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James A. Haley VA HospitalHSR&D/RR&D Center of Excellence: Maximizing
Rehabilitation OutcomesTampa, FL9/30/2010
James A. Haley VA HospitalHSR&D/RR&D Center of Excellence: Maximizing
Rehabilitation OutcomesTampa, FL9/30/2010
Clinical Outcomes Measures for scKAFO
Sam L Phillips, PhD, CP FAAOPHealth Scientist
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
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
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
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
Reported Benefits to scKAFO usage
Prevents Damage to ligaments from long term non-use
• Increased Walking Speed• Reduced falls• Improved muscle control
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
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
Problems cont.
• Walking with KAFO increases energy expenditure
• Lead to slower walking speeds• Rejection rates among traditional KAFO
users are between 22 - 80%.1
Examples of difficult situations
• Obstacles• Uneven Terrain• Steps• Ramps• Crossing Street
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
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
scKAFO Utilization from 2007-2010
• Approximate 8% of total KAFOs provided
• Utilization has not increased since 2008
0
10
20
30
40
50
60
70
80
90
2007 2008 2009 2010
0%
2%
4%
6%
8%
10%
12%
scKAFO
%scKafo
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
MethodsNext Steps
• Capture Cohort of KAFO users in NPPD• Track through DSS
– Understand the Population Mix– Track total healthcare costs– Track adverse events
Functional Balance Measures
Considerations for selections• Ease of Clinical Implementation• Likely to be affected by Knee motionFour Measures:
– Maximum Step Length– Timed Up and Go– Four Square Step Test– Dynamic Gait Index
Maximum Step Length
Requirements:• Tape Measure• Masking TapeMeasure: Length (cm)Repeat: 3 timesTake maximum value*Must return behind
starting line
8 Ft Timed Up and Go
Requirements:• Chair with Arms• Cone• StopwatchMeasure: Time(s)Repeat: 2 times
Four Square Step Test
Requirements:• Four Canes• StopwatchMeasure: Time (s)Repeat: 2 times
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
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
Motion Analysis
• Markers for– Pelvic Motion– Markers on Both KAFO
and limb– Shoes
• Scanned with Biosculptor Scorpion CAD
Motion Analysis - Measures
• Kinematics• Kinetics• Compensatory
Motions– Hip Hiking (pelvic
obliquity)– Vaulting (contralateral
plantarflexion)– Circumduction
• Minimum Toe Clearance
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
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
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
References
1. Fillaur Corporation www.fillaur.com2. Becker Orthopedic www.beckerortho.com3. 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.
4. 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.
5. 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.
Thank You