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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Naval Health Research Center
RECRUITING
San Diego
Naval Medical Center San Diego
RECRUITING
San Diego
Maryland
Walter Reed National Military Medical Center (WRNMMC)
RECRUITING
Bethesda
Contact Information
Primary
Pinata Sessoms, PhD
pinata.h.sessoms.civ@health.mil
6197674474
Backup
Kerry Rosen, PhD
kerry.b.rosen.ctr@health.mil
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 36
Treatments
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.
Authors
Kerry B Rosen
Related Therapeutic Areas
Sponsors
Leads: Naval Health Research Center
Collaborators: Congressionally Directed Medical Research Programs, United States Naval Medical Center, San Diego, Walter Reed National Military Medical Center

This content was sourced from clinicaltrials.gov