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

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

Dynamic Bracing Solutions (DBS)

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

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

Who were subjects?? Enrolled from Jan 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= (average age=63.9 yrs)

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

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

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 unable23.4 sec.15.9 sec.19.2 sec.19 seconds sec sec.25.5 sec.25.6 sec.Due 12/26/14

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) several1Several/week2 per week Still improving 0 working on gait!! 12-43

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 3 mo. L-test with DBS 6 mo. L-test with DBS 12 mo *22.72(bilat. AFOs) (bilat. AFOs) (bilat. AFOs) *21.0No results * *31.75With cane 23.0 w/cane 19.0 No cane *14.75Due 11/14Due 5/15

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) (Poly AFO)= (Poly AFO)= rare none (Poly AFO)= (Off the shelf AFO) = (Poly AFO) = none

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 3 month L-test with DBS 6 month L-test with DBS 12 months sec.Not tested Blue Rocker No info returned 13.0 sec.No info returned Not wearing any brace No info returned 22.4 secNo info returned sec sec. Blue Rocker sec sec.Due 10/1/14

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) Blue Rocker 0 1 Blue Rocker No brace No brace Blue Rocker Blue Rocker 0.3 0

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

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)

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.

Thank You!!