VR/AR Therapy for Vestibular Dysfunction (VR4VPT Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen BySarah Kruger, MS

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Naval Health Research Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for active duty service members aged 18-65 with mild traumatic brain injury (mTBI) who need vestibular physical therapy. Participants must be able to walk unassisted, have normal or corrected vision, follow instructions, and tolerate wearing a safety harness and head-mounted display for an hour.

Inclusion Criteria

I can wear a full body safety harness comfortably.

Exclusion Criteria

I am not taking medications like Phenobarbital or Ativan that cause significant drowsiness.

I am unable to give consent for medical procedures.

I have a diagnosed visual impairment such as macular degeneration or retinal detachment.

I have had seizures or fainting spells in the past.

Participant Groups

The study tests if advanced VR and AR technologies improve balance and reduce symptoms in mTBI patients compared to conventional therapy. It involves three groups: one receiving standard treatment, another using a large-scale VR system called CAREN, and the third using mobile AR technology.

3Treatment groups

Experimental Treatment

Active Control

Group I: Augmented Reality (AR) GroupExperimental Treatment1 Intervention

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

Group II: CAREN GroupActive Control1 Intervention

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

Group III: Conventional Therapy (CPT) GroupActive Control1 Intervention

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