Novel Design of an Anterior Cruciate Ligament (ACL) Injury

Novel Design of an Anterior Cruciate Ligament (ACL) Injury Prevention
Brace
Daniel Greenshields, Justin Killewald, Rachel Porter
May 7, 2014
Biomedical Engineering Program, Lawrence Technological University, MI 48075
ABSTRACT
Anterior cruciate ligament (ACL) injuries are serious and fairly frequent sports injuries.
In the United States alone 200,000 to 300,000 ACL injuries occur annually. More often than not,
ACL injuries occur with no contact from another athlete. Common ACL injury mechanisms
include: hyperextension, valgus bending, internal rotation of the tibia, anterior shear of the tibia,
and axial loading. While there are current knee braces on the market that are worn by athletes to
reduce their risk of ACL injury, these knee braces are designed primarily to prevent
hyperextension and valgus bending. Another type of knee brace commonly worn is an
osteoarthritis (OA) brace. These braces are worn by older patients with OA in one side of the
knee. The brace is classified as a unicompartmental offloading brace that reduces the
compressive load on the medial compartment of the knee. To redesign the medial hinge
mechanism of a prophylactic knee brace used to prevent ACL injuries by shifting the axial
compressive knee reaction force from the lateral to medial compartment of the knee. The hinge
will serve to reduce the occurrence of ACL injuries by protecting against hyperextension, valgus
bending, and axial compressive loading. After obtaining Institutional Review Board (IRB)
approval for our testing methods, biomechanical human subject testing was conducted on a male
and female subject. Three experiments were carried out using both a control brace and the
modified brace to validate the hinge design and determine if our brace is successful in shifting
the axial compressive force. The human subjects participated in experiments where they
completed step-off landings off of a low platform as well as run-stop-jumps onto force plates
while wearing motion capture markers. The ground reaction force, segment acceleration, knee
angles and kinematics were acquired through 3D motion capture. After analyzing data from both
subjects, it was determined that the brace allowed full range of motion for the subjects. It also
successfully reduced the compressive load on the lateral compartment of the knee by shifting the
axial compressive load from the lateral to the medial compartment. This was indicated by frontal
plane kinematics and kinetics.
Keywords
Knee brace, ACL, osteoarthritis, valgus bending, hyperextension, compression, unicompartmental
Table of Contents
BACKGROUND .......................................................................................................................................... 4
Knee Anatomy .......................................................................................................................................... 4
Knee Injuries ............................................................................................................................................. 5
ACL Injuries ............................................................................................................................................. 5
Epidemiology of ACL............................................................................................................................... 7
Existing ACL Braces ................................................................................................................................ 8
Existing OA Braces................................................................................................................................... 9
IMPLICATIONS .......................................................................................................................................... 9
DELIVERABLE ......................................................................................................................................... 10
RESEARCH PLAN PROCESS .................................................................................................................. 10
Testing Parameters .................................................................................................................................. 10
IRB Application ...................................................................................................................................... 11
Human Subject Testing ........................................................................................................................... 12
Experimental Set-up................................................................................................................................ 12
Experiments ............................................................................................................................................ 15
HINGE SPECIFICATIONS ....................................................................................................................... 17
Design Goals ........................................................................................................................................... 17
Hinge Design Process ............................................................................................................................. 17
Hinge Design .......................................................................................................................................... 19
Data Analysis .......................................................................................................................................... 19
RESULTS ................................................................................................................................................... 20
Step-Off Landing on Both Legs .............................................................................................................. 20
Step-Off Landing on One Leg ................................................................................................................ 21
Run and Stop-Jump Landing .................................................................................................................. 23
Flexion and Extension Data .................................................................................................................... 25
Valgus and Varus Moment Data ............................................................................................................. 26
DISCUSSION ............................................................................................................................................. 27
REFERENCES ........................................................................................................................................... 30
APPENDIX ................................................................................................................................................. 33
BACKGROUND
Knee Anatomy
The human knee joint is regarded as the largest and most complex joint in the body. The
knee is comprised of four bones – the femur, tibia, fibula and patella. The distal end of the femur
is shaped by the medial and lateral condyles. These condyles contact the medial and lateral
plateau of the tibia. The femur and tibia act like a hinge joint, designating flexion and extension
as the primary ranges of motion. In addition to the bone structure, the knee is comprised of many
ligaments and soft tissue. The function of a ligament is to connect bone to bone, for stabilization
purposes and support. The medial collateral ligament and the lateral collateral ligament are
located on the exterior portion of the joint. The anterior cruciate ligament and the posterior
cruciate ligament are located in the synovial capsule of the knee. The medial meniscus and the
lateral meniscus act as shock absorbers for the joint and help disperse forces on the knee. Each
anatomical feature of the knee joint is essential to an effectively functioning knee.
Figure 1. Knee anatomy [14]
Knee Injuries
The knee joint is one of the most injured structures in the body, with an increased chance
of injury when sports are involved. Knee injuries account for nearly 60% of all sports related
injuries. Continuing, ligaments are the most commonly injured constructs (40%) and, of those
injuries, 46% of those injuries are to the ACL [3]. Knee joint injuries account for roughly 1923% of all joint related injuries. The medial meniscus, medial collateral ligament, and the
anterior cruciate ligament are the most frequently injured components of the knee [10]. Among
those structures injured, the anterior cruciate ligament is the most commonly injured construct.
ACL Injuries
The ACL is responsible for approximately 200,000 – 300,000 injuries annually in the
United States [2]. Such a great amount of injuries comes with a price beyond two billion dollars
in healthcare related costs [3]. The ACL can be injured in many different ways. Possible
mechanisms for injury include: internal rotation of the tibia, valgus bending, anterior shear of the
tibia, hyperextension, and axial loading. Internal rotation injuries result when the foot is planted
firmly on the ground while the rest of the body twists. Valgus bending injuries typically occur
when the foot is planted on the ground and the knee is hit from the lateral side. Anterior shear of
the tibia result from a force being applied to the knee from the front. Hyperextension causes
ACL tearing due to the extreme amount of tension that is put on the ligament when it’s stretched
beyond the normal anatomical range of motion. Axial loading of the knee joint has also been
shown to produce injuries to the ACL. In this case, the compressive load of an axial force causes
the tibia to slip forward on the lateral side of the knee. The medial compartment of the knee can
withstand more force because it sits concavely, providing more stability and support when loads
are applied. The lateral compartment of the knee is weaker due to having a steeper and therefore
more unstable posterior tibial slope on the lateral verses the medial compartment. The tibial
slope on the lateral compartment of the knee can be seen below in Figure 3. As described, it is
understood that many ACL injuries occur without contact. With the help of video analyses, it is
observed that ACL injuries occur most commonly in low flexion angle and high knee valgus
conditions.
Figure 2. ACL injury mechanisms. From left to right: hyperextension, valgus bending, internal rotation of the tibia,
and axial compressive loading [15, 16, 17].
Figure 3. Tibial slope of lateral compartment
Epidemiology of ACL
Injury to the anterior cruciate ligament can be sustained from contact, yet injury can also
occur in non-contact conditions. In fact, one study found that 70% of ACL injuries occur
without contact. The same study examined injuries from high school soccer, basketball, and
volleyball players and found that 75% of ACL injuries occurred without contact [4]. In addition,
gender plays a vital role in the incidence of ACL injuries. In gender comparable sports such as
soccer and basketball women are more likely to damage their ACL. This is most likely due to
knee alignment or neuromuscular patterns. As seen in Figure 4, women tend to have wider hips
which gives them a wider angle where the femur meets the tibia. This provides a different knee
alignment compared to men. One study found that women competing in jumping or cutting
sports are four to six times more likely to injure their ACL compared to their male counterparts
[5].
Figure 4. Knee alignment in femals vs. males
Existing ACL Braces
There are two classes of knee braces currently on the market – prophylactic and
functional knee braces. Prophylactic knee braces are used to prevent an injury from occurring.
On the other hand, functional braces are used in post-injury circumstances. Functional knee
braces are designed to substitute for damaged ligaments by providing additional support to the
knee joint. A study that reviewed the efficacy of prophylactic knee braces reports decreased
peak tension magnitudes and impulse responses on knee ligaments when wearing the brace [6].
The only clinically proven knee brace shown to reduce ACL strain is Donjoy’s Defiance brace.
The brace is a prophylactic brace, but can also be used post-injury as well. The brace protects
against valgus bending and hyperextension. The main component of the brace is the hinge
mechanism. The FourcePoint hinge which is located on the lateral and medial side of the knee
joint incorporates a series of resistance arms in the design. The resistance arms engage in the last
25° of extension and essentially make it more difficult to straighten the leg. The most ‘at-risk’
position for ACL tears is 0°-25° of flexion, so this brace reduces the time spent in the vulnerable
position, while also allowing other muscles and tendons to help stabilize the knee.
Figure 5. Donjoy Defiance Knee Brace [18]
Existing OA Braces
Osteoarthritis is an articular disorder that affects tens of millions of United States
citizens. More specifically, approximately 9.7 million people have symptomatic osteoarthritis in
the knee joint [7]. Typically, the medial compartment of the knee joint degenerates before the
lateral compartment. This occurs as a progressive varus leg axis develops due to cartilage loss in
the knee [8]. To relieve pain in this type of circumstance, the medial compartment needs to be
offloaded. Fortunately, knee braces have been developed for people with this type of disorder.
Osteoarthritis braces act to distribute loads more evenly across the knee joint. The knee brace
performs this by creating a slightly valgus moment on the knee, reducing the pressure on the
medial compartment. This even distribution is known as unicompartmental loading.
Unicompartmental loading offloads the medial compartment and loads the lateral compartment
to a greater extent in osteoarthritis braces.
IMPLICATIONS
This knee brace design is novel in its field and has the potential to reduce the number of
ACL injured athletes. The brace protects against three injury mechanisms that have been proven
to cause ACL injuries, whereas current braces only account for two of those injury mechanisms.
The brace will serve to protect against three injury mechanisms: valgus bending, hyperextension,
and compressive axial loading. The brace functions to shift the axial compressive force from the
lateral compartment to the medial compartment of the knee joint. Additionally, the benefits of
this brace will reduce healthcare costs related to ACL knee injuries and will decrease the amount
of reconstructive surgeries. Likewise, many professional and recreational athletes can have
career ending ACL injuries, so this will aim to increase the length of athletic careers.
DELIVERABLE
The deliverable obtained from this project is a functional ACL injury prevention knee
brace. The target market for the brace include sports related institutions and the athletic industry
as a whole. Again, the knee brace will account for three injury mechanisms known to tear the
ACL.
RESEARCH PLAN PROCESS
Testing Parameters
Three studies were researched to determine the experimental tests used. The first was a
study conducted to identify female athletes with high knee loads that increase the risk of ACL
injury. Female basketball and soccer players were recruited to participate in this study. The
subjects were instructed to start on a 31cm high box with their feet positioned 35cm apart. They
were to drop directly down off the box and immediately perform a maximum vertical jump,
raising both arms while jumping. Two force plates were placed 8cm apart so each foot would
contact a different platform upon landing. 37 retroreflective markers were placed on each
subject, and data was collected using a motion analysis system consisting of ten digital cameras.
The most important results collected were peak knee abduction angle, peak knee extensor
moment, and knee flexion range of motion [12].
The second study examined the effects of changing the sagittal plane body position
during single-leg landings and if that change influences the risk of non-contact ACL injuries. 20
participants performed single-leg drop landings onto a force plate using three different landing
styles: self-selected, leaning forward, and upright. Lower extremity muscle activities were
recorded using motion analysis and surface electromyography. The participants were
recreationally active, and there were 10 men and 10 women, ages 20 to 26. After determining
the subjects’ dominant leg, the subjects were instructed to stand on a box on their dominant legs
with both arms across their chest. The box was 30 cm high for women and 45 cm high for men.
They were instructed to drop off of the box and land in the center of the force plate using their
dominant leg. Data was collected for each subject in each of the three landing styles. Some data
extracted included peak vertical ground reaction forces (vGRFs), peak plantar flexor moments,
peak knee extensor moment, sagittal plane hip and ankle moments, and knee flexion angles [13].
The final study was conducted on one of Donjoy’s knee braces. There were 20
participants - 10 male and 10 female. All participants were recreational athletes. They
performed a vertical stop-jump task with and without the knee brace they were testing. Passive
reflective markers were placed on each subject. They were instructed to complete an approach
run, with up to five steps, and a two-footed landing followed by a two-footed take off for
maximum height. Each subject performed five successful trials with and without the brace.
Three dimensional videography and force plate data was collected. Upon landing, they
determined the knee flexion angle, maximum knee flexion angle, and the peak ground reaction
forces [11].
IRB Application
The application for approval to conduct research with human participants was submitted
to the IRB for approval, along with a participant information sheet and informed consent form.
The participant information sheet is necessary because it gathers information on previous or
current injuries. It also includes information needed to use Vicon Nexus for 3-dimensional
motion capture. IRB approval was granted on January 27, 2014. The male and female test
subjects were required to sign the informed consent documents and fill out the participant
information sheet. Following the completion of the necessary documents, human subject testing
commenced.
Human Subject Testing
The participants in this study consist of one male and one female athlete, both of which
are healthy and not injured. Athletes with previous or current lower extremity injuries, along
with athletes under the age of 18, have been excluded.
Experimental Set-up
The first step in the data collection process is to attach the markers designated by the Plug-In
Gait Fullbody marker set. 35 reflective markers were placed on each subject at the right
forehead (RFHD), left forehead (LFHD), right back of head (RBHD), left back of head (LBHD),
7th cervical vertebra (C7), right back (RBAK), 10th thoracic vertebra (T10), right shoulder
(RSHO), left shoulder (LSHO), right elbow (RELB), left elbow (LELB), right wrist marker A
(RWRA), right wrist marker B (RWRB), left wrist marker A (LWRA), left wrist maker B
(LWRB), right finger (RFIN), left finger (LFIN), clavicle (CLAV), sternum (STRN), right
anterior superior iliac (RASI), left anterior superior iliac (LASI), right posterior superior iliac
(RPSI), left posterior superior iliac (LPSI), right thigh (RTHI), left thigh (LTHI), right knee
(RKNE), left knee (LKNE), right tibia (RTIB), left tibia (LTIB), right toe (RTOE), left toe
(LTOE), right ankle (RANK), left ankle (LANK), right heel (RHEE), and left heel (LHEE). Our
female subject wearing this marker set can be seen below in Figure 6. The 35 markers work to
create 15 body segment: head, torso, right upper arm, left upper arm, right lower arm, left lower
arm, right wrist, left wrist, pelvis, right upper leg, left upper leg, right lower leg, left lower leg,
right foot, and left foot.
Figure 6. Female subject wearing Full Body Marker Set
Additionally, subject parameters such as weight, height, knee width, ankle width, and total leg
length, were documented and used for data collection. This portion of the data collection takes
approximately 30 minutes to complete. All data is collected in the Experimental Biomechanics
Laboratory, which is located in the engineering building at Lawrence Technological University.
A Donjoy Armor brace was purchased to be used as the control brace for the experiment.
The purchased brace is a size medium and can be worn without harm by both the male and
female test subjects. To determine the size of the brace needed, knee width, upper thigh, lower
thigh, upper calf, and lower calf were measured for both subjects.
The platform used for the experimental tests was positioned 30cm above two force plates.
The force plates are responsible for measuring the vertical ground reaction force (vGRF) and can
be seen below in Figure 7.
Figure 7. Experimental set-up of platform and force plates
Vicon Nexus, a 3D motion capture system, was used for this project. The system consists
of eight Vicon Bonita cameras placed in the Experimental Biomechanics Laboratory. The
position of these cameras relative to the force plates can be seen below in Figure 8. As long as
two cameras can see each marker, they can triangulate the markers’ 3D location in space. After
the subject has the full body marker set on and the subject parameters have been measured and
entered in Vicon Nexus, a static trial of the subject can be completed. Then, each marker is
manually labeled to get a calibrated subject model. This model provides inertial properties for
each body segment.
Figure 8. Experimental set-up of 8 Bonita Nexus cameras and force plates.
Experiments
Three experimental tests were used to test and validate the fabricated knee brace; step-off
landing on both legs, step-off landing on one leg, and run and stop jump. The first experimental
test requires the test subject to step off of a platform 30 cm high and land on both legs, one on
each force plate. After landing, the subject is instructed to perform a maximum vertical jump.
The second experimental test instructs the subject to stand on a 30 cm high platform on the leg
with the knee brace and drop down landing with the same leg on the forceplate. The third
experimental tests is a run and stop jump. The subject starts by taking three approach steps,
starting with the brace leg. The last step should be a push-off from the brace leg followed by a
two-footed landing on the force plates. Upon landing the subject performs a vertical jump for
maximum height. Figure 9 (below) shows our female subject completing each experiment. Each
experimental test was completed with the control brace as well as the modified brace. For each
test we ran trials until six trials with good data were acquired. These tests also took place in the
Experimental Biomechanics Laboratory. The testing took up about two hours of the subjects’
time. Using a control brace allowed for comparison of the data obtained with the modified brace
and the data obtained from Donjoy’s Armor Knee Brace.
Figure 9. Experiments (a) step-off landing on both legs, (b) step-off landing on one leg, and (c) run and stop jump
The data that will be measured includes the ground reaction force, segment acceleration,
knee angles and kinematics. Those values can be used to calculate the joint reaction force and
moment about the knee. The data from the three experimental tests with both braces—step-off
landings on both legs, step-off landings on one leg, and run and stop jump will be used to
determine if our brace is successful in lessening the load to the lateral side of the knee during a
jump landing. We will be analyzing the data using Vicon Nexus and Vicon Polygon. From the
six trials, the averages and standard deviations will be taken to perform a t-test to determine if
our data is statistically significant.
While undergoing testing, there were possible risks to the participants due to the nature of
the tests. Minor negative effects included fatigue, and there were no injuries to the subjects. To
minimize risks to the participants the testing was of short duration and was not strenuous or
outside of the normal ranges of motion for the body. If at any time the subject felt pain or
discomfort they were strongly encouraged to stop testing immediately. They were jumping from
a low height and landed in a self-selected body position.
HINGE SPECIFICATIONS
Design Goals
The immediate goal of the project is create a knee brace that protects the ACL from three
injury mechanisms – hyperextension, valgus bending, and compressive axial forces. The goal of
the hinge would be to position the knee in a slightly varus bending angle orientation. This would
effectively transfer the load from the lateral compartment of the knee to the medial compartment.
The vertical ground reaction force is used to create a lateral displacement when the knee is near
full extension. This, in turn, will serve to lessen the occurrence and ultimately protect the ACL
from serious injury.
Hinge Design Process
In order to initially devise a solution that incorporates our design goals, a detailed search
and comparison of available braces was conducted. Being there is a large selection of available
braces already on the market, we felt it would be detrimental if we tried to redesign an entire
brace. The determination of altering a hinge design seemed like a more reasonable and feasible
option. Through various discussions with both advisors, Dr. Meyer and Professor Cook, and
with extensive patent searches we were able to narrow down the scope of our project to just
redesigning the medial hinge. The time frame of the project and the budget we were granted was
used as justification for our preliminary plan. The brainstorming process began with the notions
that the fabrication must be possible at LTU. Furthermore, we felt it imperative that the
materials being used were durable, but could also be modified if the testing didn’t work as
planned. The brainstorm process resulted in four ideas for hinge designs. The four conceptual
ideas were a spider gear, wedge pad, four bar linkage, and a leaf spring setup. As a group, the
pros and cons of each conceptual design were displayed, and the ultimate decision was made to
be the wedge pad option. The wedge pad appeared to be the best due to the relative ease of
fabrication. Additionally, we felt that this design would be the most effective at control the
amount of lateral displacement. Professor Cook is the largest contributor to the idea and was
initially thought of one of the weekly meetings. Multiple rough drawings were created of the
hinge design and function. The basic parts and functioning mechanisms were included in the
initial sketches. Following, an AutoCAD version of the conceptual hinge was prepared to better
represent the hinge and all of the moving parts. The AutoCAD file included all the appropriate
dimensions set to scale. Next, a rough hinge prototype was fabricated from steel. Steel was
chosen as the material for the rough prototype due to its relative inexpensive cost and just as a
method to determine if the functioning mechanisms will work. The final hinge actually used on
the brace was fabricated out of aluminum. Aluminum is much more expensive than steel, and
thus was not used as the prototype. Aluminum is much easier to machine when compared to
steel, and is also considerably lighter, a parameter necessary for a knee brace. To benefit the
fabrication process, some of the parts from the original medial hinge were used. Once all
fabrication processes were complete, the hinge was attached to the medial side of a right-legged
Donjoy Armor knee brace.
Figure 10. Hinge design process from left to right: control brace, rough drawing, CAD drawing, steel prototype,
aluminum hinge, modified hinge brace
Hinge Design
The medial hinge is designed to connect to the brace by four rods with eight hardened bolts.
The two wedges connect to the rods with bolts/pins that slide through a channel cut into the side
of the body of the hinge. The channel has two important functions. First, it does not let the
wedges go past a certain point which would lock the wedges under the wedge pad. The other
function the channel does is prevent the rods from coming out of the body when the release
springs push the rods back to the resting state. The wedges are milled at a 45° angle and push the
wedge pad out when a load is applied. The wedge pad is also milled at a 45° angle but has a
radius milled in it so when the flexion angle is increased the hinge does not lock up. To prevent
hyperextension in the hinge, the polycentric part of the original hinge was welded to the wedge
body and a bolt was used to hold the valgus plate and two hinge ends into place. The plate
prevents valgus bending and is critical to holding the hinge together and controlling the
movement. Correct movement is needed so the hinge moves in sync with the natural joint motion
of the knee. The total width of the hinge is 1 ⅛”. This is important as we needed to keep the
width as small as possible to prevent the other knee from hitting the brace.
Data Analysis
Vicon Nexus is the software program used for 3D motion capture. The system consists
of 8 infrared cameras that are all synced to a control box. The data is captured and then relayed
through the controller and displayed on the computer screen in the Experimental Biomechanics
Laboratory. Vicon Nexus is responsible for obtaining the segment model data of the test
subject’s motions. Vicon Polygon, a human skeletal model software program, was then used for
data retrieval. The program is used mainly for the graphs required for validation. Vicon
Polygon is essential because it shows the 3D human skeletal model of the motions.
RESULTS
Step-Off Landing on Both Legs
The main parameter that we want to observe is the valgus and varus knee angle for each
trial. The expectation for the results is an increased varus angle (or decreased valgus angle)
when comparing the control brace to the modified brace. Figure 11, shown below, represents
data obtained from the male control trials. The average varus angle was recorded when the
vertical ground reaction force was at a maximum. The average angle observed for the male
control trials is 16.7° ± 4.6°. Figure 12, also shown below, is representative of the step-off
landing on both legs while wearing the modified brace. The graph represents the male modified
trials. The average knee valgus/varus angles were, again, recorded at the maximum vertical
ground reaction force. The average value is 33.7° ± 8.6°. When comparing the control to the
modified trials for the male test subject, it is observed that the modified brace increased the varus
angle by 17°.
16.7° ± 4.6°
33.7° ± 8.6°
Figure 11. Male control; Step-off landing on both legs.
Figure 12. Male modified; step-off landing on both legs
Figure 13, shown below, represents the step-off landing on both legs for the female test subject
wearing the control brace. The female subject showed a much larger valgus angle initially
compared to the male subject. The average valgus/varus knee angles were taken at the maximum
vertical ground reaction force. The average value for this set of data is -6.3° ± 2.4°. The
negative value simply refers to the valgus orientation of the knee joint. In Figure 14, below, the
data is obtained from the step-off landing on both legs for the female subject wearing the
modified brace. The average knee valgus/varus angles were recorded when the vertical ground
reaction force is at a maximum. The average angle for the modified brace is 21.3° ± 6.4°. As
one can observe, the angle is in the varus portion of the graph, signifying that the modified brace
created a varus bending angle at the knee joint. The differences in the valgus/varus angle
between the control and modified braces is 27.6° of increased varus angle. This value is over
10° greater than the difference observed in the male trials.
-6.3° ± 2.4°
21.3° ± 6.4°
Figure 13. Female control; Step-off landing on both legs
Figure 14. Female modified; Step-off landing on both legs
Step-Off Landing on One Leg
The focus of the results for the step-off landing on one leg is the knee valgus/varus angle.
Represented in Figure 15 is the data obtained from the male subject wearing the control brace.
Similar to the step-off landing on both legs, the average values for the knee valgus/varus angles
are 16.0° ± 2.5°. The positive value is representative of a varus angle at the knee joint. Figure
16, shown below, is a graph of the step-off landing on one leg for the male subject wearing the
modified brace. The modified brace showed an average knee valgus/varus angle of 23.7° ± 2.2°.
In comparison to the control trials, the modified brace showed nearly 8° of additional varus
bending at the knee joint.
23.7° ± 2.2°
16.0° ± 2.5°
Figure 15. Male control; Step-off landing on one leg.
one leg
Figure 16. Male modified; Step-off landing on
The figure below, Figure 17, shows the female subject’s control trials for the step-off landing on
one leg. Similar to the female step-off landing on both legs, the control data shows a valgus
angle of -8.0° ± 1.6°. The valgus angle seen in this graph is expected based on the anatomical
make-up of the female pelvis (wider hips create a larger valgus angle at the knee). The final
figure for the step-off landing on one leg is shown below in Figure 18. The data is representative
of the female subject wearing the modified brace. The average valgus/varus angle recorded is
2.0° ± 5.8°. There is a difference of 10° from the control to the modified trials, indicating that
the brace effectively created a varus angle at the knee joint at the time of the maximum vertical
ground reaction force.
2.0° ± 5.8°
-8.0° ± 1.6°
Figure 17. Female control; Step-off landing on one leg.
leg.
Figure 18. Female modified; Step-off landing on one
Run and Stop-Jump Landing
Consistent with the previous two experiments, the valgus/varus knee angles were
recorded and observed for run and stop-jump landing trials. The collected data is portrayed by
an average valgus/varus angle (colored line), in addition to the standard deviation of the trials
(grayed area). The data shown in Figures 19 and 20 represent the male control and male
modified trials for the run and stop-jump landing task. The control trials showed an average
valgus/varus angle of 18.0° ± 1.7°. The male modified trials recorded conclude a valgus/varus
angle of 28.3° ± 2.6°. The varus angle increased by just over 10° when the modified brace was
worn by the male test subject.
28.3° ± 2.6°
18.0° ± 1.7°
Figure 19. Male control; Run and stop-jump landing.
Figure 20. Male modified; Run and stop-jump landing
The collected data for the run and stop-jump landing trials for the female test subject are
represented below in Figures 21 and 22. Figure 21 displays the average valgus/varus angles for
the control trials; the average value was determined to be -9.5° ± 3.6°. The negative value
indicates that the initial position of the knee while wearing the control brace is in a valgus
orientation. Figure 22 shows the average valgus/varus angles for the modified trials. The
average value is 5.8° ± 2.8°. The positive value suggests that the knee position at the maximum
vertical ground reaction force for the female subject wearing the modified brace is in varus
orientation. The angle difference is 15.3° of varus bending when comparing the control and
modified trials. The data found from the experimental tests signifies that the modified brace did
in fact orient the knee joint in a slightly varus position.
-9.5° ± 3.6°
5.8° ± 2.8°
Figure 21. Female control; run and stop-jump landing
Figure 22. Female modified; run and stop-jump landing
Flexion and Extension Data
The flexion and extension angles were recorded at the maximum vertical ground reaction
force for both the male and the female test subjects. The purpose of collecting flexion and
extension data is to validate that the modified brace prevents against hyperextension of the knee
joint. In Figure 23 the results are displayed for the female control trials for the step-off landing
on both legs. The average flexion and extension angle throughout the entire motion is
represented by the colored line. The standard deviation is shown as the grayed area. Figure 24
shows the average flexion and extension angle for the modified trials of the same experiment.
By visually comparing the two sets of data it is understood that the difference between control
and modified trials are quite minute. The entirety of the flexion and extension angle data is
nearly identical when comparing both the control and modified trials for the male and female test
subjects. Figures 23 and 24 are the only figures included in the report that represent the flexion
and extension angles. Due to the inherent redundancy of the flexion and extension graphs, the
remainder of the graphs can be found in the report’s appendix. The ultimate objective of
recording the flexion and extension angles is to ensure that the modified brace prevents
hyperextension in the knee. All graphs conclude that the modified brace does indeed serve that
purpose. The basis of the decision is that at no point in time did the data show a knee extension
angle larger than what is anatomically acceptable.
Figure 23. Female control, step-off landing on both legs Figure 24. Female modified, step-off landing on both legs
Valgus and Varus Moment Data
The valgus and varus moment data is the final parameter recorded to validate the
effectiveness of the modified brace. The data shown in Figures 25 and 26 is representative of the
six trials used to compute the valgus/varus moments. The trials in both the figures is not
averaged like the previous graphs due to unknown complications with force plate data. Still, the
general idea can still be observed for the valgus/varus moments for the control and modified
trials. The data comes from the female test subject during the step-off landing on both legs
experiment. The average valgus/varus moment for the control trials is -1.29 ± 0.22 N/m2. The
average value for the modified trials is -1.15 ± 0.23 N/m2. The negative value is indicative of a
valgus moment. Therefore it can be construed that the varus moment increased slightly (valgus
moment decreased) between the control and modified braces. This slight increase is expected
based on the results obtained from the valgus/varus angles. Similar to the flexion and extension
data, the valgus and varus moment data is only represented by the two figures in this section due
to redundancy in data. The remainder of the moment graphs can be found in the appendix of the
report.
Figure 25. Female control, step-off landing on both legs
legs
Figure 26. Female modified, step-off landing on both
DISCUSSION
The “New method to identify athletes at high risk of ACL injury using clinic-based
measurements and freeware computer analysis” article aimed to determine a prediction algorithm
to help identify when an ACL injury may be imminent. The article itself did not actually find
any conclusive data in terms of knee angle or knee moment values. The particular study was
chosen due to the experiment proposed within the article. The step-off landing on both legs
experiment originated from the article. Although no raw data is obtained in the study, the
article’s contents are imperative for our senior project. A future experiment that could be
completed in regards to the article would be to actually identify numerical values for both male
and female subjects. The valgus/varus angle values obtained for the male control and modified
trials are 16.7° ± 4.6° and 33.7° ± 8.6°, respectively. The angle difference is 17° of varus
bending. The valgus/varus angle values for the female control and modified trials are -6.3° ±
2.4° and 21.3° ± 6.4°, respectively. The angle difference is 27.6° of varus bending. The female
control trial initially displayed the knee in a valgus orientation. The best determination for this is
based on the notion that women have an anatomically wider pelvis. The increase in pelvis width
causes a sharper angle at the knee joint, creating more of a valgus angle, as suggested by the
valgus angle. Both the male and female trials showed a great increase in the varus angle,
however, the increased value is not consistent for both genders.
In the article titled “Changing sagittal plane body position during single-leg landings
influences the risk of non-contact anterior cruciate ligament injury” the researchers examined the
effects of single-leg landings and their association with ACL injuries. The study conducted
included twenty participants performing single-leg landings with various landing styles. The
study found that the ACL is most protected when the participant leaned forward at the landing
point. This study does record numerical values, however, a majority of the information contains
electromyography data pertaining to muscle activation during the landing. The study our group
conducted does not include any muscle activation studies. Although no direct comparison can be
made between this article and our project, a comparison can still be developed between the male
and female subjects of our project. The valgus/varus angles for the male control and modified
trials are 16.0° ± 2.5° and 23.7° ± 2.2°, respectively. The angle difference calculated is 7.7° of
varus bending. The valgus/varus angles for the female control and modified trials are -8.0° ±
1.6° and 2.0° ± 5.8°, respectively. The angle difference for the female subject is 10° of varus
bending. The step-off landing on one leg showed more consistent results in terms of the angle
difference when wearing the control and modified braces. Again, the female average initially
was in a valgus orientation, most likely due to the larger width of the pelvis. Furthermore, this
experimental test is crucial for analysis because the test subject is only landing on the leg with
the brace. This type of experiment eliminates any errors that may arise from two-legged
landings by focusing all aspects of the jump on solely the right leg.
REFERENCES
[1] Feucht, Matthias J., Craig S. Mauro, Peter U. Brucker, Andreas B. Imhoff, and Stefan
Hinterwimmer. "The Role of the Tibial Slope in Sustaining and Treating Anterior
Cruciate Ligament Injuries." Springer-Verlag (2012): n. pag. Print.
[2] Heard, B.J., N.M. Solbak, Y. Achari, M. Chung, D.A. Heart, N.G. Shrive, and C.B. Frank.
"Changes of Early Post-traumatic Osteoarthritis in an Ovine Model of Simulated ACL
Reconstruction Are Associated with Transient Acute Post-injury Synovial Inflammation
and Tissue Catabolism." Osteoarthritis and Cartilage 21 (2013): 1942-949. Print.
[3] Teng, Phillis, K.F. Leong, P.Y. Huang, and J. McLaren. "The Effect of a Knee-ankle
Restraint on ACL Injury Risk Reduction during Jump-landing." Procedia Engineering 60
(2013): 300-06. Print.
[4] Meyer, Eric G., and Roger C. Haut. "Excessive Compression of the Human Tibio-femoral
Joint Causes ACL Rupture." Journal of Biomechanics 38.11 (2005): 2311-316. Print.
[5] Hewett, T.E., Lindenfeld, T.N., Riccobene, J.V., Noyes, F.R., 1999. The effect of
neuromuscular training on the incidence of knee injury in female athletes: a prospective
study. American Journal of Sports Medicine 27 (6), 699-705.
[6] Pietrosimone, Brian G., Terry L. Grindstaff, Shelley W. Linens, Elizabeth Uczekaj, and Jay
Hertel. "A Systematic Review of Prophylactic Braces in the Prevention of Knee
Ligament Injuries in Collegiate Football Players." Journal of Athletic Training 43.4
(2008): 409-15. Print.
[7] Pollo, Fabian E., James C. Otis, Sherry I. Backus, Russell F. Warren, and Thomas L.
Wickiewicz. "Reduction of Medial Compartment Loads with Valgus Bracing of the
Osteoarthritic Knee." The American Journal of Sports Medicine 30.3 (2002): 414-21.
Print.
[8] Gaasbeek, Robert D.A, Brenda E. Groen, Brieke Hampsink, Ronald J. Van Heerwaarden, and
Jacques Duysens. "Valgus Bracing in Patients with Medial Compartment Osteoarthritis
of the Knee A Gait Analysis Study of a New Brace." Gait & Posture26 (2007): 3-10.
Print.
[9] "ACL Bracing." - Helping With Prevention, Protection & Healing. N.p., n.d. Web. 07 May
2014.
[10] Meyer, Eric. "BIOMECHANICAL RESPONSE OF THE KNEE TO INJURY LEVEL
FORCES IN SPORTS LOADING SCENARIOS." Doctor of Philosophy
Dissertation (2009): n. pag. Print.
[11] Yu, B. "Immediate Effects of a Knee Brace With a Constraint to Knee Extension on Knee
Kinematics and Ground Reaction Forces in a Stop-Jump Task." American Journal of
Sports Medicine 32.5 (2004): 1136-143. Print.
[12] Myer, G. D., K. R. Ford, J. Khoury, P. Succop, and T. E. Hewett. "Biomechanics
Laboratory-based Prediction Algorithm to Identify Female Athletes with High Knee
Loads That Increase Risk of ACL Injury." British Journal of Sports Medicine 45.4
(2011): 245-52.
[13] Shimokochi, Yohei, Jatin P. Ambegaonkar, Eric G. Meyer, Sae Yong Lee, and Sandra J.
Shultz. "Changing Sagittal Plane Body Position during Single-leg Landings Influences
the Risk of Non-contact Anterior Cruciate Ligament Injury." Knee Surgery, Sports
Traumatology, Arthroscopy 21.4 (2013): 888-97.
[14] "Knee (Human Anatomy): Images, Function, Ligaments, Muscles." WebMD. WebMD, n.d.
Web. 07 May 2014.
[15] Sandes T., et al. "Bone Contusion Patterns of the Knee at MR Imaging: Footprint of the
Mechanism on Injury."Radiographics 20 (2000): S135-151.;
[16] "PT Tip of the Month Archive." Beantown Physio. N.p., n.d. Web. 07 May 2014.
[17] Koga, H., et al. "Mechanisms for Noncontact Anterior Cruciate Ligament Injuries: Knee
Joint Kinematics in 10 Injury Situations From Female Team Handball and Basketball." The
American Journal of Sports Medicine 38.11 (2010): 2218-225.
[18] "Defiance." Medical Devices & Services. N.p., n.d. Web. 07 May 2014.
APPENDIX
IRB Application
APPLICATION TO
THE
LAWRENCE TECHNOLOGICAL UNIVERSITY INSTITUTIONAL REVIEW
BOARD FOR APPROVAL TO CONDUCT RESEARCH WITH HUMAN
PARTICIPANTS
By checking this box, the submitter of this application is providing a digital signature
confirming that she or he:
A. has completed the necessary sections of the application and included all required
forms as stipulated in the instructions;
B. has completed the required online training course in The Protection of Human Research
Participants:
http://phrp.nihtraining.com/users/login.php
WHAT IS IRB APPROVAL AND WHO SHOULD USE THIS IRB APPLICATION
FORM? The Institutional Review Board (IRB) at Lawrence Technological University is a
non-contract interdisciplinary committee comprised of faculty and staff charged with
fulfilling the guidelines established by the Department of Health and Human Services
(DHHS) and the institution regarding the rights and welfare of human participants taking part
in research conducted at, or sponsored by, LTU, regardless of the source of funding. The IRB
is designed to protect the rights and welfare of individuals recruited to participate in research
activities conducted under the auspices of the institution, and IRB approval indicates the
institution’s official review that the potential risks of the research are outweighed by the
potential benefits.
Research with human participants refers to systematic investigation, including research
development, testing, and evaluation, designed to develop or contribute to generalized
knowledge with living individual(s) about whom an investigator (professional or student)
obtains either 1) data through intervention or interaction with the individual, or 2) identifiable
private information as noted in the Code of Federal Regulations:
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
All proposed activities that satisfy the criteria for research with human participants, and that
are to be conducted at LTU or elsewhere by current LTU faculty, staff, and students, require
submission of this IRB application for review and approval by the IRB prior to the initiation of
the research and require.
The IRB is concerned with the following:
• Assuring participation is voluntary and that participants are free to withdraw at any time.
• Identifying and managing potential risks to participants and researcher to assure that a
balance exists between potential benefits of the research to the participant and/or
society and the risk assumed by the participants.
The following are not considered research with human participants, and therefore do not
require IRB review:
• Data collected for internal departmental, school, or other LTU administrative purposes (e.g.
teaching evaluations, course evaluations, quality assurance).
• Reviews and searches of existing literature and research involving a living individual, such
as a biography, that is not generalizable beyond that individual.
• Public archival data (e.g. data from public libraries, newspapers) so long as the analysis of
the data will not make the data individually identifiable.
• Class projects or term papers if all of the following are true:
o The project is limited to surveys/questionnaires/interviews/observations of public
behavior directly related to topics being studied in an official college course so long as
the assessment tools contain no sensitive personal questions or other personal
information that could stigmatize an individual (e.g., questions about criminal activity,
medical history, drug use, sexual behavior).
o No identifying information is recorded to link a person with the data such that it could
reasonably harm the individual's reputation, employability, financial standing, or place
them at risk for criminal or civil liability.
o The participants in the project are not from a vulnerable or special population (e.g.,
pregnant women, prisoners, children or adolescents under the age of 18, cognitively
impaired individuals).
o The collected data does not leave the classroom setting, or if the project involves
collecting data on an organization, agency or company, the data are shared only with
that entity.
o No LTU employee or student is receiving financial compensation for collecting,
organizing, analyzing, or reporting the data.
• Pilot projects/preliminary activities performed to determine if a study is feasible so long as
vulnerable populations, methods with more than minimal risk, or sensitive personal
questions will not be used.
In the case where a project is not subject for review, the instructor/faculty member is responsible to
uphold all applicable ethical standards and guidelines in course-related research activities when it
comes to the treatment of human participants. Since it is the responsibility of the supervising
instructor/faculty member to determine whether projects are subject to review, it is always best to
err on the safe side and seek consultation from the IRB committee if a question arises regarding
human participants, research and classroom activities. If you are not clear on whether your project is
considered research with human participants contact [email protected] for clarification.
If the proposed research to be conducted at LTU or elsewhere by current LTU faculty, staff,
and students is considered research involving human participants, this IRB application form
should be completed and submitted for review.
Once the IRB application and all supporting materials have been submitted, the IRB will commence
a review according to the following three 3 categories of review:
Exempt From Further Review: “Exempt” means that a study does not require extensive regulatory
review; it does not mean that the study is exempt from review. Activities involving reviewing of
past records and surveys and questionnaires where there is anonymous participation and no risk to
human participants may be eligible for an exemption from further review by the IRB Chairperson.
According to federal regulations, the IRB (not the researchers themselves) will make final
determination if the checklist application meets the exempt criteria.
Expedited Review: Activities involving no more than minimal risk to human participants may be
eligible for an expedited review by the Chairperson of the IRB. Minimal Risk means that the
probability and magnitude of harm or discomfort anticipated in the research is no greater than what
would ordinarily be encountered in daily life or during the performance of routine physical or
psychological examination or tests
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)
Full Committee Review: Full Committee Review occurs when there is more than minimal risk to
participants or when the identity of participants is at risk of exposure.
When the IRB review is complete, you will receive two types of feedback: “approved as is” or
“approved with revisions.” The IRB reviewers strive to limit their methodological comments to
only those that impact either the risk or benefit level of the study, thus affecting the welfare of
participants and stakeholders.
IRB approval for proposals that require expedited or full committee review lasts for 1 year and you
must submit a continuation application at least six weeks before expiration. Exempt protocols are
not subject to annual review.
IMPORTANT NOTE FOR STUDENT RESEARCHERS
You must obtain IRB approval prior to collecting data from human participants if you plan on using
the data in your senior project, master’s thesis or doctoral dissertation, plan on presenting the data at
an academic conference, or plan on publishing the data in an academic journal. It is your
responsibility to make sure that this IRB application has faculty approval and that all supporting
materials are submitted to [email protected].
WHEN SHOULD I SUBMIT MY IRB APPLICATION?
For students who will conduct human participant research, the IRB application should be submitted
after the research proposal has been approved by the dissertation/thesis committee and/or the
academic reviewer. It is expected that students will review IRB requirements as they are writing the
proposal. All other researchers should submit the IRB application as soon as it is complete. The IRB
will make every effort to help researchers move forward in a timely manner. IRB approval is
required before participants can be recruited and data collection begins.
HOW LONG DOES IRB REVIEW TAKE?
Generally, it is the intent of the committee to review all Expedited and Exempt applications as
quickly as possible, usually within 1-2 weeks, but IRB approval in these two review categories may
occur quicker if necessary. Applications requiring a Full Review may take longer than 1-2 weeks
for review. Note that when a study is “approved with revisions” the researcher should allow an
additional 1-2 weeks for those revisions to be reviewed and approved. If the revisions do not
adequately address the ethical concerns, an additional round of revisions and review might be
necessary. The IRB members make every effort to make the required revisions as clear as possible.
CAN I SUBMIT MY RESEARCH PROPOSAL TO AN EXTERNAL FUNDING AGENCY
BEFORE IRB APPROVAL?
Researchers do not need to obtain IRB approval prior to submitting their proposal to conduct
research with human participants to an external funding agency (e.g., NIH, NSF). However,
obtaining IRB approval prior to submission to the funding agency will confirm that your research
project satisfies federal regulations for the protection of human participants. Additionally, if your
proposal is funded, IRB approval will be required before you can begin your research. Therefore,
you should contact the IRB prior to submitting your proposal if you have any questions or concerns
about approval.
CAN I RECRUIT MY RESEARCH PARTICIPANTS BEFORE IRB APPROVAL?
According to federal regulations, researchers are required to obtain IRB approval before recruiting
participants (i.e., getting consent form signatures). However, other documents may be signed before
IRB approval, such as Data Use Agreements or Letters of Cooperation from community partner
organizations, and Confidentiality Agreements that are signed by transcribers, statisticians, and
research assistants who might be given access to the raw data after collection. Please email
[email protected] if you have questions about the type of activities that can be conducted prior to
obtaining IRB approval.
WHAT IF I NEED TO CHANGE RESEARCH PROCEDURES AFTER IRB APPROVAL?
Any modifications to a previously approved research protocol need to be reviewed by the IRB to
ensure that the modification continues to meet the requirements for the originally issued approval.
Minor changes to the protocol can be addressed on the Request for Change in Procedures form
found on the Lawrence Tech Provost’s Office Web site. As long as the proposed changes do not
increase the level of risk, the request will be treated as an expedited review. Extensive changes to
any previously approved protocol are best addressed by submitting a new application.
HOW LONG IS THE IRB APPROVAL PERIOD?
Federal regulations stipulate IRB research approval can be no longer than 365 days. Therefore,
unless otherwise stated in the review decision, IRB approvals are granted for a period of one year.
Projects that have been approved under the Exempt From Further Review category are not required
to submit a Request for Continuation form; all other IRB research approvals must submit a Request
for Continuation form at least 14 days prior to the IRB approval expiration date.
OVERVIEW OF REQUIREMENTS FOR THIS IRB APPLICATION
General Description of the Proposed Research
- Translate your research question(s) into lay language.
- Provide specific descriptions of the tasks the participants will be asked to complete.
Data Collection Tools
- Submit all documents and authorizations related to data collection including the actual survey
instrument; if the survey will be administered electronically, provide the link to the survey.
- Submit copyright holder’s written permission to use the instrument and reproduce it in the
dissertation/thesis, or confirmation that the tool is in the public domain (as applicable).
Description of Research Participants
- Describe the study population, noting inclusion and exclusion criteria.
- Describe the procedure for recruiting participants.
- If applicable, complete IRB application sections relevant to working with children, facility
residents, or other protected populations.
Community Research Stakeholders and Partners
- Submit a signed Letter of Cooperation from any organization who will be involved in identifying
potential participants or collecting data.
-Submit an unsigned Data Use Agreement from any organization that will be providing records to
the researcher.
- Describe your plan for sharing your research results with relevant stakeholders (i.e., individuals or
organizations with an interest, or “stake” in the conduct or outcome of the project).
Potential Risks and Benefits
- Describe anticipated risks and benefits of study participation.
- Make provisions to minimize risks to research participants and document those procedures in this
application.
- When answering questions about risks in the application, please consider the following types of
risks or discomfort which your participants may experience:
- Physical Risks: Theses risks include physical discomfort, pain, injury, illness or disease brought
about by the methods and procedures of the research. These risks are not commonly
encountered in most social, behavioral, and educational research conducted at LTU.
- Psychological Risks: Psychological risks may be experienced during participation in the research
and/or afterwards as a result of participating in the research. These risks include anxiety, stress,
fear, confusion, embarrassment, depression, guilt, shock, or loss of self-esteem.
- Social/Economic Risks: Economic risks include changes in relationships with others that are
detrimental to the participant, and may involve embarrassment, loss of respect of others, or
diminishing the participant's future employability or eligibility for insurance.
- Legal Risks: Legal risks include risk of criminal prosecution or civil lawsuits when research
methods reveal that the participant has engaged in conduct which involves criminal or civil
liability, and there is a legal mechanism which triggers release of that information (an example
is the duty to report child abuse).
- Loss of Confidentiality: Confidentiality is presumed and must be maintained unless the
investigator obtains the express permission of the participant to do otherwise. Risks from breach
of confidentiality include invasion of privacy, as well as the social, economic and legal risks
outlined above. Release of confidential information is the most common type of risk
encountered in social, behavioral, and educational research.
Data Confidentiality
- Describe procedures to maintain confidentiality.
- If data includes personal identifiers, submit signed certificates of confidentiality for everyone who
has access to the data.
- If applicable, complete extra sections relevant to protected health information.
Potential Conflicts of Interest
- Disclose and manage potential conflicts of interest.
Informed Consent
- Make provisions to obtain and document informed consent from all study participants and the
appropriate parents, guardians, or caregivers.
- Submit the informed consent document that will be provided to participants with this application.
Final Checklist and Electronic Signatures
- Researchers submitting this IRB application will complete the final checklist and provide their
electronic signature in the form of their email address that must match email address on file with
LTU.
- Student researchers will also enter their faculty advisor’s email address as confirmation of faculty
approval.
This form must be completed and submitted via email. If you have questions as you are completing the
form, please contact [email protected]
PROJECT INFORMATION
Today’s Date: 12/2/2013
1. Researcher's name
Dan Greenshields, Justin Killewald, and Rachel Porter
(must match university records)
2. Researcher's LTU ID number
3. Researcher's email address
4. Project title
Dan Greenshields: 000694879
Justin Killewald: 000689988
Rachel Porter: 000688513
[email protected]
[email protected]
[email protected]
Novel Design of an Anterior Cruciate Ligament (ACL) Injury
Prevention Brace
5. Research collaborators and roles
If researcher is a student, please provide the
name of the committee chair or other
faculty member supervising this research.
Dr. Eric G Meyer
6. Email address(es) of the supervising
faculty member and any other co-researcher
collaborators
[email protected]
7. Lawrence Tech program affiliation(s) of researcher:
Architecture and Design (specify program:
)
Arts and Sciences (specify program:
)
Engineering (specify program: Biomedical Engineering)
Management (specify program:
)
8. Type of research:
Doctoral Dissertation
Master’s Thesis
Project Seminar
Senior/Honor’s Project
Faculty Research
Research for a course (specify course number:
Other
, course end date:
, and instructor name:
)
GENERAL DESCRIPTION OF THE PROPOSED RESEARCH
9. Please check all the data collection methods below that are part of this study. Ensure that all items checked
here are fully explained in question 13.
Survey or assessment completed by participant
Interview of participant
Analysis of student work products
Analysis of existing public records/archival data
Analysis of existing privately held records (such as business records, school records, medical records)
Observation of people in public places
Observation of people in school, workplace, or other non-public location
Observational study that involves manipulation of the participants’ environment
Collection/use of biological specimens (e.g. blood, saliva, urine, tissue)
Other (please specify) Data collection based on results of physical exercise
10. Using lay terms please state your research
question(s).
Is our knee brace successful in lessening the force on
the lateral side of the knee?
Do not use of jargon or acronyms, as this application
must be comprehensible to IRB reviewers outside of
the researcher’s field.
11. Quantitative researchers: Please list each
variable of interest (identifying each, if applicable, as
independent, dependent, or covariate) and briefly
explain how they will be measured.
Quantitative:
We will be measuring the ground reaction force and
segment acceleration and using those to calculate the
joint reaction force and moment.
Qualitative researchers: Please describe the
phenomenon of interest and how it will be recorded.
The success of the knee brace will be determined by
comparing it to the force applied to the knee without a
knee brace and with a knee brace already on the
market.
Question 25 will ask for more detailed information
about your data collection tools.
12. Please briefly describe the analyses planned.
Describe which statistical or analytical methods you
will use to reveal expected relationships, differences,
or patterns. The IRB is obligated to factor the rigor of
the research design into the overall assessment of the
potential risks and benefits of this study.
We will be comparing the data from the jump
landings without a knee brace, with an existing knee
brace, and finally with our repurposed knee brace to
determine if our brace is successful in lessening the
load to the lateral side of the knee during a jump
landing. We will have five trials for each test and will
take the average and standerd deviation from the five
trials and perform a t-test to determine if our data is
statistically significant.
13. Provide a detailed description of the informed consent and data collection procedures, along with the
duration, location, and communication format for each.
In detailed description describe any of the following that apply to your study: initial contact with potential
participants; informed consent procedures; examination/review of archival records, surveys, interviews,
assessments; observations of participants; intervention/treatment procedures; interviews; collection/use of
biological specimens (describe type of specimen and how it will be collected and used); and dissemination of
study’s results to participants and stakeholders. Please provide enough information to adequately describe
your project. If there are more than 10 steps, then you may email an attachment (e.g., your proposal’s method
section) to [email protected]
Detailed description
Duration
Exact Location
Exact Communication
(include pertinent dates)
Format
Step 1
(e.g., LTU, other cite.)
(e.g., email, phone, in person,
internet, etc.)
Potential participants will be
existing group members.
Existing
LTU
N/A
Our subjects will fill out the
informed consent form which
we have created. They are
required to fill this form out in
order to participate.
Our subjects will fill out a
participant information sheet
and then be prepared to perform
the tests. This will include
recording the information from
their information sheets,
attaching markers, and fitting
the knee brace.
Our subjects will be doing jump
landing trials onto a force plate
with and without a knee brace
while wearing motion capture
system markers.
Our subjects will be doing jump
landing trials onto a force plate
while wearing our redesigned
knee brace along with motion
capture system markers. These
trials may have to be done
weekly to test changes made in
the knee brace.
5 minutes
LTU
In person
30 minutes
LTU's
Biomechanics Lab
In person
1 hour
LTU's
Biomechanics Lab
In person
1 hour
LTU's
Biomechanics Lab
In person
Typically
initial
contact
Step 2
Typically
consent
Step 3
Step 4
Step 5
Step 6
Step 7
Step 8
Step 9
Step 10
DESCRIPTION OF THE RESEARCH PARTICIPANTS
14. Provide the target number of participants, including numbers per group if your study involves multiple
groups, and provide the rationale for the target number of participants you require (e.g., Power study,
literature review, etc.). 2 participants in a pilot study
15. Describe the criteria for inclusion and exclusion of participants in this study (such as relevant experiences,
age, gender, health conditions, etc). Your inclusion criteria should define all critical characteristics of your
sample. Once you’ve defined inclusion criteria, if you have no further limitations on who can participate, just
indicate “none” under exclusion criteria. You should be prepared to justify each of these criteria.
Inclusion criteria: 1 male and 1 female athlete who are healthy and not injured.
Exclusion criteria: Athletes with previous lower extremity injuries, athletes under the age of 18.
16. Please indicate whether each of the following vulnerable or protected populations is targeted, included, or
excluded from your study.
-Mark populations as Targeted if they are part of your inclusion criteria.
-Mark populations as Excluded if they are part of your exclusion criteria, or if your inclusion criteria
automatically excludes them (for example, a study with children automatically excludes elderly participants).
All other classes should be marked as Included.
Targeted
Included
(but not targeted)
Pregnant women
Children/minors (18 and under)
Prisoners
Residents of any facility (nursing home,
assisted living)
Mentally/emotionally disabled individuals
Individuals who might be less than fluent in
English
Elderly individuals (65+)
Traumatized individuals
Economically disadvantaged individuals
Clients or potential clients of the researcher
Students or subordinates of the researcher
Other Healthy athletes
Excluded
ADDITIONAL ISSUES TO ADDRESS WHEN PARTICIPANTS INCLUDE
RESIDENTS OF A FACILITY
17. Will your sample include residents of any facility (including prisons, juvenile detention centers, nursing
homes, mental health facilities, rehabilitation facilities, etc?)
Yes → Please complete question 18.
No → Please skip ahead to question 19.
18. The use of facility residents as participants requires that the investigator comply with the additional
protections provided in the relevant code of federal regulations (link provided on the Lawrence Tech Provost’s
Office Web site).
A. Will this study examine the possible causes, effects, or processes of incarceration and/or criminal
behavior?
Yes.
No.
B. Will this study examine the facility as an institutional structure?
Yes.
No.
C. Will this study specifically examine the experience of living in that particular type of facility?
Yes.
No.
D. Will this study examine a condition(s) particularly affecting these types of facility residents?
Yes.
No.
E. Will this study examine a procedure, innovative or accepted, that will have the intent or reasonable
probability of improving the health or well being of the participants?
Yes, and residents will be assigned to groups by
.
No.
ADDITIONAL ISSUES TO ADDRESS WHEN PARTICIPANTS INCLUDE
PROTECTED POPULATIONS
19. Will your sample include any members of vulnerable or protected populations listed in question 16?
Yes → Please complete questions 20-21.
No → Please skip ahead to question 22.
20. Please briefly justify the inclusion of each
protected population. Ensure that this response lays
out a rationale for why it is not possible to conduct
the research without the use of the protected
population.
21. If competency to provide consent could possibly
be an issue, describe how competency will be
determined and your plan for obtaining consent. If
not applicable, please indicate NA.
ADDITIONAL ISSUES TO ADDRESS WHEN PARTICIPANTS INCLUDE CHILDREN
22. Will your sample include individuals less than 18 years of age?
Yes → Please complete questions 23-24.
No → Please skip ahead to the next section on Data Collection Tools.
23. If this study proposes to include minors, this inclusion must meet one of the following criteria for
risk/benefit assessment, according to federal regulations (link provided on the Lawrence Tech IRB Web site).
Check the one appropriate box:
Minimal risk.
Greater than minimal risk, but holds prospect of direct benefit to participants.
Greater than minimal risk, no prospect of direct benefit to participants, but likely to yield generalizable
knowledge about the participant’s disorder or condition.
24. Please explain how the criterion in question 15 is
met for this study.
DATA COLLECTION TOOLS
In order to approve your study, the IRB needs to review the full text of each data collection tool (e.g.,
surveys, assessments, interview questions, etc.). The final checklist of this application will direct you to
send your data collection tools and any relevant permissions at the same time you submit the IRB form.
Note that any changes made to the data collection tools after IRB approval will require submission of
the Request for Change in Procedures form.
READ THIS IF YOU ARE USING A PUBLISHED INSTRUMENT:
Many assessment instruments published in journals can be used in research as long as commercial gain
is not sought and proper credit is given to the original source (United States Code, 17USC107).
However, publication of an assessment tool’s results in a journal does not necessarily indicate that the
tool is in the public domain.
The copyright holder of each assessment determines whether permission and payment are necessary for
use of that assessment tool. Note that the copyright holder could be either the publisher or the author or
another entity (such as the Myers and Briggs Foundation, which holds the copyright to the popular
Myers-Briggs personality assessment). The researcher is responsible for identifying and contacting the
copyright holder to determine which of the following are required for legal usage of the instrument:
purchasing legal copies, purchasing a manual, purchasing scoring tools, obtaining written permission,
obtaining explicit permission to reproduce the instrument in a dissertation/thesis/journal, or
confirmation that the tool is public domain.
Even for public domain instruments, Lawrence Tech University requires students to provide the
professional courtesy of notifying the primary author of your plan to use that tool in the research
project. Sometimes this is not possible, but at least three attempts should be made to contact the author
at his or her most recently listed institution across a reasonable time period (such as 2 weeks). The
author typically provides helpful updates or usage tips and asks to receive a copy of the results.
Many psychological assessments are restricted for use only by suitably qualified individuals.
Researchers must check with the test’s publisher to make sure that they are qualified to administer and
interpret any particular assessments that they wish to use.
READ THIS IF YOU ARE CREATING YOUR OWN INSTRUMENT OR MODIFYING AN
EXISTING INSTRUMENT:
It is not acceptable to modify assessment tools without explicitly citing the original work and detailing
the precise nature of the revisions. Note that even slight modifications to items or instructions threaten
the reliability and validity of the tool and make comparisons to other research findings difficult, if not
impossible. Therefore, unless the purpose of the study is to compare the validity and reliability of a
revised measure with that of one that has already been validated, no changes should be made in any
existing measures. If the study is being conducted for the purpose of assessing the validity/reliability of
a modified version of an existing measurement tool, the original tool must also be administered to
participants, and appropriate permissions to use the original tool must be obtained.
25. Are any of your data collection tools copyrighted?
No.
Yes, the following instrument is copyrighted:
. I have consulted the copyright holder,
, and I
have complied with all of the copyright holder’s legal usage terms by (check all that apply):
obtaining legal copies of the instrument
obtaining a legal copy of the manual or scoring kit
obtaining written permission to use the instrument in my research (submitted with this
application)
obtaining explicit permission to reproduce the instrument in my dissertation (submitted with
this application)
confirming that the tool is public domain (submitted with this application)
other:
If you are working with multiple copyright holders for different instruments, you must provide the legal usage
requirements for each additional instrument:
26. Did you create any of your data collection tools yourself?
No.
Yes, I created the following instrument: Consent form and participant information sheet and its
psychometric properties (i.e., reliability and validity) are being established using the following procedures
(e.g., Cronbach’s alpha for reliability, expert panel or literature review for face validity, comparison with
similar instrument for criterion validity, exploratory or confirmatory factor analysis for construct validity,
previous pilot study, etc.):
Are you modifying an existing tool?
No.
Yes, the APA style citation for the original tool is
modifications are necessary because
.
; my modifications include
; and these
COMMUNITY RESEARCH STAKEHOLDERS AND PARTNERS
Research participants are individuals who provide private data through any type of interaction, whether
verbal, observed, typed, recorded, written, or otherwise assessed. Research participants’ willingness to
engage in research must be documented with CONSENT FORMS, after IRB approval. For example, a
teacher comparing two teaching strategies by interviewing adult students in her classes would need to
have each individual student sign a consent form.
Community partners include any schools, clinics, businesses, non-profits, government entities,
residential facilities, or other organizations involved in your research project. Community partners’
willingness to engage in research must be documented with a LETTER OF COOPERATION, before
IRB approval. To continue with the same example above, the teacher comparing two teaching strategies
would need a Letter of Cooperation from the school confirming (a) that the school approves the
teacher’s utilization of two different teaching strategies and (b) that the school approves the interview
activities. If you have questions about whether an individual or an organization should provide
permission for some aspect of the research, please email [email protected].
If a community partner’s engagement in the research involves providing any type of non-public records,
the terms of sharing those records must be documented in a DATA USE AGREEMENT, before IRB
approval. Again using the same example, the teacher comparing two teaching strategies might need a
Data Use Agreement if she wants to analyze the students’ past academic records or work products as
part of the study. Data Use Agreements must be FERPA-compliant and HIPAA-compliant, as
applicable.
A sample letter of cooperation and sample data use agreement can be downloaded from the IRB section
of the Lawrence Tech Web site. The final checklist of this application will direct you to email or fax
your community partners’ Letters of Cooperation and any applicable Data Use Agreements at the same
time you submit this IRB form.
Stakeholders include the informal networks of individuals who would potentially be impacted by the
research activities or results (such as parents, community leaders, etc). Lawrence Tech students are
required to disseminate their research results in a responsible, respectful manner and are encouraged to
develop this dissemination plan in consultation with the relevant community partners. Sometimes it is
appropriate to provide a debriefing session/handout to individual participants immediately after data
collection in addition to a general stakeholders’ debriefing after data analysis.
27. Please identify all community stakeholders who
should hear about your research results and indicate
your specific plan for disseminating your results in
an appropriate format.
28. Please specify the names and roles of any
community partner organizations you propose to
involve in identifying potential participants or
collecting data. For each organization, identify the
individual who will be signing the Letter of
Cooperation and any applicable Data Use Agreement
(see definitions above).
Stakeholders would potentially be LTU athletics or
any athlete at LTU. We plan on providing the
Athletic Director with our findings.
Business interests could also learn about the brace or
validation results to help them with commercialization
opportunities.
N/A
If you have no community research partner, that
means you are solely relying on public records to
recruit participants and collect data.
29. Please briefly describe how you chose each of
the partners listed above.
N/A
POTENTIAL RISKS AND BENEFITS
30. For each of the categories A-J below, carefully estimate risk level and describe the circumstances that
could contribute to that type of negative outcome for participants or stakeholders. Please note: Minimal
risk is acceptable but must be identified upfront. Substantial risk is acceptable as long as adequate preventive
protections are in place (which you will describe in item 31).
Level of risk:
check one
A. Unintended disclosure of confidential information
(such as educational or medical records)
B. Psychological stress greater than what one would
experience in daily life (e.g., materials or topics that
could be considered sensitive, offensive, threatening, or
degrading)
C. Attention to personal information that is irrelevant to
the study (i.e., related to sexual practices, family
history, substance use, illegal behavior, medical or
mental health)
Description of risk:
list the circumstances that
could cause this outcome
No risk
Minimal risk
Substantial risk
No risk
Minimal risk
Substantial risk
No risk
Minimal risk
Substantial risk
D. Unwanted solicitation, intrusion, or observation in
public places
No risk
Minimal risk
Substantial risk
E. Unwanted intrusion of privacy of others not involved
in study (e.g. participant’s family).
No risk
Minimal risk
Substantial risk
F. Social or economic loss (i.e., collecting data that
could be damaging to any participants’ or stakeholders’
financial standing, employability or reputation)
No risk
Minimal risk
Substantial risk
G. Perceived coercion to participate due to any existing
or expected relationship between the participant and the
researcher (or any entity that the researcher might be
perceived to represent)
No risk
Minimal risk
Substantial risk
H. Misunderstanding as a result of experimental
deception (such as placebo treatment or use of
confederate research assistants posing as someone else)
No risk
Minimal risk
Substantial risk
I. Minor negative effects on participants’ or
stakeholders’ health (no risk of serious injury)
No risk
Minimal risk
Substantial risk
Our testing will involve jump
landings and could cause
fatigue.
J. Major negative effects on participants’ or
stakeholders’ health (risk of serious injury)
No risk
Minimal risk
Substantial risk
Our testing will involve jump
landings and could present
potential risk to injury.
31. Explain what steps will be taken to minimize
risks and to protect participants’ and stakeholders’
welfare. If the research will include protected
populations, identify each group and answer this
question for each group.
32. Describe the anticipated benefits of this research,
if any, for individual participants.
33. Describe the anticipated benefits of this research
for society.
The testing will be of short duration and will not be
strenuous or outside the normal ranges of motion for
the body. If at any time, the subject feels pain or
discomfort they are strongly encouraged to stop
testing immediately. To reduce the risk of injury
participants will be jumping from a low height and
landing in a self selected body position.
There will be no direct benefit to the participants of
this study.
This research aims to help repurpose a knee brace that
will aid in preventing or lessening ACL injuries.
There is no product on the market that has
successfully done so, and tearing the ACL is an
expensive, most often career ending injury that leads
to other implications and injuries.
DATA CONFIDENTIALITY
Understanding the difference between confidentiality and anonymity:
Anonymous data contains absolutely zero identifiers and makes it impossible to determine who
participated and who did not. Confidential data contains one or more identifiers, but identifiers are kept
private by the researcher. In order to protect participant privacy and assure that study participation is
truly voluntary, anonymous data collection is preferred, whenever possible.
34. In what format will you store the data?
(e.g., paper, electronic media, video, audio)
Paper, electronic media, and video.
35. Where will you store the data?
Data will be stored in E108, binders for paper copies,
LTU laptops, external hard drive for backup.
At least 5 years.
36. How long will you keep the data?
(five years is the minimum requirement)
37. Describe what security provisions will be taken
to protect this data.
(e.g., password protection, locks)
All files will be kept in researchers home until
needed.
38. Will you record any direct identifiers such as names, addresses, telephone numbers, etc?
No.
Yes, but the written or electronic signature on the consent form is the ONLY piece of identifying
information I am collecting.
Yes, I am collecting identifiers beyond names because they are essential within my dataset.
39. Will you retain a link between study code numbers and direct identifiers after the data collection is
complete?
No.
Yes, it is necessary because
.
40. Will you provide an identifier or potentially identifying link to anyone else besides yourself?
No.
Yes, it is necessary because
.
Not applicable to my research proposal.
41. Explain who will approach potential participants
to take part in the research study and what will be
done to protect individuals’ privacy in this process.
The potential participants in this research are
ourselves.
42. Please list all individuals who will have access to
the data (including research assistants, transcribers,
statisticians, etc). If you are a student, the IRB
assumes that your supervising faculty members will
have access to the data, so you do not need to list
them.
Researchers only.
43. To ensure data confidentiality among your research colleagues, you will either need to obtain a signed
Confidentiality Agreement for each person you listed for Question 42 or de-identify the data (by removing all
identifying links) before anyone else has access to it. Please visit the IRB Web site to download a sample
Confidentiality Agreement. Either handwritten or electronic signatures will suffice. This application’s final
checklist will direct you to send the IRB your signed Confidentiality Agreement(s) at the same time you
submit this IRB form.
Please check all that apply.
I will be emailing the signed confidentiality agreement(s) to [email protected].
I will be faxing the signed confidentiality agreement(s) to (248) 204-2207.
Not applicable because I am the only one who will have access to the raw data.
Not applicable because the accessible data is anonymous or de-identified.
44. If the data collected contains information about illegal behavior, it might be appropriate for you to obtain
a Federal Certificate of Confidentiality, which can shield your data from subpoena.
Will you obtain a Federal Certificate of Confidentiality for this research?
Yes. I will be submitting a copy at the same time I submit this form to [email protected]
No. My research involves reports of illegal behavior but I have opted not to seek a Federal Certificate of
Confidentiality.
No. My research does not ask participants to report any type of illegal behavior.
ADDITIONAL ISSUES TO ADDRESS WHEN THE RESEARCH INVOLVES
PROTECTED HEALTH INFORMATION
45. As part of this study, the researcher(s) will:
Collect protected health information* from participants → Please complete question 46.
Have access to protected health information* in the participants’ records → Please complete question 46.
None of the above → Please skip to question 47.
*Protected Health Information (PHI) is defined under HIPAA (Health Insurance Portability and
Accountability Act of 1996) as health information transmitted or maintained in any form or medium
that:
A. identifies or could be used to identify an individual;
B. is created or received by a healthcare provider, health plan, employer or healthcare clearinghouse;
and
C. relates to the past, present or future physical or mental health or condition of an individual; the
provision of health care to an individual; or the past, present or future payment for the provision of
healthcare to an individual.
For more information on protected health information, please visit the Lawrence Tech IRB Web site.
46. To use PHI in research you must have approval through one of the following methods:
A. An authorization signed by the research participant that meets HIPAA requirements; or
B. Use of a limited data set under a data use agreement.
Check below to indicate which method of approval you will use.
A. Research participants in this study will sign an Authorization to Use or Disclose PHI for Research
Purposes form. If the study includes multiple activities (e.g., clinical trial or collection and storage of PHI in a
central repository), then two authorization forms must be submitted for review. You may download a sample
authorization form at the IRB Web site, fill in the required information, and fax to (248) 204-2207.
B. I will access a limited data set by signing a Data Use Agreement with the party that releases the PHI. A
limited data set must have all possible identifiers removed from the data. It is the responsibility of the
researcher and the party releasing the PHI to have in place and maintain a copy of a Data Use Agreement
which meets HIPAA requirements. Use the template Data Use Agreement and fill in the required information.
A copy of the signed Data Use Agreement must be submitted for IRB review.
POTENTIAL CONFLICTS OF INTEREST
47. This item asks you to disclose information related to separating your multiple roles as clearly as possible,
with the goal of ensuring authentically voluntary participation in your study. Doctoral research directly
benefits the student (allowing him or her to obtain a degree), and so the researcher should minimize the
potential for either (a) conflict of interest or (b) perceived coercion to participate. Researchers who are in
positions of authority must take extra precautions to ensure that potential participants are not pressured to take
part in their study. Data collection should be as detached as possible from the researcher’s authority.
Examples:
-a professor researcher may recruit students AFTER grades have been assigned
-a psychologist researcher may recruit clients from ANOTHER psychologist’s practice
-a manager researcher may conduct ANONYMOUS data collection so that subordinates do not perceive their
responses or [non]participation as being associated with their job standing
At the time of study recruitment, are the potential study participants aware of any of the researchers’ other
professional or public roles? (Such as teacher, business owner, community leader, supervisor, etc.?)
No.
Yes, at the time of recruitment some of the participants are aware of the researcher’s
role, and the
following measures will be taken to separate the researcher’s dual roles and minimize perceived coercion to
participate:
.
48. This item asks you to disclose information related to possible financial conflicts of interest, with the goal
of maintaining research integrity. Is it possible that the financial situations or professional positions (to
include promotions, contracts, clients, and reviews) of the researchers or their families could be directly
impacted by the design, conduct, or results of this research?
No.
Yes, and the conflict of interest is being managed by the following disclosures/measures:
.
49. Will the researcher give participants or stakeholders any gifts, payments, compensation, reimbursement,
free services, or extra credit? It is fine to compensate your participants as long as the compensation cannot be
interpreted as coercive among the participant population. For example, a $5 gift card to a coffee house is fine
as a thank you gift, but an Ipod would not be, especially if the participants are teenagers. It is often better to
eliminate compensation all together or make sure that 100% of your sample gets the same compensation (as
opposed to only compensating those in your experimental group).
No.
Yes. More information is provided below.
What compensation will be given?
At what point during the research will the compensation be given?
Under what conditions will the compensation be given? (i.e., how will compensation for withdrawn
participants be handled?)
INFORMED CONSENT
This application’s final checklist will direct you to email your consent/assent forms to [email protected] at
the same time you submit this IRB form. For research projects with e-surveys, page 1 of your survey
should be the informed consent. Refer to the document “Consent Form Template for Online Survey”
available on the IRB website. Please note that your application is not considered complete until you
submit your consent/assent form.
50. Federal regulations require that the informed consent procedures disclose each of the elements in the
checklist below and that consent be documented (usually by asking the participants to sign the consent form
listing all of the disclosures but there are some other arrangements that are acceptable, depending on the
privacy issues and logistics of the data collection).
Anonymous surveys rely on implicit endorsement rather than obtaining a signed endorsement (i.e., the
participant indicates willingness to participate by completing a survey that contains a coversheet disclosing
the required elements below).
When participants are between 7 and 17, researchers must obtain parental consent in addition to asking the
children to review and sign an age-appropriate assent form. You may link to the relevant regulations from the
Lawrence Tech IRB Web site.
When participants are 6 and under, researchers must obtain parental consent in addition to reading a script that
asks the children for their verbal assent to participate.
Templates for consent and assent forms can be downloaded from Lawrence Tech IRB Web site. Note that the
consent and assent forms on the IRB Web site are only templates and will likely need a great deal of tailoring
for your study. Pay particular attention to making the reading level appropriate for your targeted participant
population.
Please affirm that your consent/assent form(s) contain each of the following required
elements.
Statement that the study involves research
Statement of why participant was selected
Disclosure of the identity and all relevant roles of researcher (e.g., Ph.D. candidate, part-time
faculty member, facility owner)
An understandable explanation of research purpose
An understandable description of procedures
Expected duration of participant's participation
Statement that participation is voluntary
Statement that refusing or discontinuing participation involves no penalty
Description of reasonably foreseeable risks or discomforts
Description of anticipated benefits to participants or others
Information that participant will or will not be compensated for their participation
Description of how confidentiality will be maintained
Whom to contact with questions about the research
Statement that participant may keep a copy of the informed consent form
All potential conflicts of interest are disclosed
Consent process and documentation are in language understandable to the participant
There is no language that asks the participant to waive his/her legal rights
If appropriate, indicates that a procedure is experimental (i.e., not a standard procedure)
YES
N/A
If appropriate, disclosure of alternative procedures/treatment
If appropriate, additional costs to participant resulting from research participation
FINAL IRB CHECKLIST
51. Please indicate below which method you are using to send each of your supporting documents. We ask
that you send these supporting documents to the IRB at the same time you submit this application.
Students must obtain their supervising faculty member’s approval on the last page before submitting any
materials to the IRB.
Emailed to
[email protected]
Faxed to
(248) 204-2207
Not applicable
Data collection tools (e.g., surveys, interviews,
assessments, etc.)
All of the following that apply to any assessments’
copyright holders: written/emailed permission to
use the instrument, permission to reproduce the
instrument in the dissertation, confirmation that the
tool is public domain, proof of the researcher’s
qualifications to administer the instrument
Letters of Cooperation from community partners
Data Use Agreement from any community partners
that will be sharing their non-public records
Invitation to participate in research (e.g., letter,
flier, phone script, ad, etc.)
Signed Confidentiality Agreements for transcribers,
statisticians, research assistant, etc.
Consent/assent forms
Federal certificate of confidentiality (to shield data
from subpoena)
Please maintain a copy of this completed application for your records. Once the IRB application and all
supporting documents have been received, the IRB staff will email the researcher and any relevant
faculty supervisors to confirm that the IRB application is complete. At this time, the IRB staff will also
notify the researcher of the expected IRB review date for the proposal.
The review date will be scheduled no later than 15 business days after your completion of this
application. In the case of doctoral students, the review date will be scheduled no later than 15 business
days after both A) the application is complete and B) the proposal is fully approved.
Notice of outcome of the IRB review will be emailed to the researcher and any supervising faculty
members within 5 business days of the review. Please be aware that the IRB committee might require
revisions or additions to your application before approval can be granted.
Neither pilot nor research data may be collected before notification of IRB approval. Students collecting
data without approval risk expulsion and invalidation of data. The IRB will make every effort to help
researchers move forward in a timely manner. Please contact [email protected] if you have any questions.
RESEARCHER ELECTRONIC SIGNATURE
52. By checking each of these boxes and providing my email address below as an authentication, I am
providing an electronic signature certifying that each of the statements below is true.
The information provided in this application form is correct, and was completed after reading all relevant
instructions.
I agree to conduct this and all future IRB correspondence electronically, via email/fax.
I, the researcher, will request IRB approval before making any substantive modification to this study using
the Request for Change in Procedures Form found at the Lawrence Tech IRB Web site.
I, the researcher, will report any unexpected or otherwise significant adverse events and general problems
within one week using the Adverse Event Reporting Form found at the Lawrence Tech IRB Web site.
Neither recruitment nor data collection will be initiated until final IRB approval is received from
[email protected].
I understand that this research, once approved, is subject to continuing review and approval by the
Committee Chair and the IRB.
I, the researcher, will maintain complete and accurate records of all research activities (including consent
forms and collected data) and be prepared to submit them upon request to the IRB.
I understand that if any of the conditions above are not met, this research could be suspended and/or not
recognized by Lawrence Tech University.
Researcher email address (provides authentication for [email protected], [email protected],
electronic signature and thus must match email
[email protected]
address on file with Lawrence Tech University)
IRB Policy on Electronic Signatures
Lawrence Tech’s IRB operates in a nearly paperless environment, which requires reliance on verifiable electronic signatures,
as regulated by the Uniform Electronic Transactions Act. Legally, an "electronic signature" can be the person’s typed name,
their email address, or any other identifying marker. An electronic signature is just as valid as a written signature as long as
both parties have agreed to conduct the transaction electronically. IRB staff will verify any electronic signatures that do not
originate from a password-protected source (i.e., an email address officially on file with Lawrence Tech).
Supervising Faculty Member Electronic Signature
53. As the faculty member supervising this research, I assume responsibility for ensuring that the student
complies with University and federal regulations regarding the use of human participants in research. By
checking each of these boxes and providing my email address below as an authentication, I am providing an
electronic signature certifying that each of the statements below is true.
I affirm that the researcher has met all academic program requirements for review and approval of this
research.
I will ensure that the researcher properly requests any protocol changes using the Request for Change in
Procedures Form found at the Lawrence Tech IRB Web site.
I will ensure that the student promptly reports any unexpected or otherwise significant adverse events and
general problems within 1 week using the Adverse Event Reporting Form found at the Lawrence Tech IRB
Web site.
I will report any noncompliance on the part of the researcher by emailing notification to [email protected].
Faculty member email address (provides
authentication for electronic signature and thus must
match email address on file with Lawrence Tech
University):
[email protected]
IRB Policy on Electronic Signatures
Lawrence Tech’s IRB operates in a nearly paperless environment, which requires reliance on verifiable electronic
signatures. Electronic signatures are regulated by the Uniform Electronic Transactions Act. Legally, an "electronic
signature" can be the person’s typed name, their email address, or any other identifying marker. An electronic signature
is just as valid as a written signature as long as both parties have agreed to conduct the transaction electronically. The
Research Coordinator will verify any electronic signatures that do not originate from a password-protected source (i.e.,
an email address officially on file with Lawrence Tech).
<LTU_IRB_APPLICATION.docm> October 11, 2011
Matthew L. Cole,
Ph.D. IRB Chair
Novel Design of Anterior Cruciate
Ligament (ACL) Injury Prevention Brace
Dan Greenshields
Justin Killewald
Rachel Porter
Informed Consent to Participate in ACL Knee Brace Testing
Mr. Daniel Greenshields, Mr. Justin Killewald, and Ms. Rachel Porter of the Lawrence Technological
University, College of Engineering, invite you to be a part of the Novel Design of an Anterior Cruciate Ligament
(ACL) Injury Prevention Brace research project. This research study looks at the forces applied to the knee when
jump landing. This will be done by using motion analysis system markers as well as force plates. The subject will
be jumping off of a bench and landing on the force plates. The purpose of this study is to redesign a knee brace
that will shift the compressive load from the lateral side of the knee to the medial side of the knee to aid in
preventing or lessening ACL injuries. We are asking you to participate because you are an athlete over the age of
18 who faces no current injuries.
If you agree to be part of the research study, you will be provided with an information sheet that asks you a
couple of questions about athletic participation and current along with past injuries to determine if you are eligible
to participate in our study. We expect the information sheet to take about five minutes to complete.
Should you decide to participate further by accepting an offer to be a test subject, you should be aware of
the following information regarding our research and data collection procedures, which are outlined on the
following page.
Testing with no brace: 1 hour
1) Subjects will have markers placed on their lower extremity.
2) Subjects will then jump off of a bench onto force plates to duplicate a jump landing.
3) This test will take about an hour of the subject’s time.
Testing with a knee brace already existing on the market: 1 hour
1) Subjects will have markers placed on their lower extremity.
2) Subjects will then jump off of a bench onto force plates to duplicate a jump landing.
3) This test will take about an hour of the subject’s time.
Testing with our redesigned knee brace: 1 hour (possible retesting will be needed)
1) Subjects will have markers placed on their lower extremity.
2) Subjects will then jump off of a bench onto force plates to duplicate a jump landing.
3) This test will take about an hour of the subject’s time once a week.
Subjects should understand that our testing is not designed to inflict any injury or discomfort. You are aware
that while our testing will not be strenuous or go beyond the body’s normal ranges of motion, by participating there
is a potential risk of fatigue or injury. If significant pain or complications arise, or if for any reason you wish to
stop with testing, there is no penalty in doing so. All subjects are encouraged to stop testing at any time if they feel
unsafe or uncomfortable for any reason.
While you may not receive any direct benefit for participating, we hope that this study will contribute to the
effort of trying to reduce or minimize injuries to the ACL.
Researchers will be able to link your information sheet responses to you via your participant identification
number located on the next page. The information provided by you on the Participant Information Sheet will be
kept protected and anonymous to everyone but the researchers.
Participating in this study is completely voluntary. Even if you decide to participate now, you may change
your mind and stop at any time. You may choose to not answer an individual question or you may skip any section
of the Participant Information Sheet.
Regarding compensation, please note that you will not be provided with any monetary compensation for
participating in this study.
If you have questions about this research study, you can contact Mr. Daniel Greenshields, at [email protected],
Mr. Justin Killewald at [email protected] or Ms. Rachel Porter at [email protected]
If you have questions about your rights as a research participant, please contact the Lawrence Technological
University Institutional Review Board, 21000 West Ten Mile Road, Southfield, MI 48075, (248) 204-3541,
[email protected].
If you have read this informed consent form, understand the information contained in this informed consent
form, and agree to participate in this study, please print and sign your name or initial below, and enter today’s date.
You will be offered a copy of this form to keep.
________I hereby assume all risk of injury, damage and harm to myself arising from participating in the study of
the ACL Knee Brace at Lawrence Tech facilities. I also herby individually and on behalf of my heirs, executors and
assignees, release and hold harmless Lawrence Tech, its officials, employees and agents and waive any right of
recovery that I might have to bring a claim or a lawsuit against them for any personal injury, death or other
consequences occurring to me arising out of my volunteer activities.
__________________________________________
(please print your name)
__________________________________________
_______1________
Participant Identification Number
________________
Participant (please sign your name)
Date
__________________________________________
________________
Investigator’s signature
Date
Participant
Participant Information Sheet
Do you have any current injuries?
_________
If yes, please explain.
Have you had any past lower extremity injuries?
If yes, please explain.
How often do you participate in athletics?
Height: _________
Weight: _________
Leg length (ankle to hip):
_________
Knee width: _________
Ankle width: _________
Gender: _________
Participant identification number:
_________
_________
Institutional Review Board
Office of the Provost
research.ltu.edu
[email protected]
January 27, 2014
Rachel Porter
Lawrence Technological University
Biomedical Engineering Program
[email protected]
Dear Rachel,
I am pleased to report that the IRB application to conduct research with human participants for the
study “Novel Design of an Anterior Cruciate Ligament (ACL) Injury Prevention Brace” has been
approved under the Expedited review path for a period of one year, January 27, 2014 –January 27,
2015.
The IRB is satisfied that the following ethical concerns regarding the treatment of human research
participants used in the study have been addressed in the research protocol:
(1) The research, which will be conducted by you (Rachel Porter), Justin Killewald, and Dan
Greenshields, students in the Biomedical Engineering program at Lawrence Tech under the supervision
of Lawrence Tech faculty Dr. Eric G. Meyer, involves using motion analysis system markers as well as
force plates with athletes over the age of 18 who have no current injuries, who will voluntarily consent
to participate, who are free to withdraw from the study at any time, whose responses will be
anonymous, and who have assumed all risk of injury, damage and harm to themselves arising from
participating in the study of the ACL knee brace at Lawrence Tech facilities;
(2) The research poses no more than minimal risk to participants, potential risks to the participants
have been identified, the research is not designed to inflict any injury or discomfort, and the research
will not be strenuous or go beyond the body’s normal ranges of motion; and
(3) A balance exists between potential benefits of the research to the participant and/or society and
the risk assumed by the participants.
66
Please contact the IRB if an extension is required after one year. Please note you must contact
the IRB if any changes are made to the research protocol that impact the ethical treatment of
the research participants. Please do not hesitate to contact the IRB if you have any questions.
Sincerely,
Matthew Cole, Ph.D.
Chair, Institutional Review Board
(IRB) Lawrence Technological
University
[email protected] o: 248.204.3096 f: 248.204.3099
The Lawrence Tech IRB is organized and operated according to guidelines of the United States Office for Human
Research Protections and the United States Code of Federal Regulations and operates under Federal Wide
Assurance No. FWA00010997 that expires 02/10/2017.
67
Plug-In Gait Fullbody Marker Set
68
Standard Operating Procedure
1.
From the Windows desktop, double-click the Vicon Nexus Icon.
Data Management
2.
3.
4.
5.
6.
Click the Data Management button on the Nexus toolbar or go to the File menu and select Data
Management.
Click the New Database button on the toolbar. The database is the folder where Nexus files are saved.
Click Create to establish a database.
In the Open Database window displayed, select the database you created and click Open.
Create a hierarchy of data folders in which to store your data.
a. Click the green New Patient Classification button to add a top-level folder.
b. Click the yellow New Patient button to add a patient folder to the previous folder.
c. Click the gray New Session button to add a session folder to the patient folder.
Before closing Data Management, double-click the new session folder you just created.
Calibration & Setup
7.
Position the eight Bonita cameras in their designated location facing the capture volume.
a. Each camera should connect to the Vicon Giganet-MX controller via the purple Ethernet cables.
8. Place the 5-marker calibration wand on a horizontal surface (floor) in the intended capture volume. Record
a static calibration.
a. Take into account the motion of the subject when determining the optimal capture volume.
9. In the System Preparation tab, select Create Camera Masks and hit start to mask out any unwanted
reflections. Once the mask is complete (known when gray areas become visible in the View pane), click
Stop.
a. If reflections are still present after masking, go to the Resources pane and lower the strobe
intensity by selecting the Lower Strobe Intensity option.
10. Recalibrate the entire test volume by clicking Calibrate Cameras in the Tools pane. Move the wand
around the capture volume until each camera shows 1000 recorded frames.
a. Make sure the number of frames to record is set to 1000.
11. In System Preparation, locate the Set Volume Origin tab and click Start. After a few seconds, click Set
Origin to stop it.
12. Record a static video calibration in the Static Plug-in Gait pipeline. Then, Save the trial.
Prepare the Subject
13. In the Resources pane, select Go Live and wave the 5-marker wand in the capture area to make sure the
cameras are working properly.
14. In the Resources pane, prepare the subject template, preferred settings, and the desired Plug-in Gait marker
set.
15. Place markers on the test subject according to the Plug-in Gait Marker Placement Guide.
16. At the bottom of the Resources pane turn all markers to ‘optional’ and enter all subject parameters
(shoulder offset, height, weight, wrist width, elbow width, etc.) as needed.
a. Additional markers for medial elbow may be necessary.
b. Duct tape and double sided tape ensure the markers remain stationary.
17. In the Tools pane, click the System Preparation button, then capture a Static Trial.
18. Manually label or auto-label the markers using the Label/Edit button in the Tools pane.
19. Run the Static Plug-in Gait pipeline.
Capture a Trial
20. In the View pane, switch to 3D Perspective in the drop down box.
69
21. In the Tools Pane, click the Capture button. In the Next Trial Setup section, provide the information for
the trial name.
22. In the Tools pane, click the Capture button, and then click Start. Select Stop after the motion is captured.
Check the Trial
23. Click the Show/Hide Data Management button on the toolbar. All trials created should be located in the
session previously created.
24. Double-click the first trial to load it in Camera view.
25. In the Tools pane, click the Pipeline button. Click the Current Pipeline drop-down box and select
Reconstruct.
26. Click Play to run the operation.
27. In the Time Bar located at the bottom of the View pane, click the Play button to view your trial.
28. Instruct subject to complete the following experimental tests with the control brace and then with the
modified brace.
Stop Jump
1.
Have subject take 3 approach steps, starting with the right foot, to obtain a comfortable approach speed
2.
Instruct subject to take-off from their right foot and land 2-footed on the force plates
3.
Upon landing, have the subject complete a 2-footed vertical jump for maximum height that he/she feels
comfortable with
4.
Repeat experimental test until 6 successful trials have been recorded
Step-off landing on one leg
1.
Have the subject stand on top of a box (30 cm high) on their brace leg
2.
Instruct the subject to drop down off the box and land on their brace leg in the center of the force plate
3.
Repeat experimental test until 6 successful trials have been recorded
Step-off landing on both legs
1.
The subject starts on top of a box (30 cm high)
2.
Have the subject drop directly down off the box landing with each foot on separate force places
3.
Upon landing on the force plates, instruct the subject to perform a maximum vertical jump while
raising both arms
4.
Repeat experimental test until 6 successful trials have been recorded
70
Female subject results graphs
Step-off landing on both legs modified
Flexion/extension angles
valgus/varus angles
Valgus/varus moment
71
Step-off landing on both legs control
Flexion/extension angles
valgus/varus angles
Valgus/varus moment
72
Run and jump modified
Flexion/extension angles
Valgus/varus angles
Valgus/varus moment
73
Run and jump control
Flexion/extension angles
Valgus/varus angles
Valgus/varus moment
74
Step-off landing on one leg modified
Flexion/extension angles
Valgus/varus angles
Valgus/varus moment
75
Step-off landing on one leg control
Flexion/extension angles
Valgus/varus angles
Valgus/varus moment
76
Male subject results graphs
Step-off landing on both legs modified
Flexion/extension angles
Valgus/varus angles
77
Step-off landing on both legs control
Flexion/extension angles
Valgus/varus angles
78
Run and Jump Control
Flexion/extension angles
Valgus/varus angles
79
Step-off landing on one leg control
Flexion/extension angles
Valgus/varus angles
Valgus/varus moments
80
Step-off landing on one leg control
Flexion/extension angles
Valgus/varus angles
Valgus/varus moments
81
Male Subject Statistical Data
82
VG
RF
VGR
F (X
BW)
Kne
e
For
ce
Kne
e
Flexi
on
Knee
Valgus
/Varus
Flexio
n
Mom
ent
FM
(Nm
)
Valgus/
Varus
Moment
0.07
87.1
2
-1
-0.06
1.3
0.08
94.3
8
-1.2
-0.07
15
1
0.06
72.6
0
-1.3
-0.08
53
10
1.1
0.07
79.8
6
-1.3
-0.08
-13
65
16
0.8
0.05
58.0
8
-1
-0.06
75
19
1.5
0.09
108.
90
-1.2
-0.07
1.73
-17
14.0
0
63.3
3
16.67
1.15
0.07
-1.17
-0.07
V/V
M
(Nm
)
72.6
0
87.1
2
94.3
8
94.3
8
72.6
0
87.1
2
84.7
0
Trial 1
15
1.53
-12
70
24
1.2
Trial 2
19
1.94
-16
55
16
Trial 3
15
1.53
-12
62
Trial 4
17
1.73
-14
Trial 5
16
1.63
Trial 6
20
2.04
Average
Standard
Deviation
17.
00
2.1
0
0.21
2.10
8.50
4.63
0.24
0.01
0.14
0.01
9.92
VG
RF
VGR
F (X
BW)
Kne
e
For
ce
Kne
e
Flexi
on
Knee
Valgus
/Varus
Flexio
n
Mom
ent
Trial 1
18
1.83
-15
70
47
1.6
Trial 2
23
2.34
-20
70
42
Trial 3
17
1.73
-15
60
Trial 4
23
2.34
-19
Trial 5
20
2.04
Trial 6
24
2.45
Average
Standard
Deviation
20.
83
2.9
3
T Test
0.0
130
745
2 Legged
Step Off
Control
2 Legged
Step Off
Modified
Internal knee flexion
moment (Normalized
to body weight)
83.4
9
17.6
3
Internal knee flexion
moment (Normalized
to body weight)
FM
(Nm
)
Valgus/
Varus
Moment
0.10
116.
16
-0.6
-0.04
1.9
0.11
137.
94
-0.6
-0.04
29
1.2
0.07
87.1
2
-0.4
-0.02
65
27
1.9
0.11
137.
94
-0.7
-0.04
-17
57
30
1.7
0.10
123.
42
-0.6
-0.04
50
27
1.9
0.11
137.
94
-0.3
-0.02
2.12
-22
18.0
0
62.0
0
33.67
1.70
0.10
-0.53
-0.03
0.30
2.83
7.87
8.62
0.28
0.02
123.
42
20.0
1
0.15
0.01
V/V
M
(Nm
)
43.5
6
43.5
6
29.0
4
50.8
2
43.5
6
21.7
8
38.7
2
10.9
3
0.013
0745
26
0.00
968
481
0.39
1899
677
0.0008
36897
0.002
17048
5
0.002170485
0.00
2170
485
8.88594E-06
8.88
594
E-06
Internal knee flexion
moment (Normalized
to body weight)
8.88594
E-06
Internal knee flexion
moment (Normalized
to body weight)
83
VG
RF
VGR
F (X
BW)
Kne
e
For
ce
Kne
e
Flexi
on
Knee
Valgus
/Varus
Flexio
n
Mom
ent
Trial 1
34
3.47
-29
41
16
1.5
Trial 2
32
3.26
-28
40
15
Trial 3
28
2.85
-24
50
Trial 4
33
3.36
-30
Trial 5
31
3.16
Trial 6
31.
60
3.22
Average
Standard
Deviation
31.
60
2.0
6
3.22
-28
27.8
0
27.8
0
0.21
1 Legged
Step Off
Control
FM
(Nm
)
Valgus/
Varus
Moment
0.09
108.
90
-1
-0.06
1.5
0.09
108.
90
-1.7
-0.10
19
1.9
0.11
137.
94
-0.8
-0.05
37
12
0.7
0.04
50.8
2
-2
-0.12
39
18
1
0.06
72.6
0
-0.7
-0.04
41.4
0
16.00
1.32
0.08
95.8
3
-1.24
-0.07
41.4
0
16.00
1.32
0.08
-1.24
-0.07
2.04
4.50
2.45
0.42
0.03
0.52
0.03
VG
RF
VGR
F (X
BW)
Kne
e
For
ce
Kne
e
Flexi
on
Knee
Valgus
/Varus
Flexio
n
Mom
ent
Trial 1
30
3.06
-27
40
24
2.4
Trial 2
30
3.06
-27
37
22
Trial 3
30
3.06
-27
39
Trial 4
24
2.45
-20
Trial 5
32
3.26
Trial 6
32
3.26
Average
Standard
Deviation
29.
67
2.9
4
T Test
0.1
084
188
1 Legged
Step Off
Modified
Internal knee flexion
moment (Normalized
to body weight)
95.8
3
30.6
0
Internal knee flexion
moment (Normalized
to body weight)
V/V
M
(Nm
)
72.6
0
123.
42
58.0
8
145.
20
50.8
2
90.0
2
90.0
2
37.4
7
FM
(Nm
)
Valgus/
Varus
Moment
0.14
174.
24
-0.6
-0.04
2.4
0.14
174.
24
-0.3
-0.02
21
2
0.12
145.
20
-1
-0.06
53
27
2.5
0.15
181.
50
-0.5
-0.03
-29
39
23
2
0.12
145.
20
-1
-0.06
41
25
2.3
0.14
166.
98
-0.8
-0.05
3.02
-27
26.1
7
41.5
0
23.67
2.27
0.14
-0.70
-0.04
0.30
3.13
5.79
2.16
0.22
0.01
164.
56
15.6
8
0.28
0.02
V/V
M
(Nm
)
43.5
6
21.7
8
72.6
0
36.3
0
72.6
0
58.0
8
50.8
2
20.5
3
0.108
4188
17
0.15
443
757
0.48
7001
043
9.2583
8E-05
0.000
31316
1
0.000313161
0.00
0313
161
0.024196357
0.02
4196
357
Internal knee flexion
moment (Normalized
to body weight)
0.02419
6357
Internal knee flexion
moment (Normalized
to body weight)
84
VG
RF
VGR
F (X
BW)
Kne
e
For
ce
Kne
e
Flexi
on
Knee
Valgus
/Varus
Flexio
n
Mom
ent
Trial 1
19
1.94
-14
65
18
1.4
Trial 2
12
1.22
-9
65
20
Trial 3
14
1.43
-12
57
Trial 4
13
1.33
-10
Trial 5
8
0.82
Trial 6
11
1.12
Average
Standard
Deviation
12.
83
3.6
6
Stop Jump
Landing
Control
FM
(Nm
)
Valgus/
Varus
Moment
0.08
101.
64
-1
-0.06
0.8
0.05
58.0
8
-0.4
-0.02
18
0.7
0.04
50.8
2
-0.5
-0.03
60
15
0.8
0.05
58.0
8
-0.5
-0.03
-6
67
18
0.9
0.05
65.3
4
-0.8
-0.05
60
19
1
0.06
72.6
0
-0.5
-0.03
1.31
-10
10.1
7
62.3
3
18.00
0.93
0.06
-0.62
-0.04
0.37
2.71
3.88
1.67
0.25
0.02
0.23
0.01
VG
RF
VGR
F (X
BW)
Kne
e
For
ce
Kne
e
Flexi
on
Knee
Valgus
/Varus
Flexio
n
Mom
ent
Trial 1
8
0.82
-10
55
24
0.9
Trial 2
7
0.71
-6
59
27
Trial 3
10
1.02
-9
63
Trial 4
9
0.92
-7
Trial 5
8
0.82
Trial 6
9
Stop Jump
Landing
Modified
Average
Standard
Deviation
8.5
0
1.0
5
T Test
0.0
095
484
Internal knee flexion
moment (Normalized
to body weight)
67.7
6
18.1
7
Internal knee flexion
moment (Normalized
to body weight)
V/V
M
(Nm
)
72.6
0
29.0
4
36.3
0
36.3
0
58.0
8
36.3
0
44.7
7
16.8
2
FM
(Nm
)
Valgus/
Varus
Moment
0.05
65.3
4
-0.3
-0.02
0.7
0.04
50.8
2
-0.3
-0.02
30
1.2
0.07
87.1
2
-0.6
-0.04
75
30
0.9
0.05
65.3
4
-0.4
-0.02
-7
70
28
1.2
0.07
87.1
2
-0.2
-0.01
0.92
-5
72
31
1.2
0.07
87.1
2
-0.6
-0.04
0.87
7.33
65.6
7
28.33
1.02
0.06
-0.40
-0.02
0.11
1.86
7.89
2.58
0.21
0.01
73.8
1
15.5
1
0.17
0.01
V/V
M
(Nm
)
21.7
8
21.7
8
43.5
6
29.0
4
14.5
2
43.5
6
29.0
4
12.1
5
0.009
5483
77
0.03
059
353
0.18
7514
091
4.6062
1E-06
0.274
50721
9
0.274507219
0.27
4507
219
0.046474902
0.04
6474
902
Internal knee flexion
moment (Normalized
to body weight)
0.04647
4902
Internal knee flexion
moment (Normalized
to body weight)
85
Female Subject Statistical Data
86
2 Legged
Step Off
Control
Knee
Flexi
on
Knee
Valgus/
Varus
Flexio
n
Mome
nt
Internal knee flexion
moment (Normalized to
body weight)
Trial 1
28
2.9
59
-6
0.16
0.01
Trial 2
20
2.0
68
-6
1.2
0.07
FM
(Nm
)
9.79
2
73.4
4
Trial 3
16
1.6
62
-10
1
0.06
61.2
Trial 4
17
1.7
67
-8
0.8
0.05
Trial 5
15
1.5
70
-5
0.8
0.05
48.9
6
48.9
6
Trial 6
15
1.5
88
-3
0.1
0.01
6.12
18.5
0
1.89
-6.33
0.68
0.04
5.01
0.51
2.42
0.45
0.03
Knee
Flexi
on
Knee
Valgus/
Varus
Flexio
n
Mome
nt
Internal knee flexion
moment (Normalized to
body weight)
Average
Standard
Deviation
2 Legged
Step Off
Modified
VGR
F
VGR
F (X
BW)
41.4
1
27.4
8
Trial 1
23
2.3
82
25
1.8
0.11
Trial 2
16
1.6
90
19
1.8
0.11
FM
(Nm
)
110.
16
110.
16
Trial 3
12
1.2
100
27
1.7
0.11
104.
04
Trial 4
14
1.4
85
21
1.6
0.10
Trial 5
15
1.5
90
10
1.4
0.09
97.9
2
85.6
8
Trial 6
16
1.6
105
26
1.5
0.09
16.0
0
1.63
92.0
0
21.33
1.63
3.74
0.38
8.83
6.35
0.16
0.17
5258
374
0.175
25837
4
0.00
0935
971
8.1129
6E-07
0.000
30970
3
Average
Standard
Deviation
T Test
VGR
F
VGR
F (X
BM)
69.0
0
10.1
6
Valgus/
Varus
Moment
Internal knee flexion
moment (Normalized to
body weight)
V/V
M
(Nm
)
-1.25
-0.08
-76.5
-1
-0.06
-1.2
-0.07
-1.6
-0.10
-61.2
73.4
4
97.9
2
-1.5
-0.09
-1.2
-0.07
-1.29
-0.08
0.22
0.01
Valgus/
Varus
Moment
Internal knee flexion
moment (Normalized to
body weight)
-91.8
73.4
4
79.0
5
13.4
7
V/V
M
(Nm
)
-1.5
-0.09
-91.8
-1
-0.06
-1.3
-0.08
-0.9
-0.06
-61.2
79.5
6
55.0
8
-1
-0.06
91.8
-1.2
-0.07
0.10
99.9
6
-1.15
-0.07
0.01
9.99
0.23
0.01
-61.2
73.4
4
70.3
8
13.8
2
0.000309703
0.00
0309
703
0.14843
7199
0.148437199
0.14
8437
199
87
Trial 1
42
4.3
42
-6
0.1
0.01
6.12
-1.7
-0.11
Trial 2
42
4.3
38
-8
1
0.06
61.2
-1.8
-0.11
V/V
M
(Nm
)
104.
04
110.
16
Trial 3
50
5.1
40
-9
0
0.00
0
-0.5
-0.03
-30.6
Trial 4
43
4.4
41
-10
0.5
0.03
30.6
-1
-0.06
Trial 5
45
4.6
40
-7
2
0.12
122.
4
-1.6
-0.10
-61.2
97.9
2
44.4
0
4.53
40.2
0
-8.00
0.72
0.04
3.36
0.34
1.48
1.58
0.82
0.05
Knee
Flexi
on
Knee
Valgus/
Varus
Flexio
n
Mome
nt
Internal knee flexion
moment (Normalized to
body weight)
1 Legged
Step Off
Control
VGR
F
VGR
F (X
BW)
Knee
Flexi
on
Knee
Valgus/
Varus
Flexio
n
Mome
nt
Internal knee flexion
moment (Normalized to
body weight)
FM
(Nm
)
Valgus/
Varus
Moment
Internal knee flexion
moment (Normalized to
body weight)
Trial 6
Average
Standard
Deviation
1 Legged
Step Off
Modified
VGR
F
VGR
F (X
BW)
44.0
6
49.9
8
FM
(Nm
)
Trial 1
43
4.4
42
10
2.5
0.15
153
189.
72
183.
6
Trial 2
41
4.2
45
-6
3.1
0.19
Trial 3
35
3.6
49
3
3
0.19
Trial 4
40
4.1
41
0
2.3
0.14
Trial 5
43
4.4
40
3
2
0.12
40.4
0
4.12
43.4
0
2.00
2.58
0.16
3.29
0.33
3.65
5.79
0.47
0.03
157.
90
28.5
1
0.04
6795
726
0.046
79572
6
0.05
3331
557
0.0029
07271
0.001
10797
5
0.001107975
0.00
1107
975
140.
76
122.
4
-1.32
-0.08
0.55
0.03
Valgus/
Varus
Moment
Internal knee flexion
moment (Normalized to
body weight)
80.7
8
33.9
1
V/V
M
(Nm
)
0.5
0.03
30.6
-1.5
-0.09
-91.8
-0.25
-0.02
-1.4
-0.09
-15.3
85.6
8
0
0.00
0
-0.53
-0.03
0.88
0.05
32.4
4
54.0
3
0.064288272
0.06
4288
272
Trial 6
Average
Standard
Deviation
T Test
0.06428
8272
88
Stop Jump
Landing
Control
Knee
Flexi
on
Knee
Valgus/
Varus
Flexio
n
Mome
nt
Internal knee flexion
moment (Normalized to
body weight)
Trial 1
20
2.0
65
-9
1.4
0.09
Trial 2
15
1.5
70
-15
1.1
0.07
FM
(Nm
)
85.6
8
67.3
2
Trial 3
15
1.5
80
-12
1.2
0.07
Trial 4
22
2.2
82
-9
1.6
Trial 5
18
1.8
75
-7
Trial 6
13
1.3
55
17.1
7
1.75
3.43
0.35
Average
Standard
Deviation
Stop Jump
Landing
Modified
VGR
F
VGR
F (X
BW)
-91.8
-1.5
-0.09
73.4
4
-1.3
-0.08
0.10
97.9
2
-1.9
-0.12
1.2
0.07
73.4
4
-1.7
-0.11
-5
0.9
0.06
55.0
8
-1.7
-0.11
-9.50
1.23
0.08
-1.60
-0.10
3.56
0.24
0.01
0.21
0.01
-91.8
79.5
6
116.
28
104.
04
104.
04
97.9
2
12.8
4
Knee
Valgus/
Varus
Flexio
n
Mome
nt
Internal knee flexion
moment (Normalized to
body weight)
75.4
8
14.8
2
14
1.4
90
1
1
0.06
Trial 2
20
2.0
93
5
1.3
0.08
Trial 3
17
1.7
75
9
1
0.06
Trial 4
17
1.7
92
8
1
0.06
Trial 5
17
1.7
83
6
1.3
0.08
Trial 6
17.0
0
1.73
86.6
0
5.80
1.12
0.07
17.0
0
1.73
86.6
0
5.80
1.12
1.90
0.19
6.77
2.79
0.15
0.45
9557
078
0.459
55707
8
0.00
5555
043
4.3252
8E-06
0.175
13195
8
T Test
V/V
M
(Nm
)
-0.09
Trial 1
Average
Standard
Deviation
Knee
Flexi
on
Internal knee flexion
moment (Normalized to
body weight)
-1.5
FM
(Nm
)
3.78
0928
552
4.91
5207
117
3.78
0928
552
3.78
0928
552
4.91
5207
117
VGR
F
VGR
F (X
BW)
71.1
7
10.1
1
Valgus/
Varus
Moment
Valgus/
Varus
Moment
Internal knee flexion
moment (Normalized to
body weight)
73.4
4
85.6
8
-1.2
-0.07
-1.4
-0.09
-1.5
-0.09
-1.4
-0.09
-1.4
-0.09
4.23
-1.38
-0.09
0.07
4.23
-1.38
-0.09
-91.8
85.6
8
85.6
8
84.4
6
84.4
6
0.01
0.56
0.10
0.01
6.00
0.175131958
1.75
935E
-07
0.02110
9807
0.021109807
0.02
1109
807