1. Project Readiness Package P10009 Portable Spinal Motion Tracker Yi Xie (4 th year ISE)

2. Mission Statement The purpose of the project is to build a Portable Spinal Motion Tracker that can measure frequency and magnitude of motions in the lower back providing an accurate assessment of spinal movements throughout a normal day. In Physical Therapy, there is a strong belief that daily movements contribute to pain. It is assumed that isolated Physical Therapy exams in the laboratory reflect the entire day’s movements. The Portable Spinal Motion Tracker would validate these exams by capturing movements over extended period of time in a natural environment.

3. Project Goals 1. Accurately measure frequency and magnitude of motions (angular displacement) in spine regions:  Upper lumbar  Lower lumbar  Thoracic ◦ And planes:  Sagittal  Coronal  Transverse planes 2. Be flexible enough to be directly applicable or easily adjusted to accurately measure activity in other parts of the body.

4. Spinal Column and Body Planes http://www.yachigusaryu.com/blog/pics/top_ten_principles/10/i mage003.jpg http://pvchiropractic.com/images/spine_sections.jpg

5. Measurement of Spine http://cache1.asset-cache.net/xc/stk16470hsd.jpg?v=1&c=NewsMaker&k=2&d=81DB3D5BD9CC707D91C78C033DC869D3CA3F06C678717761 Y Z X Y Z X Y Z X T1 L1 L4 S1

6. Project Relevance Quantify normal behavior and disease progression Better define treatment goals Influence the design of treatment methods Address ergonomic issues in the workplace Set a benchmark for disability determination with regard to spinal motion

7. P10009- Spinal Motion Tracker Project Name ◦ Spinal Motion Tracker Project Number ◦ P10009 Project Track ◦ Biomedical Systems and Technologies Project Family ◦ Assistive Devices Start Term ◦ Winter 2009 End Term ◦ Spring 2010 Faculty Guide ◦ Dr. Beth DeBartolo (ME) Technical Guide ◦ Edward Hanzlik (ME) Primary Customer ◦ Dr. Sara Gombatto (Physical Therapy Nazareth Physical Therapy Clinic)

8. Related Past SD Projects P07052 Motion Tracking System (20063- 20071) ◦ Generic modular electromechanical device determines patient position with video capture support. P08006 Motion Tracking System(20063- 20071) ◦ Measured joint angles related to gait while stroke patients were walking

9. Staffing Requirements DisciplineNumberSkills Required IE (Team lead) 1Ergonomics/Biomechanics analysis Safety requirements Statistical analysis in testing ME1Motion analysis Kinematics modeling EE2Sensor and signal processing Familiar with Bio-Electrical work CE1Software development/manipulation Programming of micro processor

10. WBS/Project Plan Week 1Week 2Week 3 DisciplineTaskMonTueWedThuFriMonTueWedThuFriMonTueWedThuFri Industrial Conduct initial meeting Assign roles/responsibilities Conduct weekly meetings Ergo analysis for device fit Identify obvious safety issues Define customer needs Research/learn about device Mechanical Initial design generation Kinematics study Identify key mechanical parts Initial motion analysis Research/learn about device Electrical Initial design generation Identify key electrical parts Electrical component layout Have several intitial designs Research/learn about device Computer Familiarize self with code Identify software needs Begin framework of software Research/learn about device

11. Required Resources SourceDescriptionAvailable Sara Gombatto (PT)CustomerYes Dr. Beth DeBartoloFaculty GuideYes Edward HanzlikTechnical GuideYes SourceDescriptionAvailable EE LabElectrical TestingYes RITComputer labYes Mfg shop RITMachiningYes NazarethAccess to PT testingYes Faculty Environment SourceDescriptionAvailable Mechanical toolsMfg of deviceYes ComputerProgrammingYes Testing devicesElectrical comp.Yes TBDotherTBD SourceDescriptionAvailable Digi-keyElectrical comp.Yes McMaster CarrEnclosuresYes All-Battery.comBatteryYes TBDotherTBD Equipment Materials

12. Risk Assessment Description Possible Consequences Probability (H/M/L) Severity (H/M/L) Overall (H/M/L) Contingency Plan Short on staffing Miss key skill set needed. Overburdening LHMDouble up key skills Work outside skill set. Poor team Dynamics Team can’t accomplish goals HMMFollow team forming principles. Diffuse conflict Supplier delivers late Project cannot be completed on time MHMOrder critical parts early. Have more than one supplier. Receives faulty part Part needs to be reordered/ repaired. Delay. MMMOrder critical parts early. Have more than one supplier. Crosstalk/ coupled motions Device outputs faulty data. HLMFinish prototype early. Plan for adjustments/error Low accuracy reading Device does not meet specifications. HMHPlan for adjustments/error. Proper planning.

13. Documentation Instruction & troubleshooting manual Summary for National Science Foundation Training session for clinical staff Measurements Want to measure spine activity in lateral, sagittal and twisting planes Want to measure spine activity in upper lumbar, lower lumbar, and thoracic regions Want to collect magnitude and frequency in 4 spine regions (3 angular displacements, 3 translations) The motion tracking device must be able to detect and measure data acquired from the patient Tracker must be able to be zeroed Flexibility/robustness Modular for other body parts Be able to fit most people Requires little maintenance Able to test simultaneously with Vicon system (non reflective) Usability Constraints Minimize crosstalk across different planes Minimize errors from fat and muscle Pressure from external source should not affect it Cost effective Does not interfere with other medical devices Complies with local, state, and federal laws Safe for patients Safe for physical therapists Easy to use Easy to take off Easy to set up Patient can use at home Standard error 1 degree or better Physical Constraints Light weight Unobtrusive/ not cumbersome Rechargeable Portable Removable Information Capturing Export to Exel and C3D file Collect continuously all day Software to extract and interpret information User friendly software Affinity Diagram

14. Objective Tree Portable motion tracker measuring spine motions Usability Constraints Minimize Errors Crosstalk across planes External Sources Safe for all users Ease of setup and use Physical Constraints Battery lasts all day Portable Lightweight Unobtrusive Flexibility Modular for other body parts Robust Can test on various platforms Measurement Capabilities 3 Body Planes 4 Spine segments 3 angular displacements and 3 translations Information Handling Export to readable format Collects data all day

15. Function Tree Portable motion tracker measuring spine motions Low errors Sensors withstand external factors Physical forces Electrical interference Minimize standard error Provide distinct measure ments Safe Eliminate electrical shock Have a kill switch Easily removable Wear all day Small enough to not hinder movement Light enough to not hinder movement Battery lasts all day Measurements Measure in 3D axis Measure in 6 DOF Handles information smoothly Software is user friendly Reduce data to primary outcome variables Data transfers easily Collect data continuously Store data until needed

16. House of Quality Engineering MetricsCustomer Perception Customer Requirements Customer Weights Standard Error Pressure tolerance Weight Volume Battery life Degrees of freedom Hard drive size Learning curve time Lifespan 1 Worse 234 5 Better 1 Low errors in data 9 ABC 2 Safe for all users 9 331 1 ACB 3 Easy to set up and use 33 39 393 AC B 4 Battery lasts all day 31 9 1 ACB 5 Portable 9 999 3 1AC B 6 Modular for other body parts 13 93 1A BC 7 Robust 333333 9 ABC 8 Easily testable 39 9 A BC 9 Measure in 3 axes (angles) 931 9 ABC 10 Measures 4 spine locations 9313313 ACB 11 Data user friendly output 33 39 ACB 12 Collects data all day 93 9 9 1 AC B ` SE<1 At least.5 lbs At most 1 lb <2 cubic ft >12 hrs 6 at least 100 mb <2 hrs at least 2 yrs Better 5 BBBBB A: AcuPath industrial lumbar motion monitor 4ABC AAC BABC Technical Benchmarking3 ABC C C B: WASP motion sensing system 2 AA A Worse 1 CC C: Ascension Flock of Birds motion tracking Raw score 141 27 144153243144129 6655 Relative Weight 13% 2% 13%14%22%13%12% 6%5%

17. House of Quality

18. Intellectual Property Considerations “All work to be completed by students in this track is expected to be released to the public domain. Students, Faculty, Staff, and other participants in the project will be expected to release rights to their designs, documents, drawings, etc., to the public domain, so that others may freely build upon the results and findings without constraint. Students, Faculty, and Staff associated with the project are encouraged to publish findings, data, and results openly. “ Will start team with standard template Team Values and Norms

19. Fit as an Enabling Technology Portable obstacle course (P08003) Upper extremity exerciser (P07006) Balance training bicycle (P08001) Purpose is to quantify motion in various body parts to facilitate assessment of PT devices. Data logging system should be compatible with various sensor technologies ◦ ie: Accelerometers vs. Gyroscopes

20. This project will be a success if: Customer receives an accurate, reliable, and safe motion tracker that can output information that gives a clear idea of spine motion in a normal day. Can be easily applied to measure motion in other parts of the body.