James A Haley VA Hospital HSRDRRD Center of

James A. Haley VA Hospital HSR&D/RR&D Center of Excellence: Maximizing Clinical Outcomes Measures for Rehabilitation Outcomes sc. KAFO Tampa, FL 9/30/2010 Sam L Phillips, Ph. D, CP FAAOP Health 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 – Ergonomics Computer Science 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? ” ü Literature • There is a small, but significant energy cost savings when using a sc. KAFO 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

Reported Benefits to sc. KAFO 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 Lock 1 Offset Joint 2

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 sc. KAFOs 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 • sc. KAFO code L 2005 was added in 1/1/2005 • Hypothesis: sc. KAFO utilization over time should fit the technology adoption curve • Nationwide Data VA data was pulled from the NPPD Database

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

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

Methods Next 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 motion Four Measures: – – Maximum Step Length Timed Up and Go Four Square Step Test Dynamic Gait Index

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

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

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

Dynamic Gait Index • Requirements: • Two Cones • One object to step over • Eight Subtests • Graded on 4 pt 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. com 2. Becker Orthopedic www. beckerortho. com 3. 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. 3 S (2006): 137 -168.

Thank You