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

Description

DESCRIPTION provided by applicant Hand impairment is a common condition that contributes substantially to disability in the U S and around the world In the case of stroke alone it is estimated that of the individuals who survive a stroke each year require hand therapy Intensive rehabilitation exercise reduces long term hand impairment Unfortunately as soon as weeks after the onset of an injury people often must perform hand therapy at home without professional assistance Individuals rarely comply with written home programs for home therapy To address this problem we have developed the MusicGlove an affordable instrumented glove that requires the user to practice functional gripping movements to play a custom computer game inspired by the third most popular video game in gaming history Guitar Hero In our Phase I study with individuals with a stroke who used the device at home and an earlier pilot study with individuals with a stroke who used the device in the clinic we found that the MusicGlove accurately measures clinical hand impairment level inspires people to make over practice grip movements in minute training sessions and stimulates significantly greater improvements in hand function than conventional therapy Our aims for Phase II are to Develop a production model of the MusicGlove suitable for commercialization months We will modify our functional prototype to be robust 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 We will also develop next generation technologies for improved future models Perform a two site randomized controlled trial of the device with sub acute stroke patients months Individuals with subacute stroke are a large potential user group At two sites we will randomize individuals with a subacute stroke to receive additional therapy with the MusicGlove or additional conventional therapy for four weeks We hypothesize that the individuals who exercise with the MusicGlove will improve their Box andamp Block score by a clinically significant amount blocks compared to the control group Conduct a pilot study of use of the device with individuals with a chronic cervical incomplete SCI months We will also establish initial safety feasibility and efficacy for individuals with a SCI n another important user group Solicit feedback on usability of the device in normal clinical practice months We will distribute the MusicGlove to three 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