Impaired somatosensation or impaired use of somatosensation by the nervous system is one of the most common causes of balance and walking disability in older individuals. The human balance and gait control systems rely on somatosensory information from foot contact with the support surface during walking. Somatosensory loss is common with diabetes, normal aging, stroke, and with impaired central processing in neurological disorders such as Parkinson's disease (PD), multiple sclerosis, and ataxia. Impaired somatosensation results in increased risk of falls and is a major contributor to disability and death. In the absence of successful treatments to restore intrinsic sensory feedback, we focus on using extrinsic (augmented) sensory feedback to provide complementary sensory cueing to augment the patient's impaired sensory system. Feedback is a type of augmented feedback that provides real-time cueing to improve motor control and help close the broken sensory-motor control loop. This Fast-Track SBIR will allow APDM to prepare VibroGait for a commercial launch as the ?rst wireless, gait vibrotactile feedback system to be used during daily life. Speci?cally, we will develop a smart garment instrumented with an inertial sensing unit and a microcontroller to wirelessly communicate with a tactor housed in a smart silicone band to deliver vibrotactile stimulus to a desired body segment where there is adequate somatosensation to perceive the vibratory cues. This standalone system will be a?ordable to patients as well as easy to use and to turn o? when not needed. VibroGait can also be plugged into APDM's advanced Mobility Lab, which uses sophisticated and validated gait algorithms and a cloud database, to enable clinical researchers to monitor mobility impairments and compliance of use of VibroGait. This project has two main aims. Our technology development aim is to prepare VibroGait for clinical practice and FDA 510(k) clearance to clinical market. Our clinical research aim is to demonstrate the clinical utility and e?ectiveness of VibroGait in improving quality of mobility at home.
Public Health Relevance Statement: Project Narrative The objective of this Fast-Track application is to develop and commercialize VibroGait ; a wireless, sensory feedback system to provide real-time tactile stimulation to enhance mobility in people with somatosensory de?cits. This is the ?rst study investigating the e?ect of vibrotactile feedback at home on mobility disturbances in subjects with central somatosensory impairments.
Project Terms: Algorithms; Ankle; Area; Ataxia; Auditory; base; Biofeedback; Cessation of life; Characteristics; Clinic; Clinical; clinical practice; Clinical Research; Clinical Trials; Collaborations; Communities; cost; Cues; Custom; Databases; design; Deterioration; Diabetes Mellitus; disability; Equilibrium; Esthesia; fall injury; fall risk; falls; Feedback; foot; Gait; gait rehabilitation; Goals; Health; Health Sciences; Home environment; Human; Impairment; improved; improved mobility; Incidence; Individual; instrument; Intervention; Laboratories; Laboratory Study; Life; Limb structure; Measures; Monitor; motor control; Multiple Sclerosis; nervous system disorder; Nervous system structure; normal aging; novel; Oregon; Parkinson Disease; Patients; Pattern; Persons; Phase; Population; portability; Preparation; Process; prototype; Randomized; Research; Research Personnel; Risk; Safety; Self-Help Devices; sensor; Sensory; sensory feedback; sensory integration; sensory system; Signal Transduction; Silicones; Small Business Innovation Research Grant; somatosensory; Stimulus; Stroke; Surface; System; Tactile; Task Performances; Techniques; Technology; technology development; Time; Training; Universities; verification and validation; vibration; vibrotactile stimulation; Visual; Walking; Wireless Technology
