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MILITARY MEDICINE, Vol. 181, November/December Supplement 2016
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Development of Knee Osteoarthritis After Unilateral Lower Limb Amputation
MILITARY MEDICINE, 181, 11/12:45, 2016
Differences in Military Obstacle Course Performance Between
Three Energy-Storing and Shock-Adapting Prosthetic Feet in
High-Functioning Transtibial Amputees: A Double-Blind,
Randomized Control Trial
CPT M. Jason Highsmith, SP USAR*†‡§; Jason T. Kahle, MSMS, CPO, FAAOP‡;
Rebecca M. Miro, PhD‡∥; Derek J. Lura, PhD¶; Stephanie L. Carey, PhD**;
Matthew M. Wernke, PhD††; Seok Hun Kim, PT, PhD‡;
CDR William S. Quillen, MSC USN (Ret.)‡∥
ABSTRACT Background: Approximately 683 persons engaged in military service experienced transtibial amputation
(TTA) related to recent war in Iraq and Afghanistan. Military TTAs function at a level beyond basic ambulation. No
empirical data demonstrate which higher functioning prosthetic feet maximize injured service personnel
’s ability to con-
tinue performing at a level commensurate with return to duty. This study
’s purpose was to determine which of three
high-functioning, energy-storing prosthetic feet maximize performance and preference in a
field obstacle course (OC)
and to quantify physical performance differences between TTAs and high-functioning nonamputees. Procedures: A ran-
domized, double-blind, repeated measures experimental design compared three prosthetic feet (Ossur Vari
flex, Endolite
Elite Blade, and Ossur Re-Flex Rotate) during performance on a
field OC. TTAs accommodated with study feet and the
OC before assessment. 14 TTAs and 14 nonamputee controls completed the course. Subjective and objective perfor-
mance differences were compared across feet conditions and between groups. Results: Total OC completion times were
similar between prosthetic feet: Elite-Blade (419 seconds ± 130), Vari
flex (425 seconds ± 144), and Re-Flex Rotate
(444 seconds ± 220). Controls
’ OC completion time (287.2 seconds ± 58) was less ( p ≤ 0.05) than TTA times. In total,
controls had faster completion times ( p
≤ 0.05) compared to all prosthetic feet conditions in 13/17 obstacles. Re-Flex
Rotate had 2 additional obstacles different ( p
≤ 0.05) than controls and required more time to complete. Median RPE
values were lower ( p
≤ 0.05) for controls than TTA regardless of foot. Regarding foot preference for OC completion,
7/14 (50%) preferred Elite Blade, 5/14 (36%) preferred Re-Flex Rotate, and the remaining 2/14 (14%) preferred
Vari
flex. Conclusion: Controls completed the OC faster and with less effort than TTAs regardless of prosthetic foot. No
clear differences in prosthetic feet emerged during OC completion; however, individual task performance, perceived
effort, and preference resulted in trends of slight performance improvement with and preference for Elite Blade, a dual
function energy-storing and return foot combined with vertical shock absorption. Understanding how to maximally
improve performance in such functional tasks may allow service members to best sustain physical
fitness, return to their
military occupational specialty and possibly in-theater duty.
INTRODUCTION
Traumatic amputation represents more than 2% of all battle-
field injuries and greater than 7% of major extremity injury
associated with military service.
1,2
Speci
fic to the wars in
Iraq and Afghanistan, there have been 1,221 persons engaged
in military service who have experienced 1,631 amputations
from 2001 to 2011.
3
Of these, 683 amputations (or 41.8%)
were at the transtibial level and 366 people suffered multiple
amputations.
1
–4
Military transtibial amputation (TTAs) likely
function at a level beyond basic ambulation and will require
a longer duration of care over their remaining lifespan com-
pared to dysvascular amputees in the civilian sector. Today
’s
younger military TTA will challenge the health care sys-
tem that is best suited for management of lower function-
ing patients.
5,6
Rehabilitation following TTA routinely involves use of a
prosthesis. Optimizing the TTA prosthesis requires selecting
componentry, including a prosthetic foot best suited for the
patient
’s particular functional demands. Problematically, lit-
tle empirical data are available to guide selection of the opti-
mal foot for a high-functioning member of the armed forces
who may be interested in extreme recreational pursuits as a
Veteran or in staying on active military duty. Available
comparative effectiveness research for prosthetic feet in the
TTA population has included perceptive, biomechanical, and
*Extremity Trauma & Amputation Center of Excellence, 2748 Worth
Road, Suite 29, Fort Sam Houston, TX 78234.
†James A. Haley Veterans Administration Hospital, Center of Innova-
tion in Disabilities and Rehabilitation Research, 8900 Grand Oak Circle
(151R), Tampa, FL 33637.
‡School of Physical Therapy and Rehabilitation Sciences, University of
South Florida, 3515 E, Fletcher Avenue, Tampa, FL 33612.
§U.S. Department of Veterans Affairs, Rehabilitation and Prosthetics
Services, 810 Vermont Avenue, NW Washington, DC 20420.
∥Center for Neuromusculoskeletal Research, University of South Flor-
ida, 3515 E, Fletcher Avenue, Tampa, FL 33612.
¶Department of Bioengineering and Software Engineering, Florida Gulf
Coast University, 10501 FGCU Boulevard South, Fort Myers, FL 33965.
**Mechanical Engineering Department, University of South Florida,
4202 E, Fowler Avenue, ENB 118,Tampa, FL 33612.
††Willow Wood, 15441 Scioto Darby Road, P. O. Box 130, Mount
Sterling, OH 43143.
doi: 10.7205/MILMED-D-16-00286
MILITARY MEDICINE, Vol. 181, November/December Supplement 2016
45
bioenergetic measures in a limited selection of prosthetic feet
including solid ankle cushioned heel (SACH), energy-storing,
and vertical shock
–absorbing feet.
7
Brie
fly, compared to alter-
natives such as SACH feet, TTA
’s studied preferred energy-
storing feet and reported enhanced performance, comfort and
less effort in association with their use.
7
–12
In some cases,
additional functions have resulted in improved performance of
speci
fic functional needs. Examples include specialty running
feet improving bioenergetic ef
ficiency during ambulation
above comfortable walking speeds and vertical shock absorp-
tion improving stair-climbing kinetics.
13,14
Despite the avail-
able, however limited evidence, there is no empirical data
to demonstrate which higher functioning prosthetic feet can
maximize an injured service member
’s ability to continue
performing at a level commensurate with return to duty.
Obstacle courses (OCs) are a familiar element of military
and law enforcement culture and quali
fication. They are used
in preparatory training and skill maintenance in physically
demanding work environments. OCs are further used for
assessment to demonstrate continued preparedness in terms
of skill pro
ficiency and fitness. Use of OCs have become
even more widespread to include recreation and to determine
disease severity. In the health care literature for instance,
OCs have been used with the elderly, those using assistive
mobility aids, visually impaired, community ambulatory
transfemoral amputees, those recovering from cardiac events,
firefighters, and the military.
15
–24
Use of OCs in these exam-
ples have provided determinations of
fitness and situational
preparedness for physically rigorous work environments.
Given that OCs are familiar to military personnel to assess
physical preparedness and because there are no
field-based
physical performance assessments of high-functioning TTAs
using high-functioning prosthetic feet, use of an OC is a log-
ical assessment choice in this population. Therefore, the
purpose of this study was to determine which of three high-
functioning, energy-storing prosthetic feet maximize perfor-
mance and preference in a rigorous
field OC. A second
purpose was to quantify the differences in physical perfor-
mance between persons with TTA and a high-functioning
nonamputee control group.
METHODS
The protocol was approved by Institutional Review Boards
for the University of South Florida and the U.S. Army. The
study was also listed in a federal clinical trials registry
(www.clinicaltrials.gov; no. NCT01404559).
Study Design
A randomized, double-blind (subjects and data collectors),
repeated measures experimental design was used to compare
three prosthetic feet conditions in physical performance. The
study statistician (also blinded to the interventions) used an
electronically generated, randomized, and balanced block
allocation to sequence independent variable (prosthetic foot)
assignment to subjects (off-site and concealed) via the study
prosthetists. The study prosthetists fabricated prosthetic
blinding covers that concealed the identity of prosthetic feet
during testing to mask participants and investigators.
Subject Recruitment and Eligibility
TTA subjects were recruited in collaboration with case man-
agers through a military treatment facility specializing in
amputee rehabilitation as well as advertisement with local
prosthetic and rehabilitative clinics. Nonamputee control sub-
jects were recruited through the local County Sherriff Depart-
ment
’s Special Weapons and Tactics Team (SWAT). All
subjects had to be aged
≤45 years and provide evidence of
medical clearance to be able to participate in vigorous physi-
cal activity. Nonamputee control subjects had to be a SWAT
team member. Additional eligibility criteria speci
fic to TTAs
included that candidates had to be determined by study pros-
thetists to be at the K4 functional level and currently active
duty military or other uniformed service, a recently separated
Veteran or have a strong high-performance athletic history as
an amputee (e.g., ranked triathlete, paralympian).
Experimental Procedures
Study Feet (Independent Variables)
All amputee subjects (experimental group) were tested in
random order with each of the following three energy-storing
prosthetic feet (blinded) (Fig. 1).
(1) Vari
flex (Ossur, Reykjavik, Iceland. Energy-storing
and return [ESR]),
(2) Elite Blade (Endolite, Hampshire, United Kingdom.
Energy-storing and vertical shock absorption),
(3) Re-Flex Rotate (Ossur, Reykjavik, Iceland. Energy-
storing and vertical shock and torsion absorption).
These feet were selected as they represent differing types
of energy-storing feet including a basic energy-storing foot,
a light weight ESR foot with vertical shock absorption and
a heavier ESR foot with vertical shock and torsion absorp-
tion. A cross-section of nonamputees were also assessed to
provide a comparison to unimpaired physical performance
(control group).
Prosthetic Fitting and Accommodation Periods
Board-certi
fied and state-licensed study prosthetists dupli-
cated TTA participants
’ prosthetic sockets and suspension.
The duplicate socket was then
fit and aligned (to manufac-
turer speci
fications using a LASAR posture tool [Otto Bock
Healthcare, Duderstadt, Germany]) with the three 3 pros-
thetic feet using modular coupling components to control
potential confounding issues related to socket
fit. TTA partic-
ipants accommodated with each prosthetic foot by wearing it
for a minimum of 7 days (minimum of 8 hours per day). Par-
ticipants recorded their foot accommodation use in a written
journal provided to them during
fitting and training. Usage
MILITARY MEDICINE, Vol. 181, November/December Supplement 2016
46
Energy-Storing and Shock-Adapting Prosthetic Feet in Transtibial Amputees
and minimal accommodation were con
firmed by study staff
verbally and via journal entries before scheduling testing.
This assured a minimum accommodation period between
fitting and testing of at least 21 days total for the duplicate
socket and 7 days per foot condition in subjects
’ home envi-
ronment (Fig. 2).
OC and Familiarization
The local law enforcement and military OC were selected
and approved as the test facility. It is routinely used to train
police of
ficers, SWAT team members, and various branches
of military service members. SWAT operators and trainers
were onsite at all times to familiarize and supervise partici-
pants during study training and assessment.
As recommended,
25
OC familiarization included three
preparatory performance trials to eliminate confounding
learning effects. The study familiarization and accommoda-
tion plan also included provision of an OC map (Fig. 3) to
participants in advance of a physical familiarization and
training trip to the OC (Fig. 2). This included a 5-day pros-
thetic
fitting and familiarization visit. Using their prestudy,
preferred prosthesis, subjects visited the OC for instruction
by SWAT operators on OC safety and completion technique.
After instructional training and supervised practice, subjects
performed three supervised OC trials independently, for a
practice time.
The OC included the following obstacle tasks:
(1) Jacob
’s Ladder
(2) Rope Climb
(3) Balance Beam
(4) A-Frame
(5) Culverts
(6) Chain-Link Fence
(7) Rope Bridge and Stumps
(8) Cargo Net
(9) High Step
(10) Angle Wall (Fig. 4)
(11) Slalom
FIGURE 1.
I. Vari
flex (Ossur, Reykjavik, Iceland) is an energy storing and return foot, II. Elite Blade (Endolite, Hampshire, United Kingdom) is an
energy-storing and vertical shock absorption foot, III. Re-Flex Rotate (Ossur, Reykjavik, Iceland) is an energy-storing and vertical shock and torsion absorp-
tion foot.
FIGURE 2.
Study timeline. The timeline included two 5-day research activity periods on either side of a 21-day accommodation period. The
first 5-day
period was for prosthetic Dostları ilə paylaş: |