University of Waterloo
Date: (insert date)
Title of the project: (insert title)
Figure 1
Faculty Supervisors: (insert names, affiliation, phone, email)
Student Investigator: (insert name, affiliation, phone, email)
Purpose of the study:
This study is being conducted to model two parts of the human body involved in
tremulous elbow movement. These two parts are elbow muscles that produce the force
and brain-CNS that produce neuro-signals to control the muscles. (CNS stands for
Central Nervous System). It is worth noting that the human elbow is a joint capable of
two different motions, flexion-extension and pronation-supination. We are interested in
the first movement illustrated in the picture below:
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Figure 2
What you will be asked to do:
As a participant in this study, you will be asked to sit at a table and secure your elbow
and lower arm, using two straps, to the experimental apparatus (as in Figure 1, above).
You will be asked to apply some forces on the apparatus. The level of the required force
and what you are actually applying will be shown to you on the computer screen. The
required force level will change in a random pattern and you will try to follow that. During
the experiment 2 sets of EMG (electromyography) electrodes are going to be attached to
your upper arm to measure muscle activities. If you don’t have any problem moving your
elbow and applying forces with it, there will be no discomfort encountered. Actually, to
avoid fatigue, we are going to have 2-3 minutes of rest between every two sets of
measurements, and this break could be extended if you would like. Roughly speaking,
the experiment consists of a half- an- hour orientation and preparation and then onehour data collection.
To be able to place the electrodes, it would be easier if you can wear short
sleeves. Before placing the electrodes, we are going to use rubbing alcohol to clean the
skin, so if you are allergic to alcohol you should not participate. The electrodes are a
disposable type which stick to your skin on applying a mild pressure and can be easily
removed. To hold down the electrodes we will use elastic tape. If your skin is hairy
enough to impede electrode attachment we will ask you to shave two small areas (of 5*3
cm) on the middle of your Biceps and Triceps, or you can do it here using disposable
shavers.
Experimental procedures:
First part is mostly orientation and calibration in which after getting familiar with the
device and attaching your elbow to it, we will take the following measurements:
1. Before attaching electrodes to your skin, we’ll get their signal for 2 sec
2. You’ll try to apply your maximum force to the device for 2 sec in flexion direction
(repeated once more)
3. Apply maximum force in extension direction (twice)
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4.
5.
6.
While your muscles are at rest we’ll measure their signals for 2 sec
You will try to apply 50% of your maximum force in both (extension-flexion)
directions. You can see actual force level on the screen.
(Second or main part) there will be 15 trials which are 30sec. each. In each trial, a
desired force level with changing amplitude (between 50% of your maximum force in
flexion to 50% maximum force in extension direction) is going to be displayed on the
screen, and you will be asked to follow applying the same forces. There would be at
least 2-3min rest between each two trials.
Voluntary Participation and Withdrawing from participation:
You are absolutely free not to participate and may quit from this study at any time
without penalty.
With your agreement, we might contact you again in a few months to tell you
about another study we will be conducting to obtain brain-CNS model parameters. You
may decide at that time whether or not to participate in that part of the study.
Confidentiality:
In order to ensure the confidentiality of individuals’ data, all information collected from
participants in this study will be aggregated. Therefore, your name will not appear in any
report, presentation or publication resulting from this research. The data, with identifying
information removed, will be kept for a period of two years and will be securely stored in
a locked office on a single password protected computer.
It should be noted that, there are two groups of participants. One group is people
with noticeable tremors in their hands, the other group without such tremors. After the
study is completed, you will be provided with feedback including the difference between
the average model parameters in the two groups (average of all participants in each
group). You will also be provided with a copy of any scientific articles prepared for
presentation or publication based on the study.
Risks to Participation:
As a final note and as mentioned earlier, if you are comfortable in moving your elbow
applying flexion-extension forces (as in picture above), there is no known risk to
participation. This device does not apply any force on your body and is just a measuring
tool of your applied force. For people with tremulous hand, discomfort level (if any) will
not be greater than what is normally experienced in performing arm movements,
however, if you feel noticeable discomfort while performing the tasks, please advise the
researcher and participation will stop.
Contact Information:
If you have any questions regarding participation in this study, please feel free to ask
the researchers. In case of additional questions at a later time, please contact Professor.
(insert name) at: (519)888-4567 ext. xxxxx or by e-mail at: (insert email).
This project has been reviewed by, and received ethics clearance through a University of
Waterloo Research Ethics Committee. In the event you have any comments or concerns
resulting from your participation in this study, you may contact Dr. Maureen Nummelin,
the Director, Office of Research Ethics, at 1-519-888-4567, Ext. 36005 or
[email protected].
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Consent to Participate
By signing this consent form, you are not waiving your legal rights or releasing the
investigator(s) or involved institution(s) from their legal and professional responsibilities.
______________________________________________________________________
I have read the information presented in the information letter about a study being
conducted by (insert name of student investigator), under the supervision of
Professor (insert name of faculty supervisors) of the Department of (insert
department name) at the University of Waterloo. I have had the opportunity to ask any
questions related to this study, to receive satisfactory answers to my questions, and any
additional details I wanted. I am aware that I may withdraw from the study without
penalty at any time by advising the researchers of this decision.
This project has been reviewed by, and received ethics clearance through a University of
Waterloo Research Ethics Committee. I was informed that if I have any comments or
concerns resulting from my participation in this study I may contact the Director, Office of
Research Ethics at 519-888-4567, ext. 36005.
With full knowledge of all foregoing, I agree, of my own free will, to participate in this
study.
Participant Name: __________________________________
(print)
Participant Name: __________________________________
Dated at Waterloo, Ontario: __________________________
Witnessed: ________________________________________
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