Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI

NCT06314464 | Enrolling By Invitation

• 1 other identifier: C2023.055
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with military face-validity in a military service member (SM) population after mild Traumatic Brain Injury (mTBI). The main questions this comparative pilot study aims to answer are:

• Can the Praxis testbed provide feasible/acceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI?
• Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery? Fifteen SMs with post-acute mTBI from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will participate in the multisensory vestibular rehabilitation regimen. These SMs will go through 4 weeks of multisensory vestibular rehabilitation including:
• gaze stabilization
• dual-task balance training
• spatial navigation
• agility training Data from another fifteen SMs, who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise, will be used as the control group. Researchers will compare the Praxis and Control group to determine if the Praxis group shows improvement over the control group with respect to the military-relevant behavioral performance outcomes and patient-reported symptom scores after the end of the rehabilitation.

Conditions

Brain Concussion; Vestibular Disorder; Cognition Disorder; Mild Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Concussion; Dizziness; Vestibular Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Perceived usability of the Praxis system measured by the System Usability Scale (SUS)

  The System Usability Scale (SUS) provides an industry-standard reliable tool for measuring the usability of a system (unit of measurement: number, 0-100). This scale relates to the usability (e.g., feasibility) of the prototype device, and is not a health outcome.

  Subjects will be tested after a 4-week intervention period

Secondary Outcomes (14)

• Change in Dizziness Handicap Inventory (DHI) score

  Subjects will be tested before and after a 4-week intervention period

• Change in Pittsburgh Sleep Quality Index (PSQI) score

  Subjects will be tested before and after a 4-week intervention period

• Change in Generalized Anxiety Disorder scale (GAD-7) score

  Subjects will be tested before and after a 4-week intervention period

• Change in Post-Traumatic Stress Disorder Check List - Military Version (PCL-M) score

  Subjects will be tested before and after a 4-week intervention period

• Change in Vestibular Activities Avoidance Instrument-9 (VAAI-9) score

  Subjects will be tested before and after a 4-week intervention period

Study Arms (2)

Praxis

EXPERIMENTAL

Fifteen SMs with post-acute mTBI and residual dizziness/imbalance complaints from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will receive 4 weeks of Praxis intervention (45 minutes, 5 days per week)

Device: Praxis

Control

ACTIVE COMPARATOR

Fifteen SMs without dizziness/imbalance complaints from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will receive 4 weeks of supervised cardiovascular activity (45 minutes, 5 days per week)

Behavioral: Supervised cardiovascular exercise

Interventions

Praxis DEVICE

Praxis' gaze stabilization exercises are delivered via the tablet-based VestAid software that uses the tablet camera to automatically assess compliance in the conduct of vestibulo-ocular reflex exercises. The smooth pursuit, saccade, agility, and dual tasking exercises are delivered in the form of military-themed mixed reality games using the HTC Vive Focus 3 headset.

Praxis

Supervised cardiovascular exercise BEHAVIORAL

The supervised cardiovascular exercise does not incorporate gaze stabilization exercises (vestibulo-ocular reflex exercises) or smooth pursuit, saccade, agility, and dual tasking exercises.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participating in the SPaR Program
• years old
• Have a self-reported or clinician-confirmed mTBI
• Have continued complaints of dizziness/imbalance
• Are right-handed as determined by the Edinburgh Handedness Inventory-Short Form
• Participating in the SPaR Program
• years old
• No complaints of dizziness/imbalance

You may not qualify if:

• Having impaired mental capacity (e.g., altered capacity due to administration of any mind-altering substances or stress/life situations)
• Displaying behavior that would significantly interfere with validity of data collection or safety during the study
• Reporting significant pain during the evaluation (7/10 by patient subjective report)
• Being pregnant (balance considerations)
• Being unable to abstain from the use of alcohol and medications that might impair participant's balance or cerebral blood flow for 24 hours in advance of testing
• Being mixed or left-handed as determined by the Edinburgh Handedness Inventory-Short Form for the Praxis group undergoing rs-fMRI.

Sponsors & Collaborators

• BlueHalo: lead
• Brooke Army Medical Center: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (4)

• Hovareshti P, Roeder S, Holt LS, Gao P, Xiao L, Zalkin C, Ou V, Tolani D, Klatt BN, Whitney SL. VestAid: A Tablet-Based Technology for Objective Exercise Monitoring in Vestibular Rehabilitation. Sensors (Basel). 2021 Dec 15;21(24):8388. doi: 10.3390/s21248388.

  PMID: 34960480 BACKGROUND

• Hoppes CW, Lambert KH, Whitney SL, Erbele ID, Esquivel CR, Yuan TT. Leveraging Technology for Vestibular Assessment and Rehabilitation in the Operational Environment: A Scoping Review. Bioengineering (Basel). 2024 Jan 25;11(2):117. doi: 10.3390/bioengineering11020117.

  PMID: 38391603 BACKGROUND

• Whitney SL, Ou V, Hovareshti P, Costa CM, Cassidy AR, Dunlap PM, Roeder S, Holt L, Tolani D, Klatt BN, Hoppes CW. Utility of VestAid to Detect Eye-Gaze Accuracy in a Participant Exposed to Directed Energy. Mil Med. 2023 Jul 22;188(7-8):e1795-e1801. doi: 10.1093/milmed/usac294.

  PMID: 36208334 BACKGROUND

• Alroumi AM, Hoppes CW, Whitney SL, Li Z, Holt L, Ramakrishnan S, Barnicott SL, Logeais MT, Richard H, Salter SR, Tiede JM, Wirt MD, Hovareshti P. A virtual reality system for delivery of military-specific vestibular rehabilitation after mild traumatic brain injury: the Praxis study protocol. Front Neurol. 2025 May 21;16:1558795. doi: 10.3389/fneur.2025.1558795. eCollection 2025.

  PMID: 40470496 DERIVED

MeSH Terms

Conditions

Brain Concussion; Vestibular Diseases; Cognition Disorders; Brain Injuries, Traumatic; Dizziness

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurocognitive Disorders; Mental Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pedram Hovareshti, PhD

  BlueHalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 18, 2024
• Study Start: February 12, 2024
• Primary Completion: April 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)