Senior Project Report

ACL Injury Rehabilitation Device
Senior Design Project
The College of New Jersey
Biomedical Engineering Department

Table of Contents
ACL Injury Rehabilitation Device .................................................................................................................1
List of Tables .................................................................................................................................................4
List of Illustrations.........................................................................................................................................5
Introduction ..................................................................................................................................................6
Description of Roles......................................................................................................................................7
Chapter 1-Background..................................................................................................................................8
Chapter 2-Chassis..........................................................................................................................................9
Chapter 3-Data Acquisition/Feedback........................................................................................................11
....................................................................................................................................................................12
....................................................................................................................................................................13
Chapter 4-Resistance ..................................................................................................................................16
Chapter 5-Constant Force...........................................................................................................................19
Chapter 6-Budget Description ....................................................................................................................25
Chapter 7-Schedule.....................................................................................................................................26
Chapter 8-Conclusion..................................................................................................................................27
Chapter 9-Impact of Device ........................................................................................................................28
References ..................................................................................................................................................31
Appendix A-Member Biographies...............................................................................................................33
Appendix B-Complete Design Matrix..........................................................................................................35
Appendix C-Constraint Descriptions...........................................................................................................38
Appendix D-Standards, Specs and Codes....................................................................................................39
Appendix E-Engineering Tools Used ...........................................................................................................40
Appendix F – Life Long Learning .................................................................................................................41
Appendix G - Drawings................................................................................................................................46
....................................................................................................................................................................46
....................................................................................................................................................................47
....................................................................................................................................................................47
Appendix H-Computer Code.......................................................................................................................48
Appendix I - Ethical Testing.........................................................................................................................58
I. Research Description..........................................................................................................................58
II. Research Setting.................................................................................................................................61
III. Subject population .........................................................................................................................62

IV. Subject Recruitment.......................................................................................................................63
V. Risks ....................................................................................................................................................65
VI. Benefits...........................................................................................................................................66
VII. Privacy & Confidentiality ...............................................................................................................67
VIII. Informed Consent...........................................................................................................................68
IX. Data and Safety Management.......................................................................................................70
X. Conflict of Interest..............................................................................................................................71
XI. Checklist..........................................................................................................................................72
Appendix J- Meeting Minutes.....................................................................................................................73
Appendix K - Gantt Chart ............................................................................................................................77
Appendix L - Material List ...........................................................................................................................78
Appendix M - Budget ..................................................................................................................................79

List of Tables
Table 1. Survey Data for Comfort of Chassis Design...................................................................................10
Table 3. Angular Verification Z-axis with T values ......................................................................................12
Table 3.Angular Verification Y-axis with T values .......................................................................................12
Table 4. Verification Pass/Fail Conclusion ..................................................................................................12
Table 5. Motor Verification on and off test ................................................................................................13
Table 6. Motor Verification -5 degrees.......................................................................................................13
Table 7. Motor Verification 125 degrees....................................................................................................13
Table 8. Motor Validation for Sagittal Plane...............................................................................................14
Table 9. SD card verification for multiple angles ........................................................................................15
Table 10. BIOPAC Tension Data ..................................................................................................................17
Table 11. Resistance Verification Statistical Data.......................................................................................18
Table 13. Extension Verification Data.........................................................................................................20
Table 13. Extension Verification Statistical Analysis...................................................................................20
Table 14. Validation Data and Statistical Analysis for Constant Force Extension.......................................22
Table 15. Statistical Analysis of Change in Angle at t=30 minutes .............................................................23
Table 16. Mean and Standard Deviation of Change in Angle at t=30 minutes...........................................23
Table 17. Mean and Standard Deviation of Constant Force Validation. ....................................................24

List of Illustrations
Figure 1. Arduino Sensor Verification Setup...............................................................................................11
Figure 3. Sensor Verification Z-axis.............................................................................................................12
Figure 3. Sensor Verification Y-axis.............................................................................................................12
Figure 4. Range of motion over time ..........................................................................................................15
Figure 5. Setup of Resistance Band on Device............................................................................................17
Figure 6. BIOPAC Tension Analysis..............................................................................................................17
Figure 7. Resistance Verification Setup ......................................................................................................18
Figure 9. Verification Testing Setup............................................................................................................19
Figure 9. Motor Controller w/ Switches and Motor Driver ........................................................................19
Figure 10. Comparison of Initial and Final Angle Readings in Verification Procedure for Constant Force
Extension.....................................................................................................................................................21
Figure 11. Subject in Extension during Validation ......................................................................................22
Figure 12. Flexion Constant Force Verification Data ..................................................................................23
Figure 13. Drawing of Inner Pulley Disc ......................................................................................................46
Figure 14. Drawing of Outer Pulley Disc. ....................................................................................................46
Figure 15. Drawing of Rigid Body Supports ................................................................................................47
Figure 16. Drawing of Motor Attachment ..................................................................................................47
Figure 17. Drawing of Full Assembly...........................................................................................................47

Introduction
The ACL rehabilitation device was inspired by the large number of ACL tears that occur annually.
After consultation we learned many of the issues that physical therapists face in dealing with their
rehabilitation patients. The rehabilitation schedule is broken up into four phases. Our device focuses on
phase two to three, approximately four to six weeks after surgery. In this phase the knee is no longer
immobilized if the patient is able to demonstrate adequate quad control. This phase also incorporates
hamstring curls with light resistance and full extension and 110 degrees of flexion by the end of the
period. The schedule and routine as dictated by a physical therapist was used to craft the requirements
for the device. Dr. Todd demonstrated the need for the device.
The device as decided needed an assistive component in order to promote an increase of range
of motion. A resistive component, of late resistance in order to strengthen the muscles around the graft.
In addition the device needed a method of monitoring the progress of the patient. Dr. Todd stressed the
importance of being able to monitor the completion of at home exercises by the patient. There is a
tendency for some patients to work too little or for some to overwork themselves.
Consultation with the physical therapist aided in finalizing the objectives of the device. The
device would in theory, increase range of motion, strengthen the muscles around the quadriceps, and
provide data for the physical therapist to monitor the progression of rehabilitation. The goal is that
these objectives in conjunction will aid in rehabilitation and allow for the therapist to spend more time
on other patients.

Description of Roles
The device required several components. Each member of the group was assigned a specific
task. The tasks were completed in tandem with one another in order to ensure proper cohesion of the
device as a whole. The components were selected for each group member based on their strengths and
interests. First the overall appearance of the device was created. The device required a pivot point and
had to partially support the lower leg as well as bear the repeated cycles of use. The device also
required the understanding of the correct geometries in which to satisfy the mechanical requirements.
The external chassis was designed to be ergonomic and not too cumbersome for the user. The design
and construction of the external chassis was handled by Jonathan Popo and Timothy Eck.
The second component of the device was the resistive element. Dr. Todd advised that in this
phase of rehabilitation that there is added benefit in a resistive hamstring curls, although advised to
keep the resistance low. The resistive component provided resistance against flexion thus strengthening
the hamstring in the hamstring of the patient. Timothy Eck was responsible for the design and
construction of the resistive component.
The third component of the device is the application of a constant force in flexion and
extension. In consultations with a physical therapist it was stated that in the daily routine the physical
therapist applies a constant force to the injured leg in both tension and flexion. The device would
attempt to mimic the action of the physical therapist thereby freeing up the time for the physical
therapist. Prithvi Singh designed the motor control system responsible for applying torque on the leg in
the sagittal plane. He was also responsible for the designing and implementing verification and
validation testing apparatuses. Prithvi also maintained the team website as the web master for the
group.
The fourth component consisted of a safety feedback control system as well as a data
acquisition control system. The feedback control system ensured that the risk of further injury was
greatly reduced. The feedback system constrained extension and flexion to the sagittal plane to
minimize malposition of the leg. The data acquisition provided tangible data of the patient's progress.
The parameters recorded were number of reps and range of motion in angles. Bryan Cromwell primarily
executed data acquisition and safety feedback control. Bryan also served as the team leader.

Chapter 1-Background
Injuries to the Anterior Cruciate Ligament (ACL) have become more and more common every
year. Which the popularity of contact sports such as football, rugby, and basketball more people are
becoming susceptible to knee injuries and predominantly ACL tears. About 100,000 - 200,000 ACL repair
surgeries have been performed in the United States alone and the number continues to rise.3
After all of
these ACL reconstructive surgeries there is also a required amount of physical therapy involved. In many
cases there is reinjury of the ACL after the procedure due to rushed recovery or improper practices by
the patient during rehab which then lead to additional surgeries and the lengthy recovery process
essentially restarting.
The current devices in the market are the CPM machine and the Elite Seat. The CPM machine is
able to allow for constant assisted motion. While this helps keep the leg loose, it was not shown to
significantly aid in returning lost range of motion to the user.5
Additionally, the Elite seat is able to
provide constant force while extending the leg in a seated position. This is beneficial to recovery;
however, the device is entirely user controlled which then leads to reinjury in the recovery process as
the user may not know their exact limits at a given moment during their rehab schedule. 8
Our device's goal is to aid the user through recovery post-operation and facilitate rehabilitation
in stage 2 and 3 of the rehabilitation process. This is to be achieved by incorporating various
components from the current devices in market along with additional features to make a more robust
rehabilitation device that can aid in more effective recovery. The components that will be featured are
assisted motion within a variable range of motion, constant force extension and flexion, and finally a
data acquisition component that will be able to monitor the user's exercise progress so that the physical
therapist can keep track of how the rehab process is going and make the proper adjustments in order to
deliver the most effective means of recovery

Chapter 2-Chassis
The design of the chassis is such that it must fully engross the leg and specifically the knee
where the ACL is located. The first thing that the chassis of the rehabilitation brace must achieve is that
it securely attaches to the injured area and does not slip. The specification for this requirement is the
average lengths of legs for males and females. In order to engross the widest variety of patients, 90% of
possible leg spans will be accounted for so that the device can account for the majority of people
suffering stage 2 to 3 rehabilitation. The justification for this requirement is that the height of the
average person from the gluteal crease to the mid-calf was found to be .478 (in terms of male and
female average).2
The chassis must also be able to fully encompass the weight of the leg so that it does not
experience adverse problems due to not being support the full loading that the leg provides. The human
leg on average differs by 4 pounds from male to female leg and so the device will be able to encompass
the specification of weight of 15 +/- 1 pound to 19 +/- 1 pound.4
This specification was justified by
finding that the human leg is typically .115 of the person’s total body weight.
The design for the chassis has been finalized to be a two-pronged support system that fully
encompasses the leg symmetrically from the left and right sides through 4 rectangular bars
encompassing the femur and the calf that allow for the leg to be carried with the least amount of stress
on the leg as well as least amount of distributed stress on the group of bars as well as individual bars.
The two-pronged system will be accompanied by straps that will maintain the leg in place and will not
allow the leg to displace out of the possible plane of motion. The design for the chassis also includes a
gear based assistive system that is in line with the axis of the chassis. The brushless DC motor that
comes off the side of the chassis will allow for the full rotation of the leg. Gearboxes will be placed with
the gears so that protection for the user is given.
The chassis also has the design requirement of having to encompass every other part of the
project and so it must maintain the full weight of each component along with the leg. This includes the
resistive system, motor control and data integration system. By carrying each part, the chassis also must
allow each component to be attached to it and work as designed. The chassis component will be
designed as the design for each component is finalized so that a final chassis that must allow for each
component to be connected can also be finalized.
In order to test these parameters, a variety of testing will be done. In order to test how the
device will hold the leg, before attaching components, the device will be human tested and put through

the full range of motion for extended amounts of time to ensure that the leg will not break the device
and also that the device will be able to fully support the device without any disastrous effects. After
these tests, the device will get all other components and will be put through the same testing to ensure
that even with components will be able to rotate and go through the full range of motion.
Secure Fit - no motion(1 not secure, 10 most
secure)
Male - 8.1 Female - 7.8
Constant Extension - no motion (1 most comfort,
10 least comfort)
Constant Flexion - no motion(1 most comfort, 10
least comfort)
Smoothness of Motion(1 very smooth, 10 very
sporadic)
Table 1. Survey Data for Comfort of Chassis Design
The data from figure 1 details how the device was tested to ensure that it was able to fit at least
90% of subjects as well as not cause any adverse effects upon wearing the device, while stationary and
in motion. Given that the device fit all 10 subjects, with 5 males and 5 females, and the fact that the
averages for secure fit in stationary position as well as secure fit while moving and being held in
constant flexion and extension, the device proves that it is easily worn and very stable in any position for
the largest quotient of people.

Chapter 3-Data Acquisition/Feedback
An important feature of any device especially one with human concerns is a fail-safe or safety
feedback system. In rehabilitation of the anterior cruciate ligament angular misplacement is detrimental
to the healing process of the graft. Our device aimed to control misalignment in the Y-axis, the coronal
plane, and the Z-axis of the sagittal plane. Therefore, through the use of a triaxis gyroscope the angular
displacements of the leg during extension and flexion were measured. The gyroscope was calibrated
vertically in the direction of the leg to record angular displacements outside of the axial direction. The
materials used in the feedback system were a Getech MPU-6050 Triple Axis combination Accelerometer
Gyro Breakout board, wires, and Arduino Uno microcontroller. The breakout board was connected to
the breadboard by soldering into the pins. The Arduino Uno was then connected to the MPU-6050
breakout board, and powered via a snap connector to a 9 volt battery. The Arduino was then connected
to a relay module and then to the motor driver, which was connected to the motor. The complete setup
is shown in figure 1. There was code written to the obtain sensor angles, motor control, and data
acquisition. The code can be found in Appendix G.
In order to verify the sensors, the MPU6050 Arduino sensor was placed on a metal plate. The
plate was flattened and checked with a level to assure that it was flat due to the sensitivity of the
Sensor. Once attached to the plate was then attached to a hollow cylinder. A
wooden rod was then placed through the cylinder and clamped down to the side
of the table. This allowed for rotation of the sensor. One investigator measured
angles via a goniometer. We then monitor the sensor outputted values and
compared them to those set by the investigator. In figure 1 the experimental
setup is shown. In order for the verification to be given a pass, the sensor
values for the z axis had to fall within 127 and 123 degrees and between -6 and -4 degrees. For the Y-
axis the tolerance was between -3 and 9 degrees. The graph for the z and x axis are displayed in figures 2
and 3. From visual inspection the values appear to be relatively indistinguishable. However in order to
statistically assert that the values had no statistical difference calculation of a t critical value was utilized.
Figure 1. Arduino Sensor
Verification Setup

In tables 1 and 2 the values of the t critical calculations are displayed. Five angles were compared for five
trials for both the Z and the Y-axis. An absolute t critical value of less than 2.778 is deemed as
statistically no difference. According to this criteria the sensor failed at all angles except 18 and 90
degrees. However for all angles, but 125 degrees the sensor values fall within our tolerances. Even at
125 degrees on average were 2.22 degrees off, .22 more degrees than our tolerance. In table 3 a table of
the average values from those trials is shown with the general criteria from each plane and a pass or fail
criteria. With an average offset value of 0.7 degrees and 1.24 degrees, the coronal and sagittal plane
pass.
-20.00
0.00
20.00
40.00
60.00
80.00
100.00
120.00
140.00
1 2 3 4 5 6 7 8
Angles
Real vs. Sensor Angles Z-Values
Figure 3. Sensor Verification Z-axis
-20.00
0.00
20.00
40.00
60.00
80.00
100.00
1 2 3 4 5 6 7 8 9
Angles
Real vs. Sensor Angles Y-Values
Figure 3. Sensor Verification Y-axis
Table 3. Angular Verification Z-axis with T values Table 3.Angular Verification Y-axis with T values
Table 4. Verification Pass/Fail Conclusion
Blue = Real
Red = Sensor

The next step of the verification process was the motor control. The same metal cylinder setup
was used and connected to the motor. The board was placed at different angles and the motor
condition was monitored. If the motor turned off at -5 degrees or less and at 125 degrees or more the
verification was deemed a success. If it turned off at -9 to degrees it was successful as well. The results
of that can be seen below in table 4. The motor functioned correctly at all angles except for -5 degrees
in the sagittal plane where the motor was still on, when for our requirements. Next we verified the
motor condition while comparing the goniometer at preset angles and the sensor angles. In tables 5 and
6, angles -5 and 125 degree were compared to the sensor angle. In a two tailed two test for both angles
the P-values were greater than 0.05 and therefore there was no statistical difference between the
sensor angles and measured goniometer angles for both -5 degrees and 125 degrees.
Table 5. Motor Verification
on and off test
Table 6. Motor Verification -5 degrees
Table 7. Motor Verification 125 degrees

In order to validate the angular feedback component we attached the device to the motor and
set angles using a goniometer. We then turned on the device and allowed the motor to bring the
subject’s leg to those angles at a very slow speed. One investigator set the angle, another monitored the
subject another controlled the motor via the control box, and another recorded the data. Due to the
rigidity of the device we were unable to test angles in the coronal plane. The test was deemed as a pass
if the motor turned off at -5 degrees ± 1 degree and at 125 ± 2 degrees. A table of the validation data is
displayed below in table 6. Due to an inadequate testing method, we were unable to test for 125
degrees as the resistance of the calf caused the motor to begin to move the stool it was placed on. The
results of bringing 10 subjects to -5 degrees are displayed. The t critical value was then calculated. The t
absolute t critical value calculated was 2.880 was greater than 2.78 and therefore we were unable to
conclude that there was no statistical different. However, the angles on average were within our
tolerances and therefore we succeeded in meeting our requirements, but failed statistically.
Finally the data acquisition component needed to be verified and validated. After discussion
with a physical therapist she explained that she would like to be able to record the angles and a counter
for hamstring curls. Hamstring curls would only be counted after a full 125 degrees. In order to verify
this we placed the breadboard at several angles and checked the SD card data to see if the values
corresponded. If the values were within ± 2 degrees of those measured. To verify the rep counter, we
placed the bread bored at 115 degrees 5 times in 120 seconds, we then checked the log data to see if
the counter was equal to 5 reps. A table of the compared values is displayed below in table 8. The t
critical values were also calculated and compared. For data acquisition, we were unable to prove there
was no statistical difference for all but -70 degrees. However, on average, all angles were within ± 2
degrees.
Table 8. Motor Validation for Sagittal Plane

Finally we verified the rep counter by performing 5 reps in 1 minute. In between each rep we
returned to about -80 degrees and paused for 5 seconds. A graph of the range of motion over the course
of 2 minutes can be seen below in figure 4. As seen the 5 peaks represents each repetition. These 5 reps
corresponded to those saved in the SD card data.
Table 9. SD card verification for multiple angles
Figure 4. Range of motion over time

Chapter 4-Resistance
One finite component of the device design is the rotational resistance component in flexion
incorporated to help the patient recover hamstring strength and to be a source of data to be acquired
by our device. The main requirement for this component of the device is simply providing a constant,
controlled form of resistance against the motion of flexion. The specification for this requirement is as
follows: the resistance must be able to provide yet cannot exceed 5 pounds of force. This force
specification was taken from the Massachusetts General Hospital Orthopedics schedule for ACL
reconstruction rehabilitation schedule.
The final design solution for the resistive component is something similar, but definitively
different from earlier proposed designs. For the final design, a channel was drilled into an aluminum
disc, from the circumferential surface inwards towards the center. Through this channel, nylon cord was
threaded. Two larger aluminum discs were fixed to either side of the aluminum disc through which the
nylon cord was threaded, creating a pulley fixture. A hole was drilled concentrically through all three
aluminum discs to fit onto the axle on which the calf section of the chassis is connected. The middle
aluminum disc, the disc that the nylon has been threaded through, was pinned to the distal axle of the
medial side of the device. This allows the pulley fixture to rotate at the same angular velocity as the
knee. The nylon cord is fixed to the pulley fixture on one end and is fixed to a metal connector on the
other end using a knot. The knot prevents the cord from slipping through the channel through which it is
threaded. On the other end of the metal connector is one end of a resistance band. The resistance band
is fixed to the connector via an aluminum fastener. The other end of the resistance band loops around a
screw that is fixed on the proximal end of the medial panel of the thigh piece of the chassis. With this
setup, the pulley fixture rotates with the knee, putting the nylon cord in tension. The nylon cord, having
negligible elasticity in tension, puts tension on the resistance band through the metal connector. This
creates a linear displacement of the resistance band, and hence, creates resistance.

Verification of the component consisted of ensuring that the resistive component does not
exceed the limit of 5 pounds of resistance, which would put the recovering knee at risk for reinjury. The
resistance band was attached in series with a dynamometer using a nylon cord. The dynamometer was
connected to the computer using the BIOPAC student lab system. Using the BIOPAC system, the tension
data was recorded during flexion.
The ACL rehabilitation device was fixed over the edge of a table so that the device may rotate in
flexion to 125 degrees. The device was rotated quasi-statically to 125 degrees flexion then released,
with the resistance band pulling on the dynamometer via the nylon cord. The maximum tension during
the course of flexion was analyzed from the BIOPAC data. The process was repeated seven times,
creating seven trials. The average max tension was averaged over the seven trials, coming to an average
3.92 lbs max tension. This was statistically compared to the max allowable tension of 5 pounds to see if
Trial
Offset
(lbs)
Max Tension (lbs)
(as read)
Max Tension (lbs)
(corrected)
1 0.16 3.30 3.46
2 0.41 3.49 3.90
3 0.31 3.38 3.69
4 0.14 3.95 4.09
5 0.28 3.61 3.89
6 0.18 3.87 4.05
7 0.34 4.03 4.37
Table 10. BIOPAC Tension Data
Figure 5. Setup of Resistance Band on Device
Figure 6. BIOPAC Tension Analysis

the device did, in fact, remain below that limit. It is 99 percent confident that the device does not
provide more than 5 pounds of resistance in flexion.
Validation of the device was slightly more difficult. Realistically, the project team was not able to
verify the long-term rehabilitation results of ACL reconstruction patients, so to verify that the device
does not exceed 5 pound of rotational resistance, it will be tested on a non-recovering user to see if they
can flex to the required amount of degrees without exceeding a certain amount of resistance. Ten users
wore the device with the resistance band engaged and flexed the device. The resistance band was
disengaged and the users again flexed the device. After this process, the users were asked to fill out a
survey with one of the questions addressing the effect of the resistance band. When asked “Is there any
noticeable difference in resistance in flexion over the course of movement when the resistance band is
engaged versus when it is disengaged?”, ten out of ten users answered yes. The results showed that all
users felt a noticeable difference in resistance when the band was engaged versus disengaged.
n 7
HO X=μ
HA X<μ
X 3.92
μ 5
SEMean 0.11063515
t, calculated -3.6896198
t, 99%
confidence -3.365
Table 11. Resistance Verification Statistical Data
Figure 7. Resistance Verification Setup

Chapter 5-Constant Force
After consultation with the physical therapist, one integral component that she stressed as
extremely beneficial to the rehabilitation process was constant force in sagittal plane in extension. In
order to achieve this constant force there has been achieved with the use of a motor (BLZ362S-48V-
3500) and gearbox that act as a joint system that attach to the chassis on the upper thigh. The motor
shaft attaches to custom coupling axle which connects to the chassis. The main gear is also pinned to
this axle where is meshes with a gear on the lower leg component of the chassis and guides the
movement of the device via the system of gears. There is a separate controller box that the PT is able to
use in order to change the direction of rotation of the motor, the speed of the motor, as well as to run
and stop the device at various angles. This allows any user to have complete control over the movement
as well as speed of the device. The motor’s gearbox is a planetary 1 to 100 gear ratio box that has an
inbuilt worm gear. This worm gears resist movement when the motor is not running. Therefore, the
device is able to stop at specific angles based on the physical therapist’s discretion. The requirements
for the system are to be able to apply a constant force of about 10lbs for 20 -30 minute intervals while
lifting the leg from 0 degrees in the sagittal plane to -5 degrees ( 1 degree) and holding the angle (.5
degree) for the allotted time of use. . The amount of force applied will be gradual and controlled by
changing the speed of the motor and thus allowing the PT or user to change it based on their
development through the rehab process. This therefore achieves an extension of the leg that would
mimic that of the physical therapist manually extending the leg in order to increase range of motion.
Figure 9. Verification Testing Setup
Figure 9. Motor Controller w/ Switches and Motor Driver

Verification of the device was conducted by setting up the device such that it was in the neutral
0 degree of the sagittal plane and by having the motor and gear system lift up a dead load that is
equivalent to the average weight of a human shaft and foot which was about 6.1% of total body weight.
The assumption that the user weighed at least 180lbs was made so that the shaft and foot weight was
calculated to be 10.98lbs. The verification procedure used 12.5lbs instead in order to incorporate a
factor of safety. The motor was attached to a bench via clamp and then chassis couple was lined up with
the motor in parallel. The angle achieved and held by the device for the 20-30 minute was verified using
a goniometer that was able to manually measure the angle as well as any changes in duration of the
test. Five trials were conducted and statistical analyses were conducted in order to see if the changes in
angle were statistically significant. The results of the verification process were recorded and analyzed.
The data through initial observation shows very minimal change in angle from the initial angle where the
device was stopped and loaded with the weight. In order to determine if there were any statistically
significant differences between the initial and final angles in each trial, a t-test was performed on the
data. The T- test compared the initial and final angles and resulted a p value of .68262151. This value
was greater than the alpha value of 0.05 required for 95% confidence and therefore showed that there
was not statistical significance between the angles. Therefore, the device was able to pass verification as
it was able to lift the weight to the specified angle and maintain the angle within the tolerance for each
trail as well as statistically show there was no change and thus verifying that constant force was applied
in extension.
Table 13. Extension Verification Data
Table 13. Extension Verification Statistical Analysis

Validation of the device was performed using a healthy non-recovering user. The test subjects
were instructed to place the device onto their leg in the appropriate configuration and then run the
motor at various rates. The device then lifted their leg from a 0 degree position to the -5 degree position
in the sagittal plane and held it for the allotted amount of time. The goniometer was then used to verify
the angle and the gyroscope was able to monitor any changes in the angle after the motor was stopped.
This validation setup was identical to the verification setup where the motor was clamped down and the
device was aligned relatively parallel to the motor shaft. Making the alignment exactly parallel proved to
be more difficult than in verification as subjects had different leg proportions that would cause the
setup to be slightly adjusted for each subject. Additionally, every participant had to fill out a survey
after testing the device and each subject’s data was the recorded and analyzed. As with the verification
testing, the initial and final angles of the device for the 10 participants, 5 male and 5 female, after being
left in extension were recorded for the 30-minute time interval. The average difference in the angles
was also calculated to be 0.03 degrees which was well within the tolerance of .5 degrees. A two sample
two tailed T-Test was also performed on the initial angles (T=0) and the final angles (T=30) and revealed
a p value of 0.6017 which was greater than the alpha of 0.05 and therefore no statistical significance
between the angles over time was show for validation as well. Also from the survey data, all 10
participants said they experienced an extension force in their knee. Therefore, the data and statistical
analysis both showed that the validation passed for constant force in extension as the device was able to
maintain a constant force in extension for the time of use.
1 2 3 4 5
Desired Angle -5 -5 -5 -5 -5
Initial angle -4.90 -5.00 -5.10 -4.90 -4.90
Final Angle -4.90 -5.00 -5.00 -4.90 -4.90
-7
-6
-5
-4
-3
Degrees
Extension Constant Force Verifcation
Figure 10. Comparison of Initial and Final Angle Readings in Verification Procedure for Constant
Force Extension

As for constant force in flexion, this was achieved by using the motor and gear system as well.
Constant force in flexion is also beneficial for increasing range of motion and is a major part of the
rehabilitation process. The device assisted the leg into a position of flexion past 90 degrees, ranging up
to 125 degrees, and then held the leg in that position for 20 minutes. This therefore applied the
necessary force in order to keep the leg at that position constantly through the time. The same
verification procedure was performed for the constant force flexion component. The dead weight of
12.5lbs was attached to the chassis and the motor was turned on and used to move the device from a
neutral hanging position of 90 degrees and rotated the leg to 125 degrees in flexion. This position was
held for 30 minutes and a goniometer will be used to manually monitor and verify the angle. The results
of the testing were also recorded and analyzed. The results show that the device was able to move the
weights from the 90 degree starting position to the 125 degree flexion position with the average
position being 124.86 degrees. The data also displays that the change in angle from the initial angle to
the final on average was about 0.06 which is also well within the allowable tolerances. Additionally, a
two sample two tailed T-test was performed to compare the initial and final angles and look for
significant change. The p value acquired was 0.22160142 which was greater than the alpha of 0.05 and
therefore there is no statistically significant difference between the angles after the time interval.
Therefore, the device was also shown to pass the constant force in flexion verification testing procedure.
Figure 11. Subject in Extension during Validation
Table 14. Validation Data and Statistical Analysis for Constant Force
Extension

The validation process also mimicked that of the extension portion where a healthy human
subject was placed in the device and their leg was able to be moved and held in a 125-degree position of
flexion. The validation setup was similar to the previous extension validation where the subject was
seated and had the device strapped onto their leg. Problems were encountered when tests the
extension to the full 125 degrees of motion. Because the chassis and motor were not exactly parallel as
well as the subject were seated on a chair that did not have enough clearance on the lower thigh, the
lower part of the device would be resisted by the seat and the motor would loosen from the claps while
trying to find through to 125 degrees. This caused unnecessary strain on the gears as well as posed a
possible injury threat for the participant. Therefore, the validation testing was unable to be completed
for 125 degrees for safety reason and due to the inadequacy of materials to create the proper testing
Table 16. Mean and Standard Deviation of Change in Angle
at t=30 minutes
Table 15. Statistical Analysis of Change in Angle at t=30
minutes
1 2 3 4 5
Desired Angle 125 125 125 125 125
Initial angle 124.80 124.90 124.90 124.80 124.90
Final Angle 125.00 124.90 125.00 124.80 124.90
122
123
124
125
126
127
128
Degrees
Flexion Constant Force Verification
Figure 12. Flexion Constant Force Verification Data

setup. However, the testing in flexion was able to be done up to 110 degrees within the given apparatus
and the subjects were surveyed after the testing about the effects of the constant force flexion. The
data for the 110 degree was taken for the 10 participants and was statistically analyzed. The results
found that the average change in angle between the subjects was 0.02 degrees which was with the
tolerance of 0.5 degrees. Also a T-test was run to compare the angle at t=0 and t=30. The p value
acquired was 0.7666 which was more than the alpha 0.05 and therefore at 110 degrees of flexion there
were no statistically significant difference between the angles. Therefore, because the specification
could not be properly tested for the 125 degrees in flexion the device does not pass validation testing
for flexion. However, from the data for the 110 degree angle as well as the survey data where 9/10
participants said they felt a flexion force on their leg, it can be led to believe that possibly with a better
more efficient testing apparatus the desired results could be achieved.
Table 17. Mean and Standard Deviation of Constant Force Validation.

Chapter 6-Budget Description
The budget for our project was $400. The project budget was a major constraint for the project
as this is only a prototype of our device. The project budget contains product information, pricing,
quantities, etc. for functional components, fastening components, and all other miscellaneous
components and services that the project required. McMaster Carr was our biggest material provider
during this project.
Currently, the project has exceeded the original budget. As we continued to hit obstacles in the
process of manufacturing, additional parts became required for the most timely and successful
completion of our project. The biggest financial obstacle came soon after we had made a very
environmentally and fiscally prudent action. After we recycled an expensive, high torque motor from a
previous project, we had saved hundreds of dollars while finding a motor that fit our specifications.
However, upon testing the motor, we found that the motor controller was not functional. We had
already committed to using the motor and had to make a decision about getting the controller to
function. We could have attempted to repair it ourselves with parts we would buy; send it back to the
manufacturer for repair, with no guarantee of successful repair or even return of the controller itself; or
finally, the option we went forward with, simply buying a new motor controller. This cost of the motor
controller overall was more than half of our original budget in itself, proving to cost the team significant
funds. We also spent our budget on certain items that were not used in the project that were part of the
original design, like the steel cable. Better, less expensive alternatives were found.
The team was able to save some money by making certain parts out of spare parts and scrap
metal. For instance, the rotational resistance part was made exclusively from no-cost materials. If the
device were to go into full production, cost would be reduced by mass production and bulk ordering of
the parts of the device, yet cost would increase due to the cost of production certain parts instead of
using spare parts, scrap, or free samples. Overall, the quality of the product would increase with full
manufacturing capabilities and lower budget constraints.

Chapter 7-Schedule
The timeline for the project was designated to take place across the last semester of junior year
until May of the second semester of senior year. The timeline started with the original planned proposal
of what wanted to be done and how it would be beneficial to the world enough to warrant its creation.
The next part of the timeline included the design process which took place over the first semester of
senior year. This process laid out the framework of the design of the project as well as the engineering
principles that dictated each component as well as how each component came together to create a
single fluid device that completed its function as related to the design requirements and needs. The next
important part of the schedule took place over the winter semester in which the design was
implemented and some manufacturing began. Finally the spring semester consisted of more
manufacturing of the device, design changes, testing of the device in order to validate the design and
ensure it works and does its task. The full design schedule is detailed in appendix I.

Chapter 8-Conclusion
With the completion of the senior design project, the process taught the participants many new
skills, attributes, and lessons. The core intent of the project was to subject the senior engineers to an
example of working as a team towards a singular project and goal. This was done to simulate the real life
experiences of engineers in industry and give the students a taste of the real world. The project also
gave the students first hand insight into the medical device design process. They were able to learn
about the design process from start to finish and all the different facets that go into making a new
product and addressing a real world need. The scope of the design project stretched over various
disciplines. The design itself incorporated mechanical and electrical components from the chassis and
gears to the motor control and Arduino feedback controls respectively. In order to understand the
effects of the device along with its integration to a human subject, the use of knowledge acquired
through biomechanics was critical to determine the feasible amount of force and torque that could be
subjected to the body. Overall the scope of the design required the incorporation of a majority of the
engineering classes taken in the curriculum as well as electives that dealt in ethics and other human
factors. With all this take into account, the results of the device and testing were overwhelmingly
positive. The device was able to pass verification testing in all aspects of the design from a specifications
viewpoint. As well as the device was able to pass all validation testing except for the validation of
constant force flexion due to inadequate testing setups. The only other negative results were that
components such as the gyroscope were unable to be passed in verification due to statistically
significant difference and small sample sizes as well as aesthetic changes to the chassis. For example, the
hook used to tie the resistance bands could be more ergonomic for PT use as well as adding additional
fail safes like mechanical stops at the desired angles. Much of these problems could be easily solved in
future iterations of the project but overall, the design and final device were very successful.

Chapter 9-Impact of Device
The ACL rehabilitation device could have potential impacts to society. For instance the device
should reduce the time the therapist must spend which each patient. For flexion and extension the
physical therapist no longer has to hold the patient in these positions. Instead, the physical therapist is
allotted time to see other patients. The physical therapist can monitor multiple patients on the device
and therefore be able to maximize their time fully. In addition, the data obtained can aid the physical
therapist in being able to quantify the progress of their patient. For instance they can see which angles
their patients were able to be placed at without any pain by checking the duration of their leg in these
angles. Medicare requires that physical therapists provide progress reports of their patients. These
reports include the time, duration, frequency, and goals involved in the therapy process. Our device
could potentially change the level of coverage received for ACL rehabilitation because of the data
collected. All data collection is also stored in a physical therapy outcomes registry. The data helps
physical therapist deliver better care and better evaluate patient function. By providing data that was
previously not given, the device may be able to change patient care in physical therapy.19
There are no
real social impacts for the user. This is because the user does not need to wear the device outside of the
physical therapist's office, therefore there is no aesthetic concerns that may affect them socially.
The design of this device will not particularly impact the local, national or global economy. Due
to the safety nature of the device, it may not be able to be sold in certain countries so the global use
may be limited. Although the issue this device addresses is one that is prevalent and growing, the device
will be sold to physical therapist offices. It will be able to be used many times over by different patients
coming into the physical therapist office. The scale of market of this device is correlated to the amount
of physical therapist offices that deal with ACL reconstruction rehabilitation, which limits the device’s
large-scale marketability. Locally, this device could increase the economy of the physical therapist office.
Physical therapy can cost anywhere from 50 to 100 dollars per hour, earning the physical therapist at
least 1000 dollars per patient over the course of the rehab schedule.20,21,22
With this device, a physical
therapist will be able to increase their quality and quantity of ACL rehabilitation patients, bringing in
more money to the office.
The design of the project is powered by a normal 120 Volt AC outlet. Therefore, it impacts the
environment by using the same power source that has been used by most devices in this time period.
Although the electricity is supplied by plants that use oil, the device is no less or more impactful on the

environment than other devices that currently exist. The devices components are also all electrically
based with wires, circuit boards, aluminum 6061 alloy, steel gears and nylon rope. One ill-advised part of
this design is using the nylon rope since nylon rope when produced produces nitrous oxides which many
businesses do not use, therefore releasing them into the atmosphere. Not only does this reduce the
ozone layer, it also can be released as fumes which can interfere with human and animal life (Malloy).
Nylon also has a very slow breakdown time and so unless the device it is being used with is permanent
or at least being used for an extremely long time, the nylon that is thrown away will build up in the
environment. (Smith) For these reasons, the device may be restructured to use a more natural and
environmentally friendly alternative, such as cotton. The largest issue with the device is the use of
aluminum that has a process that unfortunately leads to aluminum runoff, which heavily affects the
environment and its animals. The aluminum, in terms of the freshwater and seawater animals that the
runoff mostly affects, is easily absorbable in their metabolic systems which affects enzymatic
production, leading to illness in fish and such. (Roseland et al.) Although aluminum was specifically
chosen for this project, this affect can be lessened by using recycled aluminum instead of freshly cut and
processed aluminum so that less runoff is created when making the aluminum chassis and other parts.
Each device is reusable for each PT office it is located in so since there is a limited amount of
places the device can be used and therefore a limited environmental impact. Another negative aspect of
the design is the need for a 9 volt battery to power the Arduino on the electrical control, and since this
will need to be replaced whenever it runs out, this part of the design will have a higher environmental
impact.
Some possible unintended consequences of the development of this new technology could be
the replacement of other ACL rehabilitation devices and the alterations of rehabilitation protocols. Our
device takes the component based machines required for the ACL rehabilitation process and
incorporates them in one device. As a result, rehabilitation procedures could change, and there could
be a decline in more single function based ACL rehabilitation devices.
The ACL Injury device is intended to be used at a Physical Therapist’s office and not
commercially in a household. Therefore, this would not increase the availability of or access to
healthcare for those who are dependent on this device. The device is meant to be used under the
supervision of a PT and therefore a user would have to go through the regular healthcare process in
order to gain access to the device and treatment required for postoperative rehabilitation for ACL tears.
However, the device will allow for more effective use of PT time as they will be able to start the device
for a specific exercise and then leave the patient in order to tend to other clients. This would allow for

the PT to tend to more patients thus increasing their client base and possibly increasing the availability
of space in a PT clinic thus increasing access to healthcare.

References
1. M,Dempster via Miller and Nelson; Biomechanics of Sport, Lea and Febiger, Philadelphia, 1973.
P, Dempster via Plagenhoef; Patterns of Human Motion, Prentice-Hall, Inc. Englewood Cliffs,
N.J., 1971. L, Dempster via Plagenhoef from living subjects; Patterns of Human Motion, Prentice
Hall, Inc., Englewood Cliffs, N.J., 1971. C, Calculated
2. Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty
in people with arthritis. Cochrane Database of Systematic Reviews 2014, Issue 2. Art. No.:
CD004260. DOI: 10.1002/14651858.CD004260.pub3
3. Knee Surgery, Sports Traumatology, Arthroscopy, 2003, Volume 11, Number 5, Page 307 G.
Cerulli, D. L. Benoit, M. Lamontagne, A. Caraffa, A. Liti
4. Dargel, J., M. Gotter, K. Mader, D. Pennig, J. Koebke, and R. Schmidt-Wiethoff. "Biomechanics of
the Anterior Cruciate Ligament and Implications for Surgical Reconstruction." Strategies Trauma
Limb Reconstr. 2.1 (2007): 1-12. Web.
5. Brosseau, Herbert. "Continuous Passive Motion after Knee Replacement Surgery." Cochrane
Database of Systematic Reviews (2013): n. pag. Web.
6. Continuous passive motion after arthroscopically assisted anterior cruciate ligament
reconstruction: Comparison of short- versus long-term use John C. Richmond, M.D., James
Gladstone, M.D., John MacGillivray, M.D. Department of Orthopaedic Surgery, Tufts University,
School of Medicine, New England Medical Center Hospital, Boston, Massachusetts USA.
7. Cruciate coupling and screw-home mechanism in passive knee joint during extension–flexion
K.E. Moglo, A. Shirazi-Adl, Department of Mechanical Engineering, Division of Applied
Mechanics, École Polytechnique, P.O. Box 6979, Station Centre-ccue, Montréal, Québec,
Canada, H3C 3A7 Accepted 26 May 2004, Available online 20 July 2004
8. Kim, Ha Yong, Kap Jung Kim, Dae Suk Yang, Sang Wook Jeung, Han Gyeol Choi, and Won Sik
Choy. "Screw-Home Movement of the Tibiofemoral Joint during Normal Gait: Three-Dimensional
Analysis." Clinics in Orthopedic Surgery Clin Orthop Surg 7.3 (2015): 303. Web.
9. Kim, Ha Sung, Jong Keun Seon, and Ah Reum Jo. "Current Trends in Anterior Cruciate Ligament
Reconstruction." Knee Surg Relat Res Knee Surgery & Related Research 25.4 (2013): 165. Web.
10. Nirtal Shah. Increasing Knee Range of Motion Using a Unique Sustained Method. N Am J Sports
Phys Ther. 2008;3(2):110–113.
11. Ward, Alex R. "Electrical Stimulation Using Kilohertz-Frequency Alternating Current." Journal of
the American Physical Therapy Association 89.2 (2008): 181-90. Web.

12. Laufer, Yocheved, and Michal Elboim. "Effect of Burst Frequency and Duration of Kilohertz-
Frequency Alternating Currents and of Low-Frequency Pulsed Currents on Strength of
Contraction, Muscle Fatigue, and Perceived Discomfort." Journal of the American Physical
Therapy Association 88.10 (2008): 1167-176. Web.
13. Setuain, Igor, Miriam González-Izal, Jesús Alfaro, Esteban Gorostiaga, and Mikel Izquierdo.
"Acceleration and Orientation Jumping Performance Differences Among Elite Professional Male
Handball Players With or Without Previous ACL Reconstruction: An Inertial Sensor Unit-Based
Study." Pm&r (2015): n. pag.
14. Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation
Response to Products and Materials That Come Into Repeated or Extended Contact with Skin,
F2808-2010 15. Device specialization— Strength fitness equipment, 10422-2012
15. Device specialization— Strength fitness equipment, 10422-2012
16. Nylon 6 Specification Sheet. Malloy, T., & Grubb, M,
skipper.physics.sunysb.edu/HBD/MSDS/NylonMSDS.pdf
17. Smith, S. E. “What is Nylon?” Wisegeek.com(2009):n.pag
18. Rosseland BO1, Eldhuset TD, Staurnes M. “Environmental effects of aluminium.” Environ
Geochem Health. 1990 Mar;12(1-2):17-27
19. "PT Outcomes Registry." PT Outcomes Registry. N.p., n.d. Web. 10 May 2016.
20. Griffin LY. Noncontact Anterior Cruciate Ligament Injuries: Risk Factors and Prevention
Strategies. J Am Acad Orthop Surg 2000;8:141-150.
21. Rosen M, Jackson D, Atwell E. The efficacy of continuous passive motion in the rehabilitation of
anterior cruciate ligament reconstructions. Am J Sports Med 1992;20(2):122-127.
22. American Academy of Orthopaedic Surgeons and American Academy of Pediatrics (2010).
Anterior cruciate ligament tear. In JF Sarwark, ed., Essentials of Musculoskeletal Care, 4th ed.,
pp. 640-646. Rosemont, IL: American Academy of Orthopaedic Surgeons.

Appendix A-Member Biographies
Timothy Eck is a senior Biomedical Engineering major on the Mechanical track. He is involved with
BMES, the Honors Program, Honors Mentors, IGC Expansion Committee and a founding father of Delta
Tau Delta. He has volunteered with TCNJ BMES at the USA Science and Engineering Festival in
Washington D.C., helping presenting material on cardiac devices. His future plans include going into
industry after graduation and hopefully graduate school after that.
Jonathan Popo is a senior Biomedical Engineering major on the mechanical track. He is a part of the
BMES, Honors Program, Delta Tau Delta as well as a previous member of the honors mentor program
and the curriculum committee in engineering. He has also volunteered at the TCNJ BMES USA Science
and Engineering Festival in DC. His plans include moving into industry after college and possibly pursuing
business school opportunities afterwards.

Bryan Cromwell is a senior Biomedical Engineering major on the mechanical track. He is a part of BMES,
was vice president of NSBE and captain of the club volleyball team at TCNJ. After college he plans on
moving on to industry and eventually pursuing his master’s degree.
Prithvi Singh is a senior Biomedical Engineering with a mechanical specialization. He is a member of
BMES, the College Ambassador program, and Sigma Pi Fraternity International-Theta Delta Chapter
where he holds the position of Public Relations Chairman. He plans on acquiring a job in industry and
then pursuing an MBA or Master’s in Engineering later on in his career.

Appendix B-Complete Design Matrix
REQUIREMENT SPECIFICATIONS JUSTIFICATION VERIFICATION VALIDATION
1.
Device must be
securely attached
to injured area.
Device doesn’t slip.
Male:33.5”±1.7”
Female:30.6±1.5”
.478*(height of
average male/
female) from
gluteal crease to
mid calf1
Device will be
placed on
subject and put
through range of
motions to
ensure stability
2.
Device must be
able to fully support
weight of leg
Female leg: 15 lbs±
1lb
Male leg: 19±1 lb
Shank and foot:
10.98±lb
Average weight of
leg is 0.115*(weight
of total body)
Shank and foot are
6.1%(weight of
body)1
Device will be
placed on subject
and will be lifted
via the human leg
to make sure it
can support leg
weight
3.
Device must :
-constrain planar
motion of knee joint
-be able to provide
stability in the
coronal plane
Must stay within
range of -9 degrees to
3 degrees of coronal
plane
During the passive
extension and
flexion motions, the
joint exhibits
coupled internal
and external
rotations7
During gait, rotation
in the coronal plane
varies between -9
degrees and 3
degrees from
extension to
flexion8
Circuit was placed
on metal plate and
different angles
were measured to
check if motor
turned off for
tolerances in
coronal plane
4.
Device must be
adjustable within
plane of motion
Extension: -5 to 0
degrees ± 1 degrees
Flexion:
0 degrees to 125
degrees ±2 degrees
Maximum extension
of the knee is 0
degrees10
According to MGHO
criteria for starting
phase III involves
achieving 125
degrees of flexion
Device will be run
in extension and
flexion through
exercise regimen
to ensure it can
fully reach human
leg ranges
Device will be
placed on subject
and will be tested
to ensure it can
reach various
stages of gait
movement.
5.
Device must have
be able to be
Must be fully
functional working
Post surgery the
CPM is used by the
Run the device for
6 hours and test
Allow device to
run for 6 hours

powered via a
standard household
outlet
from a 110 volt / 20
Amp Max outlet
patient for 6 hrs a
day5
functionality on a standard
outlet and not fail
6.
Device must be
able to provide
resistance
Resistance cannot
exceed 5 lbs
According to the
MGHO Schedule,
patients in phase 3
should not exceed
5 pounds.
Connect
dynamometer in
series with
resistance and
measure maximum
tension during
flexion
Place subject in
device and try to
move to 0
degrees with
resistance
without
discomfort
7.
Device must have a
fail safe system for
controlling the total
maximum allowable
range of motion
Monitor and control
the degree of motion
in the sagittal plane (-
5 degree ± 1 degrees
to 125 degrees ± 2
degrees )
Maximum extension
of the knee is 0
degrees10
According to
Massachusetts
General Hospital
Orthopedics,
criteria for starting
phase III of
rehabilitation
involves achieving
at least 125 degrees
of flexion
Connected feedback
circuit to the motor
with the relay
module. Tested and
monitored motor for
on or off condition at
sagittal angle
tolerances.
Placed device on
subject and
monitored motor
condition as
subject’s leg was
moved by the
motor. One
investigator
controlled the
motor and
another checked
angles to insure
safety.
8
Feedback control
for coronal plane
malplacement
Must stay within
range of -9 degrees to
3 degrees of coronal
plane
Physical therapist
consultation
Connected feedback
circuit to the motor
with the relay
module. Tested and
monitored motor for
on or off condition at
coronal angle
tolerances.
Place a human
leg in the device
apply constant
force and record
if the motor shuts
off outside of -9
to 3 degrees in
coronal and
sagittal plane

9.
Device must
provide
constant torque
during full
extension and
flexion of knee
Provide constant and
controlled torque at -5
to 0 degrees extension
and 125 degrees in
flexion
Research supports
the use of sustained
torque for 10 to 45
minutes at a time to
increase knee ROM10
The motor system
will be attached to
a dead weight
equivalent to the
weight of an
average male
shank and foot
(6.1% total body
weight) and the
motor- gear system
will be run. The
motor will then
have to be able to
pull the weight up
to the 5 degrees
above the plane of
ground/125
degrees below the
plane of the ground
and then sustain
the weight at that
height. The angle
will be checked via
a goniometer
Human testing
where a healthy
subject is placed
in the system and
the device is able
to move and hold
the leg in
extension at -5
degrees of
extension (±1
degree)/125
degrees of flexion
(±2 degree)/ for the
appropriate time
interval. Then they
will be surveyed
about the
experience and if
they felt a force on
the knee.

Appendix C-Constraint Descriptions
 The device cannot cause reinjury of the ACL or other areas of the leg or knee
o This constraint led to the control of the range of motion of the device from -9 to 3
degrees in the coronal plane and -5 degrees to 125 degrees in the sagittal plane
o This constraint led to the control of rotational acceleration of the device, which may not
exceed 10 m/s2
o This constraint led to the requirement that the device must stop if it were to breach
either of the two above limitations
 The device must not become unsecure during use
o This constraint led to the size requirements of 33.5”±1.7” of the upper fixation strap on
average for men and 30.6±1.5”of the upper fixation strap on average for women
o This constraint led to the weight bearing requirement of 19 lbs on average for men and
15 lbs on average for females
 The budget of the device must not exceed $400
o This constraint led to the use of the BLZ362S-48-3500 brushless DC motor and gearbox
for the design as well as for the constant force application instead of buying a motor and
gear box that would exceed the budget.
 This led to a change in the design from a motor mounted on the chassis to a
motor stationed in perpendicular to the device
 This led to a change in the design of an external removable worm gear to a
worm gear housed in the gearbox, therefore no need for the use of a pulley
system for extension or external worm gear for flexion

Appendix D-Standards, Specs and Codes
Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation
Response to Products and Materials That Come Into Repeated or Extended Contact with Skin
The ACL rehabilitation device will be attached to the knee via nylon straps. The patient may be
fixed in the device for extended periods of time. As a result it is important to conduct a behind the knee
test to evaluate the skin irritation from products that come into repeated contact with the skin. The test
method is intended to test the chemical and mechanical irritation for products and materials that will
experience skin contact for extended periods of time. For the ACL rehabilitation device the testing
method will be slightly modified. The method will consist of applying the strap to the patient,
demonstrating the motions that would be performed in a therapy session. The duration of time will also
be that of a physical therapy session. The area of contact will then be inspected for signs of irritation.
Part 10442: Device specialization— Strength fitness equipment Health informatics
The ACL Rehabilitation device incorporates a resistive component in its design. Therefore the
device can be classified under strength fitness equipment. The standard specifies the user interface
interactions. This is very important for the data acquisition component of the device. The device must
clearly register a repetition when it is completed. Although the device doesn’t have a user interface the
document contains are still standards and requirements for appearance of data and definition of tasks.
The data outputted for the physical therapist must be uncomplicated and easily identifiable.

Appendix E-Engineering Tools Used
The team utilized Solidworks in order to do the full modeling of each component as well as the
full assembly design. In order to see how everything would look when placed in composition, this
software made the design easier to understand. The team also utilized the Arduino IDE in order to write
the code the various modules that were attached to the Arduino. The code was utilized to create data
that would enable the therapist to understand the motion of the leg and the repetition of cycles that the
leg underwent. During manufacturing, the team utilized heavy machinery such as, but not limited to: the
belt sander, the aluminum and steel bansaw, the drill press, the metal bender, welding, milling machines
and lathe. The hand tools utilized by the team included, but were not limited to: electric hand drills,
tap/tap handles, aluminum punches, deburring tools, and locking pliers.

Appendix F – Life Long Learning
Timothy Eck
Over the course of the design and manufacture of our senior, I have learned new skills and
techniques that will be invaluable for my career in the industry. The first skill that comes to mind is
SolidWorks. I have learned so many new features about SolidWorks and so many little tips and tricks to
the program that I could not have learned without practicing making my design. In addition to what I
have already learned in SolidWorks, I am also more proficient in learning new processes in the program
itself. I am confident I know or can learn on my own anything I may need to do in SolidWorks in my
career.
I have also learned more than I ever expected about manufacturing in the machine shop. Being
part of the team that was more involved in the mechanical aspect of the design and manufacturing gave
me an opportunity to get lots of hands on experience with the machinery in the TCNJ machine shop. I
worked with the lathe, the belt sander, the aluminum and steel ban saw, the drill press, the metal
bender, and the CNC machines. All of these machines were integral in the creation and assembly of our
parts. With these machines, I was able to drill holes, drill countersinks, polish axles, grind aluminum and
steel parts, bend aluminum into appropriate shapes, cut aluminum and foam precisely, and fulfill most
any need that our team came across while putting together the structure and resistance component of
our device.
It was not just machining experience that I learned in the machine shop; I learned many
manufacturing techniques. I learned so many different considerations while fitting the frame together. I
learned to incorporate bearings or bushing to increase the stability and reduce friction of axle and the
hole it goes into. This eliminates similar metals wearing on each other. I also learned how important it is
to correctly mesh the gears together and the different methods of doing that, whether it be using an
edge finder or clamping the gears in place. I learned a good deal about tolerances and how they can
affect the design of the device, or at least affect the assembly of it. I discovered how the three
dimensional model in SolidWorks does not always accurately model how the real life device will
function. It was important for me to constantly mock up the device and see how it is fitting together as
we went along the manufacturing process. I found out what conditions must be met and what situations
are appropriate for welding. There are several factors that our team did not consider when
incorporating that we then had to account for once in the manufacturing process, like sufficient surface
area of the weld. I quickly learned that though I may know a tool that can successfully perform a task,
there may be a tool that can perform that task better that I do not know about that is worth the time to

ask about. I learned that the process of manufacturing requires a great deal of calculated machining, but
also requires a certain amount of hand-performed fine-tuning.
Most importantly, I believe, I learned how to operate in a design team environment. Our team
design was absolutely too much for one person to handle within our timeframe, so it was necessary to
split up the responsibilities between all of the team members. Due to this necessity, communication was
key in the team’s success. It was critical that all the team members kept each other updated with their
individual progress and obstacles. At times, it was necessary for more or all of the team members to
focus their efforts on one particular component of the project and we relied heavily on each to for
assistance and constructive criticism. I found out how important it is to ask for help from my peers. I
asked the students around me in the machine shop who had more experience with certain tasks to help
me with those tasks. Overall, the process of senior design was an invaluable experience in taking a
design from start to finish.
Bryan Cromwell
This senior project was a learning experience in many aspects. We had to familiarize ourselves
with software and machinery that we had not been provided experience with in the past. For instance
machining was definitely a new experience for me I had not set foot in the machine shop was once until
our senior project. Although Joe took the lead on the more dangerous and precise machining such as
welding and drilling holes through gears there were many things we had to do ourselves. For instance all
cutting of metal, foam and shafts were all done by our group members. Including things such as using a
belt sander.
Personally what was new for me was the incorporation of electrical engineering into our project.
Our Senior Project group consists of 4 Biomedical Engineers on the Mechanical tract. As such, our
experience in electrical engineering projects were very limited. However, in order to have our design be
robust and safe we required some electrical components. We included a motor, and then due to the
power of the motor and the ability of it to injure a participant we knew that we required some sort of
feedback system. I placed this task upon myself to understand the electrical components required to
control the motor via angles. I became familiar with sensory breakout boards, an Arduino
microcontroller, coding in the Arduino language, SD card modules, and relay boards. All were required in
order to complete the requirement at hand.
Although at first it was overwhelming I am glad I decided to undertake this task. I feel that a
general knowledge of microcontrollers is very beneficial. Microcontrollers are useful in a lot of projects
and can be used in multiple ways. The code, once the syntax is learned is also very intuitive and has a

self-checking feature. I believe that by undertaking this component very outside of my academic focus I
was able to expand my skill set and gain engineering knowledge outside of the classroom.
In addition to the technical lessons learned, I feel as though the Senior Project provided me with
many new experiences. Although, as a student we deal with deadlines, having to work almost a year in
advance from inception of an idea to the fruition of a concrete device was definitely a challenge. I
learned to set timelines for the progression of the design process. Having to dictate the amount of work
that you personally have to complete to stay on task was daunting, but helped to greatly improve my
time management skills. Senior Project also provided knowledge about working with a team. My team
was not well designed for the project we were undertaking. Objectively speaking the team should have
consisted of 3 Biomedical Mechanicals and one Electrical or Computer Engineer. The design process
taught me to carefully consider your personnel when assembling teams. Also, I believe working closely
with 4 individuals for the course of a year was a vital experience that will translate into the real world.
In conclusion the senior design project has expanded my skillset. I have become more
familiarized with aspects of engineering outside my specialty, learned communication and leadership
skills, and was given a glimpse into the world of medical device manufacturing. I believe senior design
project has provided me with many tools that I will utilize in the future.
Prithvi Singh
Through Senior Design Project I & II, I can say that I have learnt a plethora of skills and gained so
much new knowledge that this process has almost taught me as much as my other three years of
engineering. Through senior project, I was able to learn many new skills that will help me further along
my career. One of the major skills I picked up was a very strong understanding of the program
SolidWorks. Prior to the project I had only used it for minor projects in other classes but after having to
help design multiple components in the over design and perform various stress analyses, I have gained a
much stronger grasp on the software’s capabilities. Other skills I was able to pick up were various
machining and fabrication processes. By first observing Mr. Zanetti in the metal shop operate the
machinery, and then using the machinery myself I was able to gain hands on experience in the metal
shop. I was able to learn how to proficiently use tools such as the belt sander, lathe, band saw, lateral
metal saw, and manual metal bending apparatus. These tools allowed me to help fabricate various
components such as L brackets that were used for the gear encasing boxes as well as cutting and
sanding down the main arms of the chassis.

I also gained a thorough understanding of the design process and the real world protocols and
issues that are dealt with on any engineering endeavor. This project helped me gain the unique
opportunity to apply the concepts that I had learnt in class into a physical product as at the same time
taught me concepts I may not have seen in the classroom without hands on experience. The process
helped shed light on a variety of aspects that I did not think to associate with medical device design. For
example, I learnt that there are a lot of constraints and impacts that need to be taken into account when
designing a device. Apart from just the impact the device may have on the patient, there are impacts
such as political, economic, and environmental impacts that need to be taken into account in the design
process. I was also able to gain insight into the field of regulatory affairs as it pertains to the acquisition
of PMAs and 510ks for FDA clearance and approval. This aspect of device design was completely novel
to me and I was able to gain this new knowledge to use later in my career.
However, the biggest thing that I learnt about the design process is that you design based on
specifications and requirements of your idea and do not make specifications based on your design. By
following this logic, I learned that real design process is about making choices and decisions to fit needs
rather than trying to change your needs to fit your design. Also the design process itself is a very fluid
process that incorporates a lot of changes on the fly. I learnt that when incorporating designs that are
done on paper into the real world, there can be unanticipated challenges involving equipment,
resources, and overall assembly. Being able to combat these changes and still be able to meet
requirements has given me invaluable problem solving experience as well.
The assignment also gave me knowledge in other procedural components of project
management that I had not been exposed to in the curriculum. These components included
maintenance of a detailed budget, Gantt chart, and website. As the team’s webmaster I gained new
knowledge in the field of webpage design as well as how to use WordPress platform software to
maintain the site. I was able to learn about webpage formatting as well as the use of various themes and
uploading different media elements onto a public site.
Overall the senior design project was an invaluable addition to my college experience that
allowed me to both apply skills that I had as well as learn new skills and techniques that I will be able to
use in the future.
Jonathan Popo
Being in charge of the chassis design led to the gaining of a large array of new knowledge that
can be broken down into software and fabrication knowledge. In terms of software, I developed a new

appreciation for Solidworks. Whereas in previous classes, Solidworks was used to develop models that
seemed to be used purely for academic grading, the senior design Solidworks allowed for ease in
creating a full design that incorporated each of the other member’s designs. Creating such an integral
piece of design for a senior project allowed for a higher level of learning because of the detail involved
and the need to learn the program in more depth to allow for more detailed integration. Using
Solidworks to develop deflection analysis proved useful as well because it allowed parts to be
minimalized and cheapened for a better and more resourceful design.
The next thing learned involved the full fabrication process. Understanding the full spectrum of
tools available as well as the multitude of parts and processes that would have to be used to achieve the
preliminary Solidworks design became as important to understand as the original engineering process
that went into developing the idea. Many things that were taken for granted with the Solidworks design,
such as simple gear meshing, equal diameter through diameter axel/spacing fitting, and bending
aluminum, were not as easy to manufacture as thought. However, learning how to use adequate belt
sanding, a variety of drill presses and punches, the lathe, the band saw and a different set of vice grip
combinations allowed for the project to be finished.

Appendix G - Drawings
Figure 13. Drawing of Inner Pulley Disc
Figure 14. Drawing of Outer Pulley Disc.

Figure 15. Drawing of Rigid Body Supports
Figure 16. Drawing of Motor Attachment
Figure 17. Drawing of Full Assembly

Appendix H-Computer Code
G.1: Arduino Motor Control Code
#include "I2Cdev.h"
//For SD card reading I hope it works
#include <SPI.h>
#include <SD.h>
File myFile;
#include "MPU6050_6Axis_MotionApps20.h"
//#include "MPU6050.h" // not necessary if using MotionApps include file
// Arduino Wire library is required if I2Cdev I2CDEV_ARDUINO_WIRE implementation
// is used in I2Cdev.h
#if I2CDEV_IMPLEMENTATION == I2CDEV_ARDUINO_WIRE
#include "Wire.h"
#endif
// class default I2C address is 0x68
// specific I2C addresses may be passed as a parameter here
// AD0 low = 0x68 (default for SparkFun breakout and InvenSense evaluation board)
// AD0 high = 0x69
MPU6050 mpu;
//MPU6050 mpu(0x69); // <-- use for AD0 high
#define OUTPUT_READABLE_YAWPITCHROLL

#define RELAY1 8
#define LED_PIN 13 // (Arduino is 13, Teensy is 11, Teensy++ is 6)
bool blinkState = false;
// MPU control/status vars
bool dmpReady = false; // set true if DMP init was successful
uint8_t mpuIntStatus; // holds actual interrupt status byte from MPU
uint8_t devStatus; // return status after each device operation (0 = success, !0 = error)
uint16_t packetSize; // expected DMP packet size (default is 42 bytes)
uint16_t fifoCount; // count of all bytes currently in FIFO
uint8_t fifoBuffer[64]; // FIFO storage buffer
// orientation/motion vars
Quaternion q; // [w, x, y, z] quaternion container
VectorInt16 aa; // [x, y, z] accel sensor measurements
VectorInt16 aaReal; // [x, y, z] gravity-free accel sensor measurements
VectorInt16 aaWorld; // [x, y, z] world-frame accel sensor measurements
VectorFloat gravity; // [x, y, z] gravity vector
float euler[3]; // [psi, theta, phi] Euler angle container
float ypr[3]; // [yaw, pitch, roll] yaw/pitch/roll container and gravity vector
// packet structure for InvenSense teapot demo
uint8_t teapotPacket[14] = { '$', 0x02, 0,0, 0,0, 0,0, 0,0, 0x00, 0x00, 'r', 'n' };
// ================================================================
// === INTERRUPT DETECTION ROUTINE ===
// ================================================================

volatile bool mpuInterrupt = false; // indicates whether MPU interrupt pin has gone high
void dmpDataReady() {
mpuInterrupt = true;
}
// ================================================================
// === INITIAL SETUP ===
// ================================================================
void setup() {
// join I2C bus (I2Cdev library doesn't do this automatically)
#if I2CDEV_IMPLEMENTATION == I2CDEV_ARDUINO_WIRE
Wire.begin();
TWBR = 24; // 400kHz I2C clock (200kHz if CPU is 8MHz)
#elif I2CDEV_IMPLEMENTATION == I2CDEV_BUILTIN_FASTWIRE
Fastwire::setup(400, true);
#endif
pinMode(RELAY1,OUTPUT);
// initialize device
Serial.println(F("Initializing I2C devices..."));
mpu.initialize();
// verify connection
Serial.println(F("Testing device connections..."));
Serial.println(mpu.testConnection() ? F("MPU6050 connection successful") : F("MPU6050 connection
failed"));

// wait for ready
//Serial.println(F("nSend any character to begin DMP programming and demo: "));
//while (Serial.available() && Serial.read()); // empty buffer
//while (!Serial.available()); // wait for data
//while (Serial.available() && Serial.read()); // empty buffer again
// load and configure the DMP
Serial.println(F("Initializing DMP..."));
devStatus = mpu.dmpInitialize();
// supply your own gyro offsets here, scaled for min sensitivity
mpu.setXGyroOffset(56);
mpu.setYGyroOffset(48);
mpu.setZGyroOffset(40);
mpu.setXAccelOffset(905);
mpu.setYAccelOffset(245);
mpu.setZAccelOffset(1433); // 1688 factory default for my test chip
// make sure it worked (returns 0 if so)
if (devStatus == 0) {
// turn on the DMP, now that it's ready
Serial.println(F("Enabling DMP..."));
mpu.setDMPEnabled(true);
// enable Arduino interrupt detection
Serial.println(F("Enabling interrupt detection (Arduino external interrupt 0)..."));
attachInterrupt(0, dmpDataReady, RISING);
mpuIntStatus = mpu.getIntStatus();

// set our DMP Ready flag so the main loop() function knows it's okay to use it
Serial.println(F("DMP ready! Waiting for first interrupt..."));
dmpReady = true;
// get expected DMP packet size for later comparison
packetSize = mpu.dmpGetFIFOPacketSize();
} else {
// ERROR!
// 1 = initial memory load failed
// 2 = DMP configuration updates failed
// (if it's going to break, usually the code will be 1)
Serial.print(F("DMP Initialization failed (code "));
Serial.print(devStatus);
Serial.println(F(")"));
}
// configure LED for output
pinMode(LED_PIN, OUTPUT);
}
// ================================================================
// === MAIN PROGRAM LOOP ===
// ================================================================
void loop()
{
// if programming failed, don't try to do anything

if (!dmpReady) return;
// wait for MPU interrupt or extra packet(s) available
while (!mpuInterrupt && fifoCount < packetSize) {
// other program behavior stuff here
// .
// .
// .
// if you are really paranoid you can frequently test in between other
// stuff to see if mpuInterrupt is true, and if so, "break;" from the
// while() loop to immediately process the MPU data
// .
// .
// .
}
// reset interrupt flag and get INT_STATUS byte
mpuInterrupt = false;
mpuIntStatus = mpu.getIntStatus();
// get current FIFO count
fifoCount = mpu.getFIFOCount();
// check for overflow (this should never happen unless our code is too inefficient)
if ((mpuIntStatus & 0x10) || fifoCount == 1024) {
// reset so we can continue cleanly
mpu.resetFIFO();
Serial.println(F("FIFO overflow!"));

// otherwise, check for DMP data ready interrupt (this should happen frequently)
} else if (mpuIntStatus & 0x02) {
// wait for correct available data length, should be a VERY short wait
while (fifoCount < packetSize) fifoCount = mpu.getFIFOCount();
// read a packet from FIFO
mpu.getFIFOBytes(fifoBuffer, packetSize);
// track FIFO count here in case there is > 1 packet available
// (this lets us immediately read more without waiting for an interrupt)
fifoCount -= packetSize;
#ifdef OUTPUT_READABLE_QUATERNION
// display quaternion values in easy matrix form: w x y z
mpu.dmpGetQuaternion(&q, fifoBuffer);
Serial.print("quatt");
Serial.print(q.w);
Serial.print("t");
Serial.print(q.x);
Serial.print("t");
Serial.print(q.y);
Serial.print("t");
Serial.println(q.z);
#endif
#ifdef OUTPUT_READABLE_EULER
// display Euler angles in degrees
mpu.dmpGetEuler(euler, &q);

Serial.print("eulert");
Serial.print(euler[0] * 180/M_PI);
Serial.print("t");
Serial.print(euler[1] * 180/M_PI);
Serial.print("t");
Serial.println(euler[2] * 180/M_PI);
#endif
#ifdef OUTPUT_READABLE_YAWPITCHROLL
// display Euler angles in degrees
mpu.dmpGetGravity(&gravity, &q);
mpu.dmpGetYawPitchRoll(ypr, &q, &gravity);
Serial.print("yprt");
Serial.print(ypr[0] * 180/M_PI);
Serial.print("t");
Serial.print(ypr[1] * 180/M_PI);
Serial.print("t");
Serial.println(ypr[2] * 180/M_PI);
#endif
#ifdef OUTPUT_READABLE_REALACCEL
// display real acceleration, adjusted to remove gravity
mpu.dmpGetAccel(&aa, fifoBuffer);
mpu.dmpGetLinearAccel(&aaReal, &aa, &gravity);
Serial.print("arealt");
Serial.print(aaReal.x);

Serial.print("t");
Serial.print(aaReal.y);
Serial.print("t");
Serial.println(aaReal.z);
#endif
#ifdef OUTPUT_READABLE_WORLDACCEL
// display initial world-frame acceleration, adjusted to remove gravity
// and rotated based on known orientation from quaternion
mpu.dmpGetAccel(&aa, fifoBuffer);
mpu.dmpGetLinearAccel(&aaReal, &aa, &gravity);
mpu.dmpGetLinearAccelInWorld(&aaWorld, &aaReal, &q);
Serial.print("aworldt");
Serial.print(aaWorld.x);
Serial.print("t");
Serial.print(aaWorld.y);
Serial.print("t");
Serial.println(aaWorld.z);
#endif
//Define angles at which to turn off motor
if((ypr[2] * 180/M_PI)<=55&&((ypr[2] * 180/M_PI)>=53) || ((ypr[2] * 180/M_PI)<=-5) || (ypr[1] *
180/M_PI)<-3) {
//Turns switch on and off
digitalWrite(RELAY1,LOW);
delay(3000);
}
else {

digitalWrite(RELAY1,HIGH);
}
}
}
G.2:Arduino Data Aquisition
if((ypr[2] * 180/M_PI)<-5){
delay(5000);
Serial.print(count++);
}
//Create Data string for storing to SD card in CSV Format
String dataString = String(ypr[0] * 180/M_PI) + "," + String(ypr[1] * 180/M_PI) + "," + String(ypr[2] *
180/M_PI)+","+ count;
File logFile = SD.open("LOG.csv", FILE_WRITE);
if (logFile)
{
logFile.println(dataString);
logFile.close();
Serial.println(dataString);
}
else
{
Serial.println("Couldn't open log file");
}
}
}

Appendix I - Ethical Testing
Expedited / Full Board Review Packet
Table of Contents
APPLICATION FOR APPROVAL TO USE HUMAN PARTICIPANTS Error! Bookmark not defined.
I. Research Description 58
II. Research Setting 61
III. Subject population 62
IV. Subject Recruitment 63
V. Risks 65
VI. Benefits 66
VII. Privacy & Confidentiality 67
VIII. Informed Consent 68
IX. Data and Safety Management 70
X. Conflict of Interest 71
XI. Checklist 72
I. Research Description
1. Abstract. Provide an abstract of the proposed research or teaching in language that can be
understood by a non-scientist. The abstract should summarize the objectives of this project and the
procedures to be used, with an emphasis on what will happen to the subjects. (Maximum 250 words)
The design of this project encompasses rehabilitation of the anterior cruciate ligament. Through exercise
and stretching the device is intended to aid in the rehabilitation process for both patient and physical
therapist. The ACL device proposed attempts to remedy the loss of range of motion and strength in. The
device mimics the series of motions that a patient would experience in a therapy session. The device will
assist the leg in order to help restore range of motion. At its conclusion of the device should fit all
patients comfortably and safely push on the leg bringing it from a bent to unbent positon.

2. Objectives: List your research objectives.
 Fit all patients tested
 Should be comfortable for the user
 Allow for comfort in the span of a rehabilitation session
 Optimize time of physical therapist to work with more patients.
3. Research Procedures: Describe the research procedures that will be followed. Identify all procedures
that will be carried out with each group of subjects. Describe how participants will be involved in the
study. For example, how often will the participants be involved? For what period of time will they be
involved? Where will the study take place? What data will be recorded and how? Who will assist the
investigator? Will machines, equipment, and/or instruments be used? If so, please list and describe
their use.
The procedure will be conducted by three investigators. First, the subject will be handed the consent
form and allowed to ask any questions about the procedure. The procedure will take place in Armstrong
Hall, room 128 the physiology lab. Then the subject will be placed in the device and their comfort level
will be assessed with a rating system. At any point in the research, the subject may exit the experiment,
if they choose to do so. The machine will then be turned on and the machine will place the subject in
different preset angles. The angles will then be measured against a standard such as a goniometer. After
placing the subject in these preset angles we will then ask the subject flex their leg and we will record
the resistance. At the conclusion of the research, the subject will be aided out of the device and the
experiment will conclude. The experiment should encompass about 25 minutes of time per subject.
4. Instruments: Describe the instruments, if any, to be used to collect data in this study.
The data collected will be the degree of comfort for the patient as judged by a post survey from 1 to 5.
We will also collect angles, weight, and accelerations from the trial testing.(forgot what lau said, must
fix)
Attach copies of all questionnaires, surveys, interview questions, etc. If the research involves interviews
that could evolve as the research progresses, include a list of discussion topics and any “starter”
questions for each topic that can reasonably be expected to be covered.
5. Does this research involve FDA-regulated drugs, devices or biologics? Yes X No.
If Yes, contact the IRB Office for instructions on how to obtain IRB approval.

6. Adequacy of Resources to Protect Subjects:
a. Investigator (including co-investigators) has sufficient time to conduct and complete the research.
Yes No.
b. Adequate qualified (including experience, training and familiarity with the protocol) staff are
available for this research. Yes No.
c. Describe availability of psychological, social or medical services, including counseling or social
support services that may be required as a consequence of research participation. If none are
available, what provisions are made when necessary?
Psychological, or social support services will not be required as a consequence of research
participation. There is a medical facility on campus at The College of New Jersey in the event
that any complications occur.
d. Describe psychological, social or medical monitoring, ancillary care, equipment needed to protect
participants.
The device consists of many moving parts and as such there is a risk of injury. However this is
minimal and most will result in minor cuts or scrapes from pinching. In order to reduce this risk
we plan on housing any areas of great risk. For instanc,e the gears will be housed in plastic in
order to reduce an injury from pinching. Patients will also alert the investigator at any sign of
discomfort at which point the experiment will stop. A first aid kit will also be present during any
testing to insure the treatment of any minor cuts.
e. Describe other resources needed for the protection of subjects in the conduct of this research (e.g.
participant communication needs language translation services).
The population will be based purely on a volunteer basis of fellow students. There will be no
incentives for participation.

Senior Project Report

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