1. 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

2. 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

3. 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

4. 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!!

5. 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

6. 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}

7. 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Have enrolled 14 polio survivors, one has withdrawn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 = 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

8. 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

9. 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

10. 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

11. 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.

12. 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
42.6
AzAFO
36.7
DBS AFO
20.4
17.25
16.85
-25.75
-19.85
unable
Cane
AFO 55.9
AFO 39.5
No data
-36.6 sec
KAFO & cane
DBS AFO+cane
36.5
30.25
47.3****
-8.75 until new med. problems
27.75
Springleaf AFO
20.43
21.97
Due 9/12/12
-5.78
-3.85
37.79
PLSO 28.31
28.3
no data
To be done 9/14/12
26.8
none
22.4
Due 1/13
-4.4

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

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

15. Change in self-reported sense of security and balance-initial vs. 3 mo.
Subject
Security initial
Security
3 months
Change
Balance initial
Balance
4 to 5 8
+3 to 4 5 +3 7 +2 3 +4 1 +6 9 +8
6 to 7
7 to 8 +1 -7 6
+2 to 3
No data ?

16. Change in reported pain
Subject
Pain (0-10) initial
Max. change in pain
Difference
1 to 3
-1 to -3 3 1 -2 8 2 -6
6 to 7
-3 to -4
none 6 -4 4
20l2-005
4 to 7
-3 to 0

17. 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
+ 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
+2 (RP & BP)
29.54 initial
34.46 at 6 months
+4.92
64.93 initial
60.42 at 6 months
+ 5, decreased 3
40.21 initial
43.16 at 6 months
+2.95
56.32 initial
56.11
+ 5; -2; 1 no change
26.54 initial
37.29 at 12 months
+10.75
63.36 initial
56 at 12 months
+4; -1; 3 no change
26.96 initial
37.8 at 12 months
+10.84
61.39 initial
57.06 at 12 months
+5; -2; 1 no change
29.46 initial
39.6 at 12 months
+10.14
57.91 initial
52.81at 12 months

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