilled Driving. The first domains contain 16 tasks that include activities such as passing through standard width doorways, and turning a ninety-degree turn, turning 180 degrees. In both domains, each task is scored from 1 to 4, depending on speed and the number of collisions that occur with obstacles. A total score for the entire test is calculated out of a possible 64 points, and the final score on the test reflects the percentage of total points acquired1. A passing score is a percentage of \> 95%.
Outcome measures
| Measure |
Condition 1
n=29 Participants
Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
|
Condition 2
n=29 Participants
Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
|
Condition 3
n=25 Participants
Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
|
Condition 4
n=28 Participants
Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
|
Condition 5
n=30 Participants
Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
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|---|---|---|---|---|---|
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Composite Power Mobility Road Test (PMRT) Scores
|
95.3 units on a scale
Standard Error 5.4
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96.09 units on a scale
Standard Error 7.8
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93.75 units on a scale
Standard Error 7.03
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96.88 units on a scale
Standard Error 8.2
|
100 units on a scale
Standard Error 1.56
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Adverse Events
Power Mobility Road Test
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