nctId: NCT06381674 id: OHSU: 25890 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 overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2028-09-30 date: 2028-09-30 date: 2024-04-24 date: 2024-04-24 name: Oregon Health and Science University class: OTHER name: United States Department of Defense 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. conditions: Mild Traumatic Brain Injury, Concussion conditions: Rehabilitation conditions: Balance Impairment studyType: INTERVENTIONAL phases: NA 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 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 count: 100 type: ESTIMATED name: Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback name: Vestibular therapy for mTBI measure: Patient Global Impression of Change (PGIC) measure: Concussion Clinical Profiles Screening (CP Screening) measure: Dizziness Handicap Index (DHI) measure: Quality of Life After Brain Injury (QOLIBRI) measure: The Patient Reported Outcomes Measurement Information System (PROMIS)-Satisfaction with Participation in Social Roles-Short Form 4a measure: Hospital Anxiety and Depression Scale (HADS) measure: Headache Impact Test (HIT-6) measure: Insomnia Severity Index (ISI) measure: Neck Disability Index (NDI) measure: Convergence Insufficiency Symptom Survey (CISS) measure: Vertigo Symptom Scale (VSS) measure: Concussion Symptom Subtypes Inventory (CSSI) measure: Automated Neuropsychological Assessment Metric (ANAM) measure: Dynamic Visual Acuity ( DVA-Clinical) measure: Ocular Motor Function Tests measure: Video Head Impulse Test (vHIT) measure: Functional Gait Assessment (FGA) measure: Complex Turning Course (CTC) measure: Modified Balance Error Scoring System (mBESS) measure: Modified Clinical Test for Sensory Integration on Balance (mCTSIB) measure: Instrumented One Minute Walk (Single and Dual Task) measure: Hybrid Assessment of Mobility (HAM-4) measure: Tandem Gait (Single and Dual Task) measure: Vestibular Ocular Motor Screening (VOMS) measure: Central Sensorimotor Integration Testing (CSMI) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Oregon Health & Science University city: Portland state: Oregon zip: 97239-3098 country: United States lat: 45.52345 lon: -122.67621 facility: Fort Sam Houston city: San Antonio state: Texas zip: 78234 country: United States lat: 29.42412 lon: -98.49363 facility: University of Utah city: Salt Lake City state: Utah zip: 84112 country: United States lat: 40.76078 lon: -111.89105 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 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