NCT05326100

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Naval Health Research Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 will compare outcomes from the AR-based HMD system (e.g., Magic Leap One) to the VR-based CAREN system. With validated instruments from Phase 1, this pilot prospective, three-armed randomized, interventional clinical trial seeks to incorporate advanced VR- and AR-based technologies as modalities in physical therapy for servicemembers (SMs) with mTBI who also experience vestibular dysfunction. The three arms are: 1) conventional vestibular physical therapy only (CPT), 2) CAREN only (CAREN), and 3) AR HMD only (AR). Primary: To determine whether advanced VR- and AR-based therapy, improves functional status and reduces self- reported symptoms in SMs with vestibular dysfunction and a history of mTBI. Hypothesis: The investigators hypothesize that after completion of vestibular physical therapy, participants in the CAREN and AR groups will have better outcomes than those in the CPT group. In the CAREN and AR groups, the investigators anticipate greater improvements in static and dynamic balance, as measured by the Sensory Organization Test (SOT), Community Balance and Mobility Scale (CB\&M), and Functional Gait Assessment (FGA), as well as decreased vestibular symptoms, as measured by the Dizziness Handicap Inventory (DHI) and Activity-Specific Balance Confidence Scale (ABC). Secondary: To determine whether participants in the advanced technology groups demonstrate similar clinical improvements following treatment. Hypothesis: The investigators hypothesize that after completion of vestibular physical therapy, participants in the CAREN and AR groups will show similar improvements in static and dynamic balance as well as vestibular symptoms; essentially, the investigators believe the VR- and AR-based therapies will be comparable. Tertiary: To investigate the user experience associated with utilizing advanced technology for the treatment of vestibular dysfunction. Hypothesis: The investigators hypothesize that participants in the AR group will have greater satisfaction than the CAREN group, as measured by higher scores on the User Satisfaction Evaluation Questionnaire (USEQ). Exploratory: Efforts from this study seek to gather information to justify further implementation of AR-based therapy (using HMDs) as well as the development and incorporation of additional military-relevant tasks, such as return-to-duty tasks and measures to be developed for future research efforts.

Conditions

• MTBI - Mild Traumatic Brain Injury
• Dysfunction of Vestibular System

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-04-13
• Last updated: 2023-11-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study