Clinical trial NCT00951509: Virtual Reality Based Testing of Power Wheelchair Driving Skills
Official title: Computer-based and Virtual Assessment of Power Wheelchair Mobility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Spina Bifida
Spinal Cord Disease
Keywords: Electric power wheelchair driving
rehabilitation
driving assessments
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-08-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with physical disabilities who have a mobility impairment due to any any spinal cord disease condition (e.g. Spinal Cord Injury, Spina Bifida)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects must be between 18 to 80 years old.
* Subjects must have a diagnosis of SCI, spina bifida, syringomyelia, spinal stenosis, transverse myelitis, ALS, spinal cord disease, multiple sclerosis, stroke, polytraumatic injury, or TBI with residual motor, sensory, or cognitive impairments that impair mobility.
* Subjects must use a power wheelchair or an attendant propelled manual wheelchair for all or part of their mobility.
* Subjects must be able to provide informed consent.
* Subjects must have very basic cognitive, visual, and motor skills to interact with an interface.

Exclusion Criteria:

* Subjects who have active pelvic or thigh wounds. (They may be worsened by prolonged sitting).
* Subjects with a history of seizures in the last 90 days. (A computer screen task has the potential to induce seizures).
* Subjects who do not pass the screening protocol.

Primary outcomes:
measure: Composite Power Mobility Road Test (PMRT) Scores
timeFrame: Baseline in-lab testing
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Health Care System
state: Pennsylvania
Study officials:
affiliation: Director, Center of Excellence for Wheelchairs and Related Technology
name: Rory A. Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
References: