chose a graphic representation of spatiotemporal and bio-
mechanical differences between carbon
fiber and nominal
stiffness IDEO braces.
28
This is an acceptable method for
presenting measures of central tendency and variance and
even preferred at times to depict continuous phenomena.
However, this form of data presentation is also not condu-
cive to the calculation of magnitude of effect.
Bedigrew et al compared differences in physical perfor-
mance and perceptive measures at 3 assessment points; immedi-
ately postinjury, post physical therapy before bracing and again
following bracing with additional physical therapy.
14
This
group reported effect size (calculated as a difference in means)
in all study measures. Effect sizes for differences in physical
performance measures immediately postinjury compared to post
bracing and therapy were considerable, ranging from 24 to
166% improvements. Effect sizes for pain scores were generally
improved (i.e., reduced pain) following bracing and therapy by
a magnitude of 23 to 35%. Patients entering into rehabilitation
late experienced reduced magnitude of effect to 16 to 45% for
physical performance and 27 to 38% for perceptive measures.
Although these outcomes were of a relatively reduced effect
compared to their early-entry peers, these were still statistically
signi
ficant ( p ≤ 0.05) as well as clinically important.
In total, 82 comparisons were eligible for effect size anal-
ysis per this review
’s protocol. Of these, 64 involved use of
an IDEO. More speci
fically, IDEO was compared relative
to either a comparator (or no brace) or IDEO con
figuration
(i.e., strut stiffness) was modi
fied and compared. Within the
subset of IDEO involved comparisons, 37.5% were of a
large magnitude of effect, 25% were of medium magnitude,
and the remaining 37.5% were of a small effect size.
For instance, Haight et al studied differences in IDEO strut
stiffness between sound and involved limbs and to unimpaired
control limbs.
24
Effect size (Cohen
’s d ) was 0.03 (small)
regarding peak knee extension moment between control and
experimental subjects
’ involved limb while using a compres-
sive IDEO brace. Oppositely, effect size was 5.9 (large) when
comparing the differences in ankle range of motion between
sound and involved sides when a stiff IDEO brace was utilized.
Esposito et al identi
fied 5 statistically significant kine-
matic comparisons.
25
Of these, comparisons between com-
pliant and more rigid IDEO strut designs were larger than
those comparing nominal with stiff strut designs. Speci
fi-
cally, 3/3 kinematic comparisons were of medium effect size
when comparing compliant with nominal and stiff IDEO
struts, whereas 2/2 signi
ficant comparisons between nominal
and stiff strut designs resulted in small effects.
During functional performance tasks, IDEO use resulted
in large effects in self-selected walking velocity regardless
of comparator and again had large effects on speed over
uneven terrain and the 40-yd dash compared to a Blue
Rocker orthosis (Allard USA, Rockaway, New Jersey).
Medium effects were observed during stair climbing and in
the four-square step test when IDEO was used in compari-
son with the Blue Rocker and a no brace condition.
26
When
non-IDEO braces or no brace was used all signi
ficant com-
parisons were of a small magnitude of effect. Conversely,
when IDEO was used during these tasks, 25% of signi
ficant
comparisons were of a medium or large magnitude of effect.
Empirical Evidence Statements
The following four evidence statements were formulated and
supported by moderate-level evidence:
(1) In service personnel under 40 years of age, injured
with high-energy lower extremity trauma, potentially
confounded by post-traumatic ankle osteoarthritis,
fitting, and use of IDEO with RTR physical therapy
following limb salvage surgery may allow return
to active duty for a limited population of high-
functioning patients.
1,13,15
–17,23
(2) In service personnel under 40 years of age, injured
with high-energy lower extremity trauma, potentially
confounded by post-traumatic ankle osteoarthritis,
TABLE IV.
Internal and External Validity of Included Studies
Author (Year)
Study
Design
Internal Validity
External Validity
1
2
3
4
5
6 7 8 9 10 11 12 13 14 15 16 17 18
Total
1 2 3 4 5 6 7 8 Total
Patzkowski (2011)
O6
n/a n/a n/a n/a n/a
•
•
•
• Low
• • • • • • • High
Owens (2011)
O4
n/a n/a n/a n/a n/a
•
•
•
•
• Low
• • • • • • • High
Patzkowski (2012)
O3
n/a n/a n/a n/a n/a
• •
•
•
•
• Low
• • • • • • • High
Patzkowski (2012)
O3
n/a n/a n/a n/a n/a
• •
•
•
•
•
•
• Low
• • • • • • • High
Patzkowski (2012)
E1
•
•
• n/a
• •
•
•
•
•
•
•
• Moderate • • • • • • • • High
Harper (2014)
E5
n/a n/a n/a n/a
•
•
• •
•
•
•
•
•
•
• High
• • • • • • • • High
Blair (2014)
O1
n/a n/a n/a n/a n/a
• •
•
•
•
•
• Moderate
• • • • • • • High
Esposito (2014)
E2
•
n/a
•
• •
•
•
•
•
•
•
• Moderate • • • • • • • • High
Bedigrew (2014)
E3
n/a n/a n/a n/a
•
•
•
•
•
•
•
•
•
• Moderate
• • • • • • • High
Harper (2014)
E5
n/a n/a n/a n/a
•
•
• •
•
•
•
•
•
•
• High
• • • • • • • • High
Sheean (2014)
O1
n/a n/a n/a n/a n/a
•
•
•
•
•
•
•
• Moderate
• • • • • • • High
Haight (2015)
E2
•
n/a
•
•
•
•
•
•
•
• Low
• • • • • • • • High
“n/a” indicates this particular criteria is not applicable for the given study design. The symbol “•” indicates that the criteria was satisfied. A blank space
(no symbol) indicates that the particular criteria was not satis
fied.
MILITARY MEDICINE, Vol. 181, November/December Supplement 2016
73
Outcomes Associated With the Intrepid Dynamic Exoskeletal Orthosis