Using virtual and augmented reality for vestibular therapy in mild traumatic brain injury
Use of Virtual and Augmented Reality Devices in Vestibular Physical Therapy for mTBI
This study is testing if virtual and augmented reality treatments can help servicemembers with balance problems and symptoms from mild traumatic brain injuries feel better compared to regular therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Naval Health Research Center Federal |
| Locations | 3 sites (San Diego, California and 2 other locations) |
| Trial ID | NCT05326100 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of virtual reality (VR) and augmented reality (AR) technologies in improving functional status and reducing symptoms in servicemembers with vestibular disorders resulting from mild traumatic brain injury (mTBI). Participants will be randomly assigned to one of three treatment groups: conventional vestibular therapy, VR therapy using the CAREN system, or AR therapy using a head-mounted display. The study will measure outcomes such as balance and symptom severity using validated assessment tools. The goal is to determine if advanced VR and AR therapies provide superior benefits compared to traditional therapy methods.
Who should consider this trial
Good fit: Ideal candidates for this study are active duty servicemembers aged 18 to 65 with a history of mild traumatic brain injury and vestibular dysfunction.
Not a fit: Patients with a history of moderate or severe traumatic brain injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for patients with vestibular dysfunction following mTBI.
How similar studies have performed: Other studies have shown promise in using VR and AR technologies for rehabilitation, suggesting potential success for this innovative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Diego, California and 2 other locations
- Naval Health Research Center — San Diego, California, United States (Recruiting)
- Naval Medical Center San Diego — San Diego, California, United States (Recruiting)
- Walter Reed National Military Medical Center (WRNMMC) — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Pinata Sessoms, PhD — Naval Health Research Center
- Study coordinator: Pinata Sessoms, PhD
- Email: pinata.h.sessoms.civ@health.mil
- Phone: 6197674474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.