Investigational Study of the Ekso Bionics Powered Exoskeleton for High-Dosage Use by Individuals With Spinal Cord Injury in a Non-Clinical Environment
Phase: NA
Conditions: Spinal Cord Injuries
Sponsor: Ekso Bionics

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
1 
 
Investigational Study of the Ekso Bionics Powered 
Exoskeleton for High-Dosage Use by Individuals with 
Spinal Cord Injury Walking in a Non-Clinical Environment 
 
1. Investigator 
Facility PI: Katherine Strausser, PhD, Sr. Controls Engineer, Ekso 
Bionics 
 
2. Date Revised 
September 28, 2015 
 
3. Objectives 
3.1 
To determine the physiological effects of high-dosage use of the 
Ekso device over a 12- 36-month period. 
3.2 
To documents the quality of life benefits of using an Ekso 
device in a non-clinical setting. 
3.3 
To define the safety and efficacy of using the device in a home 
environment. 
3.4 
To determine the safety and efficacy of a non-medical 
professional spotting the subject. 
3.5 
To determine inclusion/exclusion criteria for an Ekso Bionics 
device used in a home setting. 
 
4. Background 
The incidence of spinal cord injury is estimated at 1.5-5.3 million 
worldwide.(1) “Will I walk again?” is often cited as one of the more 
common questions, with the decreased ability to walk as one of the 
most difficult challenges to live with.(2,3)  Over the last 10 years 
more research has focused on the ability for the spinal cord to” 
heal” itself, i.e. undergo plasticity,(4,5) by task-specific, high-

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
2 
 
intensity activities.(4,6) Two major groups of task specific 
activities for ambulation have been developed.  The first option is 
conventional over the ground training (CONT), where a number of 
therapists help support the subject while the others assist in moving 
the limbs in a reciprocal gait pattern. The other option, body weight 
supported training (BWST), involves partial support of the subjects 
weight via a harness while a therapists moves the lower limbs in a 
reciprocal gait pattern either over ground, in water or over a 
treadmill. A subset of BWST uses a robotic device in place of a 
therapist to move the limbs in a reciprocal gait pattern.  The 
advantages of BWST include starting training before the subject can 
fully bear weight, prior to developing adequate motor control, and 
with greater safety and less fear of falling.(7) The effort required 
of the therapists to assist and guide limb movement was the major 
challenge that resulted in development of robotic assisted 
devices.(6,8)  
 
Overall a number of studies have reported improvements in various 
gait parameters including walking speed, amount of physical 
assistance needed, and the degree and type of assistive devices 
needed.(7,9, 10-13)  Previously it was thought that CONT and BWST were 
equivalent in outcomes (7,14). More recent reviews suggest that BWST 
whether therapy assisted or robotically assisted does not produce 
greater return in walking independence or velocity of gait.(11,15)  
However the greatest benefit of CONT was seen among individuals with  
incomplete SCI while those with more severe impairments (i.e. 
complete motor paralysis) benefited from BWST(13). 
 
In addition to the potential for spinal cord plasticity and recovery 
of walking function, ambulation after SCI may also offer secondary 
health benefits.   Kohout and colleagues (16) reported that the 
ability to walk more than 1000 feet was related to a decreased need 
for pain and spasticity medications.  Similarly, BWST has been 
associated with decreased spasticity of the plantar flexors and 
quadriceps muscles (17).   In contrast, Giannantoni and coworkers (18) 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
3 
 
found a worsening of urodynamic function following ambulation in a 
reciprocating-gait orthosis.  A recent review on the physiological 
benefits of ambulation following SCI provided 2 conclusions from the 
literature: 1) the current evidence is controversial and mostly 
anecdotal; 2) physiological benefits of walking after SCI were most 
evident when ambulation was performed for at least 4-5 hours per week 
and over a long period of time (19). 
 
Currently there is no cure for spinal cord injury (20) however there 
have been improvements in therapies that promote a greater chance for 
neurological recovery. The evidence supporting gait training in 
spinal cord injuries suggests that starting early, utilizing task 
specific activities, and continuing the activities for long durations 
are beneficial.(20) CONT training offers task specificity , however is 
labor intensive, time consuming, and requires a high degree of 
expertise to avoid injury. Moreover, those that are more severely 
impaired cannot begin CONT training early or safely offering a 
potential benefit of BWST in this subpopulation.  BWST requires 
larger physical space for the treadmill can only be found at 
specialty centers and cannot be utilized at home. Therefore there is 
an opportunity to develop a “hybrid” of these 2 training paradigms. 
One that can allow for early participation despite severity of 
injury, can reduce the intensity of therapy assistance, can optimize 
the benefit of over ground training, and has the potential to be 
utilized in the home setting.  
 
Recently the benefit of body weight supported training, either 
therapy assisted or robotically, has been questioned to be no greater 
than conventional over the ground training.(21) However, traditional 
training for those subjects with severe injuries is very labor 
intensive and difficult. Technology that blends the “labor reduction” 
benefit of BWST and the task specific benefit of over the ground 
training may provide the optimal solution. Therefore development of 
technologies that are easier to use, cheaper to implement and more 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
4 
 
readily accessible by the general spinal cord injured population is 
important.  
 
One such device recently developed is the Ekso.  The 
Ekso is an anthropomorphic mobile exoskeleton that is 
intended for rehabilitation and increased mobility for 
those suffering from muscular and neurological 
conditions affecting their lower extremity. The device 
is used to drive the subject’s lower extremity joints 
through a desired trajectory in order to obtain a user 
specified motion. The device is mobile and holds all 
necessary batteries and processing on board for at 
least 2 hours of consistent use. The batteries are also 
interchangeable allowing for fully charged batteries to 
be swapped into the machine whenever required. The device is designed 
to adjust easily to fit a wide range of users. This adjustment is 
made using adjustments at the thigh and shank to adjust length and at 
the hips to adjust frontal plane width. The device is attached to the 
user’s torso with backpack style shoulder harnessing and a torso 
brace. The other harnessing on the device are upper thigh straps, 
shin guards on the shank and secure foot binding. 
 
The device is electrically powered by four electric motors at the 
user’s knee and hip joints in the sagittal plane. The flexion and 
extension directions at the hip and knee are the only actuated 
degrees of freedom on the device. The device is equipped with 
mechanical hard stops at the limits of healthy subject ranges of 
motion to prevent powering the joint of the user to a position that 
the joint cannot reach. The actuated range of motion at the hip is -
20° to 135° and the actuated range for the knee is 0° to 120°. Not 
all of this range of motion is needed in normal walking; however the 
ranges of these joints were selected to provide for other necessary 
functions such as standing and sitting. At the ankle the device is 
passive, with springs to resist sagittal plane motion and locked in 
the other degrees of freedom. The range of motion provided at the 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
5 
 
ankle is from -10° to 20° dorsiflexion with hard stops at the limits 
of this range to protect the user. The final degree of freedom is a 
manual lock for abduction at the hip. When released, the device is 
free to swing in the abduction direction (used for donning/doffing 
purposes) but when locked the device prevents motion in both the 
abduction and adduction directions. 
 
The device operates using a number of important sensors. There are 
foot pressure sensors at the heel and toe of both feet to determine 
the forces between the user and the ground at those locations. 
Multiple position sensors determine the angle of each actuated joint.  
A body tilt sensor is used to find the lean of the torso in space.  
Finally, temperature sensors are used to monitor the motor and drive 
temperatures.  
 
The control code in the device operates by creating an internal 
estimate of the subject’s current position and then coordinating the 
motion of the four actuated degrees of freedom to take the desired 
motion. The desired motion is specified through an attached user 
interface that can be controlled by the user or a therapist. The 
device can stand from a seated position, walk and sit down. In actual 
operation the device is triggered by various modes. The first mode is 
used early in training where the therapist manually triggers the 
steps with the user interface. For advanced users the machine can 
operate in a different mode and interpret their posture to determine 
when steps are desired. 
 
The Ekso provides full weight bearing, over ground reciprocal gait 
training. The robotic exoskeleton reduces the need for therapy 
guidance and can free the therapists up for safety spotting and 
feedback, ultimately reducing the number of therapists required. In 
addition the low profile allows for use in varied environments both 
indoor and outdoor, and the size of the device can potentially allow 
for ease of transport for use at home. As such subjects can continue 
to utilize the principle of “start early” as the robotic components 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
6 
 
allow for utilization of more severely injured subjects; “task-
specific” as the robotic limb trajectory mirrors a normal gait 
pattern, and “keep it going” as the ability to use the device out of 
the classic rehabilitation setting will allow for greater duration of 
use. 
 
It is anticipated that modifications to the hardware and software 
will be developed and implemented throughout the testing of the 
device as required to better meet the needs of subjects. Some of 
these modifications that already exist include a sagittal plane 
actuated ankle, a passive hip frontal plane degree of freedom, a 
passive hip rotation degree of freedom, and a leg with reduced 
actuation for higher functioning subjects. Each of these 
modifications maintains the current safety features included in the 
existing manufactured device.  These safety features include 
mechanical hardstops to limit the range of motion to less than a non-
disabled person’s range of motion, redundant position sensing at all 
actuated joints, monitoring of sensors to identify device failures 
prior to injury, and padding at all points where the subject and 
device make contact. All future device modifications will hold to 
these design safety features.  
 
1. Wyndaele M, Wyndaele JJ. Incidence, prevalence and epidemiology of spinal cord 
injury: what learns a worldwide literature survey? Spinal Cord 2006; 44: 523–
529. 
2. Brown-Triolo DL, Roach MJ, Nelson K, Triolo RJ. Consumer perspectives on 
mobility: implications for neuroprosthesis design. J Rehabil  Res Dev 2002; 39: 
659–669. 
3. Widerstrom-Noga EG, Felipe-Cuervo E, Broton JG, Duncan RC, Yezierski RP. 
Perceived difficulty in dealing with consequences of spinal cord injury. Arch 
Phys Med Rehabil 1999; 80: 580–586. 
4. Behrman AL, Bowden MG, Nair PM. Neuroplasticity after spinal cord injury and 
training: an emerging paradigm shift in rehabilitation and walking recovery. 
Phys Ther 2006; 86: 1406–1425. 
5. Fawcett JW, Curt A, Steeves JD. Guidelines for the conduct of clinical trials 
for spinal cord injury as developed by the ICCP panel: spontaneous recovery 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
7 
 
after spinal cord injury and statistical power needed for therapeutic clinical 
trials. Spinal Cord 2007; 45:190–205 
6. Liverman C T, Altevogt B M, Joy J E, Johnson R T. Spinal cord injury: progress, 
promise and priorities. Washington, DC: The National Academic Press; 2005. 
7. Dobkin B, Apple D, Barbeau H, Basso M, Behrman A, Deforge D, et al. Weight-
supported treadmill vs over-ground training for walking after acute incomplete 
SCI. Neurology 2006; 66: 484–493. 
8. Hesse S. Treadmill training with partial body weight support in hemiparetic 
patients: further research needed. Neurorehabil Neural Repair 1999; 13: 179–181. 
9.  Dobkin B, Barbeau H, Deforge D, Ditunno J, Elashoff R, Apple D, et al. The 
evolution of walking-related outcomes over the first 12 weeks of rehabilitation 
for incomplete traumatic spinal cord injury: the multicenter randomized spinal 
cord injury locomotor trial. Neurorehabil Neural Repair 2007; 21: 25–35. 
10. 
Field-Fote EC, Lindley SD, Sherman AL. Locomotor training approaches for 
individuals with spinal cord injury: a preliminary report of walking-related 
outcomes. J Neurol Phys Ther 2005; 29: 127–137. 
11. 
Swinnen E, Duerinck S, Baeyens J-P, Meeusen R, Kerckhofs E. Effectiveness 
of robot-assisted gait training in persons with spinal cord injury: a systematic 
review. J Rehabil Med 2010; 42: 
12. 
 Hornby TG, Campbell DD, Zemon DH, Kahn JH. Clinical and quantitative 
evaluation of robotic-assisted treadmill walking to retrain ambulation after 
spinal cord injury. Top Spinal Cord Inj Rehabil 2005; 11: 1–17. 
13. 
Hicks AL, Adams MM, Martin GK, Giangregorio L, Latimer A, Phillips SM, et 
al. Long-term body-weight-supported treadmill training and subsequent follow-up 
in persons with chronic SCI: effects on functional walking ability and measures 
of subjective well-being. Spinal Cord 2005; 43: 291–298. 
14. 
 Lam T, Eng JJ, Wolfe DL, Hsieh JTC, Whittaker M. A systematic review of 
the efficacy of gait rehabilitation strategies for spinal cord injury. Top 
Spinal Cord Inj Rehabil 2007; 13: 32–57. 
15. 
Wessels M, Lucas C, Eriks I, de Groot S. Body weight-supported gait 
training for restoration of walking in people with an incomplete spinal cord 
injury: a systematic review. J Rehabil Med 2010; 42: 513–519 
16. 
Kohout RK, Saunders LL, Krause JS. The relationship between prescription 
medication use and ability to ambulate distances after spinal cord injury. Arch 
Phys Med Rehabil 2011; 92: 1246-1249 
17. 
Manella KJ, Field-Fote EC. Modulatory effects of locomotor training on 
extensor spasticity in individuals with motor-incomplete spinal cord injury. 
Restor Neurol Neurosci 2013; Jun 4 [Epub ahead of print] 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
8 
 
18. 
Giannantoni A, Di Stasi SM, Scivoletto G, Mollo A, D’Ambrosio F, 
Castellano V. Urodynamics in spinal cord injured patients walking with 
reciprocating gait orthosis. J Urol 2000; 164: 115-117 
19. 
Karimi MT. Evidence-based evaluation of physiological effects of standing 
and walking in individuals with spinal cord injury. Iran J Med Sci 2011; 36:242-
253 
20. 
Dobkin BH. What matters in cellular transplantation for spinal cord 
injury: the cells, the rehabilitation, or the best mix? Neurorehabil Neural 
Repair 2010; 24: 7–9. 
21. 
Van Hedel HJ, Dietz V. Rehabilitation of locomotion after spinal cord 
injury. Restor Neurol Neurosci. 2010;28(1):123-34 
 
 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
9 
 
5. Setting of the Human Research 
This Investigative study will be conducted primarily in the 
homes of the subjects. The location could be anywhere in the 
United States but must meet the parameters defined in this 
protocol. Some preliminary training may take place at Ekso 
Bionics, 1414 Harbour Way South, Suite 1201, Richmond, CA 94804.  
6. Study Design 
 
This is a 36 month exploratory Investigational Study compliant with 
the NSF Human Subjects regulations (45 CFR 690) trialing a new device 
for the SCI populations to aid in ambulatory function in a home 
setting. Ekso Bionics will enable up to twelve (12) subjects with SCI 
to use an Ekso device in their home for a 12-month period. Qualified 
subjects will help Ekso Bionics determine the practical use of the 
device in the home environment and will enable Ekso Bionics to gather 
data to develop a device for use in a home environment.  The study 
will require a trained spotter to be present at all times that the 
device is being used. The study will also evaluate the effectiveness 
of a non-medically licensed spotter to assist the subject. 
 
6.1. 
The study will measure and evaluate the following to enable 
Ekso Bionics to determine the physiological benefits of high-
dosage use of the device in the home. Baseline measures will be 
recorded at the beginning of the study and reassessed a minimum of 
every three months over a twelve month period (+/- 2 weeks) and 
every 6 months after (+/- 2 weeks). The metrics include:  
6.1.1. The number of Ekso sessions completed 
6.1.2. Number of steps taken in device (per week, average per session, 
whole time) 
6.1.3. Time spent walking in device (per week, average per session, 
whole time) 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
10 
 
6.1.4. Duration of training session in each walking mode (FirstStep, 
ActiveStep, ProStep) 
6.1.5. Perceived rate of exertion (PRE) – Borg Perceived Rate of 
Exertion Scale  
6.1.6. Bowel function -  Modified International SCI Bowel Function Basic 
Data Set  
6.1.7. Bladder function - Modified International SCI Lower Urinary Tract 
Basic Data Set  
6.1.8. Frequency of secondary health conditions (urinary tract 
infections, pressure ulcerations, respiratory conditions) 
6.1.9. Quality of life (QOL) – International SCI Quality of Life Basic 
Data Set 
6.1.10. 
Functional abilities – Spinal Cord Independence Measure II 
(SCIM II) 
6.1.11. 
Pain – International SCI Pain Basic Data Set (between session 
pain) and Modified International SCI Pain Basic Data Set (within 
session pain)  
6.1.12. 
Spasticity – Modified Asworth Scale (MAS) at initial, 3, 6, 9 
12 months and every 6 months thereafter 
6.1.13. 
Strength – Upper and lower extremity motor scores (UEMS, 
LEMS) based on the ISNCSCI exam (Initial and 12 month and every 6 
months thereafter) 
6.1.14. 
Bone Density - DEXA Scan (Initial and 12 month) 
 
6.2. 
The subject will identify an individual to spot them for 
safety during every moment of device use. The individual may be a 
relative, friend or an individual hired by the subject. The 
spotter will not likely be a medical professional although Ekso 
Bionics will consider a medical profession as a spotter. The 
spotter must meet the Inclusion/Exclusion criteria listed below. 
Ekso Bionics clinicians will train the spotter with the subject in 
the device over a three day period in the subject’s home 
environment (Appendix A). The spotter must be certified as 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
11 
 
competent by Ekso Bionics’ clinicians in order for the device to 
be used without an Ekso Bionics clinician present. If the spotter 
is not approved, the subject may locate another spotter. Due to 
the time commitment required of the spotter, each subject may 
choose to train up to two spotters during the initial spotter 
training sessions. 
 
6.3. 
Subject training will include but is not limited to: 
6.3.1. Informing of device functions, failure modes and common 
characteristics. 
6.3.2. Safety and how to respond to various conditions including being 
off balance, uneven surfaces. 
6.3.3. Device set-up and take-down 
6.3.4. Operating the device. 
6.3.5. Putting the device on and taking the device off. 
6.3.6. Sitting/Standing 
6.3.7. Walking 
6.3.8. Balance 
6.3.9. Using hands when in the device 
 
6.4. 
Spotter training will include but is not limited to: 
6.4.1. Informing of device functions, failure modes and common 
characteristics. 
6.4.2. Safety and how to respond to various conditions including being 
off balance, uneven ground. 
6.4.3. Device set-up and take-down 
6.4.4. Operating the device. 
6.4.5. Putting the device on and taking the device off. 
6.4.6. Sitting/Standing 
6.4.7. Walking 
6.4.8. Supporting the subject  

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
12 
 
6.4.9. Helping the subject safely perform simple daily tasks 
inaccessible to the subject while in the device (e.g., bend down 
to get a plate from a cabinet or open a door) 
 
6.5. 
Ekso Bionics will: 
6.5.1.     Evaluate the efficacy of a spotter in a home environment. 
6.5.2.     Evaluate the safety of using the device in a home 
environment. 
 
6.6. 
After initial training at either Ekso Bionics or at the 
participant’s home, a follow-up evaluation device operation may be 
conducted either in-person or by video at weeks 3 and 7.  Review 
meetings will be held every three months from the time the device 
is delivered to the subject’s home (or more frequently) to 
evaluate safety and efficacy. Information gathered from the study 
and status meetings will be used by Ekso Bionics to further the 
product development. Information may also be used by Ekso Bionics 
Marketing to determine the most appropriate market for the device 
and by Clinicians to aid in training future clinical staff. 
Schedule of study measure. 
 
Baseline 
3 
months 
6 
months 
9 
months 
12 
months 
Every 
6 
months 
after 
Device measures (6.1.1 – 
6.1.4) 
 
√ 
√ 
√ 
√ 
√ 
Physiological measures 
(6.1.5 – 6.1.7) 
√ 
√ 
√ 
√ 
√ 
√ 
Frequency of secondary 
health conditions (6.1.8) 
√ 
√ 
√ 
√ 
√ 
√ 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
13 
 
Quality of Life measures 
(6.1.9) 
√ 
√ 
√ 
√ 
√ 
√ 
Functional ability 
(6.1.10) 
√ 
√ 
√ 
√ 
√ 
√ 
Pain (6.1.11) 
√ 
√ 
√ 
√ 
√ 
√ 
Spasticity (6.1.12) 
√ 
√ 
√ 
√ 
√ 
√ 
Strength testing (6.1.13) 
√ 
√ 
√ 
√ 
√ 
√ 
Bone Density (6.1.14) 
√ 
 
 
 
√ 
 
 
7. Inclusion and Exclusion Criteria 
 
7.1. 
Subject Inclusion Criteria: 
Participants must have a spinal cord injury between C7-L3 
resulting in motor paralysis. 
Participants must meet each of the remaining criteria: 
7.1.1. be an experienced user of the Ekso device with a minimum of 20 
hours and no more than 50 hours of device use and require no 
greater than minimal assist (support of up to 25% body weight) 
for safe and consistent walking. 
7.1.1.1 no more than 2 episodes of balance loss per 1 hour 
training session that require no more than moderate 
assistance (support of 26% to 50% of body weight) 
7.1.1.2 participants with more than 50 hours of device experience 
must agree to a 1 month period of non-use prior to 
acquisition of baseline measures  
7.1.2. be between 18-65 years of age.  
7.1.3. be able to physically fit into the exoskeleton device. 
7.1.4. be able to tolerate upright standing for up to 60 minutes.  

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
14 
 
7.1.5. have sufficient joint range of motion to fit safely within Ekso: 
Hip flexion contracture ≤ 15o; knee flexion contracture ≤ 10o; 
ankle dorsiflexion to neutral with no more than 10o of knee 
flexion. 
7.1.6. have sufficient upper body strength to balance themselves with 
two arms  
7.1.7. be fluent in English 
 
7.2. 
Subject Exclusion Criteria: 
7.2.1. Height below 60 inches or above 76 inches or with physical 
characteristics incompatible with device and testing procedure. 
7.2.2.       Weight above 220 lbs.  
7.2.3.       Lower extremity joint contractures that exceed device 
capacity for safe use.  
7.2.4. Any medical issue that precludes full weight bearing and 
ambulation (e.g. osteoporosis that prevents safe standing, 
orthopedic injuries, pain, severe spasticity) 
7.2.5.       Skin integrity issues that would prevent wearing the 
device. 
7.2.6. Cognitive and/or communicative disability inappropriate for 
testing as determined by Ekso Bionics clinician. Subjects must be 
able to follow directions well and demonstrate learning 
capability. 
7.2.7. Pregnancy (Self-reported) 
7.2.8. Colostomy 
7.2.9. Medical or environmental conditions arising after the start of 
the study that are deemed unsafe per Ekso Bionics discretion. 
 
7.3. 
Spotter Inclusion Criteria: 
Spotters must meet each of the remaining criteria: 
7.3.1. be between 18-65 years of age.  
7.3.2. be physically fit and  

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
15 
 
7.3.3. able to lift and carry the Ekso device (50 pounds). 
7.3.4. able to support the subject if off balance. 
7.3.5. able to guide the subject to a safe position in case of a fall. 
7.3.6. be certified in First Aid 
7.3.7. be available at least four days per week for at least five out of 
every six weeks throughout the duration of the study. If more 
than one spotter will be working with the subject, then spotters 
together must meet these criteria. 
7.3.8. be fluent in speaking and reading English 
7.3.9. be able to read the LCD display 
7.3.10. 
be able to hear device alarms and tones 
 
7.4. 
Spotter Exclusion Criteria: 
7.4.1. Known muscular-skeletal or other medical condition that could 
cause regular delays of the study if spotter is injured or 
impaired. 
7.4.2. Pregnancy (Self-Reported) 
 
 
 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
16 
 
Environmental Condition Requirements 
Use of the device must adhere to the following conditions: 
 
Environment 
General 
Specifications 
• 
Not for use in damp areas  
• 
Solid, flat terrain with less than 2% slope 
• 
Not for use on deep pile carpet (over ½” pile), 
ice, loose dirt or  
gravel, grass, rubber or high friction flooring, 
and other similar  
• 
surfaces 
Conditions of 
Visibility 
For Control Pad: 
• 
Ambient luminance range: 100lx to 1500lx 
• 
Viewing distance: 20-30 cm 
• 
Viewing angle: normal to display +/- 45 deg 
Physical Conditions 
• 
Temperature range 10-30 deg C 
• 
Relative humidity range 20-95%, non-condensing 
• 
Background sound pressure level: <70 dBA in the 
range of 100 Hz 
Frequency of Use for Operator 
Maximum Frequency 
6 hours per day 
 
 
8. Recruitment Methods 
8.1. 
Ekso Bionics will locate interested subjects from an existing 
group of prior test subjects. Additional networking for the 
purpose of identifying potential subjects will occur through 
rehabilitation hospitals currently using the Ekso Bionics device 
as well as non-for-profit organizations interested in supporting 
the individual use of Ekso.  Since all recruitment will be verbal, 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
17 
 
recruitment flyers of other marketing materials are not necessary. 
Hospitals acting as recruiting centers to locate Ekso Bionics test 
subjects may have their own IRB for recruiting only. 
 
8.2. 
Ekso Bionics Clinical team members will perform the initial 
screening of potential participants.  The team will determine 
study eligibility based on a clinical evaluation, home site 
evaluation, interviews with the prospective non-clinical 
spotter(s) and the experience and capability of the subject. They 
will discuss in detail the objectives, complete protocol, and its 
risks and potential benefits. 
 
8.3. 
Once volunteers agree to participate they will be required to 
provide a medical release from their physician. Potential 
participants will read the Ekso Bionics informed consent and have 
an opportunity to ask questions and discuss the study with their 
physician, family, and friends before agreeing to enter the study.  
The informed consent and medical release (Appendix B) also include 
contact information should the participant or his/her associates 
have any questions.  The original signed informed consent will be 
given to the participant, and a copy will be kept in a locked 
cabinet at Ekso Bionics accessible only by Investigators.   
 
9. Number of Subjects 
 
The study will consist of a minimum of two (2) subjects and a maximum of 
twelve (12). 
 
10. Study Timelines 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
18 
 
 
The Investigational study will take place over the course of 36 months. 
Each subject will be evaluated for a minimum of 12 months during the 36 
month period.  
If at any point during the study, the subject must take a break from 
regular walking for medical or personal reasons, if the break is less than 
2 month, they will be able to restart the study by notifying the principal 
investigator of the break and resuming use.  If the break is greater than 2 
months, the subject will need to be re-evaluated by an Ekso Bionics 
physical therapist to restart the study.  In the case of a break of more 
than 2 months, the study clock will be considered “paused” at this point 
and the next evaluation after the initial re-evaluation will be  3 months 
later (+/- 2 weeks) if in the first year of the study and 6 months (+/- 2 
weeks) after beyond the first year of the study.  
 
11. Endpoints 
11.1. 
At the conclusion of the 12-month training period, final 
measurements will be taken, both the subject and the non-clinical 
spotter will be interviewed or a questionnaire (Appendix C) will 
be provided to obtain information that will assist Ekso Bionics 
with further development of the device. Measurements will continue 
to be collected every 6 months for up to the conclusion of the 
study or the subject terminates his/her enrollment. 
11.2. 
Sessions will be ended for any of the following reasons: 
11.2.1. 
Subject decides to stop participation in the study at any 
time and for any reason.  
11.2.2. 
An Ekso Bionics staff member stops the subject from taking 
part in this study at any time if he believes it is in the 
subject’s best interest or if the subject does not follow the 
study protocol.  
11.2.3. 
Equipment is operating inconsistently or is deemed unsafe 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
19 
 
11.2.4. 
A therapist/researcher involved feels that the subject’s 
performance or continued usage places them at risk for injury. 
11.2.5. 
The subject is experiencing any adverse medical 
condition as evaluated by the subject, clinician or spotters. 
11.2.6. 
The subject or assistants to the subject (spotter or 
otherwise), deliberately or not, does not follow the study 
protocol or uses or permits use of the device in an unsafe 
manner. 
11.3. 
If the subject, deliberately or not, does not follow the 
study protocol or uses or permits use of the device in an unsafe 
manner, the device may be returned to Ekso Bionics without 
financial reconciliation to the subject. 
11.4. 
If the subject does not walk in the Ekso for a period of more 
than 21 days for any reason, they will be withdrawn from the 
investigation. 
11.4.1. 
If the subject wishes to resume participation in the study, 
additional training of the subject and baseline assessments may 
be necessary. 
 
 
12. Procedures Involved in the Human Research 
12.1. 
The study is designed to enable Ekso Bionics to evaluate the 
high-dosage use of a robotic exoskeleton in the home environment 
by persons with spinal cord injury. The study is based on the 
existing Ekso device. Features will include devices and controls 
to emulate proper gait training, stability and walking for common 
daily function. The device will not allow all daily functions 
including bending over, squatting, toilet use, climbing up or down 
stairs or ramps, side stepping or backward stepping. 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
20 
 
12.2. 
 Since the study involves periodic observation and data 
collection for evaluation by Ekso Bionics clinical, engineering 
and marketing personnel, the testing procedures includes: 
12.2.1. 
Periodic evaluations by trained Ekso Bionics clinicians 
according to general inclusion/exclusion criteria.  
12.2.2. 
A minimum of weekly electronic data transfer to Ekso Bionics 
of the data collected on the Ekso on-board computer. These data 
includes but are not limited to 
12.2.3. 
Number of steps.  
12.2.4. 
Length of steps 
12.2.5. 
Speed 
12.2.6. 
Walking mode used 
12.2.7. 
Battery usage 
12.2.8. 
A minimum monthly transmittal of a usage log completed daily 
by both the subject and the spotter. The log will include 
subjective and objective data including (Appendix D): 
12.2.8.1. Amount of sleep the previous night 
12.2.8.2. Any deviations from typical daily activity (e.g., 
medications, exercise, travel, illness) 
12.2.8.3. Description of physical activity other than using the 
Ekso. 
12.2.8.4. Subjective rating of quality of life 
12.2.8.5. General impressions in relation to the experience of 
using Ekso on a daily basis 
12.2.9. 
The participant will be asked to use the device in their own 
discretion as long as the use adheres to the safety protocols 
outlined.  Device features such as step length, swing time, and 
assist mode (maximum assist vs. variable assist) can be locked to 
prevent inadvertent or intentional manipulation of device 
settings which may create unsafe walking. 
12.3. 
Notable observations by Ekso Bionics will include: 
12.3.1. 
Donning/doffing the device 
12.3.2. 
Standing/sitting 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
21 
 
12.3.3. 
Walking 
12.3.4. 
Balance and stability 
12.3.5. 
Maneuverability 
12.3.6. 
Duration of sessions 
12.3.7. 
Device reliability 
12.3.8. 
Physical and psychological deviations 
12.3.9. 
Human factors and usability  
 
13. Cost and Compensation 
13.1. 
Equitable access plan:  
There is a substantial cost to enrolling a subject in the study. 
The costs fall into four categories: 
 
1. Training cost  
2. Testing costs 
3. Subject/Spotter costs 
4. Device cost 
Ekso will entirely bear the training cost (1) and cost associated 
with data acquisition (e.g. Dexa scan)(2). The subject will be 
responsible for the potential cost of obtaining a medical release 
from their physician. The subject will also be responsible for 
providing a spotter since this will often be an unpaid family 
member and therefore have no associated cost (3).   The Ekso 
device ($130,000-160,000 retail depending on features) is a 
substantial cost which some subjects will not be able to pay, nor 
can Ekso afford to provide enough devices for the desired number 
of subjects (4). Since Ekso Bionics’ objective is to study the 
objectives in Section 3, the device will be equally accessible to 
all qualified subjects at cost. This will be achieved by one of 
the following options. 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
22 
 
13.1.1. 
Subjects may purchase their own Ekso device which they may 
then keep at the end of the study. This will enable a prompt 
start to their participation in the study. 
13.1.2. 
Ekso will introduce subjects to non-profit organizations 
specifically available to fund robotic medical devices. These 
organizations include but are not limited to the Bridging 
Bionics Foundation 
(https://www.facebook.com/bridgingbionics?ref=stream, 
https://twitter.com/bridgingbionics) and SoldierSocks 
(http://www.facebook.com/pages/Soldier-
Socks/147478454297?ref=stream&hc_location=timeline). 
SoldierSocks has already committed to donating ten Ekso devices 
to veterans of war (Appendix E). 
13.1.3. 
Ekso Bionics will assist the subject to establish a 
fundraising program under the Ekso Hope program 
(http://www.eksobionics.com/eksohope). Ekso Hope has 
successfully raised hundreds of thousands of dollars to enable 
the purchase Ekso devices. The foundation set up a program and 
assist individuals reach their goal. 
 
14. Data Management and Confidentiality 
14.1. 
Data may be collected manually, on video, on a computer 
embedded in the device or transferred to an Ekso Bionics 
computer.  
14.2. 
The subject will be assigned an ID number so Ekso Bionics can 
keep all of the data collected during the duration of the study. 
Only the subject’s ID number will be associated with the test 
session, not the subject’s name. Only the Investigators will have 
access to the subject’s identifying name and number. The 
identifying information will be kept in 1) a secure, password 
protected computer file on a server and 2) hard copies stored in 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
23 
 
a locked cabinet located at the Ekso Bionics facility in 
Richmond, CA.  
14.3. 
Data obtain remotely from the device will include but is not 
limited to number of steps taken during the session, the total 
distance travelled, the distance between steps, the force on 
various device components including pressure and torque, the 
location of the subject in relation to the device to evaluate 
balance and stability.  
14.4. 
Physiological and psychological data will be gathered per 
Section 6.1. 
14.5. 
Data will be stored for ten years. 
14.6. 
An authorized Ekso Bionics staff member will transfer the 
data to the Ekso Bionics server at least once during the duration 
of the study. Data will be cleared from the device upon transfer; 
although, a portion of the data can be reviewed by the subject on 
the Ekso Pulse website. Ekso Pulse is a website designed 
specifically for users to review the data associated with their 
walking sessions. The Ekso Pulse site is protected by a user 
specific login. The server is under the same security measures as 
the primary Ekso server.  
14.7. 
Data security and subject privacy measures will be taught at 
clinical training sessions to all clinicians, engineers or any 
Ekso Bionics staff responsible for testing and capturing data. 
Ekso Investigators will agree upon a secure password, file 
location and locked cabinet prior to the start of any testing. 
Keys to the cabinet will be in the sole, personal possession of 
the Investigators.  
14.8. 
The data are intended to guide the development of the Ekso 
device for home use and to analyze the clinical effect on the 
subjects.  Much of the analysis will be subjective in nature 
where the researchers will ignore outliers and be able visually 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
24 
 
verify the data quality.  Any suspicious data will be ignored or 
verified by comparing it with the videos and pictures.   
14.9. 
The computer data, video and written notes will be evaluated 
and analyzed based on the needs of the Ekso Bionics engineering, 
marketing and business requirements. Analysis may include 
observation, statistical deviation, or other methods to enable 
results.   
14.10. Written data, including subject questionnaires, will be given 
to study personnel at each checkup.  This data will be 
transferred to the principal investigator by physical handoff or 
certified mail where physical handoff is not possible. 
15. Provisions to Monitor the Data to Ensure the Safety of 
Subjects 
15.1. 
This study does not require a Data and Safety Monitoring 
Committee or Board.  This is a pilot study. It is considered an 
intervention, behavioral, learning-based training study with 
minimal risk to subjects.   
16. Risks to Participants 
16.1. 
The risk of falling: This could be caused by loss of control 
of the ambulation activity by the participant or spotter as well 
as malfunction of the Ekso device itself. The risk of falling 
will be minimized by having a trained spotter with the subject at 
all times. The risk of falling is further mitigated by allowing 
only very experienced subjects who have been approved by the Ekso 
Bionics Clinical Team walk in the device during the study. This 
risk is similar to any gait therapy in which subjects with lower 
extremity disorders are standing and walking. 
16.2. 
Risk of exceeding subject range of motion: This would be 
caused if the Ekso moved the subject beyond their normal range of 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
25 
 
motion, resulting in a strain, sprain and/or fracture.  This risk 
is mitigated by mechanical hard stops that prevent the device 
from exceeding a normal human range of motion even in the event 
of a failure in the electrical or software systems.  Software 
systems are also in place to further reduce range of motion to 
improve fit and comfort for subjects during walking.  Subjects 
will be evaluated by trained Ekso Bionics clinicians who will 
eliminate any subjects from participation if they cannot meet the 
required range of motion.   
16.3. 
Discomfort, skin pressure/friction, bruising, pain, or 
unusual swelling caused by the exoskeleton which has the 
potential to lead to skin breakdown or abrasions. All locations 
where the subject contacts the exoskeleton are padded to prevent 
bruising or skin irritations. Also all pinch points are covered 
and protected from catching either skin or clothing.  Adjustments 
to the harness placement and additional padding will be assessed 
to decrease the risk of skin breakdown as well.  
16.4. 
Blood pressure instability during use of the device related 
to standing or activity as well as reflex bowel or bladder 
activity or autonomic instability during use of the device. This 
risk will be reduced with frequent assessment of subject’s 
symptoms as well as assessment of blood pressure, heart rate, and 
oxygen saturation during initial device training by research 
physical therapists. Activity will be stopped in the event of 
instability of vital signs and as recognized by experience 
research personnel.  Spotters will be trained to recognize signs 
and symptoms associated with blood pressure instability and to 
stop activity if present. 
16.5. 
Spasms triggered by joint movement in the device. This risk 
will be reduced through screening prior to enrollment in the 
study with exclusion of subjects with severe spasticity.  

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
26 
 
16.6. 
There is a risk of device malfunction causing injury from 
falling or unintended motion of Ekso.  Testing the device with 
Ekso Bionics employees without disability prior to a subject 
wearing the device will minimize risk of malfunction of the Ekso.  
Device malfunction is also mitigated through numerous safety 
features of the device.  Redundant position sensing on all of the 
actuated joints ensures that the motors are always controlled 
using reliable sensor information.  If the redundant sensors ever 
do not agree then the device shuts down.  An emergency disable 
button is always available to the spotter to instantly shut down 
the device.  This is implemented via hardware, so it is effective 
even during a software malfunction.  The device is equipped with 
fail-safe brakes on the actuated knee joints, so if the device 
loses power or is shut down for any reason the knees will 
continue to support the subject.  Finally there are numerous 
sensor, motor, and software monitoring systems in place.  If any 
abnormality is detected (such as excess joint speed or force) the 
software shuts down the device in a safe manner. 
16.7. 
The risk of fractures with use of the device: this will be 
minimized by requiring medical clearance for all participants and 
requiring all participants to be actively involved in a standing 
program.  
16.8. 
The risk of musculoskeletal injury for the spotter: This 
could be caused by an attempt to correct a significant loss of 
balance during ambulation by the Ekso user as well as malfunction 
of the Ekso device itself causing a need for additional support 
to prevent a fall from occurring. The risk of musculoskeletal 
injury may also occur when lifting and moving the device.  This 
risk will be minimized by providing the spotter with training 
related to safe body-mechanics during all aspects of device use. 
The risk of musculoskeletal injury for the spotter is further 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
27 
 
mitigated by allowing only experienced subjects who have been 
approved by the Ekso Bionics Clinical Team walk in the device 
during the study. 
16.9. 
The use of the Ekso system may involve risks that are 
currently unforeseeable as this is a trial to assess safety and 
efficacy of the Ekso device. 
 
17. Provisions for Research Related Harm/Injury 
17.1. 
If medical resources are required, the identified spotter 
must immediately contact appropriate medical services or call 
911. Ekso Bionics principal investigator should also be contacted 
as soon as the subject is medically stable. For minor injuries, a 
local hospital emergency room will be identified as part of an 
emergency plan established prior to allowing use of the device. 
17.2. 
This device has been determined to be NSR (non-significant 
risk) by Ekso Bionics due to the spotting requirement. 
18. Potential Benefits to Subjects 
18.1. 
There may be no direct benefit to the participants. The main 
benefit of this study is to determine the progression of 
technology to enhance functional ambulation, improved health and 
independence of people with spinal cord injuries. The feedback 
obtained from the participants and therapists will provide 
insights to the company for the next iteration of the design of 
the Ekso device.  
19. Provisions to Protect the Privacy Interests of Subjects 
19.1. 
Each participant will be assigned a coded identification 
number to designate all evaluations.  Data will be stored by the 
coded identification number without information identifying the 
individual.  All data, written and electronic, will be stored on 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
28 
 
the Ekso Bionics server with password protection.  Data will only 
be available to the researchers involved in the studies. 
 
20. Payments to Subjects 
No payments will be provided.  
 
21. Consent Process 
21.1. 
Ekso Bionics will require all participants to sign an Ekso 
Bionics Medical Release/Consent Form and Permission to Obtain 
Medical Treatment prior to the preliminary evaluation.  Spotters 
will be required to sign an Ekso Bionics Consent Form: 
21.1.1. 
All consent information will be provided to the subject in 
advance of their clinical screening. 
 
21.2. 
There will be no waiting period required between the subjects 
being informed of risks and their providing of consent for 
participation in the study. Payment for the device must be 
received in most cases prior to starting the study. 
22. Informed Consent Process for Research 
22.1. 
The consent process will be directly conducted by a member of 
the Ekso Bionics clinical team who is under the direct 
supervision of Darrell Musick, Ekso Bionics’ Clinical Director. 
The consent process typically takes 30-60 minutes for the subject 
to understand and consent to participate in the study. 
22.2. 
Only test subjects capable of comprehending and acknowledging 
the consent form will be included in the test. 
 
 

 
Protocol Name: 
Investigational Study of the 
Ekso Bionics Powered Exoskeleton 
for High-Dosage Use by 
Individuals with Spinal Cord 
Injury in a Non-Clinical 
Environment 
Principal 
Investigator:  
Katherine Strausser, PhD, Sr. Controls 
Engineer 
Primary Contact 
Name/Contact 
Info: 
Katherine Strausser, PhD, Sr. Controls 
Engineer  
KStrausser@EksoBionics.com 
510-529-2529 
Date Revised: 
9/28/2015  
Study Number: 
13098-01 
 
 
103219D 
29 
 
Appendices 
 
Appendix A 
• 103218 - Ekso Non-Clinical Spotter Training Schedule 
• 103217 - Ekso Non-Clinical Spotter Use Training Checklist 
• 103215 - Ekso Non-Clinical Spotter Competency Signoff Sheet 
Appendix B 
• 103213 - Ekso Participant Informed Consent Form 
• 103316 - Ekso Spotter Informed Consent Form 
• 103214 - Ekso Medical Release Form 
Appendix C 
• 103223 - Ekso Non-Clinical Spotter Questionnaire 
Appendix D 
• 103212 - Ekso Case Report Form - Subject Daily Log 
Appendix E 
• SoldierSocks Letter of Intent to Ekso Bionics