Abilitech Medical, Inc. — Department of Health and Human Services SBIR Phase I: NICHD

Description

! ABSTRACT Significance Spinal cord injuries SCI cause costly and morbid chronic conditions such as lack of voluntary movement increased chance of pressure sores problematic spasticity loss of bowel bladder and sexual function and more physical impairments which result in a lower quality of life and lack of independence Approximately people in the U S have SCI with new patients added each year Current treatment options include an array of electrical stimulation interventions or high intensity fitness regimens but all share one common limitation of being episodic in their treatment delivery There is a compelling need for a treatment option that can be used daily improves Activities of Daily Living ADL s allows for in home rehab and most importantly provides patient independence Enabling technology exists often proven in other medical device applications that can facilitate the design of an upper limb orthotic system to deliver the functional performance required by SCI patients The OlympEX Medical Actively Powered Exoskeleton APEX device can meet the functional movement requirements will be designed for in home use and be affordable to the user Hypothesis We hypothesize that the APEX orthotic system will achieve clinically meaningful improvement in a SCI patient s range of motion ROM capability to perform ADL s and to perform upper limb rehab in an in home setting Preliminary Work The APEX orthotic system will be the third generation of orthotic device system to be developed by OlympEX Medical Generations and are passively powered device systems that have provided the OlympEX design engineering team experience with mechanical apparatus requirements to elevate an upper limb Likewise the team has developed capabilities in advanced materials for the body chassis for these devices The APEX orthotic system evolves from these product platforms to introduce system features in device guidance and user control only obtainable with an actively powered system Specific Aims This project entails the APEX hardware electronic architecture development and the acute pre clinical evaluation of the system on N patients to evaluate patient safety and device feasibility In Specific Aim we will design fabricate and evaluate the APEX mechanical design with electronic architecture A subset of the APEX functional arm movements will be developed to demonstrate feasibility in performing a limited number of high priority ADL s In Specific Aim we will evaluate the performance of this subset of ADL s on SCI patients Success criteria will be Pass Fail as evaluated by clinicians In addition an initial patient safety assessment will be completed Safety factors including discomfort or pain before and after the fitting of the device and no uncontrolled arm movements will be evaluated Together these studies will demonstrate the feasibility of APEX device to guide arm movements required to complete ADL s and therapeutic arm movements in an ambulatory setting !Project Narrative Those with cervical spinal cord injuries SCI have reduced ability to voluntarily move and use their arms and hands which results in the inability to accomplish many activities of daily living OlympEX Medical proposes to develop and test an active powered upper extremity exoskeleton to help people with SCI and other neuromuscular conditions with their upper limb function and rehabilitation This will improve health rehabilitative technology quality of life and independence for those with SCI