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| ID | Type | Description | Link |
|---|---|---|---|
| 02691 | Other Identifier | VAPHS IRB |
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The purpose of this research study is to examine whether computer based or virtual reality based driving assessments are as useful as real-world power wheelchair driving tests in measuring driving performance and whether they may be useful in helping to identify the problems that some individuals may have with driving power wheelchairs. The specific aims are as follows:
Specific Aim 1: To develop computer-based and VR-based wheelchair driving assessments for both drivers and non-drivers that correspond to an accepted real-world driving assessment (Power Mobility Road Test) and compare them to the real-world assessment and to each other.
Specific Aim 2: To develop additional features of the computer-based and VR-based assessments that present dynamic tasks and determine whether skills on these tasks can be delineated within the virtual environment.
This study has an experimental, repeated measures design with validity and reliability testing. In Phase 1 of the study, we designed and developed the software needed to deliver the computer-based and VR-based testing environments. In Phase 2 of the study, we improved on the design iterations of Phase I, recruited a sample of 31 Electric Power wheelchair (EPW) users and delivered the simulator based driving assessment using a pool of clinicians to assess the reliability of system in real world and in the virtual environments.
Phase II: Research Protocol:
Experimental Set-up:
VRSIM consisted of two display options, three 6' X 8' back projected screens (field of view 160°) (VR screens) and a single 22" desktop monitor (field of view 90°) (PC screens), both with the first-person perspective viewpoint (Fig.1). The virtual environment consisted of a simulation of an indoor office space with a kitchen; a lounge area and set of hallways lined by offices, and incorporated the tasks of the PMRT (Fig.2). Participants interacted with VRSIM either using dual rollers that interfaced with drive wheels of the wheelchair ('Rollers ON' driving mode) or using an instrumented wheelchair joystick through a custom software ('Rollers OFF' driving mode). The custom software uses a proportional derivative mathematical model to simulate the real-world motion of the EPW within the virtual environment. VRSIM was designed with two display options and two user input modalities to assess the feasibility of using such a system with different interfaces in different settings, such as in a busy wheelchair clinic (using the much immersive VR screens with rollers) or in a user's home (with the user's personal computer and the customized joystick).
The "actor/driver" in the VRSIM was a virtual model of a person sitting in a standard commercially available EPW power wheelchair (width 0.671 m, length 0.701 m). A horizontal slider bar that indicated the real time location of the virtual wheelchair with respect to virtual obstacles was added to this version (Fig.1, 2). This helped display warnings when the chair was too close to obstacles, especially when the obstacles were behind the driver. Participants were expected to drive along the course indicated by arrows touching or passing through preset milestone markers signified by semi-transparent balloons. These sequentially displayed milestones defined the tasks of the virtual PMRT. Participants were instructed to complete every task as quickly and accurately as possible. An equivalent PMRT driving course was charted out in an office space for the real world driving evaluation.
Data collection:
After informed consent, participants performed up to 2 practice sessions within the virtual driving course. Participants reported their level of comfort and sense of being in control in the VRSIM during practice based on which a value between 1.0 and 4.0 was selected for the linear and angular speed gains in VRSIM. In addition, participants were asked to select a different pre-programmed driving profile on their wheelchairs (e.g. "indoor" profile), which was similar to their everyday driving profile to obtain optimum driving speed. Optional breaks for 5-10 minutes were provided between driving sessions. For both the PC and VR screens, participants drove through the complete driving course: two trials with the Rollers ON driving mode, one trial with the Rollers OFF driving mode, and one trial in the real-world PMRT driving course constituted to a total of 5 driving conditions (Table 1). A balanced randomization scheme was used to set the order of the five driving conditions.
From a group of 6 clinicians comprised of 1 occupational therapist, 3 physical therapists, and 2 physicians, 2 clinicians were randomly assigned as the evaluation team for each participant. The team always had 1 certified Assistive Technology Professional with more than 5 years of experience in power wheelchair driving evaluations. The assigned clinicians independently scored every PMRT task during all the driving trials using the following criteria: 4: completed independently, 3: completed hesitantly requiring several trials and minor accidents, 2: commits serious accidents that may cause harm to driver or other people, 1: unable to complete a task. Each clinician had a separate PMRT scoring sheet for each trial.
Repeat Testing:
Subjects underwent all five testing scenarios twice, returning on a second visit in no earlier than 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1 (PC Screens with No Rollers) | All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). |
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| Condition 2 (PC Screens with Rollers) | All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). |
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| Condition 3 (VR Screens with No Rollers) | All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). |
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| Condition 4 (VR Screens with Rollers) | All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). |
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| Condntion 5 (Real-world driving) | All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Power Mobility Road Test (PMRT) | Other | All subjects will underwent the Power Mobility Road Test (PMRT), and the clinicians scored the driving performance within each condition. |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite Power Mobility Road Test (PMRT) Scores | 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%. | Baseline in-lab testing |
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Inclusion Criteria:
Exclusion Criteria:
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People with physical disabilities who have a mobility impairment due to any any spinal cord disease condition (e.g. Spinal Cord Injury, Spina Bifida)
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| Name | Affiliation | Role |
|---|---|---|
| Rory A. Cooper, PhD | Director, Center of Excellence for Wheelchairs and Related Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Health Care System | Pittsburgh | Pennsylvania | 15240 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Power Mobility Road Test (PMRT) Scores | 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%. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline in-lab testing |
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Over the entire course of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Power Mobility Road Test | With 12 structured tasks and 4 dynamic tasks, adding to a total of 16 tasks with a minimum score of 1 and maximum of 4 in each task, it is possible to score in the range of 16 - 64 during a driving trial. To assess the driving performance, the total score for each trial was calculated and expressed as a percentage, termed "Composite score". A Composite score of 95 % or greater would suggest that the user is a safe driver. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rory Cooper, PhD | Human Engineering Research Labs | 412-822-3700 | rcooper@pitt.edu |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D016135 | Spinal Dysraphism |
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG000 |
| Condition 1 |
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. |
| OG001 | Condition 2 | 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. |
| OG002 | Condition 3 | 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. |
| OG003 | Condition 4 | 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. |
| OG004 | Condition 5 | 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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| 0 |
| 31 |
| 0 |
| 31 |
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| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |