TREADWELL CORPORATION — Department of Health and Human Services STTR Phase I: NIA

Description

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