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

Background Summary $5,000 $50,000

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.

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

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

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 11 th. –Project must be compatible with existing prostheses.

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

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:

Metrics MetricDescriptionTarget Value Reference (See Appendix A) Number of Steps The device will measure the number of steps the user takes over a certain period of time. ±10% of actual steps [4] Change in cadenceThe software will detect changes in cadence. ±10% change in cadence Distance The design will measure the distance the user covers in meters. ±10% of actual distance [2] Incline/Decline The device will recognize whether the user travels over an incline or decline. 20° American Disability Act Data Acquisition The device will be able to store data over a certain amount of time. This data will be able to be uploaded in a certain amount of time hours Current Technology Affordability The device should be sold to consumer below target value. <$100 Sponsor Feedback

Benchmarking Hardware SoftwareData Analysis

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

Hardware Selection - For Hardware: FitBit® One TM best fits the metrics for the desired specifications

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

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

Final Design Fitbit ® One TM Fitabase Software Development

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

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

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®

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%

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 ✔

Software Test #1 3 healthy subjects (M, 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

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

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

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

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 ✔ ✔

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

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

Project Cost Stage:Item Purchased:Cost: Development (Fall 2013) Fitbit® One TM (x7)$700 Software Development$300 Subtotal:$1000 Clinical Trial (Spring 2014) Misc. Cost per Subject$3000 Promotion & Publication$1000 Subtotal:$4000

Metrics ✔ ✔ ✔ ✔ ✔ ✔ MetricDescriptionTarget Value Reference (See Appendix A) Number of Steps The device will measure the number of steps the user takes over a certain period of time. ±10% of actual steps [4] Change in cadenceThe software will detect changes in cadence. ±10% change in cadence Distance The design will measure the distance the user covers in meters. ±10% of actual distance [2] Incline/Decline The device will recognize whether the user travels over an incline or decline. 20° American Disability Act Data Acquisition The device will be able to store data over a certain amount of time. This data will be able to be uploaded in a certain amount of time hours Current Technology Affordability The device should be sold to consumer below target value. <$100 Sponsor Feedback

Path Forward Business negotiations for intellectual property between Fitabase and 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 World Tour

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