Marny Eulberg MD 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 Ive seen about 1500 polio survivors since 1985 ID: 177513
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Slide1
Bracing Solutions for Polio Survivors—preliminary results of Research with dynamic Bracing Solutions orthoses
Marny Eulberg, M.D. Human Gait InstituteSlide2
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 survivorsSlide3
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 monthsSlide4
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!!Slide5
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 DBSSlide6
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}Slide7
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 = 3Slide8
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 scaleSlide9
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 averageSlide10
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 secondsSlide11
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. Slide12
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
DBS AFO
17.25
DBS AFO
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
unable
KAFO
&
cane 39
DBS
AFO+cane
36.5
DBS
AFO+cane
30.25
DBS
AFO+cane
47.3
****
-8.75
until
new med. problems
2011-015
27.75
Springleaf
AFO
24.28
DBS AFO
20.43
DBS AFO
21.97
Due 9/12/12
-5.78
-3.85
2011-017
37.79
PLSO 28.31
DBS
AFO
28.3
DBS AFO
no
data
To be done 9/14/12
0
2012-005
26.8
none
No data
22.4
Due
1/13
-4.4Slide13
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
DBS KAFO & AFO + crutches
31.28
DBS KAFO & AFO + crutches
32.3
-3.9 no brace
+5.85
old braces
2011-009
27.3 sec
Cane
occas.
Delay
in using DBS
Delay
in using DBS
DBS KAFO+ cane33.5
+ 6.2 sec
2011-014
43 seconds
None
DBS KAFO & AFO + walker
105.67
DBS KAFO & AFO + walker
130.28
Not
due
until
12/06/12
+87. 28Slide14
Change in frequency of falls/near falls
Subject
Initial
Falls per yr
After
DBS
per yr
Difference
Initial near falls
After
DBS
Difference
2011-001
Prior=
AzAFO
10
2
AFO
-8
20 to 30
6
-14 to -24
2011-002
Prior
= cane
0
0
AFO
0
0
1
+1
2011-005 prior = KAFO, AFO, crutches
2
3
KAFO
AFO,
crutches
+1
24 to
36
5 to 6
-19 to -31
2011-008
Prior=conv.
KAFO, cane
36-48
1
KAFO
-35
to -47
“too many to count”
1
Countless
2011-009
(occ. cane)
0
0
0
12 to 24
1 to 2
-11 to -22Slide15
Change in self-reported sense of security and balance-initial vs. 3 mo.
Subject
Security
initial
Security
3 months
Change
Balance initial
Balance
3
months
Change
2011-001
4 to 5
8
+3 to 4
5
8
+3
2011-002
5
7
+2
3
7
+4
2011-005
1
7
+6
1
9
+8
2011-008
1
5
+4
1
7
+6
2011-009
6 to 7
7 to 8
+1
6 to 7
7 to 8
+1
2011-014
8
1
-7
8
1
-7
2011-015
6
8
+2
5
7 to 8
+2 to 3
2011-017
No data
7
?
No
data
5
?
2012-005
3
7
+4
3
5
+3Slide16
Change in reported pain
Subject
Pain (0-10) initial
Max. change
in pain
Difference
2011-001
1 to 3
0
-1 to -3
2011-002
3
1
-2
2011-005
8
2
-6
2011-008
6 to 7
3
-3 to -4
2011-009
0
0
none
2011-014
6
2
-4
2011-015
6
4
-2
2011-017
4
2
-2
20l2-005
4 to 7
4
-3 to 0Slide17
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
Summar
y 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 monthsSlide18
Dynamic Bracing Solutions (DBS) braces
For detail:
www.DynamicBracingSolutions.net
Talk to John
Callan
, myself or Marmaduke Loke after this session.