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

2. Tampa VA Center of Excellence: Maximizing Rehabilitation Outcomes
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

3. Tampa VA Center of Excellence: Maximizing Rehabilitation Outcomes
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

4. The genesis of a research agenda
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

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

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. Problems with Knee Ankle Foot Orthoses
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

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

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

11. Clinical evidence
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

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

16. Functional Balance Measures
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

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. Dynamic Gait Index 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

21. Methods 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

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. Preliminary Results - Controls
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

25. Veterans
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

26. Summary
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

27. References Fillaur Corporation www.fillaur.com
Becker Orthopedic
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):
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):
Fatone, Stefania. “A Review of the Literature Pertaining to KAFOs and HKAFOs for Ambulation Journal of Prosthetics and Orthotics 18, no. 3S (2006):

28. Thank You