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

NCT05326100 | Unknown DMC FDA Device

• 1 other identifier: WRNMMC-2020-0332
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Functional Assessments: Sensory Organization Test (SOT)

  Assessment consisting of six different conditions used to measure balance and postural control. This test will be performed on the Neurocom Equitest Balance Manager and administered by a physical therapist. The first three conditions have a fixed surface, but the final three conditions are completed with a sway-referenced surface. The visual input is also changed between conditions, completed with eyes open or closed, or with either a fixed or sway referenced visual surroundings. The composite score, a weighted average of the six conditions, is able to distinguish between individuals that are healthy (higher composite scores) and those with balance deficits (lower composite scores). The test will take approximately 15 minutes to complete and will be administered at evaluation and re-evaluation.

  6 weeks

• Functional Assessments: Community Balance and Mobility Scale (CB&M)

  Assessment used to evaluate the performance of 13 tasks for ambulatory individuals with TBI, and has been found to be valid and reliable, and sensitive in this population. Each task is scored on a scale of 0-5 based on the success of task completion, with a maximum score of 96. The tasks evaluated are unilateral stance, tandem walking, 180 degree tandem pivot, lateral foot scooting, hopping forward, crouch and walk, lateral dodging, walking and looking, running with controlled stop, forward to backward walking, walk, look and carry, and descending stairs. This will take approximately 20-30 min to complete and will be administered at evaluation and re-evaluation.

  6 weeks

• Functional Assessments: Functional Gait Assessment (FGA)

  Assessment composed of 10 gait tasks, administered and scored on a 0-3 ordinal scale by a physical therapist. Scoring is based on the ability to walk over a level surface, change speed, walk while turning the head, walk and pivot, step over an obstacle (approximately 6" in height), walk with a narrow base of support (heel to toe), walk with eyes closed, walk backwards, and walk up steps, with a lower score indicating a higher degree of impairment. This will take approximately 5-10 minutes to complete and will be administered at evaluation and re-evaluation.

  6 weeks

• Vestibular Symptoms: Activity-Specific Balance Confidence Scale (ABC)

  Questionnaire of self-reported balance confidence in daily activities developed to measure the psychological impact of balance impairment and/or falls. Participants score 16 items on a scale of 0% (no confidence) to 100% (total confidence) that they can perform the activity without losing balance. The ABC has been proven to be internally consistent, reliable, and valid. This will take approximately 5 minutes to complete and will be administered at evaluation and re-evaluation.

  6 weeks

• Vestibular Symptoms: Dizziness Handicap Inventory (DHI)

  Evaluation of self-perceived handicapping of the effects imposed by dizziness. The DHI is constructed of 25 questionnaire items classified into three subgroups: physical (0-28 points), emotional (0-24 points), and functional (0-48 points). Answers are graded 0-4 with total score ranges from 0 to 100, 100 signifying the highest degree of impairment. The questionnaire has been validated and is sensitive to subtle balance deficits following mild TBI. This will take approximately 10 minutes to complete and will be administered at evaluation and re-evaluation.

  6 weeks

Study Arms (3)

Conventional Therapy (CPT) Group

ACTIVE COMPARATOR

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

Other: Conventional Therapy (CPT)

CAREN Group

ACTIVE COMPARATOR

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

Device: CAREN Therapy

Augmented Reality (AR) Group

EXPERIMENTAL

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

Device: Augmented Reality (AR) Therapy

Interventions

Conventional Therapy (CPT) OTHER

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.

Conventional Therapy (CPT) Group

CAREN Therapy DEVICE

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.

CAREN Group

Augmented Reality (AR) Therapy DEVICE

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.

Augmented Reality (AR) Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Naval Health Research Center: lead
• United States Naval Medical Center, San Diego: collaborator
• Walter Reed National Military Medical Center: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (3)

Naval Health Research Center

San Diego, California, 92106, United States

RECRUITING

Naval Medical Center San Diego

San Diego, California, 92134, United States

RECRUITING

Walter Reed National Military Medical Center (WRNMMC)

Bethesda, Maryland, 20889, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole; Therapeutics

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Pinata Sessoms, PhD

  Naval Health Research Center

  PRINCIPAL INVESTIGATOR

• Sarah Kruger, MS

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

• Kerry Rosen, PhD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pinata Sessoms, PhD

CONTACT

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

Kerry Rosen, PhD

CONTACT

kerry.b.rosen.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Biomedical Engineer

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: April 13, 2022
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)