RECRUITING

Use of Virtual and Augmented Reality Devices in Vestibular Physical Therapy for mTBI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Rapidly evolving virtual reality (VR) and augmented reality (AR) technologies are being incorporated by many large-scale industries, and the medical field is no exception. One area that has gained significant attention in recent years is virtual rehabilitation which allows physical therapists to leverage state-of-the-art immersive virtual environments to uniquely address functional deficits in patients who are unresponsive to conventional treatment techniques. Advanced VR and AR technologies are now available in commercially available small-scale, mobile head-mounted displays which can be readily used in outpatient clinic settings and possibly at home. The aim of this study is to determine whether advanced VR- and AR-based physical therapy improves functional status and reduces self-reported symptoms in individuals experiencing vestibular disorders secondary to mild traumatic brain injury (mTBI). Study participants will be randomized into treatment groups: 1) conventional therapy, 2) therapy performed using a large-scale VR system (the Computer Assisted Rehabilitation Environment or CAREN), 3) therapy performed using a mobile AR. Upon completion of treatment, groups will be compared to determine functional outcome improvements with respect to static and dynamic balance as well as reduction of vestibular symptoms.

Official Title

Use of Virtual and Augmented Reality Devices in Vestibular Physical Therapy for mTBI

Quick Facts

Study Start:2023-10-01
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05326100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women, active duty SMs between 18 and 65 years of age and enrolled in Defense Enrollment Eligibility Reporting System (DEERS)
  2. * History of mTBI based on the Ohio State University Traumatic Brain Injury Identification (OSU TBI-ID)
  3. * Require vestibular physical therapy as determined by a PT
  4. * Normal or corrected vision based on the Snellen Eye Chart of at least 20/40
  5. * Able to consistently follow verbal and written instructions and observe safety precautions
  6. * Able to tolerate up to 60 minutes of physical therapy exercise, with breaks
  7. * Able to ambulate with contact guard assistance or less, and to walk unassisted over ground or on a treadmill for 10 minutes at a time
  8. * Able to tolerate wearing a full body safety harness
  9. * Able to tolerate wearing a head mounted display weighing up to 3 pounds for up to 60 minutes
  1. * History of a moderate or severe TBI (OSU TBI-ID; or DVBIC TBI Screening Tool)
  2. * Under care of a physician for a neurodegenerative diagnosis
  3. * History of seizures or syncope
  4. * Clinical determination of Benign Paroxysmal Positional Vertigo (BPPV)
  5. * Diagnosis of any of the following visual impairments: field cuts, macular degeneration, retinal detachment, diplopia, limited peripheral or central vision, or require prism lenses
  6. * Unable or unwilling to use contacts for corrected vision
  7. * Require a medical device that can be affected by radio waves such as a pacemaker, defibrillator, or hearing devices (implantable or air conduction)
  8. * Medications with significant sedating side effects that could impact safety (i.e., Phenobarbital, Ativan, etc.)
  9. * Women who are more than 4 months pregnant may not participate in this study due to the effects advanced pregnancy can have on balance and vision. Note: Women who choose to participate will be informed up front that there are risks associated with pregnancy including decrements in postural control and falls. Additionally, changes in hormones, metabolism, fluid retention, and blood circulation during pregnancy can affect the eyes and eyesight. Women who become pregnant during the intervention should inform their PT immediately to determine if continued participation is possible.
  10. * Concurrent participation, either clinically and/or as a part of another research study, in vestibular physical therapy and/or PTSD treatment
  11. * Unable to consent for any reason

Contacts and Locations

Study Contact

Pinata Sessoms, PhD
CONTACT
6197674474
pinata.h.sessoms.civ@health.mil
Kerry Rosen, PhD
CONTACT
kerry.b.rosen.ctr@health.mil

Principal Investigator

Pinata Sessoms, PhD
PRINCIPAL_INVESTIGATOR
Naval Health Research Center
Sarah Kruger, MS
PRINCIPAL_INVESTIGATOR
Walter Reed National Military Medical Center
Kerry Rosen, PhD
PRINCIPAL_INVESTIGATOR
Walter Reed National Military Medical Center

Study Locations (Sites)

Naval Health Research Center
San Diego, California, 92106
United States
Naval Medical Center San Diego
San Diego, California, 92134
United States
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, 20889
United States

Collaborators and Investigators

Sponsor: Naval Health Research Center

  • Pinata Sessoms, PhD, PRINCIPAL_INVESTIGATOR, Naval Health Research Center
  • Sarah Kruger, MS, PRINCIPAL_INVESTIGATOR, Walter Reed National Military Medical Center
  • Kerry Rosen, PhD, PRINCIPAL_INVESTIGATOR, Walter Reed National Military Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Virtual Reality
  • Augmented Reality
  • Vestibular Physical Therapy
  • Computer Assisted Rehabilitation Environment (CAREN)
  • Head Mounted Display (HMD)
  • Physical Therapy
  • MTBI
  • Servicemember
  • Vestibular Dysfunction

Additional Relevant MeSH Terms

  • MTBI - Mild Traumatic Brain Injury
  • Dysfunction of Vestibular System