fitting, and use of IDEO with RTR physical therapy
following limb salvage surgery may allow return
to exercise, recreation and physical activity, and
decreased pain for a limited population of high-
functioning patients.
1,13,14,16,17,26
(3) In service personnel under 40 years of age, injured
with high-energy lower extremity trauma,
fitting, and
use of IDEO with RTR physical therapy following
limb salvage surgery, results in improved agility,
power, and speed, compared with no-brace or conven-
tional bracing alternatives.
26
(4) IDEO strut stiffness should be considered with respect
to patient preference.
24,27
–29
Evidence statements 1 and 2 are each supported by six
moderate-quality studies. Evidence statement 3 is supported
by a single moderate-quality study and statement 4 is
supported by two high-quality studies and two moderate-
quality studies. These combinations of evidentiary support
provide a
“moderate” level of confidence for each of the
four EESs.
DISCUSSION
With regard to study design, half of included studies were
observational and half experimental. Although this is a rea-
sonable blend of study designs, an optimal body of literature
would enable meta-analysis from more prospective, random-
ized control trials. Internal validity could have been strength-
ened in these studies with minor reporting changes in
accordance with standardized criteria.
30,31
For instance, had
the included samples been better described (i.e., more uni-
form reporting of anthropometry and demography), effect
sizes been reported and learning/accommodation and fatigue
reported, more of the studies would have likely improved
their internal validity ratings from
“low” to “moderate” or
“moderate” to “high.” Conversely, external validity was uni-
formly high which provides con
fidence that results have
clinical importance but may be biased from a methodologic
perspective (i.e., internal validity). Selection and reporting
bias could contribute to favorable results in the included
articles. Epidemiologic studies including larger samples
could clarify the potential for larger generalizability to clini-
cal practice.
Another strength of the included studies is that a blend of
outcome measures supports the evidence statements and
conclusions from these studies. Perceptive, functional perfor-
mance, biomechanical, RTD, and delayed amputation out-
comes have been studied. Although this is a strength and
provides the ability to determine how the IDEO and RTR
program may effect patients like those studied, it is unlikely
that some of the outcomes selected would be valuable to
others who may be able to utilize these interventions. For
instance, older Veterans and civilians will not have compa-
rable endpoints such as RTD. Many others such as bio-
mechanical, functional, and perceptive measures will likely
translate across populations. The fact that the majority of the
effect sizes were medium and large when IDEO and RTR
therapy were provided suggests that the outcome measures
selected were responsive to change and that these interven-
tions had clinical signi
ficance in the studied populations.
As anticipated, all of the subjects studied were young
(
≤30-year mean) in accordance with a military population.
With the exception of subjects diagnosed with post-traumatic
osteoarthritis,
16
the majority were recently injured with acute
HELET. A small number of female patients and some with
spinal cord injury were included. However, there was insuf
fi-
cient representation to determine ef
ficacy of IDEO and RTR
in either of the latter groups. Further, the performance results
described herein are largely attributed to IDEO and RTR
(independent variables). However, it must be considered that
a factor contributing to the effects observed include the
prior
fitness level and age of the subjects. It could be that
the magnitude of effect would not be as large in patients
who are older, have increased BMI and have lower levels
of
fitness. Moreover, the confounding effects of post-traumatic
stress disorder (PTSD) and traumatic brain injury (TBI) as
it relates to prescription, utilization, and ef
ficacy of IDEO
and RTR remain unknown. As patients such as those studied
begin to separate from military service and enroll for bene
fits
with the Veterans Health Administration, it is unclear the
extent to which these results will generalize to a larger Vet-
eran population.
Approximately 3% of studied subjects requested or received
an amputation despite provision of IDEO and RTR. None of
this group returned to duty and the factors preventing their
potential return were not reported.
14,16,17,26
Oppositely,
approximately 12% of patients who went directly to amputa-
tion, did RTD.
23
It is unclear what differentiated the clinical
decisions that lead each group to their respective endpoints.
However, it is important to understand through future study,
why limb salvage coupled with IDEO and RTR were not as
successful in these cases. This further emphasizes the value of
individual evaluations at the present time to determine the
best clinical path for the individual patient. Approximately
33% of patients who received limb salvage, returned to duty.
From these, approximately 80% received IDEO and RTR and
approximately a third, returned to active duty.
1,13,15
–17,23
A
signi
ficant barrier in understanding this patient demographic
and the associated clinical pathways they will follow, is the
lack of an agreed upon de
finition for “limb-salvage” cases.
Having such a de
finition would clarify which injuries are
determined to be
“salvageable” and what are the associated
functional prognoses.
Major
findings of this review include the EESs supported
by moderate evidence suggesting that following HELET it is
reasonable for a limited, homogeneous population within the
military community, to be able to RTD.
1,13,15
–17,23
Given
the high costs and time associated with training for military
service, this has obvious
financial implications. Further, pos-
itive outcomes associated with post-traumatic interventions
MILITARY MEDICINE, Vol. 181, November/December Supplement 2016
74
Outcomes Associated With the Intrepid Dynamic Exoskeletal Orthosis