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

Description

DESCRIPTION provided by applicant Approximately of the individuals who survive a stroke each year have persistent upper extremity impairment One reason why this percentage is so high is that the number of rehabilitative practice movements that they perform is too small Ideally individuals with a stroke would augment their clinical therapy by regularly attempting to use their impaired limb for functional activities throughout their day yet this is currently not the case due to the greater effort required to use the impaired limb As recently reviewed in JAMA daily pedometer feedback has proven to be an effective way to increase walking activity for many individuals Thus the goal of this Phase II SBIR project is to develop and productize an interactive andquot pedometer for the handandquot that will provide a similar benefit to people seeking upper extremity recovery after stroke We have developed a first of its kind magnetic sensor the Manumeter to wirelessly detect hand and arm movement in a socially acceptable and easy to don package The user wears a small permanent magnet as a ring and a sensing logging wristband detects changes in the magnetic field as the ring moves the wristband detects arm accelerations also We have shown in initial studies that the Manumeter can accurately quantify amounts of functional activity We thus hypothesize that people with a stroke who use the Manumeter to measure and motivate functional use of their upper extremity will improve their recovery The aims of this Phase II grant are to Develop a production model of the Manumeter suitable for commercialization months by a designing robust scalable and attractive hardware components b incorporating three novel interactive feedback functions and c partnering with a professional manufacturing firm to produce a commercial FDA compliant version at scale Perform a usability study with individuals with a chronic stroke to make sure the device is easy to use and attractive months Determine the effectiveness of interactive feedback from the Manumeter in improving upper extremity function in a pilot randomized controlled trial with chronic stroke patients months In this study eleven participants will use the Manumeterandapos s interactive feedback functions to monitor and motivate upper extremity functional activity eleven control participants will wear a Manumeter but receive no feedback and will be given the current standard of care for increasing upper extremity exercise a book of home exercises We hypothesize that the individuals who interactively monitor functional activity with the Manumeter will improve their upper extremity function significantly more as measured by the Box and Blocks score ARAT Motor Activity Log Fugl Meyer score and Manumeter itself This 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