Recruiting

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

Sponsor:

Naval Health Research Center

Code:

NCT05326100

Conditions

MTBI - Mild Traumatic Brain Injury

Dysfunction of Vestibular System

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Conventional Therapy (CPT)

CAREN Therapy

Augmented Reality (AR) Therapy

Study Details

Brief summary:

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.

Conditions

MTBI - Mild Traumatic Brain Injury

Dysfunction of Vestibular System

Study ID

NCT05326100

Start date

Oct 1, 2023

Status verified date

Nov, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

Men and women, active duty SMs between 18 and 65 years of age and enrolled in Defense Enrollment Eligibility Reporting System (DEERS)
History of mTBI based on the Ohio State University Traumatic Brain Injury Identification (OSU TBI-ID)
Require vestibular physical therapy as determined by a PT
Normal or corrected vision based on the Snellen Eye Chart of at least 20/40
Able to consistently follow verbal and written instructions and observe safety precautions
Able to tolerate up to 60 minutes of physical therapy exercise, with breaks
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
Able to tolerate wearing a full body safety harness
Able to tolerate wearing a head mounted display weighing up to 3 pounds for up to 60 minutes

Exclusion Criteria:

History of a moderate or severe TBI (OSU TBI-ID; or DVBIC TBI Screening Tool)
Under care of a physician for a neurodegenerative diagnosis
History of seizures or syncope
Clinical determination of Benign Paroxysmal Positional Vertigo (BPPV)
Diagnosis of any of the following visual impairments: field cuts, macular degeneration, retinal detachment, diplopia, limited peripheral or central vision, or require prism lenses
Unable or unwilling to use contacts for corrected vision
Require a medical device that can be affected by radio waves such as a pacemaker, defibrillator, or hearing devices (implantable or air conduction)
Medications with significant sedating side effects that could impact safety (i.e., Phenobarbital, Ativan, etc.)
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.
Concurrent participation, either clinically and/or as a part of another research study, in vestibular physical therapy and/or PTSD treatment
Unable to consent for any reason

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Conventional Therapy (CPT) Group

Each session will include vestibular exercises, customized to address the participant's symptoms of vestibular dysfunction and functional ability.

active comparator: CAREN Group

The CAREN group will undergo vestibular physical therapy that will include virtual environment (VE) applications on the CAREN.

experimental: Augmented Reality (AR) Group

The AR group will undergo vestibular physical therapy that will include VE applications on the AR HMD.

Interventions

Conventional Therapy (CPT)

The exercises may include traditional vestibulo-ocular reflex (VOR) exercises, cervical musculoskeletal exercises, somatosensory exercises, habituation, gait exercises, and aerobic conditioning. The treating PT will modify specific exercises as appropriate based on the participant's symptoms.

CAREN Therapy

The CAREN, an FDA-registered exempted Class I device, is a VR-based system which includes a six degree-of-freedom motion platform with an embedded, instrumented treadmill surrounded by an immersive 180-degree screen. The CAREN can display a variety of virtual environments (VEs), where the difficulty level and task requirements can be easily modified by the treating clinician to target patient-specific needs.

Augmented Reality (AR) Therapy

AR head-mounted displays are designed to provide immersive virtual environments similar to the CAREN, but with the portability to be used in most outpatient clinical settings and potentially for at-home therapy as well as significantly reduced cost compared to the CAREN. AR devices have integrated eye-tracking and inertial measurement units (IMUs) which can be used to objectively quantify characteristics of eye, head and body movement.

Primary outcome measure

Functional Assessments: Sensory Organization Test (SOT) [ Time Frame: 6 weeks ]
Functional Assessments: Community Balance and Mobility Scale (CB&M) [ Time Frame: 6 weeks ]
Functional Assessments: Functional Gait Assessment (FGA) [ Time Frame: 6 weeks ]
Vestibular Symptoms: Activity-Specific Balance Confidence Scale (ABC) [ Time Frame: 6 weeks ]
Vestibular Symptoms: Dizziness Handicap Inventory (DHI) [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Pinata Sessoms, PhD

6197674474 pinata.h.sessoms.civ@health.mil

Kerry Rosen, PhD

kerry.b.rosen.ctr@health.mil

Locations

Naval Health Research Center

Recruiting

San Diego, California, United States, 92106

Contacts

Pinata H Sessoms, PhD

pinata.h.sessoms.civ@health.mil

Jacob Vandehy, MS

jacob.a.vandehy.ctr@health.mil

Principal Investigator:

Pinata H Sessoms, PhD

Naval Medical Center San Diego

Recruiting

San Diego, California, United States, 92134

Walter Reed National Military Medical Center (WRNMMC)

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Sarah E Kruger, MS

301-319-3722 sarah.e.kruger.civ@health.mil

Principal Investigator:

Sarah E Kruger, MS

More Information

Sponsor

Naval Health Research Center

Last update posted

Nov 21, 2023

Last verified

Nov, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Naval Health Research Center on 2023-11-21.