MusicGlove. 9 Hole Peg Test. Box and Block. First Generation vs Next Generation Hand Rehabilitation Devices. About the Company:

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1 TM Providers Guide

2 Overview: MusicGlove is an innova ve new hand rehabilita on device that has been clinically proven to improve func onal outcomes and pa ent sa sfac on for hand therapy a er neurologic injury. It is a sensorized glove that promotes a high number of repe ons of func onally meaningful finger and thumb exercises through an immersive musicbased game. Value of MusicGlove Therapy: Improve clinical outcomes through high intensity training Two randomized controlled trials performed at the University of alifornia, Irvine showed that people using the MusicGlove had significantly greater improvements in hand func on than those who performed conven onal tabletop exercises. These gains were retained at a long term follow-up. See Appendix A for more informa on. Treat more pa ents without increasing staff MusicGlove offers a mo va ng alterna ve to conven onal one-on-one therapy. The so ware includes a self-directed 15 to 60 minute Session Mode that can be used to increase the dose of intensive therapy each pa ent receives without the need for increasing staff. No addi onal training is required! Provide objec ve outcome measures for hand therapy MusicGlove also comes with a proprietary Analy cs Suite that tracks and logs detailed measures of pa ent performance. With the touch of a bu on, therapists can view or print a pa ent s historical data in a clear, concise format. Peer-reviewed studies have shown that the MusicGlove scores are highly correlated with established clinical measures of hand func on, so these scores can also be used as an outcome measure for therapy. Reach a broad pa ent popula on ng is necessary. The device MusicGlove can be used right away by any qualified pa ent no custom caters to a wide spectrum of pa ents, from those with li le residual finger movement to those who are almost fully recovered. The difficulty and intensity of the therapy can be quickly adjusted by changing the number and type of grips required during gameplay or by selec ng faster or slower songs. M 2016 Flint Rehabilitation Devices LL

3 First Generation vs Next Generation Hand Rehabilitation Devices 9 Hole Peg Test Box and Block MusicGlove Easy to use Promotes high number of repetitions Tracks improvements in hand function Engaging game interface Rewarding user experience Healing music thearapy First generation hand rehabilitation is practical and effective, but it can grow boring and tedious fast. When patients grow frustrated, it s hard for everyone to stay motivated. MusicGlove was created to fix that. We combined the engaging aspect of video game therapy with the healing aspect of music therapy to create a game-changing hand rehabilitation device. MusicGlove helps motivate patients to actually want to do their hand therapy, which keeps everyone happy. About the ompany: Flint Rehabilitation Devices, LL is a medial manufacturer and distributor that specializes in innovative rehabilitation devices for neurologic and muscular disabilities. Flint leverages close ties with leading research institutions to commercialize and sell cutting edge technology in the field of rehabilitation. Flint is a licensed medical device manufacturer by the Food and Drug Branch of the alifornia Department of Public Health and is registered with the US Food and Drug Administration. The company is located in Irvine, alifornia and is a registered Limited Liability ompany. Flint is the exclusive retailer/distributor of all non-government purchases in the U.S. All government contracts using GSA are handled through medical distributor Best Priced Products Flint Rehabilitation Devices LL

4 Frequently Asked Questions about MusicGlove Therapy: Who is the MusicGlove for? MusicGlove is intended for use by individuals with mild to moderate hand impairment a er stroke, spinal cord injury, trauma c brain injury, or other neurologic injury to improve hand dexterity and strength. A qualified user should be able to touch their thumb to the index or middle finger and release this grip by a 1/4" or more. Is any special training required? The MusicGlove is ready for use right out of the box with no special training required. The en re unit takes less than 5 minutes to set-up and is designed to be user & clinician friendly. Is this a overed Service? MusicGlove Therapy can be billed as neuromuscular reeduca on or as a therapeu c procedure/exercise (ie: PT codes and 97110). What songs are available? Our current playlist includes unique songs from a variety of genres (jazz, folk, pop). We are always expanding our playlist, and addi onal song packs will periodically be released. an mul ple pa ents use the same MusicGlove device? MusicGlove will accommodate all adult hand sizes. The so ware allows an unlimited number of unique user accounts to be created, so each pa ent s performance can be recorded individually. How is the MusicGlove cleaned? The MusicGlove is manufactured with medical grade hard wearing fabric that is an -microbial and an -fungal. Finger cots on each glove are easily reversible and can be cleaned with the included alcohol wipes or with a disinfec ng wipes appropriate for skin contact. Refer to Appendix B for the cleaning procedure. Where can I purchase the MusicGlove? Flint Rehabilita on Devices is the sole distributor of the MusicGlove in the United States. See terms and condi ons for purchasing informa on. an I purchase an extended warranty? An addi onal 1 year warranty for a total of 2 years of coverage can be purchased for 15% of the final sales price. Where was the MusicGlove developed and where is it manufactured? MusicGlove was originally developed by a team of researchers and engineers at the University of alifornia in Irvine. The device is manufactured in Southern alifornia. an you provide MusicGlove Product Specifications? 201 Flint Rehabilitation Devices LL

5 Appendix A: linical Efficacy METHODS BAKGROUND The MusicGlove is based on the latest rehabilitation research which has shown that therapy programs should: 1 Require a large number of practice repetitions1 2 hallenge each patient at an individually appropriate level 3 Provide detailed feedback on progress over time 3 4 Use music4 and video games5 to motivate patients and stimulate neural recovery. Study 1: linical feasibility study comparing MusicGlove score to level of impairment (n = 10) Study 2: linical RT comparing MusicGlove Therapy to onventional Therapy (n = 12) 6 7 Study 3: Home-based RT comparing MusicGlove Therapy to onventional Therapy (n = 17) 10 linical Study Home Study Box & Blocks Score 8 RESULTS MusicGlove ontrol 8 1 In the initial feasibility study of the MusicGlove, researchers found that the percentage of notes hit in the MusicGlove game is strongly correlated with functional ability. This means users can set meaningful goals with the MusicGlove and receive real rewards when they achieve them. 2 In the second clinical study, researchers found that 6 one-hour therapy sessions with the MusicGlove lead to significantly greater improvements in hand function than a matched dose of conventional tabletop therapy for individuals with chronic stroke (blue bars, p = 0.01). 3 Similar results were found in the controlled study of self-guided therapy with the MusicGlove at home (orange bars, p = 0.05). Participants in both studies also reported regaining the ability to button up a shirt, type on a computer, feed themselves independently, etc. These improvements are most likely due to the large number of repetitions (>5000) patients performed during their therapy. 1. Lohse et al, Stroke 2014; 2. Lo et al, NEJM, 2010; 3. Dobkin et al, NNR, 2010; 4. Safranek, Music Therapy, 2011; 5. Brochard et al, rnt Opin Neurology, 2010; 6. Friedman et al, Intl onf IEEE EMBS, 2011; 7. Friedman et al, JNER, 2014; 8. Zondervan et al, Pending publication 2016 Flint Rehabilitation Devices LL

6 Appendix B: leaning Procedure 1 Patient clean hands with soap and water or waterless hand rub. 2 Flip finger cots inside-out and wipe down glove with included alcohol pads or disinfectant wipes. 3 Put on therapeutic glove. 4 lean hands after removing therapeutic glove. 5 Flip finger cots inside-out and wipe down glove with alcohol pads or disinfectant wipes. Developed by: Debbie Thompson RN, I Epidemiology and Infection Prevention U Irvine Health 200 S. Manchester Avenue, Suite 100 Orange, A Tele Fax Pager Flint Rehabilitation Devices LL

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