Team IPO: System for quantifying K-Level assessment in amputees

1. Team IPO: System for quantifying K-Level assessment in amputees Connor Bortz, Matthew Galbraith, Jessica Lewis, Chelsea Madden, Anthony Rossi

2. Background Summary $50,000 $5,000

3. Background Summary • K-Level system for rating amputee assessment: • K-0: Does Not Qualify. • K-1: Fixed-pace on level ground. • K-2: Walk over minor barriers. • K-3: Varied-cadence and over most barriers. • K-4: Athletic Ability with Prosthetic.

4. Background Summary • Too qualitative. • Distinction between K-2 to K-3 • Initiative to ‘work their way up’

5. Scope To develop a system to measure various gait parameters that pertain to ambulating to be used for diagnosis justification, and prosthetic prescription.

6. Product Desired Specifications • Constraints • Product must abide by any FDA, FCC, or other existing codes and regulations. • Project must make substantial progress towards use on amputee subjects before final deadline, December 11th. • Project must be compatible with existing prostheses.

7. Product Desired Specifications 1.) Measuring Capabilities 2.) Data Acquisition/Storage 3.) Low-Cost 4.) Portability 5.) Comfort 6.) Water-proof 7.) User-Readability 8.) Aesthetic • Wants:

8. Product Desired Specifications • Within “Measuring Capabilities”, there are prioritized parameters: 1.) Number of Steps 2.) Walking Cadence 3.) Distance 4.) Elevation detection. K-1: K-2: K-3:

9. Metrics

10. Benchmarking Software Data Analysis Hardware

11. Hardware Options Actibelt® Fitbit® One TM Worn around the body Available for purchase Data readout on device ~$99.99 per device In-House Manufacturing • Labor intensive • Unknown timetable • Custom software required • Cost undetermined • Worn around the hip • Available for rent • Readout software included • ~$260 per belt per month

12. Hardware Selection - For Hardware: FitBit® OneTM best fits the metrics for the desired specifications

13. Software Options Fitabase Fitbit®OneTM Online Online software provided byFitbit® Intraday data available in fifteen minute intervals No customization allowed Custom Software • Requires registering with Fitbit® • Google Doc has embedded Fitbit®extraction • Data intervals in day-by-day basis • Intraday data available inminute intervals • Customizable user interface

14. Software Selection - For Software: Fitabase best fits the metrics for the desired specifications

15. Final Design Fitabase Fitbit®OneTM Software Development

16. Test Plan Hardware Testing: Verify standard Fitbit® outputs for normal and amputee subjects Software Testing: Validate desired system outcomes, e.g. minute-by-minute step count, stair climb, change in cadence, in normal subjects Clinical Trials: Field testing of integrated hardware and software system on cohort of amputees with a range of K-levels

17. Hardware Testing: Healthy Subjects • 2 healthy subjects (M 22 yo, F 21 yo) • Walking tests on treadmill & stairs • Fast/slow cadence • Flat & incline • Location of FitBit® • Outcomes from Fitbit® software (15-minute intervals) • Step count • Distance • Floors

18. Hardware Testing: Healthy Subjects • Fitbit® Measurement Error (across all trials) • Steps: 11±13% • Floors: 0% • Observations • Incline only measured with change in elevation • Cadence not a direct output Example of standard output from Fitbit®

19. Hardware Testing: Amputee Subjects • 1 amputee subject (M, 39 yo) • Walking tests outside • Walking test (30 steps) • Stair test (1 flight of stairs) • Results: Accuracy • Step Count = 93.75% • Stair Climb = 100%

20. Test Plan ✔ Hardware Testing: Verify standard Fitbit® outputs for normal and amputee subjects Software Testing: Validate desired system outcomes, e.g. minute-by-minute step count, stair climb, change in cadence, in normal subjects Clinical Trials: Field testing of integrated hardware and software system on cohort of amputees with a range of K-levels

21. Software Test #1 • 3 healthy subjects (M, 21-22 yo) • Walking tests on indoor track & stairs • Fast/slow cadence • With/without obstacles • Pedometer & observation as gold standard • Outcomes from Fitabase® (min-by-min) • Step count • Distance • Elevation

22. * Data shown for Subject 2, 9 min walk on flat ground with change in cadence every 3 min

23. Software Test #2 • 3 healthy subjects (M 21 yo, 2xF 21 yo) • Walking tests • Simulated daily activity outside/inside with obstacles • Random changes in cadence • Cadence change as primary outcome • Blinded data analysis • Varied threshold for detecting change in cadence • Error in predicted versus actual change in cadence

25. ★ ★ ★ ★ ★ ★ ★ * Data shown for Subject 3, 23 min. walk test in native environment with subject-selected change in cadence

26. Test Plan ✔ Hardware Testing: Verify standard Fitbit® outputs for normal and amputee subjects Software Testing: Validate desired system outcomes, e.g. minute-by-minute step count, stair climb, change in cadence, in normal subjects Clinical Trials: Field testing of integrated hardware and software system on cohort of amputees with a range of K-levels ✔

27. Clinical Trials: Methods • Subjects • 60 Amputees: K-1 (15), K-2 (15), K-3 (15), K-4(15) • 20 Healthy controls • Walking tests • Clinical assessment: 6-minute walk test, 10m test • Normal daily activity for a week • Outcome Measures • Patient records • Clinical assessment • Custom outcomes from Fitabase • User survey University of Delaware Internal Review Board (IRB) approved November 20th

28. Clinical Trials: Hypotheses • The system can be used to observe cadence changes and elevation changes • The system will be well tolerated by the patients • Threshold for detection of cadence change will vary between normal and amputee subjects and can be incorporated into the design

29. Project Cost

30. Metrics ✔ ✔ ✔ ✔ ✔ ✔

31. Path Forward • Business negotiations for intellectual property between Fitabaseand IPO • Run clinical trials in Spring 2014 (UD MEEG482) • Academic publication of clinical trials in Summer 2014 • Distribution of software to other prosthetics clinics through Fitabase 2014-2015 • World Tour 2014-2015

32. Acknowledgments John Horne, Sponsor Dr. Buckley, Advisor Entire Senior Design Staff Thank you for your attendance!