Recruiting

Virtual RealityImproving Balance in TBI Using Virtual Reality

Sponsor:

Kessler Foundation

Code:

NCT02298231

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Standard of Care Balance Intervention

Mystic Isle Balance Intervention

Mystic Isle Balance Intervention with Dual Task

Study Details

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 assigned to one of three treatment groups.

Conditions

Traumatic Brain Injury

Study ID

NCT02298231

Start date

Apr, 2016

Status verified date

Oct, 2016

Completion date

Oct, 2018

Anticipated

Primary completion date

Oct, 2018

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

Standard of Care Balance (SCB) Treatment

experimental: Group 2

Mystic Isle (MI) Balance Training

experimental: Group 3

Mystic Isle (MI) Dual Task Training

Interventions

Standard of Care Balance Intervention

Standard balance therapy as performed by a physical therapist

Mystic Isle Balance Intervention

Balance therapy using virtual reality

Mystic Isle Balance Intervention with Dual Task

Balance therapy using virtual reality and performing cognitive tasks

Primary outcome measure

Balance Assessment [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Kathleen Goworek

973-324-3560 kgoworek@kesslerfoundation.org

Lea Frank

973-324-3581 lfrank@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Kate Chervin

973-324-3560 kgoworek@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Oct 14, 2016

Last verified

Oct, 2016

Keywords

Traumatic Brain Injury
Balance
TBI
Veterans
Virtual Reality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2016-10-14.