National Design Competition: Accessible Ergometer

National Design Competition: Accessible Ergometer
BME 400
University of Wisconsin – Madison
December 8, 2004
Team:
Amit Mehta
Jon Millin
Ryan Pope
Jeff Swift
Contact:
John Enderle, Ph.D.
Department of Electrical and Computer Engineering
University of Connecticut
Advisor:
Justin Williams, Ph.D.
Department of Biomedical Engineering
University of Wisconsin – Madison
Abstract
The design team is currently participating in the National Design Competition through the
University of Connecticut. The goal of this competition is to build an accessible ergometer
(exercise bike) for hypothetical persons of various ailments. Team budget is $2000, while the
design will retail less than $1000. Team purchased an existing design for $499.99 and made
necessary modifications, which includes: seat assist, power seats, arm motion, walkthrough
frame for easy access. The seat assist was built to help people who can no longer get up
unassisted due to insufficient upper or lower body strength. The power seat consisted of a 500
pound linear actuator and was used to allow automatic seat adjustment for users. Lastly, the arm
motion includes two independent, variable pistons that provide greater variability in the user’s
workout than would linked pistons. The team successfully built a working prototype by the end
of the semester. For full consideration in the contest, the team is required to apply for human
subject’s approval. Application was submitted to the Institutional Review Board on November
8, 2004 and received feedback on December 1, 2004 to make revisions prior to testing. Future
work includes obtaining human subject approval and an improved user interface. Ultimately, we
will create a more ergonomic, universal device to facilitate exercise for patients with various
disabilities.
Background Information
The design team has entered the 2004-2005 National Student Design Competition. This
is a competition sponsored by the University of Connecticut, Marquette University, and the
Rehabilitation Engineering Research Center on Accessible Medical Instrumentation (RERC on
AMI). This competition is open to design teams in biomedical engineering, industrial design,
and other disciplines. The target design area the team chose to enter was to build an accessible
ergometer (synonymous to exercise bike). The aim of this project was to build a creative cycle
ergometer that is usable by individuals with a diversity of abilities. To enter the competition, a
letter of intent was sent to Dr. John Enderle, a professor at the University of Connecticut and
contact person for this competition, detailing a proposed solution to the given problem and a
timeline of events for the project. Upon acceptance into the competition, the team was given a
preliminary budget of $500. Each time $500 is spent, the receipts of purchase are sent to Dr.
Enderle for reimbursement. The maximum budget for each team is $2000, but the ergometer
1
must retail for at most $1000. In addition to the $2000 budget, the team is allowed to allocate up
to $500 of that budget towards an existing device (Contest Announcement, Rules, and Letter of
Intent found in Appendix A).
As part of the competition, a list of six hypothetical clients was given to each team. The
team was then to design an accessible ergometer based on these six clients’ various abilities.
The client’s disabilities include post-stroke symptoms of limited arm function and requirement of
a cane while walking, diabetes, poor eyesight and/or blind, deaf, obesity, heart failure, low
strength and flexibility, and Parkinson’s disease. A description and names of the six clients can
be found on the contest announcement found in Appendix A.
Design Constraints
The ergometer must take into account each of the client’s disabilities. To accommodate
for the post-stroke symptoms of limited function in one arm and the requirement of using a cane
to walk, the ergometer arm motion should be independent between the left and right side to allow
just one arm to exercise, and it should have an easily accessible cane holder to allow placement
of the cane after sitting. For users with poor eyesight or who are blind, the user interface will
have to have a large LCD screen, well-defined, raised letters on the keypad, and an audio output.
Obese users will require a structurally stable ergometer that is capable of supporting a 400 pound
person. To accommodate heart failure users, the ergometer must be equipped with a method of
determining how hard an individual is exercising and a way to warn users of potential harm they
are inflicting on themselves from overexertion. To assist users of low strength and flexibility,
the seat position and all resistance controllers should be readily accessible and require minimal
effort to adjust. For users with Parkinson’s disease, a method of helping users initiate movement
2
to place their feet on the foot pedals and hands on the hand grips should be incorporated, as well
as a method that will assist these individuals in entering information into the user interface [5].
Further design constraints can be found in the Product Design Specification in Appendix B.
Current Competition
Commercial devices that accomplish functions similar to the one of this project include
the Schwinn Airdyne Windjammer UBE and the RST7000 Total Body Recumbent Stepper
(Figures 1 and 2 respectively). The Schwinn Airdyne Windjammer is fully adjustable and has
multi-position arms to allow for length adjustment. It consists of a dual drive train in which
allows forward and backward motion. The main disadvantage for this machine is that it has a
weight capacity of only 300 lbs, insufficient to support our overweight patient of 400 lbs and
only allows upper body workouts. In addition, the cost of this machine is $2195, far above our
maximum allowance of $500.
Figure 1: Schwinn Airdyne
Windjammer UBE [8].
Figure 2: RST7000 Total Bod
Recumbant Stepper [7].
The RST7000 Total Body Recumbent Stepper is a more versatile device compared to the
Schwinn Aridyne Windjammer describe above. The Total Body Stepper allows for total body,
upper body, or lower body workouts. This is beneficial since all of our clients vary in ability
3
with use of leg/arm motion. By having different modes of exercise, it adds variability to the
user’s exercise. The device has a walk through access that allows easy and safe entry for all
users. The Total Body Stepper has contact heart rate on handles. This is an important
component since it is vital to display the user’s heart rate during exercise to monitor their
workout accordingly. This seems to be the ideal device of the team, but this machine costs
$3995.00, which is also beyond our allowable $500 budget.
Chosen Device: NordicTrack SL710
The existing commercial design that was utilized for this project was the NordicTrack
SL710 (Figure 3). It was chosen because it is a recumbent cycle that incorporated magnetic
resistance, pulse sensors, a console and ergonomic pedals. Based on the limitation that an
existing device can be purchased for no more than $500, the team decided to purchase the cycle
ergometer for $499.99 from Sears.
Figure 3: Nordic Track SL710 [4].
4
The design team decided on a recumbent ergometer over an upright cycle ergometer due
to two main factors: support of the user and stability. A recumbent style exercise cycle allows
for the user to have their body supported when seating in a reclined seat compared to a bicycle
seat that is used for upright stationary cycles. This reduces the amount of pain that is
experienced by people in their lower back. Additionally, a seated position is more stable than
perched on a raised seat.
The magnetic resistance used on this style of Nordic Track cycle is referred to as SMRTM
Silent Magnetic Resistance. The system (Figure 4) enables changes in the resistance of pedaling
by having a metallic flywheel rotating through a magnetic field. As the flywheel passes through
a greater portion of the magnetic field, the resistance is increased. The magnetic field is
generated by permanent magnets that are mounted on a C-shaped bracket. The bracket is bolted
to the frame, which acts a pivot point, and the other end is attached to a cable, whose length is
adjusted by an electric motor. In order to increase the resistance, the cable length is decreased.
A spring is used so that the bracket does not come in contact with the flywheel. Since this design
for the magnetic resistance was exactly what was needed for our design we decided to keep it
intact and utilize it along with the pedal drive train for rotating the flywheel.
Figure 4: Sketch of Flywheel/Magnetic Resistance System [4].
5
Another aspect of the NordicTrack SL710 that was left alone for our first prototype was
the console, with which the user directly interfaces. The console (Figure 5) of the NordicTrack
SL710 was a NavigatorTM LCD console that is iFit® compatible and includes: a CoolAireTM
Workout Fan, water bottle holders and a book rack. The model that we purchased had three
LCD displays. The console displays time, speed, revolutions per minute (rpm), and distance
pedaled. Another LCD shows the training zones and shows a graphic representation of a ¼ mile
track, so that user would know where on the track they were presently going through. The last
display shows the user heart rate, fat burned, calories burned, and the current resistance level.
For all the displays, the values shown would switch between the ones shown on the display.
Figure 5: Control panel of the NordicTrack SL710 [4].
Other aspects of the console left intact were the water bottle holders, the bookrack and
the fan. The fan could be controlled by pushing a single button to toggle through low, high and
off settings. Other buttons on the console include: numbers 1 through 10 which are used to
6
select the resistance level, program select, program start, and an iFit.com button (for a full
description of the buttons, see Appendix C).
Within the system, there are eight built-in workouts that can be selected. There are six
workouts that work using resistance and pace while the other two work by using the heart rate.
The six workouts are: trail blazer, biker’s choice, victory hill, competitor’s challenge, winner’s
pace and power drive. The first two are targeted towards weight loss, the second two are for
aerobic workouts and the last two are for performance exercise routines. All the programs adjust
the resistance or prompt the user to change their pace to simulate the program. Thus, for a large
hill, the program will increase the resistance when going up the hill and decrease it for the
descent. The other two programs work by using the user’s age and calculating a maximum heart
rate by subtracting the age from 220. The two programs work to maintain your heart rate at 80%
of maximum or 85% of maximum by adjusting the resistance level.
The console also can be run by using the iFit mode where special programs that are
available on CD, video, and the internet control the resistance level of the exercise bike.
The NordicTrack SL710 also includes CardioGripTM pulse sensors (Figure 6). These
sensors work by detecting the pulse rate through the metallic conducting palm sensors and then
relaying the signal back to the console, where the heart rate is then displayed. This heart system
is not as accurate as other methods such as pulse oximetry or a telemetry strap, but it can be used
by a wide variety of people with very low strength and dexterity.
Figure 6: CardioGripTM pulse sensors.
7
Modifications to Existing Device
The first concern addressed when modifying the commercially available bike for general
accessibility was the incorporation of a walkthrough access for zero-step-in height. Zero-step-in
height means that the user would not have to lift a leg and maintain balance on one foot to get
onto the bike. This design concern leads to several small changes to the original design in which
more space was generated to allow a walkthrough access. First, the one way clutch on the pedal
linkage was reversed so that the entire pedal-magnetic resistance system could also be reversed,
yet still function normally. The location of the one way clutch can be seen highlighted in Figure
7 below. Reversal of the pedal-magnetic resistance system netted an increase of 6-8 inches in
terms of walk-in space or foot room.
Figure 7: Highlighted one way clutch that was reversed [4].
An increase in 10 inches was not quite sufficient since an average foot length is
approximately a foot long. Therefore, the original manual seat locating system was eliminated
and replaced with a power seat system that was mounted lower than the original system. By
lowering the seat locating track, an additional two inches of walkthrough space was gained,
bringing the total walkthrough space of 12 inches, a sufficient amount of room for easy access to
the ergometer.
8
Additions to existing device
As mentioned previously, the original manual seat locating system was eliminated in
favor of a powered seat locating system. The powered seat locating system was made in such a
way that the seat would travel through the same path on the new system that it traveled in the
original system, meaning that the angle of the seat track was approximately maintained at the
original 22.6o and the seat was placed in exactly the same reference to the pedals as it was
originally. A new mounting platform for the seat and the proposed arm motion was created
utilizing 1 ½ inch x 2 ½ inch x 3/16 inch thick rectangular tube fashioned into a reinforced
rectangle base with outside dimensions 20 inch x 13 inch. On the outside of the new seat
platform, 2.17 inch rollerblade wheels were attached that would ride on the new track system.
Additionally, 1 1/4 inch secondary wheels were attached to the bottom of the seat platform that
would ride below the track to keep the seat platform locked to the slide track in the same way a
roller coaster is locked to its track. The new track system was constructed from 1.5 inch x 1.5
inch x 3/16 inch thick angle iron set to the width of the seat platform and the proper length to
cover the full range of travel of the linear actuator.
To power the seat, a 500lb 12/24V electric linear actuator with a stroke of 1 ft was
chosen. The 500lb force is more than what is necessary for a final marketable version, but was
chosen for its cheap availability for the prototype. On a final version, an actuator with half as
much force would be sufficient. The actuator was mounted between the rear of the seat track and
the front of the seat platform, as seen in Figure 8. This mounting position yielded the greatest
forward travel for the seat by allowing the seat track to be as low to the ground as possible and
caused the actuator to be tucked under the seat platform when in the maximum up position. By
9
concealing the actuator under the seat in the maximum up position the overall length of the
ergometer was decreased.
Figure 8: Linear actuator mounting location.
Once the locating system for the seat was established, improvements for the seat itself
could also be addressed. Since it can be difficult for some users to stand from a fully seated
position due to insufficient upper or lower body strength, a lift assist was incorporated into the
seat. The bottom cushion of the seat was removed and a new elbowed mount was placed under
the bottom cushion. Across the elbow and at the calculated location, a 100 lb. pressurized lift
cylinder was mounted (Figure 9).
10
Figure 9: Lift seat linkages.
As the seat travels up, a portion of the 100 lbs. the lift cylinder can generate is exerted to
aid the user in getting to a standing position. The lift force generated follows the graph seen in
Figure 10. A 29 lb. load strength limiting chain was then added to allow the seat to achieve an
angle no greater than 45o for ease of sitting down.
11
Fpiston vs. Seat Angle
80
70
Fpiston (lbs)
60
50
40
30
20
10
0
0
5
10
15
20
25
30
35
40
45
50
Seat Angle (degrees)
Figure 10: Lift force as a function of seat angle.
Track system
Important considerations were first made before designing the respective seat frame for
the seat. The team took several measurements including:
•
Distance of the foot pedal axel to the closest seat position (32 inches)
•
Distance of the foot pedal axel to the farthest seat position (43.5 inches)
•
Distance of the foot pedal axel from the ground (14.875 inches)
•
Distance of the seat from the ground (16.75 inches)
•
Angle of inclination (22.6 degrees)
The team decided to drop the entire track system initiating near ground level compared to the
original NordicTrack beginning approximately 12 inches off the ground. This was accomplished
by first cutting 8 feet of steel L-beams creating a 3 foot x 1 foot rectangle (Figure 11).
12
12 inches
36 inches
Figure 11: Dimensions of track system (welded out 8 feet of steel L-Beams).
With the track system created, it was welded to the rear support of the existing device and feet
pads were placed at the front to provide support. The track system was created with attempts to
emulate the original angle of elevation. The final inclination resulted in 21 degrees.
Seat Platform
The next task was to develop the seat platform. The platform has to be strong enough to
be pulled and/or pushed by the 500 lb linear actuator and support the downward force of the seat
and user. The design of the seat platform was accomplished by creating the base using 6 feet of
2 ½ inch x 1 ½ inch rectangular, hollow steel bars. The base was welded together to form a 20
inch x 13 inch base (Figure 12).
13
13 inches
10 inches
20 inches
Figure 12: Top view of seat platform. Dark lines indicate location of the weld.
This frame will serve as the foundation from which the seat support will situate upon. The seat
platform will consist of 8 - 55 mm bearing-filled rollerblade wheels (four on each side) to allow
the platform to roll on the track. In addition to rollerblade wheels providing support on top of
the track, four additional 1 ¼ inch plastic wheels (two on each side) will roll along the bottom of
the track to ensure the base remains on the track system. These wheels will be attached to the
base by ¼ inch U-bolt. The final head-on view of the seat base is diagrammed below (Figure
13).
14
Seat Base
Stop
Nuts
U - Bolt
Seat Base
Rollerblade wheels
with bearings
L-Beam
10”
Plastic Wheels
Figure 13: Head-on view of seat platform.
After initial welding of the seat platform together and attaching the rollerblade wheels, the
platform turned out to be unbalanced. There was 1/16 inch difference between the front and
back of the platform without the wheels. With the wheels, the difference increased to 3/16
inches. Since any fluctuation in the platform is not safe for a user to sit on, we decided to drill
the holes again on the opposite side of the beams. The position of the new holes was determined
with respect to level ground. In the end, we were able to level the seat platform and have it roll
straight up and down the track. The final set-up of the seat platform on the track system and
linear actuator is shown below (Figure 14). The final angle of elevation changed to 24° with
respect to the ground due to the uneven seat base on the track system.
15
Seat platform
36”
Linear Actuator
17.3348”
3.5”
Ground Level
Figure 14: Side view of track system, seat platform and linear actuator
Seat Supports
Since the team decided to drop the track system to the ground level, a seat support system
is necessary to maintain the seat height at 16.75 inches above the ground. In order to do this, the
team designed a support emanating from each of the three crossbars in the seat platform. This
served a two fold purpose. First, the team had to ensure the user’s safety; therefore, the seat
must fit securely on the seat support. Second, the center of gravity of the seat itself should be
properly situated to make certain that the seat does not sway back and forth upon user movement
in the seat. With these criterions, the team decided the optimal support system would consist of
A-frames originating from the back and front crossbar of the seat platform and inserting on the
crossbar that is attached to the seat itself. Because the seat has to be horizontal while the seat
base sits on a 24° with respect to the ground, the A-frames would have to be cut into double
angles. The team found this a difficult task to remain consistent. As a result, the team decided to
alter the design to make the fabrication simpler, without compromising the function of the
support.
16
The new design consisted of having a single bar emanating from each of the crossbars in
the seat platform. The team purchased eight feet of 1 ½ inch square steel tubing to construct the
support system. Each of the steel pieces was welded together. Final dimensions are shown
below (Figure 15).
10.5”
5.25”
13.25”
9.5”
Figure 15: Seat support system with dimensions. Seat assist situates above the 10 ½” bar.
Arm Handles
After designing the seat assist, it became clear that the handles attached to the seat were
no longer in the correct placement. This is because when sitting on the seat if you tried to push
off the handles, your arms were already at full extension. Therefore, in order to achieve better
leverage and ability to apply force, the handles were raised four and a half inches. This was done
17
by putting two bends into the handles (Figure 16), one that bends the bar vertically and one that
bends it horizontally. The distance from the seat to the first bend (vertically) is 7 inches, the
distance to the second bend (horizontally) is 4.5 inches and the length of the handle from that
bend to the end of the handle is 16 inches. Another modification to the handles was putting the
pulse rate sensors on the handles so that they could be in easy reach of the user and would not
have the problems of motion artifact if they were placed on the arm motion handles.
16”
4.5”
Figure 16: Raised arm handles with heart rate sensors
Arm Motion with Pistons
The last component in the entire seat system consists of the arm motion design. Although
not required as part of the competition, the team felt that introducing arm motion to the design
would add greater variability to the device. Along with lower body workout by cycling motion
18
of the foot pedals, users can also obtain an upper body workout using the arm motion.
Furthermore, both components (arm motion and the foot pedals) can be performed to allow for a
total body workout. These two are independent of each other, allowing the user total control of
his/her exercise routine.
The arm motion is controlled by two independent, variable pistons. Independent pistons
is unique in the sense that it allows patients with limited one arm motion to conduct exercise
only with the one arm and not worry about the unused handle coming back at them. The pistons
were purchased from a health fitness dealer, HealthFX America, for $48.90 including shipping.
The pistons are capable of 5-200 lb loads with adjustable dials from 1 to 12 (increasing number
on the dial corresponds to higher resistance). Additional parts such as 1 ½ inch square steel
tubing left over from seat support design and five feet of 1 5/16 inch circular steel hollow rod
were used in design of the arm motion. Most importantly, brass fittings were placed within the
piston holes and are meant to slide into the screws to reduce friction on rotating components.
The insertion point of the piston onto the arm handles is vital. The team determined the
optimal placement of the pistons with respect to the seat base to allow for maximum moment
endured by the user. It was determined that the insertion point of the piston will be 9.25 inches
from the insertion point of the 1 ½ inch square tubing into the seat base. Furthermore, a six inch,
1 ½ inch square tubing was welded outwards from the ten inch 1 ½” square tubing to bypass the
seat. Lastly, 2 ½ feet of the hollow rod was inserted into the six inch bar upon 1300 pounds of
pressure and welded together. The final setup is diagrammed below (Figure 17).
19
12.5”
9.25”
Figure 17: Arm motion on the seat base with dimensions.
The team finished the arm motion by welding on the ends of the handles from the
NordicTrack SL710 onto the ends of the hollow bar to allow for a more ergonomic feel upon
upper body exercise.
Blinking Pedal Design
In an attempt to make our design as accessible as possible for as many people as possible
we looked into Parkinson’s disease. Some people with Parkinson’s have an inability to initiate
motion, which means that if you tell them to take a step they can not do so, but if you tell them to
step over a line draw on the floor they are able to do so. We took this same principle and applied
20
it to the pedals. We theorize that by putting blinking lights into the pedals and couple that with
audio output instructing the user to place their feet on the pedals will help user’s with
Parkinson’s to overcome the problem of initiating motion.
A major problem to be overcome with this is the fact that the pedals are continuously
rotating during pedaling so it is impossible to run wires into the pedals. Therefore all power
must be self contained in the pedals and the ability to turn the LED on and off must be done
wirelessly. Ideally all that would be contained in the pedal would be an LED, battery and the
wireless receiver. With the wireless transmitter would be a timing circuit and the square wave
vibrator. Our first design incorporated the timing circuit and the square wave vibrator in the
pedal.
The initial design was built off a wireless doorbell system along with a monostable 555
timer circuit, an astable 555 timer circuit and an AND gate. The wireless doorbell system is
modified so instead of using the speaker as the output it is possible to use the wires leading to the
speaker as the output for the system. The negative output to the speaker can be used as a digital
logic zero. Therefore if the negative output is inputted into a monostable 555 timer circuit
(Figure 18), it would trigger the circuit and provide a digital logic “1” or Vcc for a set number of
seconds. The period of logic “1” is determined by the values of the resistor and capacitor. In
order for the period, T, to be 180 seconds, which would allow 3 minutes for the user to get their
feet onto the pedals, the resistor value would need to be 1.64 MΩ and the capacitor would be 100
µF.
21
Figure 18: An input (trigger) of zero results in Vcc for T seconds, the value of T is determined
the values of R and C [3].
The astable 555 timer circuit is needed to make a square wave so that the LED blinks a
determined frequency. It should be noted that the astable circuit could be removed since there
are integrated circuit LED that blink at a predetermined frequency, so if an LED could be found
that has the desired frequency the astable circuit could be removed as well as the AND gate. The
astable circuit (Figure 19) was designed to have a frequency of approximately 700 mHz. In
order to do this the circuit utilizes two resistors and a capacitor to change the frequency of the
square wave. The astable circuit does not need a trigger so therefore it is always oscillating. The
values chosen for the circuit were: RA = 100 kΩ, RB = 160 kΩ and C = 4.7 µF, these results in a
frequency of 729.5 mHz. As can be seen in the accompanying graph to Figure 19 the period of
time the waveform is equal to Vcc is longer than when it is equal to zero. The values of TH and
TL are 846.846 ms and 521.136 ms respectively.
22
Figure 19: Astable 555 Timer Circuit frequency = 729.5 mHz [3].
The final part of the circuit before the LED is the AND gate (Figure 20). The AND gate
is used because it takes the output from both the monostable and astable circuits and outputs Vcc
when both the inputs for the AND gate is equal to Vcc. Accompanying the representation of an
AND gate is the truth table for an AND gate in Figure 20. The LED would then be connected
between the output of the AND gate and ground.
X
Y
X OR Y
0
0
0
0
1
0
1
0
0
1
1
1
Figure 20: AND Gate and according truth table [3].
The wireless doorbell currently runs on two ‘C’ batteries which provide 3 volts to the
circuit. The 555 timer circuits and the AND gate are designed to operate at 5 volts, also at 3
volts the LED brightness is greatly decreased when compared to 5 volts. Therefore a 5 volt
23
voltage source needs to be used in the final design. In order for this design to work, a battery
would have to be placed on the underside of the pedal. This could be problematic, except for the
fact that currently there is a piece of steel rod that is used to keep the pedals with foot surface
upright. That piece of steel rod could be replaced by the battery and will provide similar results
as the steel rod.
Currently a simple prototype was made of the circuit, in the future it is planned to have
all of the timer circuits and the AND gate be placed in the transmitter circuit to have the battery
life in the pedals be increased. The transmitter would be powered by a dc transformer that would
plug into the wall socket; therefore power consumption is not as much of a concern. Once a
design for the modifications is made the circuits would be soldered onto printed circuit boards
that would be ordered from PCExpress.com.
Critique of Design
In our first semester we have successfully designed and built a prototype and presented
our work thus far to the community and our peers. After completing our final report of the first
semester, it was possible to look at the problems with our design and how we plan to fix them in
the future.
When examining our design of the frame system the main flaw that can be seen is its
weight. The design currently weighs in excess of 150 pounds and for it to be a commercially
viable design the amount of steel used needs to be reduced to save money as well as overall
weight. By reducing overall weight we also reduce shipping costs.
When making the sliding track design it was decided to use wheels on both the top and
bottom of the track to provide stability. It was also decided to use lower costing wheels to cut
24
costs on the bottom wheels. The wheels seem to work just fine, but the U-bolts used are only
grade 2 steel of ¼ inch diameter. These bolts flex when leaning back on the seat and bend over
repeated stress. In order to make this design safe and reliable we need to come up with stiffer
bolts or redesign the lower wheel bolt design so that it will not bend.
The seat portion of the design has a multitude of flaws. One is the fact that when adding
the seat assist it raised the seat an additional two inches off the ground which altered the original
angles to the pedals and the distance from the pedals. Therefore, in order accommodate shorter
users, the seat height needs to be remedied by redesigning the seat assist. The original
NordicTrack SL710 had a side-to-side wobble in the seat which was thought to be a result of a
poor design, but in our design we have not come up with a way to reduce the wobble of the seat.
We propose building a better locking mechanism between the seat and the seat support. Another
design flaw is the dimensions of the handles; the handles do not clear the seat enough to allow
for larger users to fit in between the handles. This can be remedied by moving the handles out
about 2 inches on either side. This will cause the arm motion handles to be moved out 2 inches,
which will have to be done with spacers.
The arm motion design also provides several design flaws in our current prototype. The
length of the arms is currently too long; this can be remedied by putting in an adjustable rod
system that would adjust the arms in length vertically. It is important when designing this to
keep in mind that the adjusting portion can only use one hand and cannot require a lot of
dexterity. Another problem is that when pedaling the heel of the foot can come in contact with
the arm of the arm movement. This is troublesome because this is a risk for injury. At this time,
no solution has been proposed. When exercising the upper body, it is beneficial to have
resistance in both directions, though the current pistons used in the design only seem to provide
25
resistance in one direction. Again, no solution to this problem except for finding different two
way resistance pistons has been proposed.
Cost Analysis
Description of what bought
NordicTrack SL710
100lb gas spring
12" Stroke Linear actuator
Rollerblade wheels, 55mm diameter, 8 pk
Momentary three way switch
bolts, nuts, washers, casters, angle steel 6'
1.5"x2.5" rect. Tube, 1"x2" rect. Tube
2 Butterfly cylinders
1.25"x48" L-steel
U-bolts x 4
washers, nuts, all thread rod
Wireless doorbell chimer
1.5"x1.5"x3/16" tube, 1" tube
Misc. Nuts, bolts, and washers
Leveling feet, and nuts
Paint, battery terminals, cable ties, wire,
batteries
Electrical tape, heat shrink pcs. , terminal kit
bronze bearings, chain, steel spacers
Current total
Reimbursements
Remaining reimbursements
Budget Remaining
Retailer
Sears Madison West
MSC Industrial Supply
ebay.com
Dick's Madison East
RadioShack East Madison
Menards East Madison
AA Quality Welding & Mfg
Madison
HealthFX America
TrueValue Whitewater
Home Depot FDL
Menards East Madison
Stoughton Lumber (ACE)
AA Quality Welding & Mfg
Madison
TrueValue Whitewater
Home Depot East Madison
Amount
Spent
499.99
16.82
106.85
36.91
4.74
16.93
Fleet Farm, Beaver Dam
RadioShack West Madison
TrueValue Whitewater
42.20
48.90
8.43
4.16
3.76
18.98
73.85
30.95
5.68
33.73
12.84
8.59
974.31
499.99
474.32
1025.69
Ethical Considerations
The most important ethical consideration is human testing of persons with disabilities. It
is important to ensure user safety during and after the use of our device. Therefore, the design
team must consider all possible ailments found in persons with disabilities. In order to
accomplish this, the team must obtain approval from the Institutional Review Board (IRB) at the
University of Wisconsin (UW) - Hospital. When any testing involving human subjects is
26
undertaken, it must be assured that the subjects will be treated in an ethical, humane matter. For
patients whom are minors, parental consent will need to be obtained prior to testing (Initial
Review Application and Consent Form found in Appendix D).
Future Work
Since we have a working prototype, the most important future work is to gain acceptance
for human subjects testing. We submitted our initial proposal November 8, 2004 and received a
reply from the IRB on December 1, 2004 with feedback about our proposal that must be
modified prior to initiating human subjects testing. Therefore, we must revise our original
proposal and consent form. We must provide additional information as to the recruitment
procedure. We must obtain permission from the UW and Meriter hospitals to post flyers, state
where the flyers will be posted, how we intend to screen our subjects, and who will approach and
consent the subjects who will be invited. We need to clarify where the study will be conducted
and the approximate sample size we will be using. We have to revise the consent form to
indicate that the consent process includes a provision that subjects who cannot see well enough
to read the consent form have it read to them by an advocate (family or friend) or someone not
involved in the research. The consent form should also include a statement so that the reader can
act as a witness and attest to that the form signed by the subject is the same as was read to him
(applicable towards low vision patients). We must clarify when subjects will complete the “Post
Experimental Survey” and the general health inquiry, and instead of having the subjects sign and
date the questionnaire, a study number should be recorded. We must more clearly describe the
methods of each exercise session. The MR-IRB has requested that because subjects with various
disabilities will be involved with this study, an MD medical advisor should be added as part of
27
the key personnel. We need to find a physician to be present during testing and add him to our
key personnel, and also state that all subjects should obtain clearance from their primary care
physician for the exercise part of this study.
Besides gaining acceptance for human subjects testing, there is an abundant amount of
future work remaining for this design project. The first of this future work includes painting the
device to improve its aesthetic appeal. Another area of future work is to improve the user
interface to make it more accessible to the clients’ various abilities. This will include making
larger LCD screens for people with poor eyesight, well-defined, raised letters on the touch
keypad and an audio output for blind subjects, and bounce keys to accommodate Parkinson’s
patients’ tremors. Other future work will involve further construction of the prototype. First, we
will install a ramp and platform to make entering and exiting the device easier. Second, we will
shorten the length of the arm bars to make the exercise bike more ergonomic and comfortable.
Third, we will install a circuit for LED lights to be placed on the foot pedals to help Parkinson’s
patients initiate the movement of placing their feet on the pedals. Once these changes have been
made and approval for human subjects testing is obtained, we will begin testing our prototype
with people of similar abilities as our six hypothetical clients.
28
References
[1] Adams, C. D. & Bennett, S. “Exercise in Heart Failure: A synthesis of Current Research.”
The Online Journal Of Knowledge Synthesis for Nursing. Vol. 7, #5. February 9, 2000.
[2] ButterFly Cylinder. HealthFX America. Retrieved on November 5, 2005 from
http://healthfxamerica.com/cylinder_catalog.htm.
[3] Sendra, S. S. & Smith, K.C. “Mircoelectronic Circuits.” Oxford University Press: New
York. 2004.
[4] NordicTrack SL710. NordicTrack. Retrieved on October 1, 2004 from
http://www.nordictrack.com.
[5] Parkinson’s Disease. MSN Health. Retrieved on September 6, 2004 from
http://content.health.msn.com/hw/parkinsons/hw93188.asp.
[6] Rehabilitation Engineering Research Center. Retrieved on September 3, 2004 from
http://www.rerc-ami.org/index.htm.
[7] RST7000 Total Body Recumbent Stepper. Pro-Med Products. Retrieved on December 6,
2004 from http://www.promedproducts.com/.
[8] Schwinn Airdyne Windjammer UBE. Pro-Med Products. Retrieved on December 6, 2004
from http://www.promedproducts.com/.
[9] Simple Logic Gates. Retrieved on December 3, 2004 from
http://www.brunel.ac.uk/~castjjg/hndcfund/material/logic/part5.htm.
[10] Type 1 Diabetes. MSN Health. Retrieved on September 6, 2004 from
http://content.health.msn.com/hw/diabetes_1_2/hw34305.asp.
[11] Up-Lift Seat Assist. Up-Lift Technolgies. Retrieved on October 15, 2004 from
http://www.up-lift.com/.
29
Appendix A
2004-2005 National Student Design Competition
Open to programs in biomedical engineering, industrial design, and others.
Programs receive up to $2000 in reimbursement for design costs.
First prize: $1000, Second prize: $750, Third prize: $500.
Also $500 award for registration/travel to present a related paper accepted
at a major conference.
Contact: John Enderle, Ph.D., e-mail: [email protected], phone: 860-486-5521
Accessible Ergometer:
Aim: A creative cycle ergometer that is usable by individuals with a diversity of abilities.
Specs: It must be easy to get into, feel stable, be easy to adjust even with low strength or
flexibility, have an easy-to-view display, and be targeted for under $1000 retail. (Can start with
existing unit, if less than $500 retail.)
Clients: Joan, Lloyd, Sophia, Arnold, Wanda, Bob
Joan. Born in 1919, Joan has raised 5 children and has many grandchildren and greatgrandchildren. Now a widow and living in a convalescent home with heart failure, she is
relatively sedentary and is fragile and weak.
Lloyd. Lloyd, a retired pharmacist, was born in 1926. Diagnosed with Type 2 Diabetes in 1989,
Lloyd has poor eyesight and, due to poor diet and lack of exercise, is very overweight (400lbs).
Sophia. Sophia was born in 1920 and emigrated to the U.S. from Poland in 1937. In relatively
good health, Sophia suffered a stroke in 2002. She had several small strokes in 2003, and now
takes heparin as a precautionary measure. She has limited right arm function, walks using a cane,
and needs an exercise bike that is more stable.
Arnold. Arnold was born in 1952 and works as a janitor in a large manufacturing company. He
has diabetes and Parkinson’s disease, and experiences slight to moderate tremors.
Wanda. Born in 1994, Wanda is deaf and has diabetes. Wanda weighs 80 lbs. She is being
encouraged to start administering insulin to herself, as her mother recently passed away and her
father, Bob, is blind. She and her father would like to start an aerobic exercise routine together.
Bob. Born in 1956, Bob is blind and works as an accountant for the State of Connecticut. His
weight fluctuates a lot, and he likes to stay fit by exercising on a cycle ergometer. With the
recent death of his wife, Bob would prefer to exercise less at the local YMCA more with his
daughter, Wanda, at home.
30
Contest Rules
At least 10 projects will be funded each year; the projects can be started during the Fall or
Spring semester and take 1 or 2 semesters to complete the design. Projects are considered on a
first come basis starting early September of each year, with early submission advised. A
university/school may submit up to three team projects, one in each design area, for the
competition. Participating in this competition does not eliminate participation in other programs.
To enter the competition, the student team and faculty advisor submit an email letter of
intent to: Dr. John D. Enderle, University of Connecticut, Email: [email protected],
Phone: (860) 486-5521
The one-page letter of intent should briefly describe the project and how the team
proposes to design the project, the completion date, and contact information for the faculty
advisor and team members. Evaluation of the proposals will be carried out as they are received,
with a response provided within two weeks of submission.
Student teams accepted into the competition will receive reimbursements up to $2,000 for
the project. To receive the reimbursement, the faculty advisor sends the request to Dr. John
Enderle with original receipts, in roughly $500 increments. An “up front” request for an initial
$500 can be made, subject to there being a university account for these funds and a promise of
subsequent documentation. The money provided by the RERC on AMI is intended to build a
working prototype of the device. No other money may be used to support the project, without
prior approval by Dr. Enderle.
For the competition, each team will create a website that will be used to evaluate the
design and to help select the winners of the competition. At a minimum, the website should
contain a final report, detailed photos and a digital video clip of the project in action. The final
report should fully describe the project including detailed drawings and photographs, full
engineering analysis of optimal design and at least one alternative design, consideration of
accessible design principles and how the design addresses the needs of the hypothetical clients,
and all expenses to build the prototype and a projected cost to produce a manufactured product.
For full credit, the project should be tested with representative intended users, with feedback
used to improve the project. Appropriate terminology should be used when dealing with
disability and assistive technologies (see http://www.lsi.ku.edu/lsi/internal/guidelines.html). The
website should be easy to view and navigate from page to page, and follow web accessibility
guidelines (http://www.w3.org/WAI/). The projects will be evaluated at the end of each semester
by a team of judges, with the winners contacted directly and the results posted at the RERC
website http://www.rerc-ami.org/. The cost to produce the project will be a factor in judging;
with no project eligible if over $2000 is used to build the prototype. The top three projects will
receive for First prize: $1000, Second prize: $750, Third prize: $500. Also, all entries are eligible
for up to a $500 award to cover registration/travel to present a paper on the design if it is
accepted and published in proceedings at a major conference.
31
Letter of Intent
32
Appendix B
Product Design Specification
Function: A creative cycle ergometer that is usable by individuals with a diversity of abilities.
Client Requirements:
Joan –
Born in 1919, Joan has raised 5 children and has many grandchildren and greatgrandchildren. Now a widow and living in a convalescent home with heart failure,
she is relatively sedentary and is fragile and weak.
Lloyd –
Lloyd, a retired pharmacist, was born in 1926. Diagnosed with Type 2 Diabetes in
1989, Lloyd has poor eyesight and, due to poor diet and lack of exercise, is very
overweight (400lbs).
Sophia –
Sophia was born in 1920 and emigrated to the U.S. from Poland in 1937. In
relatively good health, Sophia suffered a stroke in 2002. She had several small
strokes in 2003, and now takes heparin as a precautionary measure. She has limited
right arm function, walks using a cane, and needs an exercise bike that is more
stable.
Arnold –
Arnold was born in 1952 and works as a janitor in a large manufacturing
company. He has diabetes and Parkinson’s disease, and experiences slight to
moderate tremors.
Wanda –
Born in 1994, Wanda is deaf and has diabetes. Wanda weighs 80 lbs. She is being
encouraged to start administering insulin to herself, as her mother recently passed
away and her father, Bob, is blind. She and her father would like to start an aerobic
exercise routine together.
Bob –
Born in 1956, Bob is blind and works as an accountant for the State of
Connecticut. His weight fluctuates a lot, and he likes to stay fit by exercising on a
cycle ergometer. With the recent death of his wife, Bob would prefer to exercise
less at the local YMCA more with his daughter, Wanda, at home.
33
Design Requirements:
1. Physical and Operational Characteristics:
a. Performance requirements: The device will be used by a variety of
individuals with various disabilities for aerobic workouts 3 to 5 times per
week. The device must be able to support from 80 to 400 lbs. The device
should measure client’s heart rate.
b. Safety: The device must meet all clients’ disability needs. The design should
comply with the Principles of Universal Design. The material used for the
device must be able to support each client and withstand the force required to
turn the flywheel and move the arm bars.
c. Accuracy and Reliability: The measurement of the heart rate should be within
+/- 3 beats. The measurement of the number of calories burned should be
within +/- 10 Calories.
d. Life in Service: The device will be in use 3-5 days per week for 30-60
minutes and approximately 1200 revolutions per use.
e. Shelf Life: The device will be able to be stored for up to 10 years at room
temperature.
f. Operating Environment: The device will be used by people ranging in weight
from 80 to 400 lbs. The device will be used in a home exercise environment
and will be subject to common household dirt and dust at a temperature range
of 64°F to 78°F.
g. Ergonomics: The device must be accessible for people with a variety of
disabilities indicated above. The device chair must be less than 3 feet high.
The handles must be easily reached when sitting in the chair. The force
required to pedal and to move the arm handles must be small enough to allow
each person to use the device.
h. Weight: The device must be light enough to be able to be transported, yet
heavy enough to provide stability.
i. Materials: The materials used in the device must be able to support the client
weight and the force each client imparts on the device.
j. Aesthetics, Appearance, and Finish: The device should look appealing and
non-threatening.
2. Production Characteristics
a. Quantity: 1 unit is needed.
b. Target Product Cost: $1000
34
3. Miscellaneous
a. Standards and Specifications: The device must follow the Principles of
Universal Design. For human testing, the HIPPA guidelines must be followed
and a Certification of Completion of Human Subjects Protection Training
must be obtained.
b. Customer: The device should be aesthetically pleasing for in home usage.
c. Patient-related Concerns: The design of the device must address all of the
client requirements/disabilities.
d. Competition: There are many varieties of exercise equipment available at
retail stores, but none of them address every disability of our clients. Other
groups are also designing a device for the same clients.
35
Appendix C
Console Buttons
PROGRAM SELECT- This button selects the operating mode of the console. Each press of this
button will reset all console values to zero and advance to the next available program. When a
resistance program is selected, P# will appear in the Speed display. When a heart rate program is
selected, H# will appear in the Speed display.
AGE SET- These three buttons, –, + and Enter, are used to enter the user’s age. The console
calculates the maximum heart rate by subtracting the user’s age from 220. The heart rate
programs then maintain the user’s pulse at a given percentage of that calculated value.
FAN- This button is used to turn the fan on and off. Press the button once turns the fan on low. A
second press turns the fan on high. A third press turns the fan off.
PROGRAM START- Pressing this button starts the currently selected program. The program can
also be started by beginning to pedal the exercise bike.
IFIT.COM- This button is used to select the iFIT© mode. When this button is pressed, the
console will be able to receive commands from iFIT© CDs, videos, and Internet programs that
will control the resistance of the bike as the user exercises.
1 STEP RESISTANCE- These buttons are used to select the resistance level of the exercise bike.
There are 10 resistance settings available. Settings range from 1 – 10, with the first setting at the
lowest resistance and the 10 setting at the highest setting.
36
Appendix D
Revised 4/30/01
Protocol #
UNIVERSITY OF WISCONSIN-MADISON
HEALTH SCIENCES HUMAN SUBJECTS COMMITTEE
Date Received:
2001-364 ver. 2.0
Training Checked:
(FOR OFFICE USE ONLY)
RESEARCH INVOLVING HUMAN SUBJECTS
APPLICATION FOR INITIAL REVIEW
Please submit the following documents to obtain initial review of your research: one copy
of any applicable federal grant proposal and 24 copies of both this application and an
original protocol. Protocols submitted without this form or accompanied by an
incomplete or unsigned form will be returned and NOT scheduled for review. Please
reformat any obvious distortions in this form to assist the review process.
I.
RESEARCHER AND PROTOCOL IDENTIFICATION.
PROTOCOL TITLE:
Accessible Ergometer
PRINCIPAL INVESTIGATOR:
applicable):
Kreg Gruben_
(name)
(608) 262-2711
(phone)
STUDY COORDINATOR (if
______
(fax)
(pager)
1081 Gymnasium-Natatorium_______
2000 Observatory Dr.
(name)
(phone)
(office address)
(office address)
(e-mail)
(e-mail)
[email protected]
(fax)
PLEASE complete the Certification of Completion of Human Subjects Protection Training form
that accompanies this application. This form serves to certify that all investigators and other key
personnel involved with the design and conduct of this research have completed the training
module “Human Subjects Protection at the University of Wisconsin – Madison.” The module must
be completed before the application can be approved.
⌧ YES
NO
YES; If yes, please submit a copy of the federal grant application ⌧ NO
__John Enderle, Ph.D._____________________________________________
University of Connecticut________(860) 486-5521______________________
Grant Number (if known)
________________________________________________________________
Title of Proposal or Award
________________________________________________________________
________________________________________________________________
Principal Investigator's Name
________________________________________________________________
(if different from above)
___________________________________________________________
If federally funded, provide the name and address of the individual to whom official notification (DHHS form 310)
should be sent:
Is the project sponsored?
Is the project federally funded?
Sponsor Name or Granting Agency
37
Signature of Principal Investigator
Date
UW Appointment Classification (e.g., Faculty)
UDDS# and Department Name
UW-MADISON HEALTH SCIENCES HUMAN SUBJECTS COMMITTEE
INITIAL REVIEW APPLICATION
If the Principal Investigator is a fellow, trainee, or student, an academic advisor must signify that he or she assumes
responsibility for ensuring that the Principal Investigator complies with federal and University regulations regarding
human subjects:
Advisor Name
______________________
Telephone ____________
Fax ______________
Advisor's Signature ____________________________
Department ________________
E-mail _______________
Date ____________________________
Final approval of the Health Sciences Human Subjects Committee may require review and/or approval by another
committee representing the University, its affiliates, a department, or a section. Please submit a notice of review and/or
approval by any of the following entities. If review is pending, please indicate the date on which it will occur.
Committee
•
Review Required
Date of Review
University of Wisconsin Comprehensive
Cancer Center Clinical Affairs Committee
YES
⌧ NO
Cardiology Clinical Research Committee
⌧ YES
NO
YES
⌧ NO
263-0169
Reviews all cancer-related research protocols.
•
•
263-9322
Reviews all Cardiology Section research protocols and provides consultation if needed on cardiac issues for protocols
Originating elsewhere.
Institutional Biosafety Committee
Office of Biological Safety
263-4856
Reviews the research use of recombinant DNA and its derivatives.
•
•
Radioactive Drug Research Committee
YES
⌧ NO
YES
⌧ NO
263-9179
Reviews research involving radiopharmaceuticals that do not deliver an intended clinical benefit or that are not FDA
William S. Middleton Memorial Veterans Hospital
Research and Development Committee
256-1901, ext 7863 or 280-7007 (Bev Birdsall)
Reviews all research protocols involving: 1) health sciences researchers with paid appointments at the Veterans Hospital;
2) enrollment of subjects (including use of residual tissue and access to medical records) associated
with the Veterans Hospital; or 3) use of Veterans Hospital facilities, e.g. space.
38
• Research Safety Committee
YES
⌧ NO
_______________________
263-8902
Reviews protocols possessing health hazards, such as gene transfer studies, and protocols intentionally exposing subjects to
infectious agents.
Other ________________________________
(Committee Name)
_____________________________
(Date of Review)
• General Clinical Research Center (GCRC)
⌧ NO
263-3271. Do you intend to use the GCRC?
YES
If yes, please complete the GCRC Addendum and submit a copy of this form and the GCRC
Addendum to the GCRC. A copy of the GCRC addendum can be found on the HSC website or from
the GCRC.
UW-MADISON HEALTH SCIENCES HUMAN SUBJECTS COMMITTEE
INITIAL REVIEW APPLICATION
II.
ABSTRACT. IN LAY TERMS using 250 words or less, please describe: 1) your research
question; 2) your experimental design; 3) the major risks to subjects; 4) the potential benefits to
subjects; and 5) your specific consent procedure(s). Please do NOT refer to sections of your protocol
or to "see attached" in this abstract.
We aim to perform a pilot study to determine if patients with a variety of abilities are able to
access an exercise machine and utilize all necessary components with minimal difficulty.
Our research focuses on the development of an accessible cycle ergometer (synonymous to a
stationary exercise bike) for persons with a variety of disabilities such as: heart failure,
diabetes, low vision, overweight, stroke, Parkinson’s disease, deaf, and blind. Subject
participation in this study is completely voluntary. If they are willing to participate in the
research, subjects will read and sign a consent form and complete a general health survey.
The participants in the study will be between the ages of 18-70 and have at least one of the
aforementioned disabilities. Participants with heart failure will not be required to exercise,
only to sit in the device and assess their ability to enter and exit the machine. The cycle
ergometer consists of foot pedals to allow for circular motion and thus, lower body workout.
Furthermore, arm handles with forward and back motion to allow for the upper body workout.
In addition to the implemented arm motion, heart rate monitor sensors are embedded in the
handles to allow for heart rate output from the user’s palms. A group of 35 subjects will be
asked to participate with multiple rounds of testing possible. Subjects will be evaluated on
ability to enter the device, situate themselves on the device, perform a short (approximately 5
minutes maximum) mild workout, and finally exit the device with little to no assistance.
Participants have the option to terminate their experiment anytime should they be fatigued in
any way or in shortness of breath. Before each new experiment, the device (including the
heart rate monitor sensors) will be sterilized with an antibacterial cleaner.
39
III. QUESTIONNAIRE. PLEASE ANSWER ALL OF THE FOLLOWING QUESTIONS.
IF YOU ANSWER “YES” TO ANY QUESTIONS, PLEASE INCLUDE DETAILS IN
SECTION IV, “STUDY DESCRIPTION.” “YES” ANSWERS ALSO INDICATE THAT
ADDITIONAL REQUIREMENTS MAY APPLY TO YOUR PROTOCOL.
A.
VULNERABLE GROUPS:
1.
⌧ YES
NO
Will this study involve minors (people less than 18 years old)?
2.
YES ⌧ NO
Will this study involve subjects who have a status relationship (e.g.,
students or employees) with the principal investigator(s)?
3.
YES ⌧ NO
Will this study involve prisoners?
3A. If Yes:
Are control group subjects randomly selected?
YES
NO
If the answer to 3A is no, please provide justification in the study
description.
UW-MADISON HEALTH SCIENCES HUMAN SUBJECTS COMMITTEE
INITIAL REVIEW APPLICATION
4.
YES ⌧ NO
Will this study recruit psychiatric inpatients or people who are
institutionalized (e.g., in a mental health facility, nursing home, or
halfway house)?
5.
YES ⌧ NO
Will this study include women with childbearing potential?
6.
YES ⌧ NO
Will this study exclude fertile women?
7.
YES ⌧ NO
Will this study include subjects from the Middleton VA Hospital?
8.
YES ⌧ NO
Will this study include adults who have impaired decision-making
capacity (e.g., coma, dementia, confusion, or mental disorders)?
9.
YES ⌧ NO
Will this study include gametes, embryos, fetuses, or involve tissues
from embryos or fetuses?
10.
YES ⌧ NO
Will this study target or exclude a particular ethnic or racial group?
B.
11.
SPECIAL PROCEDURES:
YES ⌧ NO
Will this study involve an investigational new drug (IND)?
IND #_________
If you hold the IND, please also provide 3 copies of the application submitted to the FDA.
12.
YES ⌧ NO
Will this study involve an investigational device?
40
IDE# _____________
If you answer “YES” to question 12, please include 3 copies of the IDE specifications.
13.
YES ⌧ NO
Will this study involve the administration to subjects of
radiopharmaceuticals that are NOT FDA approved?
If you answer “YES” to question 13, please contact the secretary for the Radioactive Drug
Research Committee (RDRC) at 263-9179.
14.
YES ⌧ NO
Will this study store blood or tissue samples beyond publication of
the study results?
15.
YES ⌧ NO
Will this study use an existing depository or collection of blood or
tissue samples?
UW-MADISON HEALTH SCIENCES HUMAN SUBJECTS COMMITTEE
INITIAL REVIEW APPLICATION
16.
YES ⌧ NO
Will this study do testing for genetic markers on blood or tissue
samples?
If you answer “YES” to questions 14, 15, or 16 you should consult HSC Guidelines for Genetic
Research and the Use of Storable Tissues for potential consent form language. You should also
complete the tissue collection information sheet in those Guidelines and attach it to this form.
17.
YES ⌧ NO
Will this study involve the administration to subjects of recombinant
DNA materials?
If you answer “YES” to this question you should consult the staff of the Biological Safety
Office at 263-4856.
C.
SPECIAL POLICIES:
18.
YES ⌧ NO
Will this study use a placebo?
19.
YES ⌧ NO
Will this study potentially reveal that subjects engaged in illegal
behaviors or stigmatizing behavior (e.g., illicit drug use, child abuse,
alcoholism, or gambling)?
20.
⌧YES
NO
21.
YES
⌧ NO
22.
⌧ YES
NO
Is this study minimal risk?
Are you requesting a waiver of written consent?
Will this study use advertising, recruitment letters, or recruitment
posters to invite subject participation?
If you answer “YES” to question 22, please attach copies of these materials to this form.
41
23.
⌧ YES
NO
Will this study use questionnaires, surveys, or other written
assessment instruments?
If you answer “YES” to question 23, please attach of copy of these materials to this form.
24.
25.
26.
⌧ YES
NO
YES ⌧ NO
Will this study involve non-UW researchers?
Will you conduct this study outside of the United States?
Where will you conduct this study?
⌧
⌧
UWHC
Middleton VA Hospital
Meriter Hospital
Other site(s). Please list:
_____________________________
_____________________________
_____________________________
_____________________________
UW-MADISON HEALTH SCIENCES HUMAN SUBJECTS COMMITTEE – INITIAL REVIEW
APPLICATION
HSC Protocol #2001-364 – version 2.0
7/27/01
IV. STUDY DESCRIPTION. IN NO MORE THAN 2000 WORDS (A MAXIMUM OF 4 PAGES)
please describe your study in the format outlined below. A study description longer than four pages or a
faxed copy of your study description are NOT acceptable and will NOT receive assignment for review.
Please do NOT refer to sections of your protocol or to “see attached” in your study description.
A. Explain the benefit to society that would result if you perform your study. Concisely
identify the study’s purpose in the context of currently available and relevant knowledge.
There are a variety of disabilities people can have that would impair their ability to lead a normal,
functional life. Some of these disabilities include partial or complete loss of vision, loss of motor
control, and other sensory deficits (e.g. touch). These disabilities can not only directly affect a
specific function of a person’s body, but also cause other harm to the person due to a loss of
functionality. Many times, someone who has lost sensory information or some motor control will
be unable to exercise and maintain a healthy lifestyle. An ergometer device that offers users with a
variety of disabilities the ability to exercise will allow these individuals to lead a healthier lifestyle
and ultimately increase their quality of life.
B. Describe the design of your study (i.e., hypothesis, specific aims and methods.) Use care
to distinguish experimental interventions from standard medical treatment. Specifically
include the following information:
Subjects will be asked to use an ergometer device designed to allow users with disabilities to
exercise. It is hoped that the device will allow people with disabilities to lead a more active and
healthier lifestyle.
1.
How long will this project take to complete? Provide start and end dates.
Provided HSC approval is obtained, testing of subjects commence in January 2005 and
continue through April 2005.
42
2.
Who will be the subjects of your study? Where will you find these subjects? How
many subjects will the entire study enroll? How many subjects will you enroll at
your site? How many subjects are controls? If the study involves more than two
study arms, please identify each one and its expected number of subjects. List the
primary criteria for subject selection and exclusion.
Subjects for this study will come from the Madison community. Both individuals with normal
motor control and sensory systems and those with loss of motor control and sensory system
dysfunction will be used as subjects. Our study will enroll four control subjects and eight to
ten experimental subjects with multiple rounds of testing possible. Subjects with loss of motor
control and sensory system dysfunction will be recruited through hospital advertisement and
by invitation.
3.
What method(s) will you use to recruit subjects? Will these methods involve
material inducements?
All subjects will be asked to participate in multiple experimental sessions. Participation in this
study is entirely voluntary. No monetary compensation will be provided.
4.
Does your study have a statistical justification for its sample size? For the analysis
of its results? If you answer “yes” to these questions, briefly describe each
justification.
No, the results will not be significant due to the small sample size.
C. Identify the potential risks to subjects of participation in your study. Describe the
expected frequency, severity, and reversibility of the major risks you identify. Include
possible late effects of participation (e.g., secondary cancers).
1. Risk associated with health problems: The subjects we will be testing will have either a loss
of motor control or sensory system deficiencies. If the subjects feel any discomfort of shortness of
breath, they can terminate their exercise immediately. Heart rate will be monitored while the test is
conducted, and the subject will stop the exercise immediately if their heart rate becomes 60 percent
of their maximum heart rate determined by the age-adjusted formula:
Male: 210 - (1/2 your age) - (.05 x your body weight) + 4
Female: 226 - (1/2 your age) - (.05 x your body weight).
2. Risk associated with disease transmission: Because the same ergometer will be used by
multiple subjects, there is the possibility for disease transmission. This risk is reduced to an
extremely small amount by material sterilization. Any material that may come in contact with a
subject will be first sterilized.
Prior to experiments, subjects will complete a questionnaire (attached) to assess general health and
to identify certain conditions that may contraindicate participation in this study (e.g. severe heart
problems, paraplegic). This information will be held confidential.
3. Risk associated with falling: Because we are striving to develop an ergometer that is accessible
to people with motor control and sensory disabilities, we must test the device under conditions that
allow us to determine improvements that are necessary to alleviate problems encountered with these
disabilities. The device, and therefore the study, is designed to minimize these risks to the subject.
There will be four supervising experimenters present during testing. At the time the testing will
commence, one of the experimenters will be certified in Adult and Infant CPR from the American
43
Red Cross. In the event of a medical emergency, three of the experimenters will attend to the
subject while the other will contact Emergency Services at 9-9-1-1.
D. Identify the expected benefits to subjects of participation in your study. Also identify any
potential scientific benefits produced by your study.
We do not expect that the system will provide any practical benefit to our clinical subjects.
However, it is hoped that this research will aid the subsequent development of an accessible
ergometer for not only persons with motor control and sensory problems, but also for persons with
a wide range of disabilities.
E. Describe the procedure for obtaining the consent of each subject or the subject's parent or
representative. Confirm that you have attached a copy of each consent form. The form
should include all the elements of consent listed in the HSC Guidelines.
Prior to data collection, all individuals interested in participating will be required to read and sign a
copy of the attached consent form.
Certification of Completion of Human Subjects Protection Training Program
Please list alphabetically the names, office addresses, and contact information for ALL
University of Wisconsin-Madison investigators and other key personnel who are
responsible for the design and conduct of this research.
Kreg Gruben
(608) 262-2711
[email protected]
Amit Mehta
608-347-0309
[email protected]
Jon Millin
920-251-9366
[email protected]
Ryan Pope
920-723-6532
[email protected]
Jeff Swift
920-217-9131
[email protected]
Justin Williams Ph.D.
608-265-3952
44
[email protected]
As Principal Investigator of this protocol, I certify that I and the key personnel listed above
have completed the training module “Human Subjects Protection at the University of
Wisconsin – Madison” available at
http://www.rsp.wisc.edu/humansubs/training/UWHSTraining.html.
I realize that:
1) This certification is to satisfy UW-Madison and NIH policy requirements, and
2) I am accountable for the accuracy of this certification.
______________________________
Principal Investigator’s Signature
_____________________________
Date
45
RESEARCH SUBJECT INFORMATION AND CONSENT FORM
You are invited to participate in a research project designed to evaluate how well people can
use the cyclic ergometer (exercise bike) and perform proper entry and exit to the device with little
to no assistance and still obtain an aerobic workout. You have been invited to participate in this
research because you have ailment(s) including: Heart Failure, Diabetes, Low Vision, Overweight,
Stroke, Parkinson’s disease, Deaf, and/or Blind. During the research study, you will be asked to
enter the device and situate yourself comfortably on the exercise seat. You will then perform a short
workout in which you will perform lower body workout by pedaling with your feet and perform upper
body workout by pushing and pulling the handles. During your exercise, the heart rate monitor sensors
embedded in the handles will monitor your heart rate. Lastly, we will observe you as you exit the device.
We are interested in learning how patients with a variety of abilities would be able to access this device
and if they can do it with minimal effort and still obtain a sufficient workout. We intend to test the device
on 35 other individuals with the afflictions listed above.
What does the experiment involve?
At the beginning of your trial, you will be asked to enter the device and sit on the seat. You can make
any adjustments to the seat height, its distance from the foot pedals, and arm handles until you are fully
comfortable. We will observe your ease of entering the device as well as examine any necessary
adjustments you made to the device. We will then ask you to perform a short workout (approximately
five minutes) in which you can pedal with your feet and move the arm handles either simultaneously or
independently of each other. During your exercise, we will closely monitor your ability to use the
machine and watch your heart rate from the heart rate monitor sensors embedded in the handles. At the
end of your exercise, we will then ask you to exit the device will little to no assistance and, again, observe
you ability to do so. At the conclusion of the experiment, we will ask you to complete a general health
inquiry and a post experimental survey. The information you provide will be kept confidential. Each test
session should last a maximum of half hour with about five minutes of actual exercise time.
Is there any discomfort or risk?
The same exercise bike will be used by several differently-abled subjects. There is therefore
a small chance for an infection to be transmitted between subjects via bodily fluids. However,
prior to each trial, the device will be thoroughly sanitized and sterilized with antibacterial
cleaners. This is of greater importance with the heart rate monitor sensors since previous
participants may have left behind sweat deposits. There is also the risk of temporary muscle
fatigue/strain with the possibility of accompanied muscle soreness that is expected with new
exercise routines. This soreness should diminish within 2 to 3 days without treatment.
Will compensation be paid in the event of an injury?
In the event that you are physically injured as a result of participating in this research, emergency care
will be available. You will, however, be responsible for the charges for the emergency care. There is no
commitment to provide any compensation for research-related injury. You should realize that you have
not released this institution from liability for negligence. Please contact the Principal Investigator, Kreg
Gruben Ph.D., at (608) 262-2711 if you are injured or for further information.
For more information on the rights of research subjects, you may contact the UWHC Patient Relations
Representative at (608)-263-8009.
46
Where will the study take place?
The study will take place at either the UW Hospital and/or Meriter Hospital (Room assignment TBA).
Sessions will last half hour at the maximum with approximately five minutes of actual exercise.
Will study results be confidential?
Your identity will not be revealed in publications or reports that may result from this study, nor will
your name be used in other research communications such as lectures or scientific meetings. Data
obtained from the Health Questionnaire will be kept strictly confidential. Upon your approval, we may
videotape you for the duration of the study. Your video clip will be posted on our website and will be
accessible to the investigators only upon password authorization.
Will I be paid for my participation?
No, participation in this study is completely voluntary.
Is there any benefit to participation?
You will not personally benefit from participation, but society may benefit from the creation of an
assessable exercise bike that is usable by patients of various abilities and being universally applicable to
all users.
If you change your mind:
Participation in this study is voluntary. If you change your mind at any time you are free to end the
session and to withdraw from the study. If you decide not to participate or to withdraw, it will not affect
your status as a student or employee at the University of Wisconsin or treatment at the University of
Wisconsin Hospitals and Clinics.
You may take as much time as you need to make up your mind if you will participate. Before you
sign this form, please ask any questions you wish on the aspects of the study that are not clear to you. We
will attempt to fully answer any questions you may have prior to, during, or following this study.
AUTHORIZATION: I, __________________________________________, have read, or have had read
to me, the above and I have decided to participate in the research project described above. My signature
also indicates that I have received a copy of this consent form.
___________________________________
Signature
___________________________
Date
___________________________________
Signature of Principal Investigator or
Signature of person obtaining consent
___________________________
Telephone
47