protocolSection identificationModule nctId: NCT06381674, orgStudyIdInfo id: OHSU: 25890, secondaryIdInfos id: HT9425-23-1-0845, type: OTHER_GRANT, domain: Department of Defense, briefTitle: Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation, acronym: SuBTyPE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-13, primaryCompletionDateStruct date: 2028-09-30, completionDateStruct date: 2028-09-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Oregon Health and Science University, class: OTHER, collaborators name: United States Department of Defense, descriptionModule briefSummary: Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy., conditionsModule conditions: Mild Traumatic Brain Injury, Concussion, conditions: Rehabilitation, conditions: Balance Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There will be two groups in this study that will be randomized concurrently into two different rehabilitation programs., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Parties that will be masked include those collecting and analyzing data before and after rehabilitation (post-doctorate fellows, research assistants, and statistician)., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback, interventions name: Vestibular therapy for mTBI, outcomesModule primaryOutcomes measure: Patient Global Impression of Change (PGIC), secondaryOutcomes measure: Concussion Clinical Profiles Screening (CP Screening), secondaryOutcomes measure: Dizziness Handicap Index (DHI), secondaryOutcomes measure: Quality of Life After Brain Injury (QOLIBRI), secondaryOutcomes measure: The Patient Reported Outcomes Measurement Information System (PROMIS)-Satisfaction with Participation in Social Roles-Short Form 4a, secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Headache Impact Test (HIT-6), secondaryOutcomes measure: Insomnia Severity Index (ISI), secondaryOutcomes measure: Neck Disability Index (NDI), secondaryOutcomes measure: Convergence Insufficiency Symptom Survey (CISS), secondaryOutcomes measure: Vertigo Symptom Scale (VSS), secondaryOutcomes measure: Concussion Symptom Subtypes Inventory (CSSI), secondaryOutcomes measure: Automated Neuropsychological Assessment Metric (ANAM), secondaryOutcomes measure: Dynamic Visual Acuity ( DVA-Clinical), secondaryOutcomes measure: Ocular Motor Function Tests, secondaryOutcomes measure: Video Head Impulse Test (vHIT), secondaryOutcomes measure: Functional Gait Assessment (FGA), secondaryOutcomes measure: Complex Turning Course (CTC), secondaryOutcomes measure: Modified Balance Error Scoring System (mBESS), secondaryOutcomes measure: Modified Clinical Test for Sensory Integration on Balance (mCTSIB), secondaryOutcomes measure: Instrumented One Minute Walk (Single and Dual Task), secondaryOutcomes measure: Hybrid Assessment of Mobility (HAM-4), secondaryOutcomes measure: Tandem Gait (Single and Dual Task), secondaryOutcomes measure: Vestibular Ocular Motor Screening (VOMS), secondaryOutcomes measure: Central Sensorimotor Integration Testing (CSMI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Oregon Health & Science University, city: Portland, state: Oregon, zip: 97239-3098, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Fort Sam Houston, city: San Antonio, state: Texas, zip: 78234, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: University of Utah, city: Salt Lake City, state: Utah, zip: 84112, country: United States, geoPoint lat: 40.76078, lon: -111.89105, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Protocol and ICF, date: 2024-02-13, uploadDate: 2024-03-07T11:25, filename: Prot_SAP_ICF_000.pdf, size: 1554413, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan: Updated Statistical Analysis Document, date: 2024-04-02, uploadDate: 2024-04-04T19:41, filename: SAP_001.pdf, size: 112584, hasResults: False