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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
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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
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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
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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
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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
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Reported Benefits to scKAFO usage
Prevents Damage to ligaments from long term non-use
• Increased Walking Speed• Reduced falls• Improved muscle control
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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
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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
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Problems cont.
• Walking with KAFO increases energy expenditure
• Lead to slower walking speeds• Rejection rates among traditional KAFO
users are between 22 - 80%.1
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Examples of difficult situations
• Obstacles• Uneven Terrain• Steps• Ramps• Crossing Street
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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
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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
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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
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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
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MethodsNext Steps
• Capture Cohort of KAFO users in NPPD• Track through DSS
– Understand the Population Mix– Track total healthcare costs– Track adverse events
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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
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Maximum Step Length
Requirements:• Tape Measure• Masking TapeMeasure: Length (cm)Repeat: 3 timesTake maximum value*Must return behind
starting line
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8 Ft Timed Up and Go
Requirements:• Chair with Arms• Cone• StopwatchMeasure: Time(s)Repeat: 2 times
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Four Square Step Test
Requirements:• Four Canes• StopwatchMeasure: Time (s)Repeat: 2 times
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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
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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
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Motion Analysis
• Markers for– Pelvic Motion– Markers on Both KAFO
and limb– Shoes
• Scanned with Biosculptor Scorpion CAD
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Motion Analysis - Measures
• Kinematics• Kinetics• Compensatory
Motions– Hip Hiking (pelvic
obliquity)– Vaulting (contralateral
plantarflexion)– Circumduction
• Minimum Toe Clearance
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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
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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
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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
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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.
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Thank You