Clinical Outcomes Measures for scKAFO

1. Clinical Outcomes Measures for scKAFO Sam L Phillips, PhD, CP FAAOP Health Scientist

2. Awarded COE 2009 Expansion of Patient Safety Center of Inquiry and Falls Clinic August 2009 to lead study of rehabilitation outcomes in Prosthetics, Orthotics, and amputee care Tampa VA Center of Excellence:Maximizing Rehabilitation Outcomes

3. Clinical Staff: Regional Amputation Center Clinic Falls Clinic Engineers Biomechanics Computer Science Ergonomics Health Economists Biostatisticians Health Care System Researchers Database Specialists Affiliated with University of South Florida Tampa VA Center of Excellence:Maximizing Rehabilitation Outcomes

4. Tampa has a SCI injury Center of Excellence: “How can we improve outcomes with KAFOs” “Do Stance Control KAFO’s Work?” Literature There is a small, but significant energy cost savings when using a scKAFO5 The genesis of a research agenda

5. Stance Control Knee Orthoses • Knee Joint is locked in stance • Free in swing • Stumble recovery • May be actuated: Mechanically • Force sensor • Inclinometer On Left: SCOKJ From Horton Orthotics

6. Prevents Damage to ligaments from long term non-use Increased Walking Speed Reduced falls Improved muscle control Reported Benefits to scKAFO usage

7. Standard Orthotic Knee Joints • Drop Lock • Locks in place upon standing in full extension • Walk with Fully Extended Knee • Offset Joint • Flexes during swing • Is stable when ground reaction force is anterior to knee joint center Drop Lock1 Offset Joint2

8. Offset free swing knee joints Stable when the axis of the joint is posterior to the ground reaction force. When the ground reaction force is posterior to the knee joint, the knee joint can buckle. Locked Knee Joints Very stable Require Compensatory Motions Difficult to recover from a stumble Problems with Knee Ankle Foot Orthoses

9. Walking with KAFO increases energy expenditure Lead to slower walking speeds Rejection rates among traditional KAFO users are between 22 - 80%.1 Problems cont.

10. Examples of difficult situations • Obstacles • Uneven Terrain • Steps • Ramps • Crossing Street

11. 5 patients have been fit with scKAFOs at the James A. Haley VA 2 rejected device 3 accepted device 1 was extremely successful, eventually graduating out of KAFO use Reviewing charts and interviewing providers was inconclusive Clinical evidence

12. Database Study • scKAFO code L2005 was added in 1/1/2005 • Hypothesis: scKAFO utilization over time should fit the technology adoption curve • Nationwide Data VA data was pulled from the NPPD Database

13. scKAFO Utilization from 2007-2010 • Approximate 8% of total KAFOs provided • Utilization has not increased since 2008

14. Database Study • Where are we on the curve? • Review for regional differences in use and adoption comparison of utilization for unilateral and bilateral use • No identifiable trends were seen

15. Capture Cohort of KAFO users in NPPD Track through DSS Understand the Population Mix Track total healthcare costs Track adverse events MethodsNext Steps

16. Considerations for selections Ease of Clinical Implementation Likely to be affected by Knee motion Four Measures: Maximum Step Length Timed Up and Go Four Square Step Test Dynamic Gait Index Functional Balance Measures

17. Maximum Step Length Requirements: • Tape Measure • Masking Tape Measure: Length (cm) Repeat: 3 times Take maximum value *Must return behind starting line

18. 8 Ft Timed Up and Go Requirements: • Chair with Arms • Cone • Stopwatch Measure: Time(s) Repeat: 2 times

19. Four Square Step Test Requirements: • Four Canes • Stopwatch Measure: Time (s) Repeat: 2 times

20. Requirements: Two Cones One object to step over Eight Subtests Graded on 4pt scale (0-3) Subjective Grading Walking Normal Walk Fast –Slow Walk w/ Pivot Turn Walk while turning head left/right Walk while turning head up/down Walk over object Walk around Object Up and Down Steps Dynamic Gait Index

21. Controls Functional Balance Two Stance Control KAFO devices were fabricated for healthy adults. Subjects were tested in four conditions Unbraced Free Knee Stance Control Locked Knee Methods

22. Motion Analysis • Markers for • Pelvic Motion • Markers on Both KAFO and limb • Shoes • Scanned with Biosculptor Scorpion CAD

23. Motion Analysis - Measures • Kinematics • Kinetics • Compensatory Motions • Hip Hiking (pelvic obliquity) • Vaulting (contralateral plantarflexion) • Circumduction • Minimum Toe Clearance

24. Timed up & go and Four Square Step Test show increased times for Locked knee compared to free knee Maximum Step Length shows decreased length for locked knee compared to free conditions DGI has ability to use stairs step over step Preliminary Results - Controls

25. KAFO users Repeated measures testing, Current device, Baseline at delivery and three month follow up Braced and Unbraced OPUS survey Telephone Follow-up changes and use Activity Monitors (compliance) Interviews Veterans

26. Minimum Step Length, Timed Up and Go, and Four Square Step Test may be sensitive to changes in Orthotic Knee Joint Function More work is needed Summary

27. Fillaur Corporation www.fillaur.com Becker Orthopedic www.beckerortho.com Basford, Jeffrey R, and Sandra J Johnson. “Form may be as important as function in orthotic acceptance: a case report.” Archives of Physical Medicine and Rehabilitation 83, no. 3 (March 2002): 433-435. Vinci, P, and P Gargiulo. “Poor compliance with ankle-foot-orthoses in Charcot-Marie-Tooth disease.” European Journal of Physical and Rehabilitation Medicine 44, no. 1 (March 2008): 27-31. Fatone, Stefania. “A Review of the Literature Pertaining to KAFOs and HKAFOs for Ambulation Journal of Prosthetics and Orthotics 18, no. 3S (2006): 137-168. References

28. Thank You