1. Comparison of Patient-Oriented Outcomes Between Wearing No Orthosis, a Conventional Orthosis, & Dynamic Bracing Solutions (DBS) Orthoses Marny Eulberg, M.D. Human Gait Institute, Wheat Ridge, CO

2. Dynamic Bracing Solutions (DBS) 1)Emphasis on anatomic & weight alignment of ALL segments (foot, ankle, knee, trunk, head) -—triplanar management in multiple areas 2) A stance and swing control device 3) Utilizes advanced ground reaction dynamic forces with proper movement patterns 4) Use of a SACH heel between brace & shoe 5) Training of orthotic user in standing/walking is essential to utilize improved biomechanics

3. Dynamic Bracing Solutions (DBS)

4. Summary of Research Protocol 1)Patient-oriented outcomes: functional timed walking test (L-test), self-reported info. on frequency of falls/near falls, sense of security and balance, and pain, and a SF- 36v2 questionnaire 2) Comparison with whatever orthosis client came in using. Each client = their own control 3) Longitudinal—baseline, at 3 months, at 6 months and at 12 months

5. L-test Chosen because involves more functional activities (challenge to balance in turns & longer walking distance) than Timed Up & Go Involves a 20 meter walk, two 90 degree turns, and one 180 degree turn Timed from the moment a person’s buttocks leave the chair until they are again seated. Simple, requires minimal equipment & time

6. Who were subjects?? Enrolled from Jan. 2012 to present 10 subjects with 6 mo. or more of data, + 2 with 3 months of data Diagnoses: 1 with undiagnosed neurologic condition, 2 with peripheral nerve paralysis, 9 polio survivors Ages : Undiagnosed neurologic condition=32 yrs Peripheral Nerve Injury=24 & 62 years old Polio survivors= 52-72 (average age=63.9 yrs)

7. On what I am reporting today… Comparative L-test results—before & after Change in frequency of falls & near falls Change in pain NOT REPORTING ON TODAY, but results were in abstract: Change in sense of balance and sense of security Results from SF-36v2

8. SF-36 version 2 Well validated across wide variety of ages, ethnicity, medical conditions Asks a total of 36 questions about a person’s sense of Health and Well Being— physical and emotional Our results on SF-36v2 not consistent with other data in the study and also not statistically significant so are not included today

9. Prior KAFO users/now DBS AFO users—times on L-test in seconds Subject # L-test NO BRACE L-test with prior KAFO L-test with DBS AFO 3 months L-test with DBS AFO 6 months L-test with DBS AFO 12 months 2012-009unable23.4 sec.15.9 sec.19.2 sec.19 seconds 2013-00552.78 sec.35.67 sec.25.5 sec.25.6 sec.Due 12/26/14

10. Prior KAFO users/now DBS AFO users—Falls/Near Falls/Pain Subject Number Falls/month with previous KAFO Falls/mo with DBS AFO Near Falls/mo. with prev. KAFO Near Falls with DBS AFO Change in pain scale (0-10) 2012-009several1Several/week2 per week-2 2013-005 Still improving 0 working on gait!! 12-43

11. No brace, polypro AFO, DBS AFO L-test results in seconds Subj. #L-test NO BRACE L-test with polypro AFO. L-test with DBS AFO @ 3 mo. L-test with DBS AFO @ 6 mo. L-test with DBS AFO @ 12 mo. 2012-01026.022.0 *22.72(bilat. AFOs) 22.38 (bilat. AFOs) 23.69 (bilat. AFOs) 2012-01226.028.0 *21.0No results20.57 2013-00119.3419.38 *15.2113.612.0 2013-00235.031.7 *31.75With cane 23.0 w/cane 19.0 No cane 21.0 2013-01021.1619.44 *14.75Due 11/14Due 5/15

12. No brace, polypro AFO, DBS AFO Falls/Near Falls/ change in pain Subject # Falls/month previous –no brace or AFO Falls/mo with DBS AFO Near Falls/mo. with previous Near Falls with DBS AFO Change in pain scale (0-10) 2012-010(Poly AFO)= 2 0.5 8.5 0.8 2012-012(Poly AFO)= 0.2 0 1.0 rare none 2013-001(Poly AFO)= 2 1.3 4.3 1.6 -2 2013-002(Off the shelf AFO) =.16 0.16 30.0 0.4 -6 2013-010(Poly AFO) = 1 0 4.0 none

13. No AFO, Carbon Fiber Off the Shelf AFO & DBS AFO, L-test Subject Number L-test NO BRACE L-test with Carbon fiber off the shelf AFO L-test with DBS AFO @ 3 month L-test with DBS AFO @ 6 month L-test with DBS AFO @ 12 months 2012-00426.41 sec.Not tested Blue Rocker No info returned 13.0 sec.No info returned 2012-005 26.8Not wearing any brace No info returned 22.4 secNo info returned 2013-006 25.75 sec.25.59 sec. Blue Rocker 24.44 sec. 20.34 sec.Due 10/1/14

14. No AFO, Carbon Fiber Off the Shelf AFO & DBS AFO Subject Number Falls/mo.– No brace or carbon fiber AFO Falls/mo with DBS AFO Near Falls/mo. – No brace or carbon fiber AFO Near Falls/mo. with DBS AFO Change in pain scale (0-10) 2012-004 0 Blue Rocker 0 1 Blue Rocker 0 2012-005 29.5 No brace 0.7 150 No brace 1.3 -2 2013-006 1.5 Blue Rocker 0 6-8 Blue Rocker 0.3 0

15. Summary Comparative study with “whatever client came in using” versus DBS braces—each person as their own control and with patient-oriented outcome measures 4/9 prior brace users had no improvement in times on L-test using their prior brace Interestingly, no significant change on SF- 36 v2 ? due to long length of study & the age & other co-morbidities of some of the research subjects

16. Summary-- continued Evidence that some long-time KAFO users can get adequate support & improved function from just an AFO of the Dynamic Bracing Solutions design 60% polypro AFO users had improved time on L-test with DBS compared to prior AFO— some up to 16 seconds less, all had less falls/near falls, 60% also had decreased pain --(one by 6 points on a 0-10 scale)

17. Summary-- continued The 2 subjects using prior Blue Rocker AFOs had improved times on L-test by 13 seconds & 4 seconds and had decreased frequency of falls/near falls The one subject that had worn no prior brace had improved time on L-test, markedly decreased fall frequency (29.5/mo to 0.7/mo) and decreased pain.

18. Thank You!!