FLINT REHABILITATION DEVICES, LLC — Department of Health and Human Services SBIR Phase II: NICHD

Description

DESCRIPTION provided by applicant Arm impairment is a common condition that contributes substantially to disability in the U S and around the world For example it is estimated that of the individuals who survive a stroke each year require arm therapy Intensive rehabilitation reduces long term arm impairment especially when performed early after stroke Unfortunately time with a therapist is limited during inpatient rehabilitation and individuals with severe impairment lack motivating and effective tools to increase the dose of therapy they receive To address this problem we have developed LARA an assistive lever drive wheelchair specifically designed to provide arm rehabilitation through repetitive elbow shoulder flexion extension exercise In pilot studies we found out of individuals with severe arm impairment were able to use LARA with their impaired arm to move feet overground in their wheelchair and to play engaging therapy based computer games while exercising in LARAandapos s stationary mode Thus by using LARA as their wheelchair for the several hours per day they normally spend in a wheelchair inpatients will be able to use their impaired arm to ambulate to their therapy appointments the cafeteria etc rather than being passively pushed by a caregiver or by using only their good arm and foot as is now the case They will also be able to easily access the therapy based games in their room or in the clinic common room They will thus achieve thousands more rehabilitation practice movements than is current practice improving their arm movement recovery Our aims for Phase II are to Develop a production model of LARA suitable for commercialization months We will modify our functional prototype to be robust maneuverable easy to use and efficiently manufactured in an FDA compliant way and will complete development of an intuitive easy to use game interface that automatically quantifies and logs the userandapos s movement and use habits Perform a randomized controlled trial of the device with sub acute stroke patients months Individuals with subacute stroke are a large potential user group Through a consortium with UC Irvine we will randomize individuals with a subacute stroke to use LARA or receive additional conventional therapy during their inpatient stay We hypothesize that the individuals who use LARA to exercise and ambulate to their appointments will improve their Fugl Meyer score by a clinically significant amount points more the control group as assessed at a three month follow up Solicit feedback on usability of the device in normal clinical practice months We will distribute LARA to two leading rehabilitation units and study how these units incorporate the device into their patient care This Phase II project will result in a commercially ready clinically validated product that we will produce and sell PUBLIC HEALTH RELEVANCE This research is relevant to public health because it will increase the accessibility and lower the costs of rehabilitation therapy for the upper extremity This will provide a pathway to a better life for millions of U S citizens suffering from motor impairment after stroke and other neurologic injuries Not only does rehabilitation therapy reduce the likelihood of devastating complications it also improves functional ability increasing the standard of living of individuals with impairment and reducing the burden on society caused by disability