Teleoperation Experimental Comparison With Able-bodied Subjects
Phase: NA
Conditions: Amputation; Traumatic, Arm, Upper
Sponsor: Point Designs

Cover Page 
Official Title of the Study: Teleoperation Experimental Comparison With Able-bodied Subjects 
Document Date: July 19, 2022 
NCT Number: NCT05048394 

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COMIRB 
Protocol 
COLORADO MULTIPLE INSTITUTIONAL 
REVIEW BOARD 
CAMPUS BOX F-490   TELEPHONE: 303-724-1055 Fax: 303-724-0990 
 
Protocol #: 14-0838 
Project Title: 
Biomechatronics Development Lab Myoelectric Controller protocol 
 
Principal Investigator: Richard Weir 
Version Date:   07/19/22 
 
I. Hypotheses and Specific Aims:  The purpose of this protocol is to provide guidelines for research  
and development of more intuitively controlled myoelectric prosthesis.  Self‐identified adult  
volunteers will be used for convenience sampling for the population served.  
 
 
II. Background and Significance: Currently available multi‐joint prostheses cannot 
be fully utilized because there are fewer control inputs than the number of joints that 
need to be controlled. Based on the work in the field of neuroscience, it has been 
shown that grasping is a ‘low dimensional’ task (i.e. – only 2‐3 control inputs are 
necessary). We will develop control paradigms and upper limb prostheses 
components to control a multi‐joint prosthetic hand using currently available clinical 
practices and investigate which dimensions are most important for prosthetic devices.  
 
III. Preliminary 
Studies/Progress Report: 
IV. Research Methods 
A.  Outcome Measure(s): 
Outcome measures include completion rate, time to completion and path efficiency 
metrics as well as position of the arm, wrist, and hand during these tasks.  
Additional outcome measures may include time of use, types of actions performed, 
location information (GPS), and/or power consumption. These metrics help define 
the performance of the postural control paradigm for EMG control and design of 
advanced prosthetic hands.  
 
B.  Description of Population to be Enrolled: 
The subject population will consist of a convenient sample of adult volunteers, both 
able bodied and limb deficient. The subjects will have various ethnicity, age, and 
gender. An estimated total of 60 subjects will be enrolled. The subjects must be able 
to understand and follow directions in English, assessed by their ability to respond 
during the recruitment and consent process. Exclusion criteria include any subjects 
that are not able to understand the procedures or are taking blood thinners. Subjects 
will be recruited via flyers placed at the Anschutz or Auraria  campuses, flyers emailed 
to organizations that work with our target population, or in-person at conferences 
and events to which we have been invited.  
 

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Because of the potentially long distances we will need to travel to meet with 
participants and the demands of work on other researchers we will not be able to 
have more than one researcher travel at a time.  In order to ensure the safety of a 
single researcher traveling to a participant’s location, we will enforce the following 
safety procedures:  
 
When traveling to off-site locations, researchers only a licensed and insured driver 
in a well-maintained vehicle with appropriate equipment for conditions will drive. 
Driver has AAA membership which will be used in case of emergency. 
Experimentation will only take place during normal business hours when other 
research staff can be reached in case of unanticipated emergency.  
 
We will keep a log in the lab describing where we are traveling and with whom we 
are meeting. We will only travel to participants with whom we have previous contact 
and have determined to be safe. Traveling researcher will keep a cell phone with 
them and check in with other researchers in the lab at least every 3 hours via cell 
phone to confirm that they are safe.  
  
C.  Study Design and Research Methods 
The experiments will take place at the Biomechatronics Development Laboratory in the Children’s 
Hospital on Anschutz campus, the University of Boulder Campus, and/or during normal at-home 
use. The participant will come up to 3 times for up to 4 hour sessions. An optional at-home use 
period can take place for up to 6 months.  During this session the participant will be asked to 
control a virtual hand (a 3D image of a hand on the computer screen) and/or a prosthesis by 
contracting the muscles in the forearm and to manipulate physical objects on the table. The only 
devices coming into contact with the participant will be standard of care myoelectric control and 
motion capture equipment including surface and intramuscular electromyographic (EMG) sensors.  
Other equipment to be used in the laboratory include  a data glove (Cyberglove II by Cyberglove 
Systems, LLC), vibrating motors, reflective markers (OptoTrak, Northern Digital Inc), and 
electrogoniometers (Biometrics Goniometer, Motion Lab Systems, Inc.). During at-home use, 
subjects will use standard of care surface EMG sensors installed into a prosthetic socket.  Standard 
of care procedures involving palpation of the subject's arm will be used to locate the best position 
on the arm for the surface and Intramuscular EMG and motion capture sensors. The EMG sensors 
measure muscle activation levels and send the information to the computer to enable the control of 
the virtual hand or prosthesis. The motion capture sensors and goniometers give us a measurement 
of the position of the arm. A training period will be followed by several tests to measure the 
intuitiveness and functionality of several versions of the controller. Different versions of the 
controller will be presented to the subject in a randomized order. The subject will be expected to 
try and acquire target hand postures displayed on the screen using this control interface. Subjects 
will likewise be given a training period to practice moving the physical objects. 
 
Additionally, we may travel to the subject’s preferred location (e.g. home or office) to conduct 
testing with surface EMG, motion capture, goniometers, or video. This will allow us to maximize 
recruitment and include subjects who live too far from the Anschutz campus to participate. 
 
Video will be taken from behind and will not include identifying information such as the subject’s 
face. Video will be used to record arm and shoulder motion during the experiment to be analyzed 
later. This allows us to determine whether compensatory motion is affected by different 
prostheses.  
 
An optional home-use period may take place.  A prosthetic limb system using surface EMG sensors 
and a prosthetic hand will be sent home with the subject.  It will be used during everyday activities.  
The surface EMG sensor will be permanently installed into the prosthetic limb system and will not 
need to be replaced.  The subject will be asked to use the prosthetic limb system as their primary 
prosthetic limb (daily use) unless it is not appropriate due to the task/environment.  The home-use 
period will last up to 6 months. 
 

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D.  Description, Risks and Justification of Procedures and Data Collection Tools: 
We will be acquiring muscle activity data for the control of a prosthesis using Electromyography 
(EMG) in conjunction with motion capturing devices and finger mounted force sensors. Surface 
EMG allows us to create pattern recognition of a composite muscle signal, and intramuscular EMG 
allows us to focus on particular muscles, or muscle slips. Risks of Surface EMG and motion capture 
are possible minor skin discomfort from the medical tape/adhesive used to attach sensors to the 
skin and/or from preparation of skin for attachment. The intramuscular EMG electrodes introduce a 
minimal risk of infection, and nerve injury as well as minimal bleeding. Any injury to nerves is temporary 
and may involve numbness or pain. When the procedure is finished, the electrodes will be removed. All 
equipment and insertion sites will be sterilized in accordance to standard of care procedures. The 
Intramuscular EMG electrodes may be used in conjunction with surface EMG or as an alternative to 
surface EMG. If you feel that you have been harmed while participating in this study, you should 
inform Richard Weir at 847‐912‐1032 immediately. 
 
E.   Potential Scientific Problems: 
Potential scientific problems include a lack of subjects with upper‐limb amputation and the 
inability of subjects to learn the postural control paradigm to a high level. 
 
F.  Data Analysis Plan: 
Data will be processed with standard techniques in MATLAB (Mathworks, Inc.) in order to produce 
the metrics described previously (completion rate, time to completion, and path efficiency). 
 
G. Summarize Knowledge to be Gained: 
The development of more intuitive and functional prosthesis controllers will augment the quality 
of life for people with upper‐limb amputation. 
 
H. References: 
N/A