protocolSection identificationModule nctId: NCT06314464, orgStudyIdInfo id: C2023.055, briefTitle: Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI, acronym: Praxis, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: BlueHalo, class: INDUSTRY, collaborators name: Brooke Army Medical Center, collaborators name: University of Pittsburgh, descriptionModule briefSummary: 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 trainingData 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., conditionsModule conditions: Brain Concussion, conditions: Vestibular Disorder, conditions: Cognition Disorder, conditions: Mild Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Praxis, interventions name: Supervised cardiovascular exercise, outcomesModule primaryOutcomes measure: Perceived usability of the Praxis system measured by the System Usability Scale (SUS), secondaryOutcomes measure: Change in Dizziness Handicap Inventory (DHI) score, secondaryOutcomes measure: Change in Pittsburgh Sleep Quality Index (PSQI) score, secondaryOutcomes measure: Change in Generalized Anxiety Disorder scale (GAD-7) score, secondaryOutcomes measure: Change in Post-Traumatic Stress Disorder Check List - Military Version (PCL-M) score, secondaryOutcomes measure: Change in Vestibular Activities Avoidance Instrument-9 (VAAI-9) score, secondaryOutcomes measure: Change in Headache Impact Test-6 (HIT-6) score, secondaryOutcomes measure: Change in Santa Barbara Sense of Direction Scale (SBSOD) score, secondaryOutcomes measure: Change in time required to perform 300-yard shuttle run (single- and dual-task), secondaryOutcomes measure: Change in perceived fogginess, secondaryOutcomes measure: Change in time required to perform 5-10-5 shuttle run, secondaryOutcomes measure: Change in score for 4-Item Hybrid Assessment of Mobility for mTBI (HAM-4-mTBI), secondaryOutcomes measure: Change in time required to perform POrtable WARrior Test Of Tactical AgiLity (POWAR-TOTAL) (single- and dual-task), secondaryOutcomes measure: Change in Vestibular/Ocular Motor Screening (VOMS) total symptom score, secondaryOutcomes measure: Compliance with 20-minute daily dose of gaze stability exercises, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Brooke Army Medical Center, city: Fort Sam Houston, state: Texas, zip: 78234, country: United States, geoPoint lat: 29.45746, lon: -98.4472, hasResults: False