TheraBracelet, Inc. — Department of Health and Human Services STTR Phase I: NICHD

Description

Project SummaryPost stroke hand impairment is highly prevalent and severely restricts functional ability and independenceIn facteveryseconds a new stroke occursand stroke is recognized as the leading cause of long term disabilityYetthere is no assistive device to help hand function at homeevery dayduring activities of daily livingExisting devices such as hand opening orthoses are expensivee gMyomo and Bioness are priced at $uncomfortablebulkyand meant for use during short therapy sessions as opposed to during daily livingThus their impact is limitedConsequentlythe development of efficacious and affordable assistive device is of paramount importanceThis proposal addresses this critical gap by providing an innovative patent pending technologyTheTheraBraceletis a wristband applying imperceptible white noise vibration to skinTheraBracelet is efficaciousas it has been shown to immediately improve chronic stroke survivorstouch sensation and hand dexterity in preliminary studiesTheraBracelet is affordable by using only a low cost vibratorTheraBracelet is also translationalbecause a vibrator strategically placed at the wrist does not interfere with dexterous finger motionsand it is low risk by involving only imperceptible vibration on skinThese practicalities assure easy adoption in home environment for large impact on sensorimotor impairmentThe essential next step toward commercializationthus the objective of this Phase I proposalis to determine the feasibility and safety of using this assistive device all day every day for a month during daily activityand to determine if TheraBracelet s instant effects are sustained during prolonged useThis objective will be accomplished in a double blindedrandomizedcontrolledcrossover design studyFeasibilitycompliance of using the device everydayand safetyno worsening of sensationstrengthdexteritypainspasticityskin irritationwill be assessed for the treatment condition compared to the control conditionwearing the device without vibrationthrough weekly evaluationsThe feasibility and safety level comparable to those of wearing a watch and of a comparable FDA approved device will support commercial viability of TheraBracelet with necessary regulatory approvalsIn additionTheraBracelet s instant benefits in improving hand function will be assessed weeklyPersistence of TheraBracelet s instant benefits across all weekly evaluations will support durabilityi edesensitization to vibration does not occur during extended daily use over a one month periodThe knowledge of feasibilitysafetyand durability will pave the way toward commercialization of this novel technologyThis project is expected to lead to an assistive wristband that increases hand function during activities of daily livingthus increasing independence and quality of life and reducing caregiver burden for a large number of stroke survivors with hand impairment