team ipo: system for quantifying k-level assessment in amputees connor bortz, matthew galbraith,...
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Team IPO: System for quantifying K-Level assessment in amputees
Connor Bortz, Matthew Galbraith, Jessica Lewis, Chelsea Madden, Anthony Rossi
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Background Summary
$5,000 $50,000
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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.
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Background Summary
• Too qualitative.
• Distinction between K-2 to K-3
• Initiative to ‘work their way up’
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Scope
To develop a system to measure various gait parameters that pertain to ambulating to be used for diagnosis justification, and prosthetic prescription.
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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.
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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
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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:
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Metrics
Metric Description Target ValueReference
(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 cadence The 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 AcquisitionThe 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.
25000 hours Current Technology
Affordability The device should be sold to consumer below target value. <$100 Sponsor
Feedback
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Benchmarking
Hardware Software Data Analysis
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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
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Hardware Selection
- For Hardware: FitBit® OneTM best fits the metrics for the desired specifications
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Fitabase• Intraday data available in
minute intervals• Customizable user interface
Fitbit® OneTM 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
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Software Selection
- For Software: Fitabase best fits the metrics for the desired specifications
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Final Design
Fitbit® OneTM
Fitabase Software Development
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Test PlanHardware 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
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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
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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 outputExample of standard output from Fitbit®
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Hardware Testing: Amputee Subjects
• 1 amputee subject (M, 39 yo)
• Walking tests outside – Walking test (30 steps)– Stair test (1 flight of stairs)
Results: AccuracyStep Count = 93.75%
Stair Climb = 100%
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Test PlanHardware 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
✔
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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
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* Data shown for Subject 2, 9 min walk on flat ground with change in cadence every 3 min
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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
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* Data shown for Subject 3, 23 min. walk test in native environment with subject-selected change in cadence
★★
★
★★
★
★
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Test PlanHardware 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
✔
✔
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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
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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
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Project Cost
Project FundingStage: Item Purchased: Cost:
Development (Fall 2013)
Fitbit® OneTM (x7) $700Software Development $300Subtotal: $1000
Clinical Trial(Spring 2014)
Misc. Cost per Subject $3000Promotion & Publication $1000Subtotal: $4000
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Metrics
✔
✔
✔
✔
✔
✔
Metric Description Target ValueReference
(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 cadence The 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 AcquisitionThe 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.
25000 hours Current Technology
Affordability The device should be sold to consumer below target value. <$100 Sponsor
Feedback
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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 2014-
2015• World Tour 2014-2015
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Acknowledgments
John Horne, SponsorDr. Buckley, Advisor
Entire Senior Design Staff
Thank you for your attendance!