Improving Balance in TBI Using Virtual Reality

Status unconfirmed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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 assigned to one of three treatment groups.

Key facts

Study ID

NCT02298231

Run by

Kessler Foundation

People needed

180

Starts

2016-04-01

Expected to finish

2018-10-01

Last updated by the study team

2016-10-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Kessler Foundation — West Orange, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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