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A momentum-enabled treadling methodology to improve gait and enhance mobility in patients with peripheral arterial disease

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AG060764-01
Agency Tracking Number: R41AG060764
Amount: $216,521.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIA
Solicitation Number: PA17-303
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-30
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Burgaw, NC 28425-5215
United States
DUNS: 620533310
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (910) 599-8281
Business Contact
Phone: (910) 617-9703
Research Institution
104 Airport Drive, Suite 2200
CHAPEL HILL, NC 27599-0001
United States

 Nonprofit College or University

Project SummaryA significant cause of mobility impairment in the elderly is peripheral arterial diseasePADPAD results in
significant functional declinereduced walking speed and distanceand lower physical activity levelsresulting
in a loss of independence and impaired quality of lifeThe most effective therapy for PAD is rigorous exercisee gwalkingHowevermost PAD patients will not participate in supervised exerciseand walking related pain
provides a substantial barrier to unsupervised exerciseresulting in a lack of complianceIn additioncommon
comorbidities act as difficult to surmount barriers to rigorous physical exerciseTreadwell Corporation is pioneering an innovative treadling methodology and devicethe TREDLRTMto
provide a therapy that can improve exercise tolerance in patients with PADaccelerating their progress to reaping
the functional benefits of more rigorous physical exerciseThe TREDLRTM contains an internal flywheel that
generates momentum while the user initiates repetitive ankle flexion and extension movementsPreliminary studies with the TREDLRTM prototype have demonstrated clear hemodynamic improvements in
the lower extremities of participants who treadleAdditional pilot data from the collaborating sub award PIDrJason Franzhave demonstrated in part that treadling affords the same ankle and calf muscle fascicle kinematics
as walking without comparable levels of muscle activationa finding that we posit will translate to improved
compliance and prolonged participation prior to onset of discomfort in people with PADWe hypothesize that this
will improve patientsfunctional exercise capacity and accelerate their progress to participation in more rigorous
exercise therapyIn this Phase I STTRthe investigative team will evaluate this novel treadling methodology in individuals aged
overyears with diagnosed PADTo accomplish several early and critical milestonesthis study will evaluate
joint and muscle kinematic differences between treadling and conventional exerciseAimexplore
improvements in mobility and functional exercise capacity in individuals who treadle as compared to a control
cohortAimand assess user affect that may impact compliance andultimatelywidespread adoptionAimPhase I is expected to demonstrate the feasibility of Treadwell s proprietary treadling methodology as
a method to improve exercise tolerance and mobility in older adults with PADThese results will support further
commercialization of the methodology and poise Treadwell to initiate rigorous multi site clinical trials coupled
with mechanistic outcomes in Phase IIwhich will be necessary to drive clinical acceptance of the methodology Project Narrative
Mobility impairment significantly impacts quality of life for elderly individuals with peripheral arterial diseasePADdecreasing independence and increasing health care costsmorbidityand mortalityTreadwell is
pioneering a proprietary treadling methodology and device thatin this Phase I studyseeks to improve mobility
and exercise tolerance in elderly individuals with PADThe ease of use of momentum enabled treadling can
improve compliancecreating a novel and accessible method to improve mobilitymaking rigorous exercise more
accessible for the elderly

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

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