1. Remote Monitoring of Rehabilitation after Total Knee Replacement: The StepRite System Carolee Winstein, Christopher Powers, Helen Bacon Industry Sponsor: MedHab, Johnny Ross, Co-founder and CEO

2. A few facts, definitions, and the future: Exponential advances across myriad technological fields are conspiring to usher in an era of profound change Never underestimate an exponential. --Carl Sagan

6. Background and Motivation More than 400,000 TKAs are performed per year. More are expected with aging baby boomers reaching 65 yr of age. The operation typically involves substantial postoperative pain, and includes vigorous physical rehabilitation. Healthcare dollars allotted to rehabilitation declining. 6

7. Need to develop remote monitoring of rehabilitation after TKA To enable better adherence with exercise protocols Optimize self-management of recovery Variation in patient’s independent exercise and activity after TKA surgery may contribute to variable functional gains (Franklin et al., 2006) 7

8. StepRite System Developed by MedHab (http://www.medhab.com/)http://www.medhab.com/ Allows the physical therapist to monitor physical activity and exercise remotely StepRite provides a pressure sensing dashboard for the physical therapist and physician. It provides 3D tracking, pressure sensing, real-time wireless communication and a HIPAA secured user interface website. 8

9. StepRite System Provides quantitative feedback about exercise compliance comparing the surgical side with the non-surgical side Real time feedback during exercise and weight-bearing activities It is a developing remote, interactive monitoring system 9

10. Development of a Smart Insole Tracking System for Physical Therapy and Athletics Johnny Ross Jr. CEO MedHab LLC PETRA ‘14

11. Motivation for the Industry Partner Johnny Ross - Knee surgery in 2008 Poor results with traditional rehab methods Enhance rehabilitation with quantitative data

12. Design Goals Wireless, remote monitoring, force sensing device Monitor patient rehabilitation Enhance athletic training

13. Insole Hardware Force sensors 9-axis sensor (gyroscope)

14. Pressure Sensor insole (earlier version) 14 Based on pressure sensing and accelerometry technology

15. Algorithm Development Custom algorithms needed –Translate raw sensor data into various information Gait Analysis Range-of-Motion analysis Power Meter

16. Quality Assurance Hardware challenges –Calibration –Validation

17. System Architecture Two versions – Medical & Athletic

18. Mobile Applications StepRite (Medical) –Simple interface –Collect data from insoles –Sends data to web service

19. Log in screen shot

20. Medical version: Web-based Clinician Interface – enter protocol, review recorded patient data, adjust protocol Patient Interface – review progress Protocol page with showing standing pressure Protocol page showing icons of from which to choose

21. Gait screen shotCycling screen shot

22. Range of motion herePressure here

23. Provider compliance dashboard Patient compliance dashboard

24. Provider and Patient Compliance Reports

25. Stage of Research Intervention development Intervention efficacy 25

26. Project Objective: We will test the hypothesis that patients who use the device post-surgery will demonstrate superior short-term improvements (i.e., 6 months post TKA)—two outcome measures: –Self-reported functional outcomes (WOMAC) –Gait parameters (GaitRite system) Compared to a control group who does not use the device (standard care with log book). 26

27. Specific Aims: To compare the short-term changes in gait parameters after TKA between those who use the StepRite device and those who follow a standard therapy program with out the device. To compare the short-term self-reported functional outcomes after TKA between those who use the StepRite device and those who follow a standard therapy program without the device. 27

28. Work in progress Exercise protocol will be programmed into the device. IRB and development of industry partner contract. Development of protocol including the number of HH (home health) and OP (out-patient) visits (in-person and remote) for each group. N= 25/group for the efficacy study Proposed time line (~1-1.5 yr project) )28

29. Acknowledgements Deaton Engineering TECH Fort Worth Technical Incubator Angelo State, Lamar Universities, & Texas A&M, Corpus Christi Texas Manufacturers Assistance Center

30. Questions