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

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

Interventions

OTHER

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• United States Naval Medical Center, San Diego

  collaborator FED

• Walter Reed National Military Medical Center

  collaborator FED

• Congressionally Directed Medical Research Programs

  collaborator FED

• Naval Health Research Center

  lead FED

Principal Investigators

• Pinata Sessoms, PhD · Naval Health Research Center

• Sarah Kruger, MS · Walter Reed National Military Medical Center

• Kerry Rosen, PhD · Walter Reed National Military Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-01

Primary Completion

2024-12-31

Completion

2024-12-31

FDA Device

Yes

Countries

• United States

Study Locations