The WISE Trial - Walking Improvement for SCI With Exoskeleton
Phase: NA
Conditions: Injuries, Spinal Cord
Sponsor: Ekso Bionics

  
 
 
 
 
 
 
Clinical Protocol 
 
 
Study Title: 
The WISE Trial  - Walking Improvement for SCI with Exoskeleton 
 
 
Protocol Number:                      105333 
 
NCT:  
NCT02943915 
 
 
Sponsor:                                         Ekso Bionics, Inc. 
1414 Harbour Way S Ste 1201 
Richmond, CA  94804 
 
 
Protocol Change Status: 
 
 
 
 
Revision 
Date of revision 
Reason for amendment 
A 
10 June, 2016 
 
B 
15 July, 2016 
Expanded upper age limit, changes to sample size 
and statistical analysis plan, additional clarifications 
and corrections 
C 
30 March, 2017 
Additional clarifications, definitions, and rules 
required after several run-in cases were performed 
and site feedback obtained; addition of/change in 
some assessments (see summary table of changes) 
 
 
 

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Study Acknowledgement and Confidentiality Statement 
 
The information in this document and future information which will be provided to the Principal Investigator 
and study staff contains information that is confidential to Ekso Bionics, Inc. and may not be disclosed 
without prior written approval of Ekso Bionics, Inc., unless such disclosure is required by federal or other 
laws or regulations.  Information that is provided to Participants by Ekso Bionics, Inc. may be communicated 
by Participants to other persons who have a “need to know” the information in order to facilitate and 
implement the study in which Participants are participating. However, such persons must be informed that 
the information provided is confidential to Ekso Bionics, Inc and may not be further disclosed by them. 
 
The signature of the investigator below constitutes approval of this protocol and agreement to the 
confidentiality statement above.  
 
The investigator agrees to supervise all testing of the device and to ensure that requirements for obtaining 
informed consent are met. 
 
The investigator agrees to: 
• 
conduct the study according to the protocol and approved protocol amendments.  
• 
conduct the study in accordance with the ethical principles stated in the latest version of the 
Declaration of Helsinki, the applicable guidelines for good clinical practices, and/or the applicable 
local and international regulations, whichever provide the greater protection of the individual. 
 
 
 
 
Signature of Investigator 
 
Date 
 
 
 
 
Investigator Name (Print) 
 
 
 
 
 
 
 

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Table of Contents 
 
1. 
Literature Summary and Study Rationale .................................................................................................................... 12 
2. 
Study Purpose, Plan, and Objectives ............................................................................................................................... 13 
3. 
Study Design .............................................................................................................................................................................. 14 
4. 
Study Endpoints ....................................................................................................................................................................... 14 
5. 
Participant Enrollment ......................................................................................................................................................... 16 
6. 
Duration of Participation/Study ....................................................................................................................................... 16 
7. 
Inclusion/Exclusion Criteria .............................................................................................................................................. 16 
8. 
Screening, Enrollment, and Treatment Allocation ................................................................................................... 18 
8.1 
Screening and Informed Consent ................................................................................................................................ 18 
9. 
Ekso Device Description and Safety Features ............................................................................................................ 20 
10. 
Training Regimen and Rules .............................................................................................................................................. 22 
11. 
Participant and Therapist Assessments ........................................................................................................................ 26 
12. 
Adverse Events ......................................................................................................................................................................... 33 
13. 
Participant Termination ....................................................................................................................................................... 34 
14. 
Data Collection and Reporting .......................................................................................................................................... 34 
15. 
Confidentiality of Data .......................................................................................................................................................... 34 
16. 
Record Retention ..................................................................................................................................................................... 35 
17. 
Statistical Methods ................................................................................................................................................................. 35 
17.1 
General Principles .............................................................................................................................................................. 35 
17.2 
Primary Endpoint ............................................................................................................................................................... 35 
17.3 
Subgroup analysis .............................................................................................................................................................. 36 
17.4    
    Sample Size ............................................................................................................................................................................ 36 
18. 
Visits and Visit Windows ..................................................................................................................................................... 36 
18.1 
Handling of Dropouts, Treatment Rescues and Missing Data ........................................................................ 37 
18.2 
Subgroup Definitions ........................................................................................................................................................ 37 
19. 
Investigative Centers/Minimum and Maximum Enrollment .............................................................................. 37 
20. 
Quality Assurance of the Data ........................................................................................................................................... 37 
21. 
Study Termination .................................................................................................................................................................. 37 
22. 
Personnel Responsibilities .................................................................................................................................................. 37 
22.1 
Principal investigator responsibilities ...................................................................................................................... 37 
22.2 
Sponsor Responsibilities ................................................................................................................................................. 38 
23. 
Potential Risks to Study Participants and Mitigation of Risks ............................................................................ 38 
24. 
Provisions for Research Related Harm/Injury .......................................................................................................... 39 
25. 
Potential Benefits of Participation ................................................................................................................................... 39 
26. 
Monitoring Procedures ......................................................................................................................................................... 39 
27. 
Publication ................................................................................................................................................................................. 40 
28. 
References .................................................................................................................................................................................. 40 
29. 
Appendix A – Description of Standardized Measures and Assessments ........................................................ 43 
 
 

STUDY OUTLINE 
 
Study Title: 
 
 
Sponsor:                    
The WISE Trial - Walking Improvement for SCI 
with Exoskeleton 
 
Ekso Bionics, Inc. 
1414 Harbour Way S Suite 1201 
Richmond, CA  94804 
 
 
Study Description: A randomized, controlled trial comparing exoskeleton gait training with standard gait 
training or no gait training in community-dwelling participants with chronic 
incomplete spinal cord injury. 
 
Overall goal: 
 
We aim to demonstrate that Ekso exoskeleton training can significantly improve gait 
speed in stable chronic, community-dwelling incomplete SCI (iSCI) participants. 
 
Rationale: 
 
Community dwelling iSCI participants may improve clinical gait function by engaging 
in a gait training regimen, where robotic exoskeletons can readily deliver a dose and 
simultaneously reduce the physical stress imposed on therapists who use 
conventional manually assisted stepping practice. Participants receiving exoskeleton 
training are predicted to show improved function compared to participants receiving 
no gait training (daily home care), but not superiority to intensity-matched manual 
gait training. The rationale to implement exoskeleton robotics as preference in gait 
training is based on high repetition during overground training and reduced 
therapist burden. 
 
Hypothesis: 
 
 
 
 
 
Design: 
Participants undergoing exoskeleton training for 12 weeks /36 sessions will 
demonstrate equal progress in walking speed as those participants undergoing 
standard gait training for 12 weeks/36 sessions. Participants in both the exoskeleton 
group and the standard gait training group will show greater progress after 12 
weeks/36 sessions than the participants in the passive control group. 
 
Multi-center, randomized, controlled study. 
 
Participants: 
Chronic (> 1 year after the injury), community-dwelling men and women 
between the ages of 18 and 75 years, inclusive, diagnosed with motor 
incomplete spinal cord injury (AIS C and D), with minimal walking function, 
who may benefit from participating in a 12-week (36-session) outpatient 
rehabilitation therapy and who fulfill the inclusion/exclusion criteria.  
 
Inclusion criteria: 
1. Motor incomplete paraplegia or tetraplegia, chronic (> 1 year after the 
injury). Non-traumatic SCI injuries can be included, given they are 
neurologically stable conditions for 12 months (e.g. tumor, transverse 
myelitis, but NOT Guilliane-Barré) 
2. NLI C1- approximately T10 (inclusive, for upper motor neuron injuries only), 
as determined by the International Standards for Neurological Classification 
of SCI (ISNCSCI)  
3. Sufficient diaphragmatic strength such that respiration is not compromised 
with exercise. 
4. Sufficient upper extremity strength to use a front wheeled walker by manual 
muscle testing (minimum triceps strength bilaterally of 3/5, shoulder 
abduction and flexion/extension 4/5)  
5. AIS-C SCI & AIS-D SCI, as determined by the International Standards for 

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Neurological Classification of SCI (ISNCSCI)  
6. Ambulates at a self-selected speed of <0.44 meters/second with or without 
physical assistance and assistance device 
7. Able to advance at least one leg forward volitionally with lower extremity 
muscles (not as a result of trunk movement or spasticity) while using parallel 
bars, walker or crutches, with or without braces, and with up to 2 people to 
assist with safety and balance only. Stepping is to be performed by the 
patient without PT assistance at the lower extremities and no BWS.  
8. 18 – 75 yrs old, inclusive 
9. No current or history of other neurological conditions 
10. Screened and cleared by a physician 
11. Involved in standing program or must be able to tolerate at least 15 min 
upright without signs or symptoms of orthostatic hypotension 
12. Weigh 220 pounds (100kg) or less 
13. Be able to fit into the Ekso device 
14. Between approximately 5’0” and 6’4” tall 
15. Standing hip width of approximately 18” or less 
16. Have near normal range of motion in hips, knees and ankles 
 
Exclusion criteria: 
1. AIS-A SCI or AIS-B SCI 
2. Lower motor neuron injuries, as shown by absent reflexes during bilateral 
quadriceps and Achilles tendon taps 
3. < 3 months since previous intensive gait training regimen, FES cycling 
program, and lower extremity botox injections. The gait training regimen is 
meant to be formal gait training with feedback for progression of walking 
(i.e. PT sessions). Participant may have a regular home exercise program 
and/or a walking exercise program with a companion/ trainer for safety, but 
not for verbal or tactile cues or feedback regarding gait in the 3 months 
before initiating the protocol. If participant has a home exercise program 
and/or a walking exercise program, these programs (except FES cycling) 
should be continued without changes throughout the protocol.  Electrical 
stimulation devices used regularly for foot drop during ambulation should be 
considered a brace and should continue to be used as usual throughout the 
protocol. Upper extremity botox injections are permissible before and during 
the protocol. One or two PT sessions are allowed to obtain a new brace or 
progress bracing and check for fit and safety, but no sustained gait training 
should occur.  
4. Already walking at self-selected ambulation speeds of at least 0.44 
meter/second with or without assistance 
5. Currently involved in another intervention study 
6. Concurrent neurological disease 
7. Hip flexion contracture greater than ~17° 
8. Knee flexion contracture greater than 12° 
9. Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral 
with max 12° knee flexion) 
10. Leg length discrepancy 
a. 
Greater than 0.5” for upper leg 
b. Greater than 0.75”  for lower leg 
11. Spinal instability 
12. Unresolved deep vein thrombosis 
13. Uncontrolled autonomic dysreflexia  
14. Severe muscular or skeletal pain 
15. Spasticity that prevents joint motion (severe stiffness or rigidity,) where both 

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legs have a MAS score of 3 or higher for half or more of their proximal lower 
extremity muscles; proximal muscles include hip flexors/ extensors/ 
adductors and knee flexors/extensors. 
16. Open skin ulcerations on buttocks or other body surfaces in contact with 
exoskeleton or harness 
17. Pregnancy 
18. Cognitive impairments – unable to follow 2 steps commands and 
communicate for pain or to stop session 
19. Shoulder extension ROM < 50° excludes crutches during sit to stand or vice 
versa. (Walking with crutches permitted.) 
20. Participant requires the assistance of more than one therapist to transfer 
safely. 
21. Uncontrolled or severe orthostatic hypotension that limits standing 
tolerance; defined as sustained, symptomatic drops in systolic and diastolic 
blood pressure when moving from sitting to standing 
22. Active heterotrophic ossification (HO), hip dysplasia or hip/knee axis 
abnormalities 
23. Colostomy  
24. History of long bone fractures since the SCI, secondary to osteoporosis  
25. Unable to sustain current medication regimen, specifically those medications 
that may impact study outcomes (such as spasticity).    
26. Any reason the physician may deem as harmful to the participant to enroll or 
continue in the study  
 

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Treatment 
Groups: 
Run-In Group:  The first 1 to 4 Participants at each site will be assigned to the Run-in 
Group. The Run-in Group follows the Group 1 assignment described below. After the 
site has completed the Run-in phase, Participants who meet study entrance criteria 
will be randomized to one of three groups: 
Group 1: Ekso Intervention - Participants in this group receive Ekso GT robotic gait 
training 3 times per week for 12 weeks (36 sessions). The goal is a minimum of 300 
steps of gait training in the Ekso GT per 45 minute session. Overground walking 
starts when Participants require only minimal assistance of one therapist and one 
aide to assist with assistive device, without any BWS, for at least 10 meters. This will 
be assessed every 3rd session during the 10MWT. At this point, sessions will consist of 
30 minutes of gait training in the Ekso, followed by 15 minutes of standard 
overground gait training without BWS for a total of 45 minutes of walking. See Table I 
A for the training progression strategy and section 10 – Training Regimen and Rules 
for details. 
 
Group 2: Active controls - Participants in this group receive a matched number of 
sessions of standard gait training. Sessions will consist of 45 minutes of walking 3 
times per week for 12 weeks (36 sessions).  Standard gait training will be a 
combination of body-weight supported treadmill training and overground training 
without BWS, with a goal of a minimum 300 steps during BWSTT per session. 
Overground walking starts when Participants require only minimal assistance of one 
therapist and one aide to assist with the assistive device, without any BWS, for at 
least 10 meters.  This will be assessed every 3rd session during the 10MWT. Once the 
overground criterion is achieved:  If the initial 300 steps are not completed by the 
end of the first segment, the middle 15-minute segment must be gait training in 
BWSTT, and the final 15-minute segment must be OG gait training.If the initial 300 
steps are completed by the end of the first segment, the middle 15-minute segment 
can be continued gait training in BWSTT or OG gait training, per PT choice. The final 
15-minute segment must be OG gait trainingSee Table 1 B for the training 
progression strategy and section 10 – Training Regimen and Rules for details. 
 
Group 3: Passive controls with cross-over option - Participants in this group 
continue with daily activities as normal over 12 weeks. No new gait training, mobility 
therapy, nor new medications (including Botox) are commenced during the study 
period. Participants in this group will come to the study sites for evaluations at 
baseline, 6 and 12 weeks.  After the 12 week evaluation, the participants in this group 
will have an opportunity to choose to receive either Ekso or standard gait training 
therapy for 12 weeks.  
 
 
Sample Size: 
Up to 40 Run-In Participants and up to 127 total Randomized Participants; 
Randomization by groups is 2:2:1.  
 
Blinding: 
 
 
Setting/Sites: 
 
Outcomes data will be collected by independent, blinded evaluators trained in 
standard assessment techniques. 
 
Outpatient Rehabilitation Setting involving up to 15 clinical sites.  Sites to be chosen 
based on having Ekso Level 2 training certification, ability to match manual therapy 
regimen prescribed by this protocol, location, enrollment capabilities, and resources.  
 
Duration: 
 
 
Each randomized Participant is expected to engage in this study for approximately 6 
months. Run-in Participants are expected to be active in the study for approximately 
14 weeks. The duration of the study is expected to be approximately 3 years. 

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Assessment 
periods: 
 
The study consists of a screening/pre-evaluation period, a 12 week training period 
(36 sessions) with limited weekly assessments (every 3rd session) for safety/ 
progression measures, and full evaluations at the end of training weeks 6 
(midpoint/following session 18) and 12 (endpoint/following session 36). 
Randomized Participants are to return 3 months after the last training session 
(follow up) at which time they will undergo the same full evaluation as training 
weeks 6 and 12. Assessments are to be performed outside of exoskeleton or any body 
weight support. 
 
 
Primary 
Objective: 
 
To demonstrate that a 12 week robotic gait training regimen can lead to a clinically 
meaningful improvement in independent gait speed on the 10 Meter Walk Test 
(10MWT) in community dwelling participants with chronic iSCI. 
 
Secondary 
Objectives: 
To examine the economic factors such as number of physical therapists/staff 
required during training. 
 
To analyze the physical burden on therapists assisting and supervising during 
training.  
 
To study the influence of factors that may modify the gait recovery in the chronic 
incomplete SCI population (demographic, clinical, functional, psychological, balance, 
etc.)  
 
Primary End 
Point:  
 
 
The primary endpoint is the mean increase in gait speed demonstrated during the 
10MWT after 12 weeks/36 sessions of training and compared between groups. Both 
self-selected and fast speeds will be performed on the 10MWT, with the fast speed 
taking precedent.  
Secondary 
Endpoints:  
 
Participant outcomes related to physical performance, physiology, quality of life, and 
safety are to be measured at weeks 6 / following session 18 (midpoint), week 12/ 
following session 36 (endpoint), and week 24 /3 months after the last sessions ( 
follow-up) (unless otherwise indicated) and compared between groups. By category, 
these are the following: 
 
PHYSICAL PERFORMANCE OUTCOMES 
 
10MWT for both self-selected and fast gait speeds 
 
Number of participants who achieve the Minimal Clinically Important Difference 
(MCID) of 0.15 m/s21 during the 10MWT 
 
Number of participants who transition from exercise or household ambulation 
(defined as a self-selected walking speed of < 0.44 meters/second) to limited 
community or full community ambulation (> 0.44 meter/second) during the self-
selected 10MWT13 
 
Time point of recovery at which participants reach the MCID and/or community 
ambulation speeds of > 0.44 meters/second13  
 
6MWT for endurance 
 
TUG for balance during sit-stand, walking, turning, and stand-sit 

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WISCI-II score for need of assistance and devices. 
 
SCI-FAI for observational gait quality 
 
GAITRite for temporospatial gait parameters and symmetry (if site has access to this 
device) 
 
SCIM-III, mobility subscale for ability to perform transfers and walking different 
distances 
 
Berg Balance Scale for measurement of static and dynamic sitting and standing 
balance  
 
QUALITY OF LIFE/PSYCHOLOGICAL  OUTCOMES 
 
International SCI Quality of Life Basic Data Set 
 
Epidemiological Studies Depression Scale (CES-D 10)  
 
NASA Task Load Index for participant self-reported work load 
 
PHYSIOLOGICAL OUTCOMES 
 
ISNCSCI exam between baseline and 12 weeks/36 sessions  
 
Number of participants who convert from AIS C to D per ISNCSCI exam 
 
Body mass index for a general health measure 
 
UEMS and LEMS as measured by the physical therapist for muscle strength  
 
Heart rate and blood pressure before and after 6MWT 
 
Borg Scale for self-reportedmaximal Rate of Perceived Exertion (RPE) during either 
intervention 
 
SECONDARY COMPLICATIONS 
 
International SCI Pain Basic Data Set 
 
Numeric Pain Rating Scale  for Pain upon resting and during gait training  
 
SCATS, Modified Ashworth Scale, patient-report SCI-SET and Numeric Rating Scale 
for spasticity 
 
Modified International SCI Bowel Function Basic Data Set  
Modified International SCI Lower Urinary Tract Basic Data Set  
 
Incidence of urinary tract infections per Participant 
 
Incidence of pressure ulcers per Participant 
 
Incidence of falls per Participant   
 

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See Appendix A for description of assessments. 
 
 
 
Incidence of re-hospitalization/unexpected doctor visits per Participant 
 
THERAPIST OUTCOMES 
 
Number of therapists/staff required for each active group (Group 1 and 2), and set-
up/donning time for cost effectiveness of the two active therapies 
 
 
Borg Scale for self-reported maximal RPE during either of the interventions 
 
NASA-Task Load Index for therapists’ self-reported work load 
 
Video assessment of training posture for ergonomics  
 
Occupational safety measured by number and severity of therapist reports of 
orthopedic problems and/or pain 
 

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List of Abbreviations 
 
6MWT – 6 Minute Walk Test 
10MWT – 10 Meter Walk Test 
AE - adverse events 
AIS - ASIA (American Spinal Injury Association) impairment scale 
ASIA -  American Spinal Injury Association 
BBS - Berg Balance Scale 
BMI - body mass index 
BP - blood pressure 
BWS – Body weight support 
BWSTT – Body weight supported treadmill trainingCRF - case report form 
DSMB - Data Safety Monitoring Board 
EU – European Union 
FDA – Food and Drug Administration 
GCP -  Good Clinical Practice 
HR -  heart rate 
IRB -  Institutional Review Board 
ISNCSCI – International Standard for Neurological Classification of Spinal Cord Injury 
iSCI – incomplete spinal cord injury 
LEMS -  lower extremity motor scores 
LOCF - last observation carried forward 
MAS -  Modified Ashworth Scale 
MCID – minimal clinically important difference 
MMT -  manual muscle test 
NASA – National Aeronautics and Space Administration 
NLI -  neurological level of injury 
NRS – Numeric Rating Scale 
PT -  physical therapist 
QOL -  quality of life 
RPE -  rate of perceived exertion 
ROM -  range of motion 
SAE  - serious adverse event 
SCATS – Spinal Cord Assessment Tool for Spastic Reflexes 
SCI -  spinal cord injury 
SCI-FAI - Spinal Cord Injury Functional Ambulation Index 
SCI-SET – Spinal Cord Injury Spasticity Evaluation Tool 
SCIM -  Spinal Cord Independence Measure 
TUG -  Timed Up and Go 
UE -  upper extremity 
UEMS  - upper extremity motor score 
UL – Underwriters Laboratory 
WISCI -  Walking Index for Spinal Cord Injury 
 
 

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1. 
Literature Summary and Study Rationale 
 
The incidence of spinal cord injury (SCI) in the U.S. is approximately 40 cases per million or 12,500 new 
cases each year. The number of SCI patients living in the U.S. in 2014 has been reported to be roughly 
276,000 (range, 240,000 to 337,000).1 Spinal cord injury usually results in life-long disability with 
restricted movement. Consequently, many patients remain non-ambulatory and wheelchair-dependent. 
Life-long inability to stand and walk decreases patient quality of life and may increase the risk of 
secondary complications, such as skin breakdown, muscle atrophy, osteoporosis and cardiovascular 
diseases, with resultant psychological depression.2–4 One of the principle goals for rehabilitation is 
recovery of walking ability; however, 25% of people with incomplete traumatic SCI fail to become 
ambulatory.5–7  
 
Despite the lack of neuromuscular function in the lower extremities, various interventions have been 
developed to retrain and improve gait function in these individuals. Manual and robotic-assisted body 
weight-supported treadmill training (BWSTT) try to optimize sensory inputs relevant to step training, 
repeated practice, and improvement of neuroplasticity. However, manual BWSTT involves personnel-
intensive training with simultaneous physical guidance from up to four staff members, including at least 
one therapist. Indeed, the major difficulty of BWSTT is the non-ergonomic effort required by the trainers 
to guide the movements of the individual’s legs.8  
 
There is increasing evidence that inclusion of variable practice conditions during training enhances 
motor performance.9,10 Indeed, early evidence pointed to recovery of basic walking function in those with 
motor-incomplete SCI after intensive, task-specific training.11 Gait speed can be evaluated in terms of 
timed measures, such as the 10-meter walk test (10MWT), and endurance measures, such as the 6-
minute walk test (6MWT). Evidence for independent walking indicates that over-ground training is just 
as effective for AIS C or D individuals than is therapist-assisted BWSTT.12 Reported velocity requirements 
for community ambulation suggest a gait speed of 0.44 m/s, and the ideal training would allow for 
independent ambulation.13  
 
Gait training should include outcome measures—such as speed (m/s), walking distance (m), walking 
index for spinal cord injury (WISCI) scores, functional independent measurement (FIM) and Ashworth 
scores, and visual analogue scale (VAS) pain scores. These outcomes can be used to assess those walking 
skills that represent requirements of everyday ambulation.14  Results from Lam et al’s pilot study suggest 
the value of robotics-based (Lokomat™, Hocoma AG, Switzerland) BWSTT, which incorporates motor 
learning principles. Likewise, Musselman et al reported on an iSCI case series (n = 4) describing the use of 
a method (skill training) to retrain walking over-ground, which was intensive, variable, and relevant to 
daily walking.15 The authors concluded that retraining walking skills over-ground in challenging 
situations (over and around obstacles of various sizes) resulted in clinically important changes in walking 
speed. Median walking speed improved by 0.09 m/s for skilled walkers compared to an improvement of 
0.01 m/s for BWSTT walkers.15  
 
Mehrholz et al investigated and reviewed the effect of automated electromechanical and robotic-assisted 
gait training devices on the improvement of walking after stroke.16 Twenty-three trials involving 999 
participants were included. The gait-training devices in combination with physiotherapy significantly 
increased the odds of participants becoming independent walkers [OR: 2.39; 95% CI: 1.67, 3.43; p < 
0.00001] but did not significantly increase walking velocity [mean difference = 0.04 m/s; 95% CI: -0.03, 
0.11; p = 0.26] or walking capacity [6MWT = 3 m; 95% CI: -29, 35; p = 0.86]. The results should be 
interpreted with caution as various devices (some included electrostimulation) were studied over 
different durations and different frequencies, and some of the trials included participants who could walk 
at prior to the gait training intervention. The principal finding suggests that people in the acute phase, 
who are non-ambulatory at intervention onset, may benefit whereas those who are ambulatory may not 
benefit from this kind of training. 
 

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In one randomized controlled trial, the hybrid assistive limb (HAL™) exoskeleton (Cyberdyne, Japan) was 
compared to conventional BWSTT in terms of gait training in the subacute phase after stroke; 22 
participants were randomized equally to the two investigative groups.17 A significant difference (p = .04) 
in Functional Ambulation Categories (FAC) was achieved, favoring HAL training. The study was limited by 
small Participant numbers, differing periods between stroke and training, and lack of blinding by 
outcome assessments. 
 
The investigational Indego® exoskeleton (Parker Hannifin Corp., USA) was recently studied to evaluate 
in-device mobility outcomes for individuals with SCI after five 1.5-h gait-training sessions with the 
device.18 The average walking speed after the five sessions for those with T9–L1 paraplegia (n = 8) was 
0.45 m/s during the 10MWT and the average distance achieved during the 6MWT was 121 meters. Six of 
the eight study participants were able to walk, while in the device, on a variety of surfaces. The authors 
concluded that powered exoskeletons can provide individuals with iSCI the ability to ambulate in both 
indoor and outdoor environments. Interpretation of the study results is limited by the small number of 
participants; lack of randomization, blinding, and provision of a control group; and no evaluation of 
independent ambulation. 
 
In a controlled environment, ambulation with the Ekso™ wearable robotic exoskeleton (Ekso Bionics, 
Inc., USA) was studied to evaluate the feasibility and safety of Ekso to aid ambulation in 8 individuals who 
had experienced SCI within 2 years of study participation.19 The lack of consensus regarding the benefit 
of body weight supported training (BWST) compared to traditional over-ground therapy (TOG) in 
improving ambulation for those with SCI inspired the study. Results from six weekly sessions with Ekso 
over increasing session time and with less assistance suggested that the exoskeleton was safe to use in a 
controlled environment. In 2016, Sale et al. reported gait analysis and clinical outcomes in a prospective 
pilot study (n = 3) of Ekso. Mean velocity improved statistically from T0 (0.17 ± 0.04 m/s) to T1 (0.23 ± 
0.04 m/s) (p = .0188). Improvement over baseline in cadence (steps/min) and step length (m) were also 
statistically significant. 
 
Locomotor training, whether over-ground or on a treadmill and using partial body weight support, 
promotes recovery and improvement in mobility in humans with iSCI. Walking repetitively in a natural 
manner similar to the over-ground gait and with correct proprioceptive and exteroceptive feedback is of 
critical importance.20 Sorensen et al conducted a spinal cord injury study in multiple sites across Europe. 
Fifty-nine participants were divided into four groups. Investigators found that the incomplete spinal cord 
(n=28) Participants using the Ekso Bionics exoskeleton improved dramatically in 12 weeks (Personal 
communication.) Complete data on this trial is expected to be presented later in 2016. 
 
2. 
Study Purpose, Plan, and Objectives 
 
Community dwelling iSCI participants may improve clinical gait function by engaging in a gait training 
regimen, where robotic exoskeletons can readily deliver a precise dose and simultaneously reduce the 
physical stress imposed on therapists using conventional manually assisted stepping practice. 
Exoskeleton training is predicted to improve function in participants receiving usual care, but not 
superior to intensity-matched manual training. The rationale to implement exoskeleton robotics as 
preference in gait training is based on precision dosing, over-ground training, and reduced therapist 
burden for high repetition training.  
 
We aim to demonstrate that Ekso exoskeleton training can significantly improve gait speed in stable 
chronic, community-dwelling incomplete SCI (iSCI) participants. The objectives of this study are the 
following: 
 
A. Primary Objective:  
To demonstrate that a 12 week robotic gait training regimen can lead to a clinically meaningful 
improvement in independent gait speed on the 10 Meter Walk Test (10MWT) in community dwelling 

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participants with chronic iSCI. 
 
B. Secondary Objectives: 
1. To examine the economic factors such as number of physical therapists/staff required during 
training. 
2. To analyze the physical burden on therapists assisting and supervising during training.  
3. To study the influence of factors that may modify the gait recovery in the chronic incomplete SCI 
population (demographic, clinical, functional, psychological, balance, etc.). 
 
3. 
Study Design 
 
This is a post-market, randomized, prospective, multi-center, blinded, longitudinal, comparative study to 
evaluate the efficacy of robotic exoskeleton gait training versus standard gait training or usual care.  The 
Run-in phase is designed to 1) to train and carefully supervise the sites prior to starting the 
randomization 2) test the recruiting ability of the selected sites 3) test the assessment time-points for 
primary and secondary endpoints, and 4) ensure that the inclusion/exclusion criteria is adequate. Each 
site is expected to enroll 1-4 Run-in Participants.  
 
4. 
Study Endpoints 
 
The primary and secondary endpoints are as follows: 
 
The primary endpoint is the mean increase in gait speed demonstrated during the 10MWT after 12 weeks/  
36 sessions of training and compared between groups. Both self-selected and fast speeds will be performed on the  
10MWT, with the fast speed taking precedent. 
 
The secondary endpoints of Participant outcomes related to physical performance, physiology, quality of life,  
and safety are to be measured at week 6/following 18 sessions (midpoint), week 12/following 36 sessions 
(primary endpoint), and week 24/3 months after the last session (follow-up) (unless otherwise indicated) and  
compared between groups.  
 
By category, these are the following: 
 
PHYSICAL PERFORMANCE OUTCOMES 
 
10MWT for both self-selected and fast gait speed  
 
Number of participants who achieve the Minimal Clinically Important Difference (MCID) of  
0.15 m/s 21 during the 10MWT 
 
Number of participants who transition from exercise or household ambulation (defined as self-selected  
walking speed of < 0.44 meters/second) to limited community or full community ambulation  
(> 0.44 meter/second) during the self-selected 10MWT13 
 
Time point of recovery at which participants reach the MCID and/or community ambulation  
speeds of > 0.44 meters/second13  
 
6MWT for endurance 
 
Timed Up and Go (TUG) for balance during sit-to-stand, walking, turning, and stand-to-sit 
 
WISCI-II score for need of assistance and devices 
 

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SCI-FAI for observational gait quality 
 
GAITRite for temporospatial gait parameters and symmetry (if site has access to this device) 
 
SCIM-III, mobility subscale for ability to perform transfers and walking different distances 
 
               Berg Balance Scale for measurement of static balance  and dynamic sitting and standing balance. 
 
QUALITY OF LIFE/PSYCHOLOGICAL OUTCOMES 
 
International SCI Quality of Life Basic Data Set 
 
Epidemiological Studies Depression Scale (CES-D 10) 
 
NASA Task Load Index for participant self-reported work load  
 
PHYSIOLOGICAL OUTCOMES 
 
ISNCSCI exam between baseline and 12 weeks/36 sessions  
 
Number of participants who convert from AIS C to D per ISNCSCI exam 
 
Body mass index for a general health measure 
 
UEMS and LEMS as measured by the physical therapist for muscle strength  
 
Heart rate and blood pressure before and after 6MWT 
 
Borg Scale for self-reported maximal RPE during either intervention. 
 
SECONDARY COMPLICATIONS 
 
International SCI Pain Basic Data Set 
 
Numeric Pain Rating Scale for self-reported neuropathic pain upon resting and during gait training 
SCATS, Modified Ashworth Scale, patient-report SCI-SET, and Numeric Rating Scale for spasticity 
 
Modified International SCI Bowel Function Basic Data Set 
 
Modified International SCI Lower Urinary Tract Basic Data Set 
 
Incidence of urinary tract infections per Participant 
 
Incidence of pressure ulcers per Participant 
 
Incidence of falls per Participant   
 
Incidence of re-hospitalization/unexpected doctor visits per Participant 
 
THERAPIST OUTCOMES 
 
Number of therapists/staff required for each active group (Group 1 and 2), and set-up/donning time for cost 
effectiveness of the two active therapies 
 

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5. 
Participant Enrollment  
 
Participants will be identified and recruited from outpatient clinics.  Participants will be presented with a 
study consent form. The point of enrollment is after the patient has met the inclusion/exclusion criteria, 
and has signed the study consent form. Run-in Participants (the first 1 to 4 recruited) are to be consented 
using the Run-in consent form. Run-in Participants follow the same assignment as described in Group 1 
but are NOT randomized. After the Run-in phase, subsequent Participants are consented using the 
Randomized Consent Form and then randomized to Group 1, Group 2, or Group 3. This is further detailed 
in the section on “Screening and Informed Consent.” 
 
6. 
Duration of Participation/Study 
 
Each Run-In participant will be enrolled for approximately 14 weeks. Each randomized Participant will 
be enrolled for approximately 6 months. The enrollment period for the given target number of 
Participants is estimated to be 2.5 years and the duration of the study is anticipated to be 3 years 
following study initiation.   
 
7. 
Inclusion/Exclusion Criteria  
 
Inclusion criteria: 
1. Motor incomplete paraplegia or tetraplegia, chronic (> 1 year after the injury). Non-traumatic SCI 
injuries can be included, given they are neurologically stable conditions for 12 months (e.g. tumor, 
transverse myelitis, but NOT Guilliane-Barré) 
  
2. NLI C1- approximately T10 (inclusive, for upper motor neuron injuries only), as determined by the 
International Standards for Neurological Classification of SCI (ISNCSCI)  
 
3. Sufficient diaphragmatic strength such that respiration is not compromised with exercise. 
 
4. Sufficient upper extremity strength to use a front wheeled walker by manual muscle testing 
(minimum triceps strength bilaterally of 3/5, shoulder abduction and flexion/extension 4/5)  
 
5.. AIS-C SCI & AIS-D SCI, as determined by the International Standards for Neurological Classification 
of SCI (ISNCSCI)  
 
6.. Ambulates at a self-selected speed of <0.44 meters/second with or without physical assistance 
and assistance device 
 
7. Able to advance at least one leg forward (volitionally with lower extremity movement ( not as a 
result of  trunk movement or spasticity) while using parallel bars, walker or crutches, with or 
without braces,  and up to 2 people to assist with safety and balance only. Stepping is to be 
performed by the patient (without PT assistance at the lower extremities and no BWS).   
Borg Scale for self-reported maximal RPE during either of the interventions 
 
NASA-Task Load Index for therapists’ self-reported work load 
 
Video assessment of training posture for ergonomics  
 
Occupational safety measured by number of therapist reports of orthopedic/neurologic problems and/or pain 
 
See Appendix A for description of assessments. 

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8. 18 – 75 yrs, inclusive 
 
9. No current or history of other neurological conditions 
 
10. Screened and cleared by a physician 
 
11.  Involved in standing program or must be able to tolerate at least 15 min upright without signs or 
symptoms of orthostatic hypotension 
 
12. Weigh 220 pounds (100kg) or less 
 
13. Be able to fit into the Ekso device 
 
14. Between approximately 5’0” and 6’4” tall 
 
15. Standing hip width of approximately 18” or less 
 
16. Have near normal range of motion in hips, knees and ankles 
 
Exclusion criteria: 
1. AIS-A SCI or AIS-B SCI 
 
2. Lower motor neuron injuries, as shown by absent reflexes during bilateral quadriceps and 
Achilles tendon taps 
 
3. < 3 months since previous intensive gait training regimen, FES cycling program, and lower 
extremity botox injections. The gait training regimen is meant to be formal gait training with 
feedback for progression of walking (i.e. PT sessions). Participant may have a regular home 
exercise program and/or a walking exercise program with a companion/ trainer for safety, but 
not for verbal or tactile cues or feedback regarding gait in the 3 months before initiating the 
protocol. If participant has a home exercise program and/or a walking exercise program, these 
programs (except FES cycling) should be continued without changes throughout the protocol.  
Electrical stimulation devices used regularly for foot drop during ambulation should be 
considered a brace and should continue to be used as usual throughout the protocol. Upper 
extremity botox injections are permissible before and during the protocol. One or two PT 
sessions are allowed to obtain a new brace or progress bracing and check for fit and safety, but 
no sustained gait training should occur.  
 
4. Already walking at self-selected ambulation speeds of at least 0.44 meter/second with or 
without assistance 
 
5. Currently involved in another intervention study 
 
6. Concurrent neurological disease 
 
7. Hip flexion contracture greater than ~17° 
 
8. Knee flexion contracture greater than 12° 
 
9. Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee 
flexion) 
 
10. Leg length discrepancy 

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a. 
Greater than 0.5” for upper leg 
b. Greater than 0.75”  for lower leg 
 
11. Spinal instability 
12. Unresolved deep vein thrombosis 
13. Uncontrolled autonomic dysreflexia  
14. Severe muscular or skeletal pain 
15. Spasticity that prevents joint motion (severe stiffness or rigidity,) where both legs have a MAS 
score of 3 or higher for half or more of their proximal lower extremity muscles; proximal 
muscles include hip flexors/extensors/adductors and knee flexors/extensors. 
16. Open skin ulcerations on buttocks or other body surfaces in contact with exoskeleton or harness 
17. Pregnancy 
18. Cognitive impairments – unable to follow 2 steps commands and communicate for pain or to 
stop session 
19. Shoulder extension ROM < 50° excludes crutches during sit to stand or vice versa. (Walking with 
crutches permitted.) 
20. Participant requires the assistance of more than one therapist to transfer safely. 
21. Uncontrolled or severe orthostatic hypotension that limits standing tolerance; defined as 
sustained, symptomatic drops in systolic and diastolic blood pressure when moving from sitting 
to standing 
22. Active heterotrophic ossification (HO), hip dysplasia or hip/knee axis abnormalities 
23. Colostomy  
24. History of long bone fractures since the SCI, secondary to osteoporosis  
25. Unable to sustain current medication regimen 
26. Any reason the physician may deem as harmful to the participant to enroll or continue in the 
study  
 
8. 
Screening, Enrollment, and Treatment Allocation 
 
8.1 Screening and Informed Consent  
 
Study participants will be recruited after the Institutional Review Board (IRB) has approved the study.  
The investigator or the investigator’s designee will inform all patients who express willingness to enter 
the study about the purpose of the study, the required testing, procedures, and assessments, the expected 
duration, and the potential risks and benefits of study participation.   
 
Potential participants are identified by the investigator or the investigator’s designee. The investigator or 
designee will review the patient’s history to determine the patient’s initial eligibility for study entry.  This 

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may be accomplished first by phone screening. After determining an applicant’s initial eligibility status, 
the applicant may be offered the opportunity to participate in the study and will be given the opportunity 
to further discuss the available treatments, the risks and benefits, alternative therapies, and study 
requirements with the investigator or investigator’s designee during the consent process. The applicant 
will be informed by the investigator or investigator’s designee that he/she is free to change his/her mind 
and may withdraw from the study at any time without prejudicing further care. The study investigator or 
designee will give the applicant an informed consent document to read and time to ask questions and 
think about his/her decision prior to signing and dating the consent form.  After the Run-in phase has 
been completed, subsequent applicants must understand that if they qualify for participation in 
the study, they will be randomized to one of three possible treatments.  Further, the investigator or 
the investigator’s designee will inform the applicant that as a Participant in a study, his or her medical 
records may be reviewed by the sponsor and representatives of regulatory bodies, and that study 
information will be used during the analysis of the results of the clinical study, but that the identity of the 
participant would not be disclosed to any reports emanating from this study. Applicants must sign a 
consent form before any study-specific evaluations or procedures are performed. 
 
Applicants become enrolled as Participants in the study upon signing the consent form. The 
original signed consent form will be returned to the investigator and filed in the Participant’s study file; 
the Participant will be given a copy of the signed consent to keep.  
 
8.2    Run-in Participants, Randomization to Treatment Groups, and Treatment Rules 
 
All sites will be allowed to enroll between one and four Run-in Participants. Run-in Participants are 
necessary for the study staff to demonstrate adequate knowledge and training using the Ekso device and 
to practice the data collection process that is required for this study. Run-in Participants are not 
randomized; they will be enrolled using a separate consent form. Run-in participants will train in the 
Ekso device for 12 weeks (36 sessions) and assessments will be done according to the Group 1 schedule 
except run-in participants will not complete the follow up evaluation visit and assessments (week 24). .  
It is not required for a site to complete all 12 weeks of training with all Run-in Participants before 
beginning the screening, enrollment, randomization, and baseline tests of other Participants. All 
subsequent study Participants are randomized via computer to one of three treatment arms, either Group 
1, 2 or 3 defined respectively as Ekso intervention, active control or passive control in a 2:2:1 
randomization ratio (respectively).  Group 1, 2, or 3 descriptions are as follows: 
 

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Group 3: Passive controls with cross-over option - Participants in this group continue with daily 
activities as normal over 12 weeks. No new gait training, mobility therapy, nor new medications 
(including Botox) are commenced during the study period. Participants in this group will come to the 
study sites for evaluations at 6 and 12 weeks (midpoint and endpoint).  After the 12 week (endpoint) 
evaluation, the participants in this group will have an opportunity to choose to receive either Ekso or 
standard gait training therapy for 12 weeks/36 sessions. 
 
9. 
Ekso Device Description and Safety Features 
 
The Ekso GT is a powered motorized orthosis intended for those experiencing muscular and neurological 
conditions affecting their lower extremities to perform ambulatory functions including gait training. (See 
Figures 1 and 2.) It consists of a fitted metal brace that supports the legs, feet, and torso. It is adjustable to 
accommodate different length lower legs, thighs, and different hip widths. Typically a physical therapist 
straps the patient’s feet, legs, and torso into the device. When patients become more familiar with the 
Ekso they may strap themselves in. The straps are designed for the patient to easily get in and out of the 
device either on their own or with minimal assistance. Softgoods (pads, spacers, straps, and supports) are 
Group 1: Ekso Intervention - Participants in this group receive Ekso GT robotic gait training 3 times per 
week for 12 weeks (36 sessions). Sessions will consist of 45 minutes of gait training in Ekso with a goal of 
a minimum 300 steps per session, and if possible, overground training without BWS. The 45 minutes will 
exclude set-up/donning/doffing time and include standing/up time, walking time, and seated rest breaks. 
Standard overground gait training will be included when the Participant requires only minimal 
assistance of one therapist and one aide to help control the assistive device. This will be assessed weekly 
during the 10MWT performed every 3rd session.   At this point, sessions will consist of 30 minutes of 
session time gait training in the Ekso, followed by 15 minutes of session time performing standard 
overground gait training outside the Ekso, for a total of 45 minutes. See Table 1 A for the Ekso training 
progression strategy.  The 15-minute overground gait training may take place at the first session if 
criterion for assistance is met.  During the 15-minute overground gait training, any intervention, device, 
or bracing may be used EXCEPT Ekso, BWSTT, or any BWS.  Stairs may be included during this 
overground gait training for a maximum of 5 minutes per session when the participant is able to perform 
them with only minimal assist or less of one PT. 
 
Group 2: Active controls - Participants in this group will receive matched number of sessions of standard 
gait training 3 times per week for 12 weeks (36 sessions). Sessions will consist of 45 minutes a of body-
weight supported treadmill training, and if possible, overground training without BWS. The 45 minutes 
will exclude set-up/harnessing time and include standing time, walking time, and seated rest breaks.. 
Sessions will begin with a minimum of 300 steps during BWSTT. Overground gait training will be 
included when the Participant requires only minimal assistance of one therapist and one aide to help 
control the assistive device for at least 10 meters.  This will be assessed weekly during the 10MWT 
performed every 3rd session. Once the overground criterion is achieved:   
1) If the initial 300 steps are not completed by the end of the first segment, the middle 15-minute 
segment must be gait training in BWSTT, and the final 15-minute segment must be OG gait 
training. 
2) If the initial 300 steps are completed by the end of the first segment, the middle 15-minute 
segment can be continued gait training in BWSTT or OG gait training, per PT choice. The final 15-
minute segment must be OG gait trainingSee Table 1 B for the training progression strategy and 
section 10 – Training Regimen and Rules for details. 
 
See Table 1 B for the BWSTT training progression strategy.  The overground gait training may take place 
at the first session if criterion for assistance is met. During overground gait training, any intervention, 
device, or bracing may be used, EXCEPT Ekso, BWSTT, or any BWS.  Stairs may be included during this 
overground gait training for a maximum of 5 minutes per session when the participant is able to perform 
them with only minimal assist or less. 
 

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available for bracing and adapting to numerous body types.  The straps and softgoods are specifically 
designed to prevent pressure points or other skin issues.  There is also a link (Don-Doff Link) just below 
each hip joint, which permits abducting the legs while seated to facilitate donning and doffing the device.   
 
 
 
 
 
Figure 1: The Ekso GT in use during gait 
training of an SCI patient. 
 
 
 
 
Figure 1 - The Ekso GT structure and general 
dimensions. 
 
The Ekso GT manipulates the patient’s legs and waist to stand up, walk over level ground, and then to sit 
down. Battery powered motors drive knee and hip joints. The batteries are designed to last for 
approximately three hours of normal use. The patient is required to assist with balance and body 
positioning using a cane, crutches, or walker provided with the device.  The physical therapist monitors 
the patient to ensure balance is maintained and operates the device. The device is operated in various 
modes. In some modes, steps are triggered with the attached user interface. In other modes, steps are 
triggered when the machine is in certain target postures. In other modes, the therapist may adjust the 
level of assistance provided so that, if the patient has some residual strength, the patient performs some 
of the walking motion with their own muscles. 
 
The Ekso GT has a number of features to ensure patient safety.  It 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 ankle is from -10° to 20° dorsiflexion with hard stops at the 
limits of this range to protect the user and a setting to specify the neutral angle. 
 
Redundant position sensing on all of the actuated joints ensures that the motors are always controlled 
using reliable sensor information. In addition, the device has numerous sensor, motor, and software 
monitoring systems.  If any abnormality is detected (i.e. excess joint speed or force, or if redundant 
sensors do not agree) the device enters a safe mode, which prevents continued walking and enables the 
physical therapist to safely remove the patient.  The device is also equipped with fail-safe brakes on the 
actuated knee joints, such that if the device loses power or is shut down for any reason the knees will 
continue to support the patient. Finally, an emergency disable button is available to instantly shut down 
the device for any reason.  This is implemented via hardware, so it is effective even during a software 
malfunction.   
 

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The Ekso GT is intended to be used under the supervision of a physical therapist who has successfully 
completed the level 2 Ekso Bionics training program.  This program covers all aspects of device operation 
and adjustment, including proctored and individual hands-on experience with patients.  The program 
also covers methods of ensuring patient safety and requires participants to demonstrate their knowledge.  
To date, the Ekso GT has had no adverse events and has not caused any issues of compromised skin 
integrity. 
 
If a Participant is randomized to Group 1, he/she must meet all criteria related to the Ekso GT per Ekso 
GT Operating Manual. All Ekso gait training will be conducted using the Ekso GT with SmartAssist base 
software. The Ekso will be programmed to allow bilateral assist mode with adaptive and fixed swing 
assist options, as well as unilateral and 2Free modes with neutral, high/low assistance, and high/low 
resistance options. Weight shifting training will be available as a pre-gait option.  
 
10. 
Training Regimen and Rules 
 
1. The participants in Groups 1 and 2 will gait train three times per week for 45 minutes per 
session, ideally over twelve weeks, for a total of 36 sessions.   
2. The first patient training session occurs on a separate day from the screening and baseline data 
collection visit(s). 
3. After the 18th and 36th sessions, the evaluations (mid-point and endpoint) are to be performed on 
a day without a gait training session.  
4. It is recommended to schedule ~75 minutes per session not only to allow for set up, 
adjustments, and donning and doffing time, but also potential participant tardiness and restroom 
breaks, as well as data collection/testing time, as needed.   
5. Donning time excludes all adjustments that can be accomplished prior to patient arrival (such as 
hardware adjustments and software programing).   
6. All 36 sessions must be completed within 15 weeks of beginning training.  
7. There should be no more than 4 visits (sessions/evaluation) per week, and no more than 1 
session per day.   
8. No more than a two week gap in training should occur at any time.  
9. Given rules 6, 7, and 8:  It is recommended to plan ahead for holidays and participant vacations 
during the training protocol.  
10. Given rules 6, 7, and 8:  Evaluations may be able to occur in keeping with a regular schedule (e.g. 
always MWF, if the participant works) or may be scheduled as a 4th visit for the week. Keep in 
mind the participant’s potential fatigue effects, particularly during evaluation visits, if scheduling 
4 visits in a week. 
11. Every effort should be made to complete sessions and assessments within the appropriate 
windows.   
12. Total session time is to be 45 minutes, +/- 10 minutes.   
13. The 5-minute warm up and 2-minute cool down are counted as part of the walking time. 
 
Table 1A consists of the progression strategy and guidelines for Group 1 (Ekso active group) and Run-in 
Participants and Table 1B consists of the progression strategy and guidelines for Group 2 (Active control 
group). 
 
 
 

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Table 1A Group 1 (Ekso) Progression Strategy 
General rules for Ekso Active Group:  
1) 
Sessions are divided into three 15-minute segments. This includes any rest breaks required, as well as a 5-minute warm-up and 2-minute 
cool down per session required by week 2. 
2) 
Sessions begin with a goal of a minimum of 300 steps per session in Ekso within trajectory. Then can do outside of trajectory. 
3) 
All sessions after session #3 must include a 5-minute warmup and end with a 2 minute cool down in Bilateral/Adaptive. 
4) 
All device and assistive device progressions should be done in Bilateral/Adaptive. (Examples: FRW to Crutches; step length increase; step 
height decrease; target adjustment; turning mode or technique). 
5) 
Each leg may be considered individually when considering reducing Fixed assist level, or choosing high/low assistance/resistance in 2Free. 
No unilateral trajectory-free stepping is allowed to avoid promoting gait asymmetries. 
6) 
If the participant is exceeding 750 steps per session, the therapist should increase the challenge to the participant. 
7) 
Excluding Ekso donning and doffing time, each session will last a total of 45 minutes, which will include standing/up time, walking time, and 
seated rest breaks.  
8) 
Overground walking will be included when the Participant requires only minimal assistance of one therapist and the assistance of one aide 
to control the assistive device for at least 10 meters. 
9) 
If participant is not yet performing overground gait training, all 45 minutes of session will be done in Ekso.   
10) If participant is performing overground gait training, session will consist of 30 minutes of gait training in the Ekso, followed by 15 minutes 
performing overground gait training for a total of 45 minutes.  
11) Step monitors are to be used during any OG gait training. 
 
Timeline and 
settings 
Assist 
Swing Assist 
Progression and Adjustments 
Considerations: 
Sessions    1-
3 
Bilateral 
Trajectory Controlled: 
Adaptive 
Pre-gait weight shifting 
 
Stance support remains at “Full” 
 
Minimize upper extremity loading. 
Optimize step height; swing time; step 
length; targets; etc. 
 
Balance and gait progression 
 
Consistently hitting >300 steps per session 
 
Adjust targets/swing time/step length as 
appropriate 
 
 
Anytime 
Session 3+ 
Bilateral 
Trajectory Controlled: 
Adaptive 
Pre-gait weight shifting when needed. 
 
Once participant has consistently 
managed >300 steps/session, progress 
to crutches if appropriate and 
encourage minimal UE loading 
 
 
Adjust targets/swing time/step length as 
appropriate 
 
Step count with crutches should be at least 80% of 
step count with walker. 
Training 
Guidelines 
 
Bilateral  
Trajectory Controlled: 
Adaptive->Fixed 
 
 
 
 
 
 
Trajectory Free: 
2Free 
 
PT may progress the participant by 
lowering the fixed assist for each leg, as 
tolerated and clinically appropriate. 
 
Stance support may be changed from 
“Full” to “Flex”.  
 
 
Once initial 300 steps in trajectory are 
completed, PT may progress the 
participant via trajectory free stepping 
using “2Free”. 
 
Stance support should begin at 
appropriate level”. As participant 
improves stance control, support may 
be reduced as tolerated and clinically 
appropriate. 
 
Swing support should be assessed at 
“neutral”. If a leg is not able to complete 
a step, “high”/”low assistance” may be 
provided for more normalized stepping. 
If a leg is stepping far outside of the 
general trajectory, “high”/”low 
resistance” may be provided for more 
normalized stepping. Progress to more 
symmetrical gait. 
Step count must be at least 300 within trajectory. 
 
Must include 5 min warm-up at beginning and 2 
min cool down at end in bilateral adaptive. 
 
Borg range 12-17 to prevent fatigue early in the 
session 
 
No more than 3 swing completes per minute in 
Fixed assist.  
(If so, then increase Fixed swing assist by 10 or 
reduce swing complete time) 
 
No unilateral trajectory free stepping to avoid 
promoting gait asymmetries.  
 
 

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Progression 
Guidelines  
Bilateral  
Trajectory Controlled: 
Adaptive->Fixed 
 
  
 
 
 
 
 
 
 
 
 
 
Trajectory Free: 
2Free 
 
 
If initial 300 steps within trajectory is 
achieved/projected, the therapist may 
challenge the participant by the 
following, as tolerated and clinically 
appropriate: 
 
Lower the Fixed assist bilaterally as 
appropriate 
 
Stance support may be changed from 
“Full” to “Flex”.  
 
 
 
Once initial 300 steps in trajectory are 
completed, set swing support at 
appropriate assistance/resistance for 
an appropriate clinical challenge 
 
Step count must be at least 300 within trajectory. 
 
Must include 5 min warm-up at beginning and 2 
min cool down at end in bilateral adaptive. 
 
Borg range 12-17 to prevent fatigue early in the 
session 
 
No more than 3 swing completes per minute in 
Fixed assist     
(If so, then increase Fixed swing assist by 10 or 
reduce swing complete time) 
 
No unilateral trajectory free stepping to avoid 
promoting gait asymmetries.  
 

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Table 1B Group 2 (Active Controls) Progression Strategy 
General rules for Active Controls:  
1) 
Sessions are divided into three 15-minute segments. This includes any rest breaks required, as well as a 5-minute warm-up and 2-
minute cool down per session required by week 2. 
2) 
Participants will perform gait training with BWSTT for the full session (all 3 segments) until the OG criterion is met.  This gait 
training must continue for a minimum of 300 steps at the beginning of each session.  
3) 
Manual assistance from the physical therapy team to facilitate normal stepping kinematics is permissible. 
4) 
BWS and speed are to be determined by the physical therapist based on appropriate stepping kinematics, level of challenge to the 
participant, and safety of the participant and trainer(s). 
5) 
Participants will perform gait training with BWSTT for the full session (all 3 segments) until the OG criterion is met. Participants 
may proceed to overground gait training without BWS only when they require minimal physical assistance of the physical therapist, 
plus assistive device control or supervision of another team member for at least 10 meters.  
6) 
Once the OG criterion is achieved:   
a. 
If the initial 300 steps are not completed by the end of the first segment, the middle 15-minute segment must be gait training 
in BWSTT, and the final 15-minute segment must be OG gait training. 
b. 
If the initial 300 steps are completed by the end of the first segment, the middle 15-minute segment can be continued gait 
training in BWSTT or OG gait training, per PT choice. The final 15-minute segment must be OG gait training. 
7) 
Step monitors are to be used during the full 45 minutes of gait training. 
 
 
Focus 
Progression and Adjustments as 
Tolerated** 
Considerations: 
  
Sessions 1-3 
• 
Determine parameters 
for best kinematics 
• 
Participant 
familiarization 
• 
Posture 
Determine comfortable BWS, 
stepping speed range, amount of 
physical assistance at each location, 
and bout length 
 
Educate and engage posture and basic 
stepping  
 
Educate and ensure joint protection 
 
Sessions 4-6 
• 
Posture 
• 
Good stepping kinematics 
• 
Increase load as 
tolerated* 
• 
Increase speed range as 
tolerated 
 
All sessions should have 5 
minute warmup and 2 minute 
cool-down. 
• 
Decrease BWS if tolerated 
• 
Increase/decrease speed 
• 
Increase bout lengths 
 
 
Engage posture and both swing/stance 
phases of stepping 
 
Ensure good posture, stepping kinematics, 
and joint protection. 
 
Borg range 12-17 to prevent fatigue early 
in the session 
 
Sessions 7-18 
• 
Increase load weekly if 
tolerated* 
• 
Increase speed range as 
tolerated 
• 
Increase independence 
• 
Increase endurance 
 
All sessions should have 5 
minute warmup and 2 minute 
cool-down. 
• 
Decrease BWS if tolerated 
• 
Increase/decrease speed  
• 
Decrease physical assistance 
• 
Increase bout lengths, decrease 
rest breaks 
• 
Introduce walking sideways, 
backwards, stepping over 
obstacles, quick speed changes, 
quick start/stops if tolerated 
Engage hip control and motor control 
(concentric/eccentric) of stepping, arm-
swing 
 
Ensure good posture, stepping kinematics, 
and joint protection. 
 
Borg range 12-17 to prevent fatigue early 
in the session 
 
 
Sessions 19-36 
• 
Increase load weekly if 
tolerated* 
• 
Increase speed range by 
as tolerated 
• 
Increase independence 
• 
Increase endurance 
• 
Increase adaptability 
 
All sessions should have ~5 
minute warmup and ~2 
minute cool-down.  
• 
Decrease BWS if tolerated 
• 
Increase/decrease range 
• 
Decrease physical assistance 
• 
Increase bout lengths, decrease 
rest breaks 
• 
Continue or introduce walking 
sideways, backwards, stepping 
over obstacles, quick speed 
changes, quick start/stops 
 
Engage motor control of posture, hips, 
symmetric stepping, arm swing (when 
evaluable) 
 
Ensure good posture, stepping kinematics, 
and joint protection. 
 
Borg range 12-17 to prevent fatigue early 
in the session 
 
 
* Training intensity should be increased first by increasing loading. If amount of loading puts participant or trainers at risk for 
injury, then increasing speed range or independence can be the focus of increasing intensity. 
** PT can adjust one or multiple parameters at a time. PT can adjust parameters for interval training, e.g. lower BWS for 5 minutes. 
 
 

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11. 
Participant and Therapist Assessments 
 
Phone or in-person limited screening procedures are conducted to assess minimal trial inclusion.  
Baseline procedures establish a baseline for future comparisons.  (Prior to initiating physical or 
psychological screening evaluations, study personnel must obtain a signed informed consent.)  
Participant screening can then proceed to ensure the individual meets inclusion/exclusion criteria and 
baseline data will be collected for comparisons. The screening and baseline procedures can occur over 
one or two visits.  
 
The following information will be obtained during screening and, if Participant passes screening, may be 
used for baseline. 
1. Demographic data including date of birth, gender, date and cause of injury, (self-reported)  
2. Past and current medical history (self-reported)  
3. List of current medications 
4. Weight, height, Body Mass Index (BMI) 
5. Blood pressure (sit to stand) 
6. Written documentation from the participant’s SCI physician verifying the participant is medically 
stable and cleared for full weight bearing locomotor training and does not have any conditions 
that would exclude the Participant including: spinal instability, unresolved DVT, decreased 
standing tolerance due to orthostatic hypotension, two or more spontaneous lower extremity 
long bone fractures in the last 48 months, hip subluxation, autonomic dysreflexia, known 
pregnancy (if relevant), colostomy, history of head injury or other central nervous system 
disorders that may impact motor planning or impulsivity, significant cardiac or pulmonary 
disease (screening).  (see Inclusion/Exclusion criteria) 
7. Current practice of standing or walking, level of assistance required, assistive devices and braces 
used, and any associated adverse events (self-reported) 
8. Observation of a level surface wheelchair to mat transfer.  
9. Range of motion for hip flexion/extension, knee flexion/extension/ ankle dorsi/plantar flexion  
10. Upper extremity MMT to include: shoulder flexion/extension/abduction and elbow extension 
11. Spasticity of the hip, knee and ankle muscles as assessed by the Modified Ashworth Scale at 
screening.  
12. Skin check of back, sacrum, shins, and feet (must be done at each visit) 
13. Neurological exam will be obtained using the ISNCSCI examination for motor and sensory testing 
and for designation of AIS and ISNCSCI motor scores of UEMS and LEMS 
 See Appendix A for description of assessments. 
 
If the participant continues to meet criteria for this study the following data will be collected as baseline 
data. NOTE: All Participant evaluations are conducted outside of Ekso, BWSTT, or BWS for 
overground walking. Baseline examinations may not occur more than 30 days prior to initiation 
of the training regimen: 
1.  10 Meter Walk Test (10MWT), at both self-selected and fast speeds  
2. GAITRite Pressure Map for Temporospatial Gait Parameters  (if site has one) 
3. Timed Up and Go (TUG) 
4. 6 Minute Walk Test (6MWT) 
5. Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)  
6. Walking Index for Spinal Cord Injury (WISCI II) 
7. Upper and Lower Extremity Muscle Strength  
8. Berg Balance Scale  
9. The Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)  
10. Spinal Cord Independence Measure III (SCIM-III), Mobility subscale only, by interview 
11. Modified Ashworth Scale 
12. Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET)  

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13. Numeric Rating Scale for spasticity  
14. International SCI Quality of Life Basic Data Set  
15. Epidemiological Studies Depression Scale (CES-D 10) 
16. Borg Scale for maximal Rate of Perceived Exertion (collected at baseline 6MWT and at training  
session 1) 
17. International SCI Pain Basic Data Set 
18. Modified International SCI Bowel Function Basic Data Set 
19. Modified International SCI Lower Urinary Tract Basic Data Set  
   
See Appendix A for description of assessments. 
 
The following data will be collected per session: 
1. Any adverse events/complications (related to Participant or staff) noted following prior training 
session and during present session 
2. Assessment of skin integrity of the anterior and posterior torso, anterior tibia, sacral area and 
bilateral feet (before and after training) 
3. Walk time* 
4. Stand time* 
5. Seated rest time 
6. Number of steps total and in each mode* or number of steps at each BWS% 
7. Time spent in each mode* or time spent at each BWS% 
8. Any equipment used for training, including type of assistive device and braces  
9. Number of therapists/staff required at each training session to ensure the safety of the 
Participant and to complete the training session goals 
10. Amount of assistance (e.g. min, mod, max) as reported  by staff members at each training 
position (hips, trunk, right LE, left LE, etc.) 
*  For Group 1 Participants, these data are automatically collected by Ekso (in Ekso Pulse) at the end of each training session 
 
The following data will be collected at every 3rd session (i.e. session 3, 6, 9, etc.,(refer to Table 2): 
1. 10MWT without braces at self-selected speed 
2. Borg Scale for maximal RPE during intervention and overground training 
3. Numeric Pain Rating Scale of neuropathic pain during rest and during the intervention 
4.  Numeric Rating Scale for spasticity 
5. NASA – Participant Task Load Index 
6. Heart rate and blood pressure 
 
Therapist assessments include the following: 
1. NASA-Task Load Index 
2. Video Assessment of therapist posture during sessions 1 and 36 
3. Borg Scale for maximal RPE during intervention and overground training 
4. Reports of injuries or pain (includes all treating staff) 
Table 2 shows the list of Participant assessments and data collection intervals. Therapist measures are included in 
Table 3.  

 
 
Table 2  - 
Participant 
Assessments 
and  Data 
Collection 
Intervals 
 
 
Assessment 
Screening1 
Visit 8 
 
(may be used 
for baseline 
data if done 
over 1-2 
days) 
Baseline1 
Visit8  
 
Week 0 
(Not > 30 days 
prior to first 
training 
session) 
Session 
Assessments  
GROUPS 1 & 23  
(and Run In⬧)  
Sessions 1-36 
 
Evaluations  
ALL GROUPS 
(including Run In) 
After session 18    
Week 6** 
Midpoint 
(+/- 1 week of 
completing session 
18) 
Evaluations  
ALL GROUPS 
(including Run In) 
After session 36    
Week 12** 
Endpoint 
(+/- 1 week of 
completing session 
36)  
 
Evaluations 
GROUPS 1 & 2 only 
(Not Run-In or Group 3 
Participants) 
Week 24** 
Follow-Up, 
3 months following the last training 
session 
(+/- 3 weeks) 
 
 
 
B2 
D2 
A2 
 
 
 
Physician Clearance 
 
✓ 
 
 
 
 
 
 
Demographics ˆ  
✓ 
 
 
 
 
 
 
 
Medical History ˆ 
✓ 
 
 
 
 
 
 
 
Concomitant 
Medications4  
✓ 
✓ 
✓ 
 
 
✓ 
✓ 
✓ 
BMI ˆ ‡ 
✓ 
✓ 
 
 
 
✓ 
✓ 
✓ 
Vital Signs ° ˆ 
✓°° 
✓°°° 
✓৯” 
 
 
✓°°° 
✓°°° 
✓°°° 
ROM: Hip, Knee, 
Ankle ˆ 
✓ 
 
 
 
 
 
 
 
UE MMT5 ˆ 
✓ 
 
 
 
 
 
 
 
Skin Assessment6 
✓ 
✓ 
✓ 
 
✓ 
 
 
 
Modified Ashworth 
Scale 
✓ 
✓¤ 
 
 
 
✓ 
✓ 
✓ 
SCATS 
 
✓ 
 
 
 
✓ 
✓ 
✓ 
UEMS  
✓ 
✓ 
 
 
 
✓ 
 
✓ 
LEMS  
✓ 
✓ 
 
 
 
✓ 
 
✓ 
Full ISNCSCI Exam ˆ 
✓ 
 
 
 
 
 
✓ 
 
 
 
 
 
 
 
 
 
 

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Assessment 
Screening1 
Visit 8 
 
(may be used 
for baseline 
data if done 
over 1-2 
days) 
Baseline1 
Visit8   
Week 0 
(Not > 30 days 
prior to first 
training 
session) 
Session 
Assessments  
GROUPS 1 & 23  
(and Run-In⬧)  
Sessions 1-36 
No braces for 
10MWT 
Evaluations  
ALL GROUPS 
(including Run-In) 
After session 18**    
(Week 6) Midpoint 
(+/- 1 week of 
completing session 
18) Braces OK for 
walking tests 
Evaluations  
ALL GROUPS 
(including Run-In) 
After session 36**    
(Week 12)Endpoint 
(+/- 1 week of 
completing session 
36) Braces OK for 
walking tests 
Evaluations 
GROUPS 1 & 2 only 
(Not Run-In or Group 3 
Participants) 
3 months following the last training 
session** (Week 24) Follow-Up, 
 (+/- 3 weeks) 
Braces OK for walking tests 
 
 
 
B2 
D2 
A2 
 
 
 
Berg Balance Scale 
 
✓ 
 
 
 
✓ 
✓ 
✓ 
10 Meter Walk Test 7 
(self-selected  and 
fast) 
✓ 
✓  
(both with and 
without braces) 
✓11  
 
 
 
✓                 
(baseline + current 
device/braces) 
✓                
(baseline + current 
device/braces) 
✓                             
(baseline + current device/braces) 
Timed Up & Go (TUG)  
10 
 
✓ 
 
 
 
✓ 
✓ 
✓ 
6 Minute Walk Test 10 
 
✓ 
 
 
 
✓ 
✓ 
✓ 
SCI-FAI 
 
✓ 
 
 
 
✓ 
✓ 
✓ 
WISCI II12ˆ 
 
✓ 
 
 
 
✓ 
✓ 
✓ 
SCIM-III, Mobility 
subscale only 
 
✓ 
 
 
 
✓ 
✓ 
✓ 
SCI-SET 
 
✓ 
 
 
 
✓ 
✓ 
✓ 
Numeric Rating Scale 
(for spasticity) 
 
✓ (after 1st 
session) 
 
 
✓11 
 
 
 
International SCI 
Quality of Life 
Basic Data set 
 
✓ 
 
 
 
✓ 
✓ 
✓ 
Epidemiological 
Studies Depression 
Scale (CES-D 10) 
 
✓ 
 
 
 
✓ 
✓ 
✓ 
Borg - Maximum 
during training and 
6MWT  
 
✓ (during 
baseline 6MWT 
and after 1st 
session) 
 
✓11 
 
✓ 
✓ 
✓ 
NASA- Task Load 
Index  
 
✓ (after 1st 
session) 
 
 
✓11 
 
 
 
International SCI Pain 
Basic Data Set 
 
✓ 
 
 
 
✓ 
✓ 
✓ 
Numeric Pain Scale  † 
(for neuropathic pain ) 
 
✓ (after 1st 
session) 
✓11 
✓11 
 
 
 
 

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Footnotes (Table 2): 
‡ Height may be obtained verbally; weight must be measured via scale.  Calculate BMI using NIH National Heart Lung and Blood Institute calculator at: 
http://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm 
*  Skin assessment to be performed before and after training sessions 
• Maximum Borg to be done during session 1 then during weekly sessions (every third session)  thereafter, and after 6 minute walk test during evaluations 
** Assessments to be performed outside of exoskeleton or any body weight support and on a non-training day. 
° Vital signs (BP and HR) will be measured as follows: 
                 _      °° Upon relaxation (5 minutes) in sitting position after arrival.  After 1 minute of standing (may hold on to something for balance or use standing in frame as needed) 
                  
                 _     °°° Vitals should be taken in sitting before and immediately after 6 minute walk  
                 -       ৯ To be taken prior to 10MWT 
-   ” To be taken prior to each session and needed only if orthostatic hypotension was present at the time of the previous session and/or if 
symptomatic upon standing at the time of the current session. 
 ⬧ Run In will follow Group 1 assessments but will not complete the follow up evaluation visit and assessments 
ˆ To be obtained during Screening, and if participant passes screening can be used for Baseline 
† Numeric Pain Scale: to be completed before and during session 1 and weekly thereafter 
¤ To be done by blinded evaluator for comparison to week 6, 12, 24 (midpoint, endpoint, and follow-up) evaluation visit results. 
 Done by blinded evaluator for comparison.  Testing to be done according to ISNCSCI instructions (supine, using the correct limb positioning and angles for resistance) 
1 May occur over one or two visits 
2 B = before session, D = during session, A = after session 
3 Passive Group 3 will complete all evaluations at Baseline, Week 6 and week 12, the same as Groups 1 and 2, then have the option (per participant decision) to undergo 12 weeks of training using 
the exoskeleton or standard gait training. The optional 12 week period will consist of training only.  No further evaluations will be completed at this time. 
Assessment 
Screening1 
Visit 8 
 
(may be used 
for baseline 
data if done 
over 1-2 days) 
Baseline1  
Visit 8   
 
Week 0 
(Not > 30 days 
prior to first 
training 
session) 
Session 
Assessments  
GROUPS 1 & 23  
(and Run-In⬧)  
Sessions 1-36 
 
Evaluations  
ALL GROUPS 
(including Run-In) 
After session 18    
Week 6** 
Midpoint 
(+/- 1 week of 
completing session 
18) 
Evaluations  
ALL GROUPS 
(including Run-In) 
After session 36    
Week 12** 
Endpoint 
(+/- 1 week of 
completing session 
36)  
 
Evaluations 
GROUPS 1 & 2 only 
(Not Run-In or 
Group 3 
Participants) 
Week 24** 
Follow-Up, 
3 months following 
the last training 
session 
(+/- 3 weeks) 
 
 
 
B2 
D2 
A2 
 
 
 
Modified 
International SCI 
Bowel Function 
Basic Data Set 
 
✓ 
 
 
 
✓ 
✓ 
 
           ✓ 
International SCI 
Lower Urinary 
Tract Basic Data 
Set 
 
✓ 
 
 
 
✓ 
✓ 
 
           ✓ 

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4 Update Concomitant Medication Log accordingly 
5 To include shoulder flexion/extension, abduction/, and triceps  
6 Skin assessment with focus on back, sacrum, shins, and feet to be collected before and after each training session 
7 To be collected outside of the exoskeleton or any body weight support, and prior to any training session; can be used to assess readiness to transition to overground training weekly. 
Screening: (10MWT) 1 walk with or without braces at self-selected speed to confirm qualification self-selected speed of <0.44 m/s. A second trial may should be done if first trial is close to 0.44 
m/s. 
Baseline:  up to 8 trials  (total) of 10MWT (2 trials each, with and without braces at both self-selected and fast speeds (to be done by blinded evaluator) 
Every 3rd session: 10MWT (2 trials, without braces at self-selected speed), every 3rd session, if possible.  The walk is done without braces (to determine neurological recovery changes). Pt can 
complete second walk to donn Ekso, or to donn the harness for BWSTT (depending on randomization and tolerance). 
Evaluations at 6, 12, 24 weeks (midpoint, endpoint, and follow-up): up to 8 trials (total) of 10MWT (2 trials each, with baseline device/braces at both self-selected and fast speeds, then 2 trials 
with current device/braces at self –selected and fast speeds, performed with whatever assistive devices are needed for safe ambulation  (to be done by blinded evaluator) 
8 The first training in the exoskeleton occurs separately from screening and baseline data collection 
9 Form to be completed at the time of study completion or at any time of early termination 
10 Use baseline assistive device(s) and brace(s) for all TUG and 6 MWT assessments. 
11 Every 3rd session 
12 Score WISCI for current device/braces at self-selected speed 
 

 
Table 3 -  Therapist 
Assessments, and 
Data Collection 
Intervals (to be 
completed by the lead 
treating PT). Report of 
pain/injury to be 
completed by all 
participating session 
staff 
 
 
 
 
Assessment 
Baseline Visit 
After 1st Session 
 
Session 
Evaluations  
GROUPS 1 & 23  
(and Run-In) 
Sessions 1-36 
 
Evaluations  
ALL GROUPS 
(including Run-In) 
After session 18**    
(Week 6) 
Midpoint 
(+/- 1 week of 
completing session 
18) 
Evaluations  
ALL GROUPS 
(including Run-In) 
After session 36**    
(Week 12) 
Endpoint 
(+/- 1 week of 
completing session 
36)  
 
 
 
B2 
D2 
A2 
 
 
NASA – Task Load Index, 
therapist physical load***  
✓ (after 1st 
session) 
 
 
✓ 
 
 
Video assessment of posture 
during training 
✓ (after 1st 
session  
 
✓* 
 
 
 
Borg Perceived Exertion (in 
each training environment) ** 
✓ (after 1st 
session  
 
✓ 
 
 
 
Therapist/staff report of pain 
and/or injury **** 
✓ 
 
 
✓ 
 
 
 
*During first and last sessions only (sessions #1 and #36) 
 Video of session # 36 should be taken at the same general point as session #1 as noted on source document. 
** During session 1 and every 3rd session thereafter (starting with session 3) 
*** After session 1 and every 3rd session thereafter (starting with session 3) 
**** Baseline upon registration for ID in EDC (before first session) and every  session thereafter .  To be completed by all staff participating in a 
treatment session. 
 
 
 
 
 

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12. 
Adverse Events 
An adverse event (AE) is any untoward medical event that occurs to a study participant once the individual 
has signed the informed consent form until the study participant’s last study visit.   
Examples include: 
• 
Any sign, symptom, or physical examination finding that worsens in nature, severity or 
frequency compared to baseline 
A serious adverse event (SAE) is one that meets any of the following criteria: 
• 
Results in death 
• 
Is life threatening 
• 
Requires inpatient hospitalization or prolongation of an existing hospitalization  
• 
Results in persistent or significant disability/incapacity 
• 
An important medical event that may not result in death, be life-threatening, or require 
hospitalization, may be considered a serious adverse event when, based upon appropriate 
medical judgment, it jeopardizes the participant and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. 
A life-threatening adverse event is defined as any adverse experience that places the participant, in the view 
of the Investigator, at immediate risk of death from the event as it occurred, i.e. it does not include an event 
that, had it occurred in a more severe form, might have caused death.  ALL serious adverse events must be 
reported to the Sponsor within 24 hours of the knowledge of the event and reported to the respective IRB as 
soon as possible but no later than ten working days after the investigator learns of the event or as required by 
the IRB.  In the event of subject death, a copy of death records, medical records pertaining to the events 
leading up to the death and an autopsy report (if performed) must be sent to the Sponsor as soon as possible.   
All subject identifiers other than the subject number and initials must be removed from the documents 
submitted to the Sponsor.  
 
A pre-existing condition is one that is present prior to or at the start of the study and is to be reported as part 
of the participant’s medical history.  It should be reported as an adverse event only if the frequency, intensity, 
or the character of the condition worsens during study participation.  
An unexpected adverse event is one not identified in nature, severity, or frequency in the current protocol. 
Adverse events (AE) data collection must begin once the Participant has signed the informed consent 
document. AEs will continue to be collected each visit during the entire 12 week training period and end at 
the 6 month visit. In general, AEs should be reported and classified by the investigator using a diagnosis.  The 
diagnosis should be confirmed through specific signs, symptoms, and (if necessary) laboratory tests.  Data to 
be collected will include the description of the event, onset and resolution dates (or whether the event is 
ongoing), severity, management/treatment, outcome, and determination of the relationship to the device 
used during training.  The relationship of the event to the device used will be further described as related or 
unrelated to a specific device.  If related to a device, the categories will be further described as definitely, 
probably, or possibly-related using the following definitions: 
1. Definitely device-related:  Any event that is associated with the device by timing and physiology, and 
was caused or contributed to by the device. 
2. Probably device-related:  Any event that is associated with the device by timing and physiology, and 
there is a good chance that it may have been caused or contributed to by the device. 
3. Possibly device-related: Any event that is associated with the device by timing and physiology, and 
there is a possibility that it may have been caused or contributed to by the device. 
 
Severity of the AE will be coded as to the degree of severity as follows: 
A. Mild: Awareness of the event but easily tolerated. 

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B. Moderate: Discomfort enough to cause interference with usual activity. 
C. Severe: Inability to carry out usual activity (not necessarily the same as a Serious Adverse Event.  
Subjects may have a severe flu but not require hospitalization.) 
 
Treatment for the AE includes all of the commercially approved products or standard procedures that are to 
be administered according to standard medical practice.  Investigational products or procedures are not to be 
used as a treatment for an adverse event. All unresolved AEs should be followed by the Investigator until all 
events are resolved, the event is identified as being a chronic condition, or the participant is lost to follow-up.   
 
The case report form package for this study includes dedicated adverse event and serious adverse event 
forms.  
 
An independent Data Safety Monitoring Board (DSMB) will assess and adjudicate all SAEs and protocol 
violations.  
 
13. 
Participant Termination 
 
Participants will be advised that they may voluntarily withdraw from the study at any time and will be 
instructed to notify the investigator immediately if they choose to withdraw.  Participants may choose to 
withdraw for any reason and are not obligated to reveal their reason(s) for withdrawal.  Should Participants 
withdraw prior to follow-up completion, they will be asked to complete the final questionnaires if withdrawn 
prior to the end of the participation period.  In addition, Participants may be involuntarily withdrawn by the 
investigator if the investigator believes it is in the best interests of the Participant (e.g., adverse event that 
prevents further visits).   
 
If a Participant is lost to follow up, the End of Study CRF must be completed and submitted to the data 
manager as soon as possible.  If a Participant fails to comply with the follow up evaluations, the study site 
must attempt to contact the Participant at least three times, including once as a registered letter.  
 
In order to minimize loss to follow-up, at the baseline evaluation visit the study coordinator will request that 
the Participant provide names and contact information of two individuals who have a close relationship with 
the Participant.  The contacts will be utilized in the event that the Participant relocates or cannot be reached 
by mail or telephone.  This information will be treated as confidential and for use by the investigative site 
only. Every effort will be made to retain Participants for the entire 6 months of follow up.  
 
14. 
Data Collection and Reporting  
 
Source documents will be used to record demographic and assessment data as well as any adverse events 
which may occur during the study period. Source document data will be transferred to case report forms that 
will be submitted to the data manager. The Sponsor reserves the right to use a third-party data manager 
and/or electronic data capture during this study. 
15. 
Confidentiality of Data 
 
All information and data sent to the Sponsor, Contract Research Organizations, DSMB, or the Data Manager 
concerning Participants or their participation in this study will be considered confidential.  All data used in 
the analysis and reporting of this evaluation will be used in a manner without identifiable reference to the 
Participant.  The principal investigator consents to visits by the staff of the Sponsor and its authorized 
representatives or any other local or national governmental body to review the study Participants’ medical 
records including any test or laboratory data that might have been recorded on diagnostic tests media (e.g., X-
rays, video, photographs, etc.). 
 

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16. 
Record Retention 
 
The study site is required to retain all study records required by the applicable regulations in a secure and 
safe facility.  The study site must consult with the Sponsor before disposal of any study records, and must 
notify the Sponsor of any change in the location, disposition or custody of the study files.  The study site must 
take measures to prevent accidental or premature destruction of essential documents, that is, documents that 
individually and collectively permit evaluation of the conduct of a study and the quality of the data produced, 
including paper copies of study records (e.g., patient charts) as well as any original source documents that are 
electronic as required by applicable regulatory requirements.  All study records must be retained for at least 
two years after the study is completed. Participant files and other source data must be kept for the maximum 
period permitted by the hospital, institution or private practice, but not less than two years.  These 
documents should be retained for a longer period, however, if required by the applicable regulatory 
requirements.  The Sponsor must be notified and will assist with retention should study site be unable to 
continue maintenance of participant files for the full two years.  It is the responsibility of the study site to 
inform the Sponsor as to when these documents no longer need to be retained. 
 
17. 
Statistical Methods 
 
17.1 
General Principles 
 
The primary analysis for all baseline characteristics and study outcomes will include all available data for all 
enrolled subjects.  Standard summary statistics will be calculated for all study variables.  For continuous 
variables, statistics will include means, standard deviations, medians and ranges.  Categorical variables will 
be summarized in frequency distributions. 
 
Statistical analyses will be conducted according to the principles of intent-to-treat, under which subjects will 
be evaluated according to their randomized assignment regardless of the treatment actually received.  P-
values for tests of superiority will be two-sided and for non-inferiority one-sided, with values less than 0.05 
deemed statistically significant. 
 
Statistical analyses will be conducted in SAS version 9.3 or above (SAS Institute, Cary, N.C.), R version 3.2 or 
above (R Foundation for Statistical Computing, Vienna, Austria, http://www.R-project.org) or another 
validated statistical software package. 
 
17.2 
Primary Endpoint 
 
The primary endpoint is change in gait speed (self-selected and fast) demonstrated during the 10MWT after 
12 weeks of training, compared to baseline.  Two hypotheses are associated with this endpoint; first, that the 
mean change in the Ekso intervention group will be statistically superior to that in the passive control group, 
as follows: 
 
 
H0: µE ≤ µP 
 
HA: µE > µP, 
 
where µE and µP are the mean change in the Ekso and passive control groups, respectively.  The hypothesis 
will be tested using a two-sample Student's t or Wilcoxon rank-sum depending upon normality of the trial 
data. 
 
The second hypothesis is that the mean change in the Ekso intervention group will be statistically non-
inferior to that in the active control group, as follows: 
 
 
H0: µE ≤ µA - Δ 
 
HA: µE > µA - Δ, 
 

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where µE and µA are the mean change in the Ekso and active control groups, respectively, and Δ is the non-
inferiority margin.  Δ is selected based upon the principles that it should be substantially less than the 
expected effect size comparing Ekso to passive control, and that it should represent a clinically acceptable 
margin of effect when differentiating Ekso from active control. 
 
For this purpose, Δ is therefore defined to be 0.055 m/s, which is one-half of the hypothesized treatment 
effect of Ekso over passive control as stated below, and one-eighth of the threshold of 0.44 m/s (1.0 mph) 
commonly used to represent gait speed associated with community ambulation. 
 
17.3 
Subgroup analysis 
 
A subgroup analysis of gait quality, including left and right lower extremity single support time, initial double 
support time, step length, and stride width will be performed in centers using GAITRite equipment and 
software and compared between randomized groups. The sample available for this sub-analysis is expected 
to be approximately 30% of the total study population. 
 
17.4   Sample Size 
Computations for sample size and power are based on effect sizes derived from internal study data and the 
relevant clinical literature for the primary endpoint.  For the Ekso intervention group, the postulated effect 
(derived from internal study data) is a mean change from baseline in gait speed of 0.11 m/s, with a 
corresponding standard deviation of 0.18 m/s.  For the active control group, the postulated effect is a mean 
change from baseline in gait speed of 0.078 m/s (derived from the relevant clinical literature), with a 
corresponding standard deviation of 0.108 m/s. 
 
The passive control group is postulated to have a mean change of zero with the same standard deviation as 
active control, or 0.108 m/s.  Sample size and power are then computed for both statistical tests cited above: 
superiority of Ekso to passive control and non-inferiority of Ekso to active control. 
 
Under 2:2:1 randomization with a desired power of 80%, the required sample size for superiority of Ekso 
intervention to passive control is 38 subjects with evaluable data in the Ekso group and 19 in passive control 
(incorporating the 2:1 Ekso: passive control randomization).  For non-inferiority of Ekso to active control, the 
groups are of equal size and the required sample size is 37 per group. 
 
Taking the greater of these numbers for each randomized group, total sample size under 2:2:1 randomization 
is therefore 38 for Ekso intervention, 38 for active control and 19 for passive control, a total of 95.  To account 
for possible attrition as well as potential variance from the postulated effects, up to 127 subjects in the 
randomized group will be enrolled. 
 
18. 
Visits and Visit Windows 
 
The following are the planned Participant visits and their associated windows. Missed visits should be made 
up so that testing can be conducted within the appropriate window of time.  
 
Table 4 – Planned Participant Assessments and Assessment Windows 
Time point 
Window 
Baseline 
No more than 30 days prior to start of training 
6 Weeks(after 18 
session) 
No more than 1 week after session 18 
12 Weeks (after 36 
session) 
No more than  1 week after session 36 
6 Months 
+/- 3 weeks 
 
 

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18.1 
Handling of Dropouts, Treatment Rescues and Missing Data 
 
Values for missing data will not be imputed, but exploratory analyses may be performed using the last real 
assessment for that patient (LOCF). 
 
18.2 
Subgroup Definitions 
 
Subgroup factors of interest include age, level of assistance (based on FIM-Scores), non-responders vs. 
responders, time since injury, spasticity, and other differences among this diverse group.  
 
* Exploratory analyses on these subgroups of Participants will be performed provided that there are a 
sufficient number of Participants in a given subgroup.   
 
19. 
Investigative Centers/Minimum and Maximum Enrollment 
 
Up to fifteen centers will participate in the study. Centers are chosen based on experience with the Ekso 
device and having appropriate personnel to conduct and support research studies. Each center is expected to 
contribute at least 1 Run-in and 8 Randomized Participants and no center shall contribute more than 4 Run-
ins and 37 Randomized Participants (30% of total maximum enrollment for the Randomized group).  If very 
low enrolling centers (<8 Randomized Participants) exist after study close, these may be combined with other 
centers for analysis purposes assuming that all centers maintained adherence to the protocol and that the 
data gathering mechanism is the same for all centers.   
 
20. 
Quality Assurance of the Data 
 
Participant case report forms will be collected and reviewed for completeness and accuracy by the Monitor as 
well as for any evidence suggesting Participant risk.  Where discrepancies are noted, they will be resolved 
with the investigator and/or an individual designated by the investigator.  Where the data are incomplete, 
attempts will be made to obtain the missing data.  The Sponsor reserves the right to use a third-party data 
manager throughout the study period.  The data manager will be required to have quality assurance 
procedures in place.   
 
21. 
Study Termination  
 
The Sponsor reserves the right to terminate the study before enrollment has been completed and to report on 
study results at interim time-points without statistical penalty.  
 
22. 
Personnel Responsibilities 
22.1 
Principal investigator responsibilities 
 
a) 
Permit monitor inspection of facilities and records. 
b) 
Permit inspection of facilities and records by government bodies. 
c) 
Submit protocol and informed consent to IRB and await approval. 
d) 
Submit proposed amendments to protocol and informed consent to IRB and await approval, unless 
the change reduces the risk to Participants. 
e) 
Obtain informed consent of Participants. 
f) 
Implement study in accordance with protocol. 
g) 
Complete source documents and case report forms.  
h) 
Explain deviations from protocol and report to monitor. 
i) 
Submit annual progress reports, final reports, and adverse effect reports to IRB and sponsor as 
required by law. 
j) 
Maintain medical histories of Participants. 
k) 
Retain records for two years following study completion. 

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22.2 
Sponsor Responsibilities 
    
Listed below are the Sponsor’s responsibilities for this study. 
a) 
Assure IRB approval of protocol and informed consent is obtained 
b) 
Select and train monitors 
c) 
Select investigators 
d) 
Train site personnel in device use (as appropriate) 
e) 
Obtain protocol signature, curriculum vitae and proof of appropriate licensure of investigator and 
other study staff 
f) 
Investigate device-related adverse events 
g) 
Oversight responsibility for data review and analysis 
h) 
Obtain statement of financial disclosure for publication and presentation purposes 
 
23. 
Potential Risks to Study Participants and Mitigation of Risks 
 
1) The risk of falling: Having experienced therapists conduct the training sessions will minimize the risk of 
falling. 
 
2) Risk of exceeding range of motion: This would be caused if any device moves the Participant beyond the 
normal range of motion, resulting in a strain, sprain or fracture.  For the Ekso device, this risk is lessened by 
mechanical hard stops that prevent the device from exceeding a normal human range of motion even in the 
event of an electrical or software failure.   Software systems are also in place to further reduce range of 
motion to improve fit and comfort during walking.  Participants will be evaluated by clinicians who will 
eliminate Participants from being included in the study if Participants cannot meet the required range of 
motion. For all other devices, this risk will be mitigated through proper settings by the physical therapist in 
charge of Participants treatment.  
 
3) Discomfort, skin pressure/friction, bruising, pain, or unusual swelling caused by any device that contacts 
the skin. This risk will be minimized by a thorough skin check performed by experienced personnel at each 
training session. Adjustments to the harness placement and additional padding will be assessed to decrease 
the risk of skin breakdown as well.  
 
4) Blood pressure instability related to standing or activity. This risk will be reduced by checking blood 
pressure and heart rate prior to training, and as necessary during training and after. 
 
5) Reflex bowel or bladder activity or autonomic instability during walking. This risk will be minimized by 
requiring Participants to relieve bowels and bladder prior to walking.  
 
6) Spasms triggered by joint movement in the device. This risk will be reduced through screening prior to 
enrollment in the study.  Participants cannot take part if the Participant’s muscles are too stiff. 
 
7) Any device used during this study could malfunction. In the event of device malfunction, Participants will 
be able to safely transfer out of the device. 
 
8) There is a risk of fractures when participating in a therapy program: this will be minimized by requiring 
medical clearance if Participants are at risk for severe osteoporosis.  
 
9) Risk from loss of confidentiality. To minimize this risk, Participants will be assigned a unique numeric 
identifier to be included on test records and test documentation. Research information shared with people 
outside the study center will not include Participants’ name, address, telephone number or any other direct 
personal identifier unless disclosure of the personal identifier is required by law. Records may be viewed by 
the study sponsor and Investigators, study monitors and auditors (such as the IRB) who make sure that the 
study is being done properly. 

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10) Muscle strains and tendon sprains and swelling due to joint misalignment during stepping. To minimize 
this risk, therapists and trainers will have undergone training to protect joints. The Ekso minimizes this risk 
by allowing movement of the hip, knee, and ankle only in the sagittal plane. BWSTT reduces this risk by 
providing body weight support during stepping. 
 
24. 
Provisions for Research Related Harm/Injury 
 
Non-Significant Risk 
The Ekso GT is a non-significant risk device in the context of the WISE trial. The device is 510(k) cleared by 
the FDA (K161443) for Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor 
function of at least 4/5 in both arms), and individuals with spinal cord injuries at levels of C7 to T3 (ASIA D 
with upper extremity motor function of at least 4/5 in both arms).  Where injuries at a higher level than 
currently cleared by the FDA are included (C1 to T3), the inclusion criteria is in line with the Ekso GT 
intended use in the EU per the CE certification (UL as notified body), which has been in effect since 2013 
without any serious adverse events.  Users must meet functional requirements, including but not limited to 
sufficient upper body strength to control a walking aid such as a walker, crutches, or a cane.  Users must also 
obtain physician clearance of health status prior to inclusion.  Further, the Ekso GT has a number of 
safeguards to minimize risk to patients and therapists, as outlined below, and is used under the supervision of 
a physical therapist who has successfully completed the level 2 Ekso Bionics training program.   
The Ekso GT 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 ranges of these joints 
were selected to provide for necessary functions such as standing, sitting, and walking.  Redundant position 
sensing on all of the actuated joints ensures that the motors are always controlled using reliable sensor 
information. In addition, the device has numerous sensor, motor, and software monitoring systems.  If an 
abnormality is detected (i.e. excess joint speed or force, or if redundant sensors do not agree) the device 
enters a safe mode, which prevents continued walking and enables the physical therapist to safely remove the 
patient.  The device is also equipped with fail-safe brakes on the actuated knee joints, such that if the device 
loses power or is shut down (as in safe mode) for any reason the knees will continue to support the patient. 
Finally, an emergency disable button is available to instantly shut down the device for any reason.  This is 
implemented via hardware, so it is effective even during a software malfunction.   
 
25. 
Potential Benefits of Participation 
 
Community-dwelling participants often exhaust their medical insurance coverage for physical rehabilitation 
and retreat from community involvement unless they are presented with an opportunity to participate in a 
study or are willing to pay out of pocket for training sessions. This study affords those individuals an 
opportunity to undergo training when they may not have otherwise done so. Participants may also make 
improvements physiologically, psychologically, as well as in physical performance, specifically walking. This 
study is set up to benefit all groups though equal benefits cannot be ensured.  
 
26. 
Monitoring Procedures 
 
Study monitoring will be performed in accordance with sponsor procedures, or those approved by sponsor.  
The Clinical department will have overall management responsibility for this study.  In addition the Clinical 
department will direct regional monitoring staff, and may serve as clinical study monitors, study 
administrators, and/or have oversight responsibility for data review and data integrity.  Ekso Bionics, Inc. 
may engage the services of one or more qualified organizations or individuals to perform monitoring and 
data management functions, and provide participating sites with relevant contact information, as necessary.  
Study monitors may change periodically over the course of this study.  All monitors will be qualified to 
perform their assigned responsibilities, and participating investigators/site personnel will be notified of any 
changes as they occur. 
 
On-site monitoring of all participating sites will be frequent enough to assure continued acceptability of the 

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data by assessing site compliance with the study protocol, adherence to data collection procedures, and 
maintenance of study records.  Scheduled site visits may include, but are not limited to, the following:  
 
• 
Site initiation visit: An initiation visit will be conducted by clinical personnel to review this study 
protocol, review the progression strategy for both groups, undergo an evaluation of the site’s 
training status and refresh as required, and discuss source document/ CRF completion and 
transmittal procedures.  Alternatively, a meeting may be conducted for several sites at a common 
location. 
• 
Interim monitoring site visit: On-site monitoring visits will be conducted at all sites to assess the 
progress of the study and identify any concerns that result from review of the study records, 
study management documents, or Participant informed consent documents.  To assure the 
integrity of the data, a representative number of individual Participant records and other 
supporting source documents will be compared to CRFs completed at the site to determine that: 
o 
The study protocol is being followed, and only eligible Participants are being enrolled; 
variances, if they occur, are recorded and reported as appropriate 
o 
Informed consent is properly documented  
o 
Adverse Events are being reported appropriately 
o 
Information recorded on CRFs is complete, accurate and legible 
o 
Missed follow-up visits and multiple attempts to contact Participant are properly 
documented 
o 
Participants failing to complete the clinical study and the reason for failure are properly 
recorded 
• 
Final monitoring/Close-out site visit: At the close of the study, appropriately trained personnel 
appointed by the Sponsor will perform a close-out process via the telephone or on-site.  The 
purpose of this visit is to collect all outstanding study data documents, ensure that the 
investigator's files are accurate and complete, review record retention requirements, provide for 
appropriate disposition of any remaining supplies, and ensure that all applicable requirements 
are met for the study.  The observations and actions made during this procedure will be 
documented and communicated to the investigator. 
 
27. 
Publication 
 
Manuscripts, abstracts, posters, or other informational materials may be presented at scientific meetings, or 
published in professional journals. The Sponsor reserves the right to publish the results of the run-in group 
and/or primary endpoint analysis results on the minimum sample size needed in a single publication. Longer-
term, qualitative and quantitative analysis may be reported in a separate publication. This study will be listed 
on clinical trials.gov. Therefore, results will be published per FDA requirements.     
28. 
References 
 
1. https://www.nscsic.uab.edu/Public/Facts%202015.pdf Accessed March 24, 2016. 
 
2. Raab K, Krakow K, Tripp F, Jung M. Effects of training with the ReWalk exoskeleton on quality of life in 
incomplete spinal cord injury: a single case study. Spinal Cord Series Cases 2016;3:15025 
doi:10.1038/scsandc.2015.25 
 
3. Dietz V, Fouad K. Restoration of sensorimotor functions after spinal cord injury. Brain 2014;137:654–67. 
 
4. Post M, Norear L. Quality of life after spinal cord injury. J Neurol Phys Ther 2005;29:139–46. 
 
5. Alcobendas-Maestro M, Esclarin-Ruz A, Casado-Lopez RM, Munoz-Gonzalez A, Perez-Mateos G, Gonzalez-
Valdizan E, et al. Lokomat robotic-assisted versus over-ground training within 3 to 6 months of 
incomplete spinal cord lesion: randomized controlled trial. Neurorehab Neural Repair2012;26(9):1058–
63. 

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6. Wirz M, Zemon DH, Rupp R, Scheel A, Colombo G, Dietz V, et al. Effectiveness of automated locomotor 
training in patients with chronic incomplete spinal cord injury: a multicenter trial. Arch Phys Med Rehabil 
2005;86:672–80. 
 
7. Wirz M, Zemon DH, Rupp R. Response to letter to the editor. Arch Phys Med Rehabil 2005;86:2386–7. 
 
8. Liverman CT, Altevogt BM, Joy JE, Johnson RT. Spinal cord injury: progress, promise and priorities. 
Washington, DC: The National Academic Press; 2005. 
 
9. Zeigler MD, Zhong H, Roy RR, Edgerton VR. Why variability facilitates learning. J Neurosci 
2010;30(32):10720–6. 
 
10. Lee C, Won D, Cantoria MJ, Hamlin M, de Leon RD. Robotic assistance that encourages the generation of 
stepping rather than fully assisting movements is best for learning to step in spinally contused rats. J 
Neurophysiol 2011;105(6):2764–71. 
 
11. Barbeau H, Fung J. The role of rehabilitation in the recovery of walking in the neurological population. 
Curr Opin Neurol 2001;14(6):735–40. 
 
12. 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;66:484–92. 
 
13. van Hedel HJand the EMSCI Study Group. Gait speed in relation to categories of functional 
ambulationafter spinal cord injury. Neurorehabil Neural Repair 2009 May;23(4):343-50. 
 
14. Lam T, Pauhl K, Ferguson A, Malik RN, Krassioukov A, Eng JJ. Training with robot-applied resistance in 
people with motor-incomplete spinal cord injury: pilot study. J Rehab Res Dev 2015;52(1):113–29. 
 
15. Musselman KE, Fouad K, Misiaszek JE, Yang JF. Training of walking skills over-ground and on the 
treadmill: case series on individuals with incomplete spinal cord injury. Phys Ther 2009;89:601–11. 
 
16. Mehrholz J, Elsner B, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after 
stroke. Cochrane Database Syst Review 2013 doi:10.1002/14651858.CD006185.pub3 
 
17. Watanabe H, Tanaka N, Inuta T, Saitou H, Yanagi H. Locomotion improvement using a hybrid assistive 
limb in recovery phase stroke patients: a randomized controlled pilot study. Arch Phys Med Rehabil. 
2014;95(11):2006–12. 
 
18. Hartigan C, Kandilakis C, Dalley S, Clausen M, Wilson E, Morrison S, et al. Mobility outcomes following five 
training sessions with a powered exoskeleton. Top Spinal Cord Inj Rehabil. 2015;21(2):93–9. 
 
19. Kolakowsky-Hayner SA, Crew J, Moran S, Shah A. Safety and feasibility of using the EksoTM bionic 
exoskeleton to aid ambulation after spinal cord injury. Spine. 2013 doi.org/10.4172/2165-7939.S4-003 
 
20. Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, et al. Effects on mobility training and de-
adaptations in participants with spinal cord injury due to a wearable robot: a preliminary report. BMC 
Neurology. 2016;16:12. doi 10.1186/s12883-016—0536-0 
 
21. Forrest GF, Hutchinson K, Lorenz DJ, Buehner JJ, Vanheil LR, Sisto SA, Basso DM. Are the 10 meter and 6 
minute walk tests redundant in patients with spinal cord injury? PLoS One. 2014 May 1;9(5):e94108. 
doi: 10.1371/journal.pone.0094108. eCollection 2014. 

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 22. The CES-D Scale A Self-Report Depression Scale for Research in the General Population. Lenore Sawyer 
Radloff 
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Studies 
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PubMed 
1177/014662167700100306 Applied Psychological Measurement June 1977 vol. 1 no. 3 385-401. 
23. Charlifue S, Post MW, Biering-Sorensen F, et al. International Spinal Cord Injury Quality Of Life Basic Data 
Set. Spinal Cord 2012;50(9):672–5. Available at: http://www.ncbi.nlm.nih.gov/pubmed/22450884. 
 
24. Krogh K, Perkash I, Stiens S a, Biering-Sorensen F. International bowel function basic spinal cord injury 
data set. Spinal Cord. 2009;47(3):230–4. Available at: http://www.ncbi.nlm.nih.gov/pubmed/18725887. 
 
25. Juul T, Bazzocchi G, Coggrave M, et al. Reliability of the international spinal cord injury bowel Function 
basic 
and 
extended 
data 
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Spinal 
Cord 
2011;49(8):886-91. 
Available 
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http://www.ncbi.nlm.nih.gov/pubmed/21445082. 
 
26. Biering‐Sorensen F, Craggs M, Kennelly M, Schick E, Wyndaele J-J. International lower urinary tract 
function basic spinal cord injury data set. Spinal Cord 2008;46(5):325–30. Available at: 
http://www.ncbi.nlm.nih.gov/pubmed/18040278. 
 
27.  Anon. National Institute of Neurological Disorders and Stroke Common Data Elements. Available at: 
http://www.comm 
 
28.  Poncumhak P, Saengsuwan J, Kamruecha W, Amatachaya S. Reliability and validity of three functional 
tests in ambulatory patients with spinal cord injury. Spinal Cord 2012;(September):1–4. Available at: 
http://www.ncbi.nlm.nih.gov/pubmed/23147127. 
 
29. Van Hedel HJ, Wirz M, Dietz V. Assessing walking ability in subjects with spinal cord injury: validity and 
reliability of 3 walking tests. Arch of Phys Med Rehabil 2005;86(2):190–6. Available at: 
http://www.ncbi.nlm.nih.gov/pubmed/15706542. 
 
30. Marino RJ, Scivoletto G, Patrick M, et al. Walking index for spinal cord injury version 2 (WISCI--‐II) with 
repeatability of the 10‐m walk time: Inter‐and intrarater reliabilities. Am J Phys Med Rehabil. 
2010;89(1):7–15. Available at: http://www.ncbi.nlm.nih.gov/pubmed/20026943. 
 
31. Burns AS, Delparte JJ, Patrick M, Marino RJ, Ditunno  JF. The reproducibility and convergent validity of the 
walking index for spinal cord injury (WISCI) in chronic spinal cord injury. Neurorehabil Neural Repair. 
2011;25(2):149–57. Available at: http://www.ncbi.nlm.nih.gov/pubmed/21239706. 
 
32. Benz, E. N., Hornby, T. G., et al. (2005). A physiologically based clinical measure for spastic reflexes in 
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33. Robertson RJ1, Goss FL, Metz KF. Perception of physical exertion during dynamic exercise: a tribute to 
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34. Steffen T. M.; Hacker T. A.; Mollinger L. (2002). "Age- and Gender-Related Test Performance in   
Community-Dwelling Elderly People: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and 
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35. Datta, S., Lorenz, D. J., et al. (2009). "A multivariate examination of temporal changes in Berg Balance Scale 
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36. Donoghue, D. and Stokes, E. K. (2009). "How much change is true change? The minimum detectable 
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37. Farrar JT et al. Validity, Reliability, and Clinical Importance of Change in a 0–10 Numeric Rating Scale 
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29. 
Appendix A – Description of Standardized Measures and 
Assessments  
International SCI Basic Data Sets and Modified Basic Data Sets 
The purpose of the International SCI Basic Data Sets is to promote data collection in a uniform manner and 
documented in a standard format, with precise instructions for each question.¹ The International SCI Basic 
Data Sets used for the purposes of this study include:  
 
1. Medical History (study specific minor modifications/deletions were made to the exploratory data 
set) and Demographics (core data set).   
 
2. The International SCI Quality of Life (QOL) Basic Data Set will be used to collect data on quality of life.  
The International SCI (QOL) Basic data set collects information on three variables: ratings of 
satisfaction with general quality of life, satisfaction with general quality of life, satisfaction with 
physical health, and satisfaction with psychological health which are rated on a scale of 1-10.23 
 
3. The International SCI Pain Basic Data Set collects information on up to three pain problems, their 
location, severity, and temporal pattern, as well as impact in daily activities and well-being.  
 
4. Bowel function data will be collected using the Modified International SCI Bowel Function Data Set, 
which contains 12 items to assess the impact of neurogenic bowel dysfunction ranging from bowel 
dysfunction unrelated to SCI, surgical procedures related to bowel function, awareness of the need to 
defecate, defecation method and frequency, incontinence and the use medications impacting bowel 
function. 24 Reliability has been assessed for this data set. 25 
 
5. The Modified International SCI Lower Urinary Tract Basic Data Set will be collected to assess lower 
urinary tract function. 26 The following data will be collected: urinary tract impairment unrelated to 
spinal cord lesion, awareness of the need to empty the bladder, bladder emptying, average number of 
voluntary bladder emptyings per day during the last week, incontinence, collecting appliances for 
urinary incontinence, any drugs for the urinary tract, surgical procedures on the urinary tract and 
any change in urinary symptoms. 
 
The Medical Research Council Manual Muscle Test (MMT) Scale (as used in the ISNCSCI exam) 
The manual muscle test is a standardized assessment to measure muscle strength.  Score range 0-5, minimum 
0, and maximum 5/5.  For the purpose of this study, the Medical Research Council MMT Scale as used in the 
ISNCSCI exam will be used.3-4 
 
Modified Ashworth Scale 
As summarized in the National Institute of Neurological Disorders and Stroke Common Data Elements 
(NINDS CDE) for multiple sclerosis, the Ashworth scale is a widely used method of measuring spasticity, due 
in a large part to the simplicity and reproducible method23. Scores range from 0--‐5, plus a 1+ scoring 
category to indicate resistance through less than half of the movement.  A score of 0 indicates no resistance 
and 4 indicates rigidity. Assessment techniques for the MAS must be standardized. Some critics question the 
validity of the scale and Modified Ashworth Scale in measuring spasticity. It may be a description of 
resistance to passive movement. Therefore, it measures only one aspect of spasticity, and is not a 
comprehensive assessment. Administration time is approximately 5 minutes for the six muscle groups tested 
in this study. 
 
 
 

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Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) 
The Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) assesses three types of spastic motor 
behaviors in SCI patients - clonus, flexor spasms, and extensor spasms. SCATS Clonus scale uses passive 
dorsiflexion to assess clonus.  SCATS flexor spasm is assessed with a pinprick to the medial arch with the knee 
and hip fully extended.  SCATS extensor spasms are assessed by extending the hip and knee joints from a start 
position of 90 to110 degrees of hip and knee flexion. Administration time is usually 5 to 10 minutes. 32 
 
Berg Balance Scale (BBS) 
The Berg Balance Scale is a 14-item objective measure designed to assess static and dynamic balance and in 
adult populations.34,35,36  Scores range from 0-56, and cut-off scores exist for inferring a participant’s 
categorical fall risk. This test takes an average of 15 minutes to administer. Low-level participants may 
complete the test in a couple of minutes, if they cannot perform any of the 12 tasks done in standing. 
However, high-level participants may require up to 30 minutes, because they will be able to attempt all 14 
tasks, and may require rest breaks.  
 
International Standards for Neurological Classification of SCI (ISNCSCI) 
The International Standards for the Classification of Spinal Cord Injury (ISNCSCI) were developed by the 
American Spinal Injury Association in 1982 in order to promote common definitions of neurological levels 
and the extent of complete injuries in patients with SCI and to achieve more consistent and reliable data 
among centers participating in the National Spinal Cord Injury Database. The Standards have been revised, 
with the last revision occurring in 2011 with an accompanying article to clarify the changes. The ASIA 
Standards are the most commonly used neurological examination for classifying patients with SCI for both 
clinical and research purposes.   Since the last publication of a reference manual an electronic on line training 
program was developed, the International Standards Training e-Learning Program (InSTeP).  
The neurological examination consists of both a motor and sensory exam that have been standardized to 
promote consistency.  The ISNCSCI exam consists of the following: 
1. Motor examination: 10 key muscles are tested in each half of the body. Each muscle is graded from 0 
to 5 and then the total score is calculated, the maximum being 100. 
2. Sensory examination: 28 key regions are tested in each half of the body for pinprick and light touch 
sensations. Each region is given a score of 0 (absent), 1 (impaired), 2 (normal) or NT (not testable). 
The total score is then calculated with a maximum of 112. 
In addition, based on the data collected from the motor and sensory exams, neurological level, completeness 
of neurological loss, the zone of partial preservation and the ASIA Impairment Scale (AIS) can be determined. 
 
10 Meter Walk Test 
The objective of this test is to assess walking speed in meters per second over a short duration.  
individual
a
acceleration
beginning
  Data will be collected using both baseline and current 
braces/devices at both self-selected and fast gait speeds during the 6, 12, and 24 week (midpoint, endpoint, 
and follow-up) evaluations. Data using current devices and no braces at self-selected speed will be collected 
every 3rd session as an indicator of incremental neurological recovery.  
GAITRite Pressure Map 
The GAITRite pressure map is an optional test that may be used during the 10MWT, if the site has access to it, 
at any 10MWT evaluation timepoint. This pressure map will digitally record the placement and pressure of 
the participant’s footprints as they walk over it during the 10MWT. From this data, it will calculate 
temporospatial gait parameters, such as swing and stance times, lengths, widths, etc. If used, the GAITRite 
mat will be placed to begin at the 2 meter mark on the 10MWT pathway. Clear packing tape will be used to 
tape the ends to the floor to reduce the risk of any walking device being caught in its edges and disrupting the 
flow of the step pattern. This should also reduce the participant’s tendency to slow down or pause at the edge. 
Because the GAITRite is not placed in the middle of the pathway, each trial of the 10MWT will need to start 
from the same place. 

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Timed Up and Go (TUG) 
As summarized in the National Institute of Neurological Disorders and Stroke Common Data Elements 
(NINDS CDE) for multiple sclerosis, the original purpose of this test was to test basic mobility skills of frail 
elderly patients.27 The test has been used in other populations, including individuals with SCI.28,29  The 
original Get Up and Go Test used an ordinal scoring system based on the observer’s assessment of the 
patient’s risk of falling. The participant wears their regular footwear and uses their customary walking aid 
(none, cane, walker). No physical assistance is given. The subject walks through the test once before being 
timed in order to become familiar with the test. Either a stopwatch or a wristwatch with a second hand can be 
used to time the trial. The timed “Up and Go” test measures, in seconds, the time taken by an individual to 
stand up from a standard arm chair with approximate seat height of 46 cm [18in], arm height 65 cm [25.6 
in]), walk a distance of 3 meters (118 inches, approximately 10 feet), turn, walk back to the chair, and sit 
down. Patients are timed (in seconds) when performing the TUG: from sitting in a chair, stand up, walk 3 
meters, turn around, walk back, and sit down. The time taken to complete the task is strongly correlated to 
level of functional mobility, (i.e. the more time taken, the more dependent in activities of daily living) but will 
take less than 3 minutes. Psychometric properties for use in SCI have been assessed in multiple publications 
including but not limited to Ponchumak, et al., and van Hedel, et al. 28. 29. 
 
6 Minute Walk Test 
The objective of the test is to cover as much distance as possible within a six-minute time frame walking laps 
around 2 cones placed 100 ft apart in a straight path.The level of assistance and assistive devices used during 
the 6MWT and distance walked will be recorded.  
 
Spinal Cord Injury Functional Ambulatory Index (SCI-FAI) 
The SCI-FAI is an observational gait assessment instrument that includes a 2-minute walk test of gait 
biomechanics and use of assistive device.  This SCI ambulatory outcome measure is included as an 
observational assessment of the quality of the gait pattern. Physical therapists will score the SCI-FAI based on 
the first 2 minutes of the 6MWT.  Video footage should be taken to assist with scoring. 
 
Walking Index for Spinal Cord Injury II 
The Walking Index for Spinal Cord Injury II (WISCI II) measures the ability of an individual to complete a 
locomotor task in a standardized environment. The goal is to rank the severity of the underlying impairment 
in relation to function. The WISCI II has a total of 21 levels and includes information on the type of gait, 
bracing and assistive devices utilized and level of assistance walking while walking 10 meters or less. The 
WISCI II will be scored based on the 10MWT at self-selected speed using the current braces and devices as 
needed. Reliability of the WISCI II in SCI has been assessed in several publications including but not limited 
to: Marino et al., Burns et al. 30.31 Completion time is less than 5 minutes. 
 
Spinal Cord Independence Measure (SCIM-III, Mobility subscale) 
The SCIM was developed as a comprehensive rating scale specifically for persons with SCI. The instrument 
assesses independence in all aspects of primary daily activities relevant for patients with SCI; and scores 
every task or area of function according to its relative weight in the total relevant daily function.  SCIM-III 
consists of 17 items in the following subscales: self-care, respiration and sphincter management, room and 
toilet mobility and mobility indoors, outdoors and on uneven surfaces. Scores range from 0‐100. For the 
purposes of this study, only the mobility subscale of the SCIM-III will be completed via an interactive 
interview with the participant. Completion time is approximately 5-10 minutes. The mobility sub-scale 
consists of 9 items with a maximum score of 40. 
 
Spinal Cord Injury Spasticity Evaluation (SCI-SET) 
The SCI-SET is a participant self-report composed of 35 items that assess the degree to which spasticity 
affects aspects of daily life activities over the past 7 days.  Responses are on a 7-point scale that ranges from 
+3 (extremely helpful) to -3 (extremely problematic).4  The administration time is 3-9 minutes. 
 
 

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Center for Epidemiologic Studies Short Depression Scale (CES‐D 10) 
The CES-D is a screening tool measure developed to identify current depressive symptomatology related 
to major or clinical depression in adults and adolescents. Items include depressed mood, feelings of guilt, 
worthlessness and helplessness, psychomotor retardation, loss of appetite, and sleep difficulties. There are 10 
and 20 item versions of the scale. The most commonly used version of the CES‐D is the 10 item version (CES-
D 10) which was developed in the 1970’s by Lenore Radloff (researcher at National Institute of Mental 
Health). 22 
 
Borg Rating of Perceived Exertion  
The Borg Rating of Perceived Exertion (RPE) is a way of measuring physical activity intensity level. Perceived 
exertion is based on the physical sensations a person experiences during physical activity, including 
increased heart rate, increased respiration or breathing rate, increased sweating, and muscle fatigue. 
Participants are asked to rate their maximal perception of exertion of physical activity during a session and 
during the 6MWT.  The severity is measured either on the original scale of 6-20 (6 meaning no exertion at all 
and 20 meaning maximal exertion),. 33 
 
Numeric Rating Scale (NRS) for spasticity and pain 
The Numeric Rating Scale is a participantself-report on a  0-10 scale of overall spasticity or overall pain over 
the past week. 37 Zero denotes no spasticity/pain, and 10 denotes “worst spasticity/pain imaginable.” 
Completion time for both, inclusive, should be no more than 5 minutes. 
 
NASA Task Load Index for self-reported work load 
The NASA Task Load Index is a 6-item, subjective, multidimensional assessment tool that rates perceived 
workload during a task, or other aspects of performance. The questions include rating physical and mental 
workloads, as well as psychological/emotional reactions to the workloads. It was developed by NASA Ames 
Research Center’s (ARC) Sandra Hart in the 1980s and has become the gold standard for measuring 
subjective workload when working with human-machine interface systems. Completion time is no more than 
5 minutes.