NCT00951509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
2 years until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

August 24, 2015

Completed
Last Updated

August 24, 2015

Status Verified

July 1, 2015

Enrollment Period

1.4 years

First QC Date

August 3, 2009

Results QC Date

November 7, 2014

Last Update Submit

July 28, 2015

Conditions

Keywords

Electric power wheelchair drivingrehabilitationdriving assessments

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (5)

Condition 1 (PC Screens with No Rollers)

All subjects (Repeated - measures study design): All subjects were evaluated with the Power Mobility Road Test (PMRT).

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).

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).

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).

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).

Other: Power Mobility Road Test (PMRT)

Interventions

All subjects will underwent the Power Mobility Road Test (PMRT), and the clinicians scored the driving performance within each condition.

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)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Health Care System

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesSpinal DysraphismSpinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeural Tube DefectsNervous System MalformationsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Rory Cooper, PhD
Organization
Human Engineering Research Labs

Study Officials

  • Rory A. Cooper, PhD

    Director, Center of Excellence for Wheelchairs and Related Technology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

August 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 24, 2015

Results First Posted

August 24, 2015

Record last verified: 2015-07

Locations