Spinal Cord InjuryNCT00951509
Virtual Reality Based Testing of Power Wheelchair Driving Skills
An observational study of Spinal Cord Injury and Spina Bifida, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injury, Spina Bifida, Spinal Cord Disease
- What is being tested?
- Power Mobility Road Test (PMRT)
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jan 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240
About this study
Official title: Computer-based and Virtual Assessment of Power Wheelchair Mobility
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.
Read the 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.
- Conditions
- Spinal Cord Injury, Spina Bifida, Spinal Cord Disease
- Being tested
- Power Mobility Road Test (PMRT)
- Keywords
- Electric power wheelchair driving, rehabilitation, driving assessments
- Medical subject headings
- Spinal Cord Injuries, Spinal Dysraphism, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 (PC Screens with No Rollers) | All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). Receives: Other: Power Mobility Road Test (PMRT) | |
| Condition 2 (PC Screens with Rollers) | All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). Receives: Other: Power Mobility Road Test (PMRT) | |
| Condition 3 (VR Screens with No Rollers) | All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). Receives: Other: Power Mobility Road Test (PMRT) | |
| Condition 4 (VR Screens with Rollers) | All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). Receives: Other: Power Mobility Road Test (PMRT) | |
| Condntion 5 (Real-world driving) | All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). Receives: Other: Power Mobility Road Test (PMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline in-lab testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startAug 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rory A. Cooper, PhD, Principal investigator, Director, Center of Excellence for Wheelchairs and Related Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951509
- Sponsor's protocol ID
- A6035-R
- Other IDs
- 02691
- Status last verified
- Jul 2015
- First submitted
- 3 Aug 2009
- Last updated
- 24 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based and Virtual Assessment of Power Wheelchair Mobility
- ClinicalTrials.gov ID
- NCT00951509
- Acronym / sponsor ID
- A6035-R
- Conditions
- Spinal Cord Injury, Spina Bifida, Spinal Cord Disease
- Keywords
- Electric power wheelchair driving, rehabilitation, driving assessments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Posted 24 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Condition 1 (PC Screens with No Rollers) | – | Other: Power Mobility Road Test (PMRT)All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). |
| Condition 2 (PC Screens with Rollers) | – | Other: Power Mobility Road Test (PMRT)All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). |
| Condition 3 (VR Screens with No Rollers) | – | Other: Power Mobility Road Test (PMRT)All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). |
| Condition 4 (VR Screens with Rollers) | – | Other: Power Mobility Road Test (PMRT)All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). |
| Condntion 5 (Real-world driving) | – | Other: Power Mobility Road Test (PMRT)All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power Mobility Road Test (PMRT)All subjects will underwent the Power Mobility Road Test (PMRT), and the clinicians scored the driving performance within each condition. | Other | Condition 1 (PC Screens with No Rollers), Condition 2 (PC Screens with Rollers), Condition 3 (VR Screens with No Rollers), Condition 4 (VR Screens with Rollers), Condntion 5 (Real-world driving) |
Primary outcome
Composite Power Mobility Road Test (PMRT) Scores
Time frame: Baseline in-lab testing
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%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rory A. Cooper, PhD principal investigator
Director, Center of Excellence for Wheelchairs and Related Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury and Spina Bifida, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Power Mobility Road Test (PMRT) Scores (time frame: Baseline in-lab testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.