Improving Balance in TBI Using Virtual Reality

NCT02298231 | Unknown

• 1 other identifier: R-831-14
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

Traumatic Brain Injury; Balance; TBI; Veterans; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Balance Assessment

  Physical tasks scored based on performance, e.g., 10 Meter walk, Balance Tasks and Computerized Sensory Organization Test

  4 months

Secondary Outcomes (2)

• Global Functioning evaluating the impact of the intervention on everyday life

  4 months

• Neuropsychological Assessment examining changes in cognitive functioning

  4 months

Study Arms (3)

Group 1

EXPERIMENTAL

Standard of Care Balance (SCB) Treatment

Other: Standard of Care Balance Intervention

Group 2

EXPERIMENTAL

Mystic Isle (MI) Balance Training

Other: Mystic Isle Balance Intervention

Group 3

EXPERIMENTAL

Mystic Isle (MI) Dual Task Training

Other: Mystic Isle Balance Intervention with Dual Task

Interventions

Standard of Care Balance Intervention OTHER

Standard balance therapy as performed by a physical therapist

Group 1

Mystic Isle Balance Intervention OTHER

Balance therapy using virtual reality

Group 2

Mystic Isle Balance Intervention with Dual Task OTHER

Balance therapy using virtual reality and performing cognitive tasks

Group 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Kessler Foundation: lead
• Fort Belvoir Community Hospital: collaborator
• University of Southern California: collaborator
• VA Office of Research and Development: collaborator
• Kessler Institute for Rehabilitation: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Karen J Nolan, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

• Denise Krch, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Goworek

CONTACT

973-324-3560; kgoworek@kesslerfoundation.org

Lea Frank

CONTACT

973-324-3581; lfrank@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 21, 2014
• Study Start: April 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

US (1)