Treatment of mTBI Balance Dysfuntion via Multimodal Biofeedback.

Multimodal Sensory Enrichment Device (SEMD) is a medical device system for the testing and training of static and dynamic postural control of sway in patients with dizziness, balance deficit, and/or movement disorders. SEMD provides vibrotactile, visual, and audio cueing referenced to center of pressure for postural control of small and large movement tasks, limited locomotion, dual tasking, and spatial orientation within a hierarchy of skill set protocols. Successful Phase I outcomes provide the basis for SEMD Phase II parallel military and clinical population clinical trials. Results from the clinical trials will: 1) standardize postural sway assessment tests, 2) develop multimodal treatment protocols, 3) establish SEMD efficacy in both military mTBI populations, and civilian populations that fall. Clinical trial results will 1) help refine the in-clinical device model software, 2) determine design specifications for the in-home exercise model, 3) establish regulatory pathways, 4) deliver manufacturing specifications, and 5) will guide the devices into Phase III commercialization.