Marny Eulberg, M.D. Human Gait Institute Bracing Solutions for Polio Survivors—preliminary results of Research with dynamic Bracing Solutions orthoses Marny Eulberg, M.D. Human Gait Institute

Background I am a family physician and a polio survivor I have been medical director of a post polio clinic in Denver since 1985 I’ve seen about 1500 polio survivors since 1985 In January 2011, I began a research project to compare outcomes of persons fit with a Dynamic Bracing Solutions orthosis(es); about half the subjects have been polio survivors

A few observations about research.. In order to get results published in journals, if using human subjects one must get approval from an Institutional Review Board (IRB). Rules/policies from IRB may discourage patient participation Co-ordination between sites/researchers is challenging! There frequently is a significant drop-out of subjects if research exceeds 3 months

Polio survivors, bracing & this research Sometimes there has been the belief that polio survivors are not willing to change from the type of bracing they have had. While this is true for some, others have been searching for more choices and embrace change. Individuals with long standing gait deviations, need to “unlearn” old inefficient gait patterns and to learn a new more efficient gait pattern to use DBS – this is not easy and may require significant gait training and time. Patient commitment is very important!!

Research Design Subjects recruited from one of six orthotic practices. If a candidate for a DBS brace(s), they were asked to participate in research study The research subjects completed a self-report questionnaire, a SF-36v2 (Sense of Health and Well-Being) questionnaire, and had a functional timed walking test (the L-test) done at baseline, and at 3 months, 6 months, and 12 months post fitting of DBS

Some essential orthotic elements for Dynamic Bracing Solution braces Detailed video gait analysis, triplanar correction of deformities, ground reaction, dynamic materials and meticulous fitting especially around bony prominences (not unusual to take 2 to 3 hours or more for fitting) Post brace gait training initially by orthotist & then daily practice at home (PT, with DVD instruction, etc). Generally initial gait training by orthotist takes 5 to 8 hours over two days. {fatigue in PPS must be taken into consideration}

Breakdown of research subjects Have enrolled 14 polio survivors, one has withdrawn 13 polio survivors are still in the study: we have 12 months worth of data on 5; 6 months of data on 4 more; and only initial data on an additional 4 Initial use of devices: no orthoses = 4 single AFO (various types) = 3 single KAFO, + or – single cane = 3 multiple devices (KAFO & AFO or bilateral or with or without crutches, canes, or walker = 3

Questions asked in self reports What type of bracing, if any, client came in with and follow-up questions about type of DBS issued How far can comfortably walk Frequency of falls and near falls Sense of security barefoot & in previous brace (if applicable), and with DBS on scale of 0 to 10 Sense of balance barefoot, in previous bracing system and with DBS on scale of 0 to 10 Pain rating on 0 to 10 scale

SF-36v2 questionnaire Well validated questionnaire that has been used for multiple different diagnoses and across a variety of treatment settings Eleven single or multiple item questions with a 5 point scale for each Eight scales– Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health Two summary scales- Physical Component Summary and Mental Component Summary Weighted so a score of 50 on each scale is “normal” or average

The L-test (longer version of TUG) L-test involves timing the client from when they arise from a chair, walk a total of 20 meters, making two 90 degree turns and one 180 degree turn and return to sitting in the chair. Equipment needed: a device to measure at least 25 feet, a chair, space to walk the distances (an exam room leading into a hall works well), and a stopwatch To be considered a significant change there must be a difference of at least 3 seconds

Why were these measures chosen? A single measure is not sufficient –some people do well on one test even pre-brace but not on others To look at factors that are important to the end user in their daily life—decrease pain, ability to participate in life more easily, decrease falls, improved security Easy to perform, required little equipment, required a minimum of additional time from orthotist The L-test– because several studies have shown that, at least in some pathologies, the Timed Up & Go (TUG) showed no difference in time or worsened times between no orthosis and AFOs.

Changes in L-test times DBS AFOs (in sec Changes in L-test times DBS AFOs (in sec.) (3 seconds change considered significant) Subject No devices Conv. Brace/devices DBS-3 mo DBS-6 mo DBS-12 mo Change 2011-001 42.6 AzAFO 36.7 DBS AFO 20.4 17.25 16.85 -25.75 -19.85 2011-002 unable Cane 76.1 AFO 55.9 AFO 39.5 No data -36.6 sec 2011-008 KAFO & cane 39 DBS AFO+cane 36.5 30.25 47.3**** -8.75 until new med. problems 2011-015 27.75 Springleaf AFO 24.28 20.43 21.97 Due 9/12/12 -5.78 -3.85 2011-017 37.79 PLSO 28.31 28.3 no data To be done 9/14/12 2012-005 26.8 none 22.4 Due 1/13 -4.4

Changes in times with DBS KAFOs Subject No devices Con. Brace/devices DBS -3 mo DBS-6 mo DBS-12 mo. Change in seconds 2011-005 Crutches, no brace 37.25 sec KAFO & AFO + crutches 26.45 DBS KAFO & AFO + crutches 36.21 31.28 32.3 -3.9 no brace +5.85 old braces 2011-009 27.3 sec Cane occas. Delay in using DBS DBS KAFO+ cane33.5 + 6.2 sec 2011-014 43 seconds None DBS KAFO & AFO + walker 105.67 130.28 Not due until 12/06/12 +87. 28

Change in frequency of falls/near falls Subject Initial Falls per yr After DBS per yr Difference Initial near falls After DBS 2011-001 Prior=AzAFO 10 2 AFO -8 20 to 30 6 -14 to -24 2011-002 Prior = cane 1 +1 2011-005 prior = KAFO, AFO, crutches 3 KAFO AFO, crutches 24 to 36 5 to 6 -19 to -31 2011-008 Prior=conv. KAFO, cane 36-48 -35 to -47 “too many to count” Countless 2011-009 (occ. cane) 12 to 24 1 to 2 -11 to -22

Change in self-reported sense of security and balance-initial vs. 3 mo. Subject Security initial Security 3 months Change Balance initial Balance 2011-001 4 to 5 8 +3 to 4 5 +3 2011-002 7 +2 3 +4 2011-005 1 +6 9 +8 2011-008 2011-009 6 to 7 7 to 8 +1 2011-014 -7 2011-015 6 +2 to 3 2011-017 No data ? 2012-005

Change in reported pain Subject Pain (0-10) initial Max. change in pain Difference 2011-001 1 to 3 -1 to -3 2011-002 3 1 -2 2011-005 8 2 -6 2011-008 6 to 7 -3 to -4 2011-009 none 2011-014 6 -4 2011-015 4 2011-017 20l2-005 4 to 7 -3 to 0

Change in SF-36v2 responses (normal/average scores = 50) Subject—data for months # of scales changed Physical Component Summary score Change in PCS Mental Health Component Summary Score 2011-001 12 + all 8, 4 scales at least 3 fold increase 22.02 initial 43.98 at 12 months +21.96 40.1 initial 49.74 at 12 month 2011-002 6 +2 (RP & BP) 29.54 initial 34.46 at 6 months +4.92 64.93 initial 60.42 at 6 months 2011-003 3 + 5, decreased 3 40.21 initial 43.16 at 6 months +2.95 56.32 initial 56.11 2011-005 12 + 5; -2; 1 no change 26.54 initial 37.29 at 12 months +10.75 63.36 initial 56 at 12 months 2011-008 12 +4; -1; 3 no change 26.96 initial 37.8 at 12 months +10.84 61.39 initial 57.06 at 12 months 2011-015 6 +5; -2; 1 no change 29.46 initial 39.6 at 12 months +10.14 57.91 initial 52.81at 12 months

Dynamic Bracing Solutions (DBS) braces For detail: www.DynamicBracingSolutions.net Talk to John Callan, myself or Marmaduke Loke after this session.