Status:
UNKNOWN
Use of Virtual and Augmented Reality Devices in Vestibular Physical Therapy for mTBI
Lead Sponsor:
Naval Health Research Center
Collaborating Sponsors:
United States Naval Medical Center, San Diego
Walter Reed National Military Medical Center
Conditions:
MTBI - Mild Traumatic Brain Injury
Dysfunction of Vestibular System
Eligibility:
All Genders
18-65 years
Phase:
NA
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 sig...
Detailed Description
This protocol represents Phase 2 of a project that seeks to implement mobile AR-based technologies into vestibular physical therapy. The Phase 1 protocol (EIRB Number - NHRC.2019.0002) is ongoing and ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05326100
Start Date
October 1 2023
End Date
December 1 2024
Last Update
November 21 2023
Active Locations (3)
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1
Naval Health Research Center
San Diego, California, United States, 92106
2
Naval Medical Center San Diego
San Diego, California, United States, 92134
3
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, United States, 20889