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TheraBracelet: The first and only wearable to instantly improve stroke hand function

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD090792-01A1
Agency Tracking Number: R41HD090792
Amount: $274,256.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PA18-314
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-08-01
Award End Date (Contract End Date): 2018-06-01
Small Business Information
Louisville, KY 40204-1715
United States
DUNS: 045576080
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (843) 792-0084
Business Contact
Phone: (435) 300-0466
Research Institution
CHARLESTON, SC 29403-5120
United States

 Nonprofit College or University

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

* Information listed above is at the time of submission. *

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