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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00951509 |
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Date of registration:
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03/08/2009 |
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Primary sponsor: |
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Public title:
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Virtual Reality Testing of Power Wheelchair Driving Skills
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Scientific title:
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Computer-based and Virtual Assessment of Power Wheelchair Mobility |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00951509 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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Annmarie Kelleher, MS OTR |
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Address:
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Telephone:
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412-954-5287 |
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Email:
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annmarie.kelleher@va.gov |
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Affiliation:
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Name:
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Annmarie Kelleher, MS OTR |
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Address:
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Telephone:
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(412) 954-5287 |
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Email:
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annmarie.kelleher@va.gov |
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Affiliation:
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Name:
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Rory A. Cooper, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Director, Center of Excellence for Wheelchairs and Related Technology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subjects must be between 18 to 80 years old.
2. 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.
3. Subjects must use a power wheelchair or an attendant propelled manual wheelchair for
all or part of their mobility.
4. Subjects must be able to provide informed consent.
5. Subjects must have very basic cognitive, visual, and motor skills to interact with an
interface.
Exclusion Criteria:
1. Subjects who have active pelvic or thigh wounds. (They may be worsened by prolonged
sitting).
2. Subjects with a history of seizures in the last 90 days. (A computer screen task has
the potential to induce seizures).
3. Subjects who do not pass the screening protocol.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Power Wheelchair Driving
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Intervention(s)
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Other: Computer-Based Test
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Other: Power Mobility Road Test (PMRT)
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Other: Virtual Reality Test
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Primary Outcome(s)
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Power Wheelchair Driving Skills
[Time Frame: Baseline and 2 week follow up]
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Secondary Outcome(s)
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Performance on the computer-based assessment of driving skills
[Time Frame: Baseline and 2 week follow up]
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Performance on the Power Mobility Road Test of real world driving skills
[Time Frame: Baseline and 2 week follow up]
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Performance on the virtual based assessment of driving skills
[Time Frame: Baseline and 2 week follow up]
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Secondary ID(s)
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02691
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A6035-R
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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