Status:
UNKNOWN
Improving Balance in TBI Using Virtual Reality
Lead Sponsor:
Kessler Foundation
Collaborating Sponsors:
Fort Belvoir Community Hospital
University of Southern California
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This research study evaluates the effectiveness of a low-cost Virtual Reality-based (VR) training system in providing a customized balance treatment in a skilled clinical setting. Participants will be...
Detailed Description
Traumatic Brain injury (TBI) is a major health concern for the U.S. military and civilian populations, resulting in more than 5.3 million people who require rehabilitation and assistance for the short...
Eligibility Criteria
Inclusion
- Have been diagnosed with a mild to severe Traumatic Brain Injury (TBI). My TBI severity will be categorized by research study staff based on length of loss of consciousness (LOC), alteration of consciousness/mental state (AOC) or post-traumatic amnesia (PTA).
- Must be out of PTA, as indicated by O-log score of \> 24 on 2 consecutive days as determined by study staff.
- Be at least 3 months post injury.
- Speak English.
- As determined by study personnel, have at least 20/60 acuity in worst eye according to the Snellen Eye Exam.
- As determined by study personnel, receive an acceptable score on the Token Test.
- Balance dysfunction as determined by impairment on standing balance measures (Sensory Organization Test)
- Be able and willing to comply with study procedures, including follow-up requirements.
- Be willing and able to give informed consent
Exclusion
- Have an unstable or uncontrolled seizure disorder.
- Have a diagnosis of excessive fluid surrounding my brain.
- Have severe cardiac disease (e.g. heart attack or heart failure).
- Have uncontrolled or unstable orthostatic hypotension (blood pressure drops suddenly when one stands, causing one to feel light headed or dizzy).
- Have had a lower limb injury in the past 90 days.
- Have any other injury that affects one's ability to balance.
- Have a pre-existing condition that significantly affects one's alignment or function of one's lower limb while standing.
- Be on any medication that may affect one's balance, strength, or muscle coordination (e.g. Botox, Baclofen).
- Have significant neurological history (e.g.epilepsy that began before TBI, multiple sclerosis) other than TBI.
- Have significant psychiatric history (i.e. schizophrenia).
- Have a history of significant drug abuse.
- Have had physical or occupational therapy or treatment for balance disorder in the past 30 days.
- Have difficulty following or responding to commands that would limit study participation.
- Be currently enrolled in another research study that is likely to affect participation in this research study.
- Have any underlying medical conditions that would limit study participation.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT02298231
Start Date
April 1 2016
End Date
October 1 2018
Last Update
October 14 2016
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052