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

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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

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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

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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 Figure 2: RST7000 Total Bod Windjammer UBE [8]. 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

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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].

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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].

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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

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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.

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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.

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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

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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).

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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.

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Fpiston vs. Seat Angle

0

10

20

30

40

50

60

70

80

0 5 10 15 20 25 30 35 40 45 50

Seat Angle (degrees)

Fpis

ton

(lbs)

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).

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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).

36 inches

12 inches

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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).

20 inches

10 inches

13 inches

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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.

L-Beam

Plastic Wheels

U - BoltRollerblade wheels with bearings

10”

Stop Nuts

Seat BaseSeat Base

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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.

17.3348”

36”

3.5”

Seat platform

Linear Actuator

Ground Level

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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).

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

13.25”9.5”

5.25”

10.5”

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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.

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

4.5”

16”

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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).

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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

9.25”

12.5”

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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.

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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.

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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.

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

X Y X OR Y

0 0 0

0 1 0

1 0 0

1 1 1

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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

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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

26

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 Retailer Amount Spent

NordicTrack SL710 Sears Madison West 499.99100lb gas spring MSC Industrial Supply 16.8212" Stroke Linear actuator ebay.com 106.85Rollerblade wheels, 55mm diameter, 8 pk Dick's Madison East 36.91Momentary three way switch RadioShack East Madison 4.74bolts, nuts, washers, casters, angle steel 6' Menards East Madison 16.93

1.5"x2.5" rect. Tube, 1"x2" rect. Tube AA Quality Welding & Mfg Madison 42.20

2 Butterfly cylinders HealthFX America 48.901.25"x48" L-steel TrueValue Whitewater 8.43U-bolts x 4 Home Depot FDL 4.16washers, nuts, all thread rod Menards East Madison 3.76Wireless doorbell chimer Stoughton Lumber (ACE) 18.98

1.5"x1.5"x3/16" tube, 1" tube AA Quality Welding & Mfg Madison 73.85

Misc. Nuts, bolts, and washers TrueValue Whitewater 30.95Leveling feet, and nuts Home Depot East Madison 5.68Paint, battery terminals, cable ties, wire, batteries Fleet Farm, Beaver Dam 33.73Electrical tape, heat shrink pcs. , terminal kit RadioShack West Madison 12.84bronze bearings, chain, steel spacers TrueValue Whitewater 8.59 Current total 974.31Reimbursements 499.99Remaining reimbursements 474.32Budget Remaining 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

27

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

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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.

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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/.

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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: jenderle@bme.uconn.edu, 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 great-grandchildren. 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.

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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: jenderle@bme.uconn.edu, 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.

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Letter of Intent

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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 great-grandchildren. 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.

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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

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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.

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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.

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Appendix D

Revised 4/30/01 UNIVERSITY OF WISCONSIN-MADISON HEALTH SCIENCES HUMAN SUBJECTS COMMITTEE

Protocol # 2001-364 ver. 2.0 Date Received: 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: STUDY COORDINATOR (if applicable):

Kreg Gruben_ ______ (name) (name) (608) 262-2711 (phone) (fax) (pager) (phone) (fax) 1081 Gymnasium-Natatorium_______ 2000 Observatory Dr. (office address) (office address) gruben@education.wisc.edu (e-mail) (e-mail) 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.

Is the project sponsored? Is the project federally funded? Sponsor Name or Granting Agency Grant Number (if known) Title of Proposal or Award Principal Investigator's Name (if different from above)

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______________________ ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

If federally funded, provide the name and address of the individual to whom official notification (DHHS form 310) should be sent:

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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 ______________________ Department ________________

Telephone ____________ Fax ______________ E-mail _______________ Advisor's Signature ____________________________ 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 YES NO

Cancer Center Clinical Affairs Committee 263-0169 Reviews all cancer-related research protocols.

• Cardiology Clinical Research Committee YES NO

263-9322 Reviews all Cardiology Section research protocols and provides consultation if needed on cardiac issues for protocols Originating elsewhere.

• Institutional Biosafety Committee YES NO

Office of Biological Safety 263-4856 Reviews the research use of recombinant DNA and its derivatives.

• Radioactive Drug Research Committee 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 YES NO

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.

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• 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)

263-3271. Do you intend to use the GCRC? YES NO 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.

40

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. SPECIAL PROCEDURES: 11. 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?

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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 Is this study minimal risk? 21. YES NO Are you requesting a waiver of written consent? 22. YES NO 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.

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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. YES NO Will this study involve non-UW researchers? 25. YES NO Will you conduct this study outside of the United States? 26. 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.

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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

44

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 gruben@education.wisc.edu Amit Mehta 608-347-0309 amitmehta@wisc.edu Jon Millin 920-251-9366 jsmillin@wisc.edu Ryan Pope 920-723-6532 poper@cae.wisc.edu Jeff Swift 920-217-9131 jaswift@wisc.edu Justin Williams Ph.D. 608-265-3952

45

jwilliams@engr.wisc.edu 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

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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.

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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 Telephone Signature of person obtaining consent