1. P15001: Soft Ankle-Foot Orthotic
Adam Start, all team members introduce yourselves
Present: Adam Podolec Geni Giannotti Noah Schadt
Absent: Jared Green Tyler Leichtenberger Megan Ehrhart
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

2. P15001: Soft Ankle-Foot Orthotic
Agenda
Project Overview
Customer and Engineering Requirements
System Overview
Testing Results
Performance vs. Requirements
Budget Plan
Commercialization Plan
Device Limitations
Questions
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

3. P15001: Soft Ankle-Foot Orthotic
Project Description
Active Ankle Foot Orthotic
Assistive walking device
Utilized by individuals with Foot Drop
Foot Drop
Inability to dorsiflex the foot (i.e. point toe upward)
Affects 20% of stroke survivors and individuals with MS, ALS, and nerve damage [1]
Causes clients to drag foot (trips and falls)
Current AFO’s are…
Bulky and rigid
Designed to provide assistance at all times
Geni,, Adam add market potential
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

4. Project Overview- Goals
Create a soft active orthotic, which provides assistance only during appropriate times during the gait/walking cycle
Assistance timing determined using…
Heelstrike sensor to measure gait
Distance sensor to distinguish terrain
Foot lifted by a McKibben air muscle
Untethered device
Geni
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

5. Customer Requirements
How the System Addresses the Need:
Hold foot up when stepping forward
Increased Dorsiflexion Mobility with Air Muscle
Last for full day without recharging
Muscle can provide correct number of flexes for target demographic
Fit into clients existing shoe
Adds only 0.12 inches to clients foot
Adapt to different terrain
Manual switch added to provide desired support up stairs
Utilizes a McKibben muscle
Muscle used and designed for needed deflection and number of flexes
The device must be soft and flexible rather than rigid
Device is machine washable and more aesthetically pleasing than previous project
Geni
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

6. Engineering Requirements
Geni
rqmt. #
Importance
Source
Function
Engr. Requirement (metric)
Unit of Measure
Ideal Value
Marginal Value
Current Value
Direction of improvement
ER6 3 P1
 Mechanical
Number of muscle flexes untethered #
1500
1000
1761 ▲
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

7. P15001: Soft Ankle-Foot Orthotic
System Architecture
Noah
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

8. Concept Summary- Entire System
Noah
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

9. Concept Summary- Lower Component
Noah
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

10. System Testing Results
Foot lift & release occur at proper time
Data saved to micro SD could be used by therapists
Muscle ramping allows a more natural movement
Planted Foot
Heel Off
Swing
Heelstrike
Noah, add picture of Megan and results
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

11. Performance vs. Requirements
Successfully satisfied all customer requirements and more with the exception of:
FT3: Small software hang-up would need a higher power processor with more peripherals
ST1 & ST2: Manual passive mode available for stairs instead of active sensing
Noah
From EDGE:
P15001 meet all of the following requirements that are in green to the customer’s satisfaction. *The three yellow requirements are addressed below: Operate smoothly – this requirement was not perfectly met because of the software hang up which caused jarring operation every 14 steps. To address this issue, the team would order a higher power processor with more peripherals.
*Allow natural movement on stairs – the way that the team addressed this was to add a manual switch rather than using the more unpredictable distance sensing to adapt to terrain. This sacrifice for a more robust design was discussed with the customer. Terrain adaptation was proven to work in senior design I during feasibility testing.
*Adapt to different terrains – as discussed above, the adaptation was user driven.
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

12. Economic Plan: Prototype Budget
Funded by Rochester Institute of Technology
Project Budget:   $500
Total Prototype Cost:   $397.45
Cost Break-Down (including shipping costs)
Mechanical Components: $98.46
Brace, fastenings ($125 Air tank & reg. inherited)
Electrical Components: $214.04
PCB & components, batteries, sensors, SD card
Air Tank Maintenance and Refills: $89.95
Geni
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

13. Commercialization Plan
Production Estimate
Production Cost: $323.00
Retail Price: $1,000
U.S. Market Potential
Total: 34,353 *$1,000 = $34.4 million
Path to Market
Use revenues from the success of Second Stride
Condition
Population Affected (US)
Foot Drop
Percentage
Percentage of Market Captured
Number of Users
Stroke [2]
795,000
20%
795,000 * 0.2 * 0.2 = 31,800
MS [3][4]
10,900
76%
10,900 * 0.76 * 0.2 = 1,657
ALS [5]
5,600
80%
5,600 * 0.8 * 0.2 =
Adam
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

14. P15001: Soft Ankle-Foot Orthotic
Device Limitations
Software Hang-up
Solution(s): Order high power processing unit and new solenoid
Air Tank Capacity
Solution(s): Carbon Fiber Air Tank; Research: CO2 usage, alternate muscles
Large Profile on Leg
Solutions: Design for a new low profile IR sensor
Create alternative product without distance monitoring capabilities
Adam
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

15. P15001: Soft Ankle-Foot Orthotic
Acknowledgements
Rochester Institute of Technology, College of Engineering:
Elizabeth DeBartolo, PhD
Edward Hanzlik, BSME NYSPE
Kathleen Lamkin-Kennard, PhD
Nazareth College, Physical Therapy Clinic:
J.J. Mowder-Tinney, PT PhD NCS C/NDT CSRS
Elizabeth Clark, PT DPT NCS
SUNY Geneseo, College of Business:
Judith Albers, PhD
Adam
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

16. P15001: Soft Ankle-Foot Orthotic
References
[1] Kesar, Trisha M., Ramu Perumal, Angela Jancosko, Darcy S. Reisman, Katherine S. Rudolph, Jill S. Higginson, and Stuart A. Binder-Macleod. "Novel Patterns of Functional Electrical Stimulation Have an Immediate Effect on Dorsiflexor Muscle Function During Gait for People Poststroke." Journal of the American Physical Therapy Association (2010): US National Library of Medicine National Institutes of Health. Web. 14 Dec
[2]
[3] Foot_drop_CMSC.pdf
[4]
[5]
Adam
June 2, 2019
P15001: Soft Ankle-Foot Orthotic

17. P15001: Soft Ankle-Foot Orthotic
Questions?
Adam
June 2, 2019
P15001: Soft Ankle-Foot Orthotic