PowerPoint - The Human Gait Institute

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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, RoleEmotional, 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.)
(3 seconds change considered significant)
Subject
No devices
Conv.
DBS-3 mo
Brace/devic
es
DBS-6 mo
DBS-12 mo
Change
42.6
AzAFO
36.7
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
30.25
DBS
AFO+cane
47.3****
-8.75 until
new med.
problems
Springleaf
DBS AFO
AFO 24.28 20.43
DBS AFO
21.97
Due
9/12/12
-5.78
-3.85
2011-001
2011-015
27.75
DBS AFO
20.4
DBS
AFO+cane
36.5
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
22.4
Due 1/13
-4.4
No data
Changes in times with DBS KAFOs
Subject
No devices
Con.
DBS -3 mo
Brace/devic
es
DBS-6 mo
DBS-12 mo. Change in
seconds
2011-005
Crutches, no KAFO &
brace
AFO +
37.25 sec
crutches
26.45
DBS KAFO
& AFO +
crutches
31.28
DBS KAFO
& AFO +
crutches
32.3
2011-009
27.3 sec
Cane occas. Delay in
using DBS
Delay in
using DBS
DBS KAFO+ + 6.2 sec
cane33.5
2011-014
43 seconds
None
DBS KAFO
& AFO +
walker
130.28
Not due
until
12/06/12
DBS KAFO
& AFO +
crutches
36.21
DBS KAFO
& AFO +
walker
105.67
-3.9 no
brace
+5.85 old
braces
+87. 28
Change in frequency of falls/near falls
Subject
Initial After
Falls DBS
per yr 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
1 to 2
-11 to -22
0
12 to 24
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
+3
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 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
+21.96
43.98 at 12 months
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
+10.75
37.29 at 12 months
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.

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