Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (AGILE SCI) Trial
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (AGILE SCI) Trial 
IRBnet#: 1524181-1 
Funding Agency: VA RR&D 
Principal Investigator: Keith Gordon, Ph.D. 
Version 5.0 – April 7, 2023 
NCT number: NCT04340063 
 
 
 
 

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List of Abbreviations 
10MWT – 10 Meter Walk Test 
ASIA – American Spinal Injury Association 
AIS – American Spinal Injury Association Impairment Scale 
ABC – Activities-Specific Balance Confidence scale 
BBS – Berg Balance Scale 
BESTest – Balance Evaluations Systems Test  
BP – Blood Pressure 
COM – center of mass 
FGA – Functional Gait Assessment 
HR – Heart Rate 
IC – initial foot contact 
ICIQ-UI SF – International Consultation on Incontinence Questionnaire-Urinary Incontinence 
Short Form  
INVO – Northwestern University’s Innovation and New Ventures Office 
IP – Intellectual Property 
ISNCSCI – International Standards for Neurological Classification of Spinal Cord Injury 
iSCI – incomplete spinal cord injury 
ISO – Information Security Officer 
kHz – kilohertz 
LEMS – Lower Extremity Motor Scores 
MOS – margin of stability 
NMH – Northwestern Memorial Hospital 
PCT – Patent Cooperation Treaty 
PHI – Protected health information 
PTHMS – Department of Physical Therapy and Human Movement Sciences 
PO – Privacy Officer 

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QoL – Quality of Life 
RIC – Rehabilitation Institute of Chicago 
RPE – Rate of Perceived Exertion 
SBP – Systolic blood pressure  
SCI – spinal cord injury 
SCI/D – Spinal Cord Injury/Disorder 
SD – standard deviation 
SEAs – Series Elastic Actuators 
SRAL – Shirley Ryan AbilityLab 
TO – toe-off 
VA – Veteran’s Affairs 
VI – LabVIEW program’s subroutines are termed virtual instruments  
VISN 12 – VA Great Lakes Health Care System 
WISCI II – Walking Index for Spinal Cord Injury II  
WHOQOL-BREF – World Health Organization Quality of Life scale 
 
 

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Contents 
Protocol Title: ................................................................................................................................ 5 
1.0 
Study Personnel ................................................................................................................. 5 
2.0 
Introduction ........................................................................................................................ 6 
3.0 
Objectives ........................................................................................................................ 15 
4.0 
Resources and Personnel ................................................................................................ 17 
5.0 
Study Procedures ............................................................................................................. 18 
5.1 Study Design ..................................................................................................................... 18 
5.2 Recruitment Methods ........................................................................................................ 30 
5.3 Informed Consent Procedures .......................................................................................... 32 
5.4 Inclusion/Exclusion Criteria ............................................................................................... 33 
5.5 Study Evaluations .............................................................................................................. 33 
5.6 Data Analysis .................................................................................................................... 35 
5.7 Withdrawal of Subjects ...................................................................................................... 37 
6.0 
Reporting .......................................................................................................................... 37 
7.0 
Privacy and Confidentiality ............................................................................................... 38 
8.0 
Communication Plan (for multi-site studies) ..................................................................... 39 
9.0 
References ..................................................................................................................... 40 
 
 
 

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Protocol Title:   Amplify Gait to Improve Locomotor Engagement in  
 
 
   
Spinal Cord Injury (AGILE SCI) Trial 
 
1.0 
Study Personnel 
 Provide name, contact information, facility/organization, and 
affiliations/employee status for the following: 
 
o Principal Investigator: 
 
Keith Gordon, PhD 
 
keith.gordon2@va.gov and keith-gordon@northwestern.edu 
 
(312) 503-3339 
 
Hines VA and Northwestern University 
 
5/8 VA appointment  
o Co-Investigators: 
 
Jennifer Kahn, PT, DPT, NCS (physical therapist) 
 
jennifer-kahn@northwestern.edu 
 
(312) 908-8239 
 
Northwestern University 
 
IPA 
o Collaborators: 
 
Christine Jelinek, MS (clinical coordinator) 
 
Christine.jelinek@va.gov 
 
(708) 202.4429  
 
Hines VA 
 
8/8 VA appointment 
 
Geoffrey Brown, MS (research engineer) 
 
 
gbrown@northwestern.edu 
 
 
Northwestern University 
 
 
IPA 
 
Tara Cornwell, BS (research engineer) 
 
 
tcornwell@u.northwestern.edu 
 
 
Northwestern University 
 
 
IPA 
 
 
 
 
 Indicate the number of potential participating sites (both VA and non-VA) 
and if there is any graduated start-up plan for the sites 
 

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The study will be conducted through the Edward Hines Jr. VA Hospital. A partial offsite 
waiver will be obtained to collect and analyze data at the Feinberg School of Medicine, 
Northwestern University.  
2.0 
Introduction 
 
 Provide scientific background and rationale for study.   
 Include summary of gaps in current knowledge, relevant data, and 
how the study will add to existing knowledge.   
 
Regaining the ability to walk is a priority for individuals with incomplete spinal cord injury (iSCI) 
[1]. The development of intense locomotor training interventions [2, 3] targeting recovery rather 
than compensation [4] has changed the future prospects for many Veterans with iSCI who now 
have evidence-based resources to support their efforts to walk again that did not exist two 
decades ago. As successful as these interventions have been, there is broad recognition that 
better methods to enhance dynamic balance are needed [5-7].  
For ambulatory individuals with iSCI, residual balance deficits negatively impact three 
major areas of concern during walking: stability, speed, and endurance. To walk, one must 
be able to balance [8-10], which is encompassed by the ability to control one’s center of mass 
(COM) dynamics as the body progresses over a continuously changing base of support [11]. 
Following iSCI, sensory and motor deficits impair balance [12, 13], directly impacting walking 
function [14, 15]. Individuals with iSCI compensate for balance impairments by selecting gait 
patterns that passively assist in recovery from movement errors [16]. Passive infers that the body 
will “self-correct” when errors occur without requiring a sensory-motor response, making this 
method of balance desirable for people with iSCI. These passive mechanisms include decreasing 
walking speed [17] and step length [18], as well as increasing step width [18-21] and double 
support time [16, 22]. There are trade-offs associated with choosing gait kinematics that rely on 
passive mechanisms to provide dynamic balance. Increasing double-support time creates a more 
stable base of support but limits maximum walking speed [8, 23]. Similarly, taking wider steps 
creates a larger base of support but makes it more difficult to change directions [24] and 
significantly increases metabolic energy consumption [19]. In individuals with iSCI, 10% of the 
total metabolic energy required to walk is expended to maintain lateral balance [21]. These 
balance deficits contribute to high fall rates [25] (~75% of individuals with iSCI fall each year [25] 
and most falls occur during walking [26]) and the avoidance of walking in challenging 
environments [27]. Thus, interventions that can effectively enhance dynamic balance should 
enable individuals to select faster, more metabolically efficient gait patterns, without 
compromising safety.  
 
People with iSCI exhibit a strong positive relationship between balance and both functional 
walking ability [14, 15, 28-30] and participation in walking activities [31]. Across ambulatory 
individuals with iSCI, balance is a better predictor of participation in walking activities than lower-
extremity muscle strength, spasticity, balance confidence, or metabolic efficiency [31]. 
Ambulatory individuals with iSCI average only 2,600 steps per day [9], well below the sedentary 
lifestyle threshold of 5,000 steps [32]. Restricted participation in walking activities may limit social 
engagement and critical activities of daily living [33]. Thus, the development of interventions able 
to enhance dynamic balance of ambulatory individuals with iSCI may improve participation 
in walking activities. However, it is currently unknown how training interventions impact 
participation in walking activities. While many studies have examined the effects of exercise, 

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balance, and locomotor interventions on walking function in individuals with iSCI (for review see 
[34]), only two studies (recumbent cycling [35] and underwater walking [36]), neither of which 
contained a control group, have quantified changes in steps per day following an intervention. 
There is growing evidence in individuals post-stroke that improvement in functional walking 
capacity, a person’s ability to execute walking in the laboratory or clinic, does not necessarily 
translate to increased participation in walking activities [37, 38]. If a primary goal of gait 
rehabilitation is to increase participation, then it is imperative that we quantify how specific 
interventions directly affect walking participation. 
Background 
Dynamic Balance during Walking 
 
Human 
walking 
is 
inherently 
unstable [11]. During forward walking our 
COM naturally oscillates in the fore-aft and 
medio-lateral directions relative to our base 
of support [39]. Dynamic balance, the 
ability of the nervous system to anticipate 
and react to changes in balance during 
movement, 
is 
essential 
for 
creating 
effective and efficient goal-directed walking 
trajectories. In particular, the requirements 
of the nervous system to select strategies 
to 
successfully 
control 
medio-lateral 
motions are considerable in comparison to 
fore-aft 
motion, 
which 
benefits 
from 
stabilizing mechanics [40-42]. 
 
An examination of the single limb 
support phase of the gait cycle illustrates 
the challenge of controlling medio-lateral 
COM motion. Beginning at toe-off, the 
lateral velocity of the COM is relatively 
large and directed towards the stance limb 
(Figure 1A). To maintain a straight-ahead 
walking trajectory, this lateral velocity must be reduced to zero (ocurring around midstance), and 
then redirected towards the midline. Failure to arrest the lateral momentum of the COM will result 
in motion beyond the lateral base of support border (determined by the stance limb medio-lateral 
foot-placement). COM travel beyond the lateral base of support border will require a corrective 
step(s) to prevent a fall and restore the desired forward walking trajetory. Two moments, acting 
in the frontal-plane about the stance limb ankle joint, work collectively to arrest and then redirect 
the COM lateral velocity [43]. The larger of the two moments is created by gravity [43]. The 
magnitude of the gravitational moment arm will be proportional to the medio-lateral foot placement 
location relative to the COM (i.e. step width) (Figure 1B). The second moment about the ankle 
joint is create by muscle actions that modulate the magnitude, direction, and origin of the ground 
reaction force vector (Figure 1B).  
 
The intact nervous system uses a combination of anticipatory and reactive control 
mechanisms to modulate the gravitational and ground reaction force moments. The anticipatory 
component actively controls medio-lateral foot placement. During swing phase, the nervous 
system modulates hip musculature to control the trajectory of the swing limb [44], which in turn 
will determine foot placement location for the ensuing stance phase. In non-impaired individuals, 
medio-lateral foot placement is highly correlated with the state of the COM dynamics during the 
preceeding swing phase [45, 46]. Simply stated, if the COM is falling rapidly to the right and a 
Figure 1. Control of medio-lateral motion during gait. A) 
During single limb support the laterally-directed COM 
velocity is arrested and then redirected toward the midline. 
B) Gravity (Fg) and the stance limb ground reaction force 
(GRF) create moments about the ankle joint to control 
medio-lateral COM velocity. 

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larger than normal moment is required to control the body’s lateral motion, then people will take 
a wider step to the right. The significant linear relationship between COM dynamics and lateral 
foot placement in non-impaired individuals suggests active involvement of the nervous system to 
anticipate the future requirements to control lateral COM dynamics. In comparison, the selection 
of consistently wide steps among individuals with iSCI [21] that are not modulated on a step-by-
step basis in anticipation of COM dynamics, suggests that this population relies on passive 
mechanisms to maintain dynamic balance. The importance of this anticipatory component of 
dynamic balance for controlling lateral COM motion is highlighted by the fact that individuals post-
stroke, who are classified as fallers, do not modulate their step-by-step lateral foot placement [45] 
in response to changes in COM dynamics during walking.  
 
The reactive component of dynamic balance is necessary to make up for any difference 
between the total required moment needed to arrest and redirect the lateral COM motion and the 
gravitational moment created by foot placement. Specifically, the nervous system rapidly 
modulates muscle activity in the stance limb in response to ongoing sensory feedback [47] to 
create an appropriate ground reaction force vector that will supply the additonal moment about 
the ankle joint. Time delays associated with sensory feedback, and sensory-motor impairments 
create challenges for individuals with iSCI to to generate a rapid and appropirate ground reaction 
force in situations when the gravitational moment is insufficient to arrest the lateral COM motion. 
Thus, rather than try to anticipate COM dynamics and risk the possibility that the nervous system 
is unable to generate an appropriate ground reaction force, a more robust solution is to select 
passive stratiges, such as consistently wide steps, that decrease the requirements of the nervous 
system to generate an appropriate ground reaction force. However, the selection of passive 
stratagies to maintain dynamic balace will impart metabolic [19] and maneuverability penalties 
[24]. Thus, the ability of the nervous sytem to both anticipate and react to ongoing COM 
dynamics during walking has important implications for how an individual chooses to 
maintain dynamic balance. 
Learning Dynamic Balance is Difficult Following ISCI 
 
A series of compounding factors make learning dynamic balance very challenging after 
SCI. Research suggests that error detection is essential for the nervous system to form and 
update an internal model [48, 49]. The internal model is a neural representation relating a given 
motor command to the resulting movement [50]. An internal model allows the nervous system to 
predict motion, which is vital for anticipatory control of dynamic balance. For individuals with iSCI, 
sensory-motor impairments limit the ability of the nervous system to detect small movement errors 
and consequently to recalibrate their internal model so that the nervous system can correctly 
anticipate the natural COM oscillations during gait.  
 
An inability to anticipate COM oscillations creates uncertainty every step. To deal with 
uncertainty, the nervous system adapts impedance mechanisms (specific passive mechanisms 
that are resistant to perturbations) to control movements [51, 52]. During walking, impedance 
mechanisms used to control COM motions may include body postures (e.g. wide steps [21]) and 
muscle co-contractions (increasing joint stiffness) [53] that are typical of “cautious gait patterns”. 
An advantage of these impedance mechanisms is that if small movement errors or perturbations 
occur, the body’s mechanical system can recover from these disruptions without time delays or 
requiring active involvement of the nervous system to accurately detect and respond. However, 
reliance on impedance mechanisms to maintain dynamic balance comes with metabolic penalties 
and can result in a relatively inflexible walking patterns that collectively may deter an individual 
from choosing to engage in walking activities.  
To learn new motor patterns motor exploration is necessary [54]. When learning active 
mechanisms of dynamic balance (e.g. modulation of medio-lateral foot placement every step as 
needed to control ongoing COM oscillations) people must explore and practice this strategy. For 
individuals with iSCI, exploration and practice imply decreasing reliance on passive mechanisms 

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of dynamic balance (e.g. indiscriminately wide steps). There are two primary reasons why this is 
difficult. First, the risk of falling and fall-related injuries during walking is considerable for 
individuals with iSCI [25]. When perceived risk is great, people select risk-aware control strategies 
based on uncertainty of their current state [55]. For individuals with iSCI, implementation of risk-
aware control strategies means choosing to exploit existing passive strategies for maintaining 
dynamic balance that will limit the risk of falling rather than to explore new active strategies for 
maintaining dynamic balance that may expose the individual to greater fall risk during the learning 
process. Second, reliance on passive mechanisms (e.g. slow walking [56], increased periods of 
double support [16]) becomes a “physiologic crutch” during balance training that limits the 
involvement of the nervous system in actively detecting and responding to movement errors and 
perturbations. Much like training wheels that impede a child’s ability to learn to balance on a 
bicycle, heavy reliance on passive mechanism of balance deprive the nervous system of the 
experience (i.e. exploration) necessary to identify cause and effect relationships between motor 
commands and their resulting motion.  
From this perspective, it becomes clear why popular forms of balance-training used with the 
iSCI population are inconsistent. The natural extension of the principle of task-specific training 
[57] when applied to improving dynamic improving balance of individuals with iSCI, is to 
supplement gait training with additional challenges that further increase the balance demands 
during walking. One method of challenging balance is to use unexpected perturbations to directly 
disrupt balance [5, 7]. For an individual who is highly reliant on passive mechanisms to maintain 
dynamic balance, the introduction of greater environmental uncertainty will only serve to reinforce 
reliance on these passive mechanisms used to maintain balance. We have observed this effect 
in our research. When individuals with iSCI are exposed to frequent and unpredictable 
perturbations during walking, their gait patterns become stiff and highly resistant to external 
perturbations [58]. While such gait patterns may be robust to perturbations, there is limited 
motivation for an individual to explore or practice alternative (and potentially more effective) 
strategies for dynamic balance. A second popular method to incorporate dynamic balance training 
into gait rehabilitation programs is to introduce variable balance-challenging elements (e.g. 
narrow pathways or obstacles) [59, 60]. Results thus far have been mixed. The experience of 
practicing variable tasks of progressive difficultly may be sufficient for some individuals to explore 
their dynamic work space and to use the feedback to form an appropriate internal model. For 
others, heavy reliance on passive mechanisms of stability may limit the benefits of simply 
engaging in variable, balance-challenging walking activities. 
Movement Amplification to Improve Dynamic Balance following iSCI 
An alternative model for motor learning does exist that may be particularly beneficial for 
retraining active control of movement patterns. Error augmentation strategies involve the 
performance of movements in an unstable robotic force field that exaggerates an individual’s own, 
self-generated motions [61]. Error augmentation may accelerate motor learning by augmenting 
sensory-motor feedback [62] and allowing the impaired nervous system to identify otherwise 
imperceptible errors. The intensified feedback may aid an individual with sensory-motor 
impairments to recalibrate their internal model so that it can be used to control anticipatory 
components of movement. Indeed, there is evidence that error augmentation can be used 
successful for accelerating the adaptation of desired walk patterns [63]. A more general form of 
error augmentation, known a movement amplification [64], does not utilize a reference trajectory 
to identify errors, but instead uses a negative viscosity force field to amplify all movements (not 
just errors). Movement amplification is believed to aid in the acquisition of new motor patterns by 
encouraging movement exploration. Training in a movement amplification environment may 
allow an individual to experience a greater range of movement velocities and thus improve their 
ability to adapt to environmental dynamics [65]. While error augmentation and movement 

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amplification 
approaches have 
shown promise for 
retraining 
control 
of 
reaching 
movements 
in 
impaired 
populations 
[61, 
64], 
these 
methods have not 
been applied to 
training dynamic balance during walking. 
 
Thus, we propose to evaluate if locomotor training performed in a movement amplification 
environment can enhance motor learning of dynamic balance in individuals with iSCI. Our 
approach to train dynamic balance has required the development of a new set of tools able to 
amplify COM movement during human walking. While the principle is relatively simple, apply a 
force to the pelvis that is proportional in magnitude and in the same direction as a user’s real-time 
lateral velocity, the development of such a tool is non-trivial. To create the movement amplification 
environment, we have constructed a cable-driven robot, the Agility Trainer (Figure 2). This is a 
VA-owned device developed by the PI through a VA Career Development Award, [66]. Our 
system is designed to addresses several important considerations; create forces large enough to 
substantially accelerate the mass of a person, minimally restrict normal walking movements, 
precisely control an unstable (movement amplification) robotic system, and operates at 
bandwidths greater than the frequency of lateral COM movements during walking. 
 
The Agility Trainer couples an oversized treadmill with a set of high fidelity, low inertia, 
back-drivable series-elastic linear actuators, capable of applying forces up to ~15% of an 
individual’s bodyweight. A cable system routed through a series of pulleys connects each actuator 
to a side of a pelvic harness worn by a user. The pulleys are mounted to a trolley allowing free 
fore-aft motion and minimal restriction of normal COM motion during walking. Controlling 
movements of the two actuators in tandem allows us to quickly create velocity-based laterally-
directed force fields experienced by individuals as they stand, walk, or maneuver on the treadmill. 
We use a combination of inner and outer feedback control loops with force and motion inputs to 
create a consistent movement amplification environment.  
 Innovation 
  
Gait rehabilitation research following iSCI has largely focused on the effects of repetitive 
unobstructed walking practice performed either on a treadmill or over ground [34], and 
supplementation of these methods with bodyweight support [2, 3], robotic assistance [67], or 
functional electrical stimulation [68, 69]. For individuals with iSCI and AIS grades of C or D, these 
walking intensive interventions have a high probability of restoring and improving over ground 
walking ability [2, 3, 34]. However, residual deficits in dynamic balance remain a significant 
problem for individuals with iSCI [16, 25, 26]. As such, current clinical practice is to include 
variable forms of over ground walking activities that challenge balance [70]. Surprisingly, there 
has been relatively little research examining methods to directly improving walking balance after 
iSCI [59, 71]. We need to expand our gait rehabilitation toolbox so that clinicians have access to 
effective evidence-based approaches and tools that can enhance the recovery of dynamic 
balance for individuals with varying needs. 
In our opinion, this research proposal is innovative in both its approach to addressing the 
recovery of balance after iSCI and in the development of new tools to deliver balance 
interventions. Our approach to training dynamic balance following iSCI centers on challenging the 
control of COM motions in a predictable (learnable) manner by amplifying an individual’s own 
Figure 2. The Agility Trainer, a large cable robot used to apply lateral forces 
during gait that challenge dynamic balance. 

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motions. The movement amplification environment that we propose to use in this trial is similar in 
principle to error augmentation methods that have been shown to enhance experience-based 
learning of reaching movements [64], leg swing trajectories [63], and walking symmetry [72]. The 
consistent amplification of movements provides intensified sensory-feedback that will make it 
easier for the nervous to identify the relationship between a given efferent command and the 
resulting motion. This information is critical in the formation of a predictive internal model. As an 
individual improves their ability to predict their COM dynamics, reliance on passive impedance 
mechanisms such as an indiscriminately selecting a wide base of support, that are valuable for 
maintaining balance in uncertain environment, can be slowly released [73]. In addition, training 
dynamic balance in a movement amplification environment may speed motor learning by 
facilitating exploration of new movement strategies and the dynamic work space [65]. 
The proposed method of enhancing dynamic balance is in line with our goal to structure 
interventions aimed at recovery of function (active control 
of dynamic balance), not development of compensatory 
behaviors, (passive control of dynamic balance). 
Training dynamic balance of individuals with iSCI by 
amplifying their own self-generated COM motion is a 
radical departure from current practice and may 
significantly improve our ability to train active 
mechanisms of stability. 
Preliminary Studies 
Verification of Tools Used to Create the Movement 
Amplification Environment   
 
To assess the Agility Trainer’s peak performance 
capabilities and quantify its capacity to create the 
movement amplification environment, we conducted a 
system identification test and an experimental simulation 
of human walking, respectively. For these tests, the Agility 
Trainer was connected to an external servomotor 
(Kollmorgen, USA) used to simulate the lateral motion of 
a person’s COM during walking. We found the force 
bandwidth of our system was in the range of 4 Hz. Since 
human walking occurs almost entirely within this 
bandwidth, this performance exceeds the requirements for our purpose. As shown in Figure 3, 
the Agility Trainer was able to effectively create the movement amplification environment. As 
intended, the forces created by the Agility Trainer are qualitatively similar to movement velocity. 
However, there is an approximately 30 msec. lag between velocity input and force output. This 
lag is slightly noticeable to participants at zero-velocity when they change direction. However 
applied forces are small during this time period, making the effect difficult to detect. Overall, the 
unique robotic tool we have developed is able to generate the desired movement 
amplification training environment during human walking. 
Response of Non-Impaired Individuals to the Movement Amplification Environment 
Figure 3. Movement Amplification 
Performance. Solid line is simulated 
lateral COM mass velocity (m/s) 
created by an external servo motor. 
Dashed line shows the net force (N) 
created in response to the oscillations. 
For this test the Agility Trainer was 
driven at a frequency of 1 Hz, with an 
amplitude of 10 cm. The movement 
amplification gain was set to 55 Nsm-
1, the peak gain that will be used in the 
proposed intervention. 

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Quantification of walking in the 
movement 
amplification 
environment 
was initially assessed in non-impaired 
participants where the effects of the 
environment could be isolated from 
neuromuscular 
impairment. 
Fifteen 
healthy participants walked for 10 
minutes at their preferred speed in the 
movement amplification environment, 
with the gain set to 55 Nsm-1, the peak 
gain that will be used in the proposed 
intervention. Participants adapted their 
steady-state 
walking 
patterns 
in 
response to the challenge of controlling 
their 
lateral 
COM 
motion 
in 
the 
movement 
amplification 
environment 
(Figure 4). Following 10 minutes of 
walking in the movement amplification 
environment, people adapted their gait 
patterns to reduce their peak lateral COM speed each stride (14% slower than baseline walking). 
However, this metric was 73% more variable in the movement amplification environment than 
during normal walking. Controlling lateral motion required energy. Metabolic cost of transport was 
18% larger in the movement amplification environment than during baseline walking. Control was 
achieved by regulating foot placement each step. Lateral foot placement was significantly more 
correlated to COM dynamics (p < 0.05); regression R2 was 0.82 in the movement amplification 
environment compared to 0.71 during baseline walking. When walking in the movement 
amplification environment individuals selected gait patterns that stressed active control of 
lateral motion. In addition, the increased step-to-step variability of COM speeds may facilitate 
exploration of movement dynamics that may be beneficial for motor learning [54]. These findings 
suggest that gait training in a movement amplification environment may be valuable for training 
impaired populations to actively control dynamic balance during walking. 
Lane Width Optimization Test: A Method to Assess Dynamic Balance during Walking 
 
There is no current standard for assessing dynamic balance during walking in individuals 
with iSCI [74]. We specifically quantify dynamic balance as the capacity of an individual to control 
their lateral COM dynamics during forward walking. The narrow beam walking test, in which an 
individual attempts to walk as far as possible on a raised beam that gets progressively narrower 
with walking distance, [75] is a clinically-feasible method to identify the capacity of individuals with 
a range of abilities to control dynamic balance during walking. However, this test might not be 
accessible to individuals with substantial impairments because the narrowing beam restricts 
medio-lateral foot placement. As such, we have developed the Lane Width Optimization test to 
quantify the capacity to control lateral COM motion during treadmill walking without restricting foot 
placement.  
 
During the Lane Width Optimization test, individuals perform two minutes of continuous 
treadmill walking at their preferred speed with no external assistance. A short throw projector 
(Hitachi, Tokyo, Japan) projects the participant’s real-time medio-lateral COM position and a 
Figure 4. Non-impaired participants rapidly adapted their 
gait patterns to the movement amplification environment. 
After 10 minutes of practice, cost of transport was 
significantly greater in the movement amplification 
environment than during normal walking. Participants 
also adapted gait patterns that reduced their lateral COM 
speed per stride in the movement amplification 
environment. This was achieved by increasing the 
coupling between lateral foot placement and COM 
dynamics each step.  

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target lane on the treadmill belt 
(Figure 5). To identify COM position, 
real-time 3D locations of LED-
markers placed on the pelvis are 
collected using a 12-camera motion 
capture 
system 
(Qualisys, 
Gothenburg Sweden) and streamed 
to a custom LabVIEW VI (National 
Instruments, 
Austin, 
TX). 
The 
LabVIEW VI calculates medio-
lateral COM position [76] and 
transforms 
the 
data 
into 
the 
treadmill coordinate system for 
display. Simultaneously, the LabVIEW VI adjusts and projects the width of a green, dynamic target 
walking lane (Figure 5). Participants are instructed to maintain their medio-lateral COM position 
within this dynamic target walking lane. The area outside of the target lane (to either the left or 
right) changes to red if the COM moves outside the target lane, providing an immediate visual 
cue that the participant has made an error and should try to return their COM to the lane 
immediately. The LabVIEW VI incrementally increases or decreases the lane width every 10 
seconds based on performance (total time that the participant’s COM is within the dynamic target 
lane and the number of times the COM crosses the borders of the lane during the preceding 10 
second period). The narrowest lane width achieved and the associated lateral COM excursion 
per stride during 5 consecutive gait cycles will be the primary measures used to assess the ability 
to control (minimize) medio-lateral COM motions during treadmill walking.  
 
We have conducted the Lane Width Optimization test on 12 ambulatory individuals with 
chronic iSCI, who met the inclusion/exclusion criteria of the current proposed intervention, to 
assess feasibility and construct validity. Participants walked at their preferred treadmill speed with 
their arms free to move throughout the experiment. Participants were instructed to do their best 
to keep the line representing their COM position within the green target lane. All participants were 
able to perform the test and the target lane rapidly converged on a width that was challenging for 
everyone. There were strong and significant (p < 0.05) Pearson correlations between the final 
(narrowest) lane width achieved during the two-minute test and clinical outcome measures 
recorded from each participant (Pearson correlations of final lane width and the Berg Balance 
Scale r = -0.67; the 10-Meter Walk Test at maximum speed r = -0.61; and the Timed Up and Go 
r = 0.80). Thus, a narrower lane width corresponded with higher functional balance, walking 
speed, and adaptability. The Lane Width Optimization test shows convergent validity with 
established clinical measures of dynamic balance and gait function. This test will provide a 
quantitative method to assess control of lateral COM motion during walking. 
Feasibility of Locomotor Trailing in a Movement Amplification Environment for Individuals 
with iSCI 
We have collected pilot data demonstrating that locomotor training performed in a 
movement amplification environment is safe, feasible, and likely effective for improving 
dynamic balance of ambulatory individuals with iSCI. Three individuals with chronic iSCI, who 
met inclusion/exclusion criteria matching the proposed trial, received 16-18 treadmill training 
sessions in the movement amplification environment. One participant was classified as lower 
functioning (initial preferred gait speed < 0.5 m/s). All three participants used assistive devices 
(straight cane, wheelchair) during community ambulation. The goal of each 45-minute training 
session was to perform as much walking as possible within the movement amplification 
environment. We aimed to progress the movement amplification gain and treadmill walking 
speeds within and across sessions. As individuals’ ability to walk in the movement amplification 
Figure 5. Lane width 
Optimization Test.  Real-
time medio-lateral COM 
position of the participant 
is projected on the 
treadmill. The participant 
is instructed to maintain 
the COM within a target 
lane. If successful, the 
target lane width is 
progressively decreased.  

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environment improved, we introduced additional balance challenges to forward walking including 
lateral maneuvers, head turns, and 
obstacle 
avoidance. 
Training 
parameters were adjusted to sustain 
high intensity.  
All 
participants 
tolerated 
the 
intervention. The lower functioning 
participant required regular handheld 
assistance 
that 
decreased 
with 
training. The other two participants 
rarely required handheld assistance 
after the initial training session. One 
participant inverted their ankle during 
training. This injury was minor, and 
the participant was able to continue 
training. During future sessions, this 
participant wore an ankle brace as a 
precautionary measure. No other 
injuries or other participant safety 
concerns occurred during training. 
All participants learned to control 
walking in the movement amplification environment. Over multiple training sessions the 
movement amplification gait was gradually increased from 25 Nsm-1 (low gain) to 55 Nsm-1 
(maximum gain) for all participants. Peak treadmill speeds during training also increased by 0.67, 
0.27, and 0.63 m/s. Average peak RPE for each participant was 14.9, 18.3, and 17.4 indicating 
training parameters (gain, speed, and balance challenging tasks) were able to be adjusted to 
achieve high intensities. Average total walking time per session varied between participants: 
32:04, 27:43, and 28:52 minutes. These results demonstrate that locomotor training in the 
movement amplification environment is safe and feasible for individuals with iSCI.  
All participants demonstrated improvements in dynamic balance following the training 
intervention as assessed by narrowest target lane achieved on the Lane Width Optimization test 
and associated lateral COM excursion per stride (Figure 6). Participants’ improved dynamic 
balance by 31-35% compared to baseline as measured by the Lane Width Optimization test. 
All three participants retained these gains at their 3-month follow up test. Clinical outcome 
measures supported these findings. All participants increased their fastest 10-meter walk speed 
(increasing by 0.1-0.22 m/s). Two participants improved their scores on the reactive postural 
control items from the Mini Balance Evaluation Systems Test 
(improvements of 2 and 4 out of 6, changing from no reaction 
to a single or multi-step successful response).  
We conducted additional laboratory assessments to 
quantify baseline and post-training unassisted walking 
mechanics in two of the participants (unfortunately, these 
measures were not collected from our first high-functioning 
participant). Following training, participants selected a 
narrower base of support and increased their step-by-step 
modulation of lateral foot placement in response to COM 
dynamics. Specifically, participants decreased step width 
(12% and 13%) and increased step length (42% and 52%). In addition, lateral foot placement and 
lateral COM dynamics were significant and more strongly correlated after training (Table 1). 
These findings suggest individuals changed their strategy to control lateral motion and improved 
their ability to actively modulate their foot placement in response to changes in COM dynamics. 
Figure 6. Lane Width Optimization Test. A participant with iSCI 
improved control of the lateral motion of the COM position (white 
line) following gait training performed in a movement 
amplification environment. Following training, the target lane 
(green lines) in which the individual could control their COM 
decreased substantially. 
Table 1: Correlation and 
significance between lateral 
foot placement and COM 
dynamics. 

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Finally, all participants self-reported improved participation in walking activities, including being 
able to carry food with two hands while walking in the kitchen, ability to walk alongside family 
members, desire to return to work, and participation in dance classes. The lowest functioning 
participant increased their WHOQOL-BREF raw score by 55 points, suggesting substantial 
improvement in quality of life. Finally, two participants self-reported substantial improvements in 
urogenital and/or sexual function. These results suggest that the benefits of locomotor training 
performed in the movement amplification environment may translate to activities of daily living. 
3.0 
Objectives 
 Describe the study’s purpose, specific aims, or objectives.  
 State the hypotheses to be tested. 
 
Dynamic balance – the ability to anticipate and react to changes in balance during 
movement – is essential for walking, a task with regular periods of instability resulting from 
periodic motion of the center of mass (COM) beyond the base of support [1]. Among ambulatory 
individuals with incomplete spinal cord injury (iSCI), balance deficits are common [2] and are a 
primary determinant of participation in walking activities (i.e. number of steps per day) [3]. This 
population averages only 2,600 steps per day [3], well below the 5,000 step sedentary threshold 
[4]. Improving dynamic balance may promote participation in walking activities. However, the 
capacity to enhance dynamic balance through locomotor training has been inconsistent [5, 6] and 
its impact on participation in walking activities is difficult to evaluate. To date, few studies have 
performed locomotor training interventions specifically targeting dynamic balance in iSCI 
populations [7, 8], and none have quantified changes in daily stepping. There is broad recognition 
that effective evidence-based interventions are needed to enhance dynamic balance of 
individuals with iSCI [7, 9, 10]. Our research finds, in response to viscous force fields that alter 
the requirements to control COM motion during walking, individuals with iSCI rapidly adapt their 
neuromechanical control strategies to maintain dynamic balance [11, 12]. This observation 
motives our proposal to examine a promising new approach to retrain dynamic balance by 
amplifying COM motion. 
 
Improving dynamic balance after iSCI is very challenging because sensory-motor 
impairment limits the nervous system’s capacity to detect movement errors. Error detection is 
necessary for updating the nervous system’s internal model to correctly relate motor commands 
to their resulting movement. On a step-by-step basis, an internal model that poorly predicts motion 
limits the nervous system’s ability to anticipate predictable balance challenges during gait (i.e. 
periodic COM motion). As such, individuals with iSCI often select passively strategies (e.g. wide 
steps) that maintain dynamic balance with minimum requirements from the nervous system to 
anticipate ongoing balance demands. These passive strategies are inflexible, inefficient [13], and 
limit walking speed [14]. Experimental interventions that amplify self-generated movements (e.g. 
error augmentation) may accelerate motor learning by augmenting sensory-motor feedback [15] 
and thus allowing the impaired nervous system to identify otherwise imperceptible errors. Such 
interventions could enhance dynamic balance by recalibrating the internal model to better predict 
COM motion. We have developed a cable-driven robot that creates a movement amplification 
environment by applying a continuous viscous force field to the pelvis that is proportional in 
magnitude to a participant’s real-time COM velocity [16]. Our purpose is to investigate if locomotor 
training performed in a movement amplification environment can effectively improve dynamic 
balance and increase participation in walking activities of individuals with iSCI. 
Specific Aim 1: To evaluate if locomotor training performed in a movement amplification 
environment is effective for improving dynamic balance of individuals with iSCI.  

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Hypothesis 1: Improvements in dynamic balance during walking will be greater when locomotor 
training is performed in a movement amplification environment when compared to a traditional 
treadmill environment. 
We will conduct a two-arm parallel-assignment intervention. Participants will be 
randomized into either a Control group receiving locomotor training [5] or an Experimental 
group receiving locomotor training performed in a movement amplification environment. 
All participants will receive 20 training sessions. We will assess changes in dynamic 
balance using clinical outcome measures and a quantitative laboratory test we developed 
to measure capacity to control COM motion during walking. Our pilot data suggests that 
locomotor training performed in a movement amplification environment substantially 
improves dynamic balance. Following locomotor training in the movement amplification 
environment, three individuals with iSCI improved dynamic balance as evidenced by 
greater than 30% improvements in COM control during walking. 
Specific Aim 2: To evaluate the impact of locomotor training performed in either a movement 
amplification environment or in a traditional treadmill environment on participation in walking 
activities.  
Hypothesis 2: Participation in walking activities will increase more in the Experimental Group that 
receives locomotor training in a movement amplification environment. 
To design more effective locomotor training programs, it is essential we understand how 
specific interventions impact walking participation outside of the clinic. We will use activity 
monitors [17, 18] to quantify changes in daily stepping activity. Based on evidence 
identifying a strong relationship between balance and steps per day in ambulatory 
individuals with iSCI [3], we anticipate that training in the movement amplification 
environment will positively impact dynamic balance, and in turn increase participating in 
walking activities. 
 
Positive outcomes from Aim 1 would support development of clinically-feasible tools to 
first replicate, and then evaluate, the movement amplification environment within VA clinics. Data 
from Aim 2 will expand our understanding of if, and how, current locomotor training interventions 
and targeted dynamic balance training impact participation in walking activities in the home and 
community settings. 
 
 Indicate the relevance to Veterans and the VA 
 
Spinal Cord Injury (SCI) affects between 259,000-1,275,000 people in the United States 
[77, 78], of which ~42,000 are Veterans [79]. The Department of Veterans Affairs provides the 
single largest network of SCI care in the nation through its 24 Spinal Cord Injury Centers. With 
the lifetime financial burden of SCI ranging from $682,000 to over $3 million [78], identification of 
methods to improve the effectiveness of SCI rehabilitation programs would directly benefit 
Veterans living with iSCI and improve the ability of the VA to provide Veterans with first-class 
health care. A major cost of SCI is impaired mobility. Limited ambulatory function can result in 
decreased ability to work, increased care requirements, secondary injury, depression, bone 
mineral density loss, diabetes, and decreased cardiovascular health. Over half of spinal cord 
injuries are motor incomplete [80]. Depending on the severity of the initial injury, the prognosis for 
the recovery of independent ambulation after iSCI is 50-95% [81]. This portion of the SCI 
population would directly benefit from the development of evidence-based methods to enhance 
dynamic balance which could improve health and reduce the physical, social, and financial costs 
associated with limited mobility. 

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4.0 
Resources and Personnel 
 Include a list of personnel, their location, role in the study and their 
VA affiliation status  
o Principal Investigator: 
 
Keith Gordon, PhD 
 
Hines VA and Northwestern University 
 
5/8 VA appointment  
o Co-Investigators: 
 
Jennifer Kahn, PT, DPT, NCS  
 
Northwestern University 
 
IPA 
o Collaborators: 
 
Christine Jelinek, MS  
 
Hines VA 
 
8/8 VA appointment 
 
Geoffrey Brown, MS  
 
 
Northwestern University 
 
 
IPA 
 
Tara Cornwell, BS 
 
 
Northwestern University 
 
 
IPA 
 
 Provide a brief description of each individual’s role in the study.  Be 
sure to indicate who will have access to protected health information 
and who will be involved in recruiting subjects; obtaining informed 
consent; administering survey/interview procedures; and performing 
data analysis. 
 
Keith Gordon, PhD 
 
 
Role: Principal Investigator 
 
 
 
Involved in all aspects of project 
 
Jennifer Kahn, PT, DPT, NCS  
 
 
Role: Co-Investigator, Research Physical Therapist 
 
 
Screening, recruitment, consenting,  
 
 
Will oversee gait training interventions,  
 
 
Will contribute to data analysis, data dissemination 
 
Christine Jelinek, MS 
 
Role: Clinical coordinator 
 
 
 
Screening, recruitment, consenting, scheduling  
 
 
 
 
Participant Activities 
 
Geoffrey Brown, MS (research engineer) 
 
 
Role: Research Engineer  

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Responsible for maintenance and operation of all   
 
 
 
hardware 
 
Tara Cornwell, BS (research engineer) 
 
 
Role: Research Engineer 
 
 
 
Will oversee laboratory data collections and will  
 
 
 
 
perform data analysis 
 
5.0 
Study Procedures 
 
5.1 Study Design 
 
Describe experimental design of the study.  Include sequential 
and/or parallel phases of the study, including durations, and 
delineate which interventions are standard of care and which 
are research.    
Overview 
Our objective is to evaluate the effects of locomotor training performed in a movement 
amplification environment on dynamic balance and participation in walking activities of people 
with chronic iSCI. We will conduct a two-arm parallel assignment intervention. Participants will be 
randomized into a high intensity locomotor training intervention that will be conducted in either a 
normal treadmill environment or in a movement amplification environment.  
Specific Aim 1 will assess changes in dynamic balance following the interventions. Based on 
the substantial improvements observed during our case series, we hypothesize that study 
participants will have greater improvements in dynamic balance when the locomotor training 
is conducted within the movement amplification environment.  
Specific Aim 2 will evaluate the impact of the two interventions on the number of daily steps 
individuals take in the home and community.   
 
The knowledge gained from this study will expand our understanding of how locomotor 
training performed in a movement amplification environment effects dynamic balance and 
participation in walking activities. Positive outcomes from this randomized controlled trial would 
motivate translation efforts to develop clinically-feasible devices that can easily replicate the 
movement amplification environment for use within the VA’s system of care.  
Target Population 
Among individuals living with SCI, 67% have motor incomplete lesions [80]. Depending on the 
severity of the initial injury, the prognosis for independent ambulation after iSCI is between 50 
and 95% [81]. We will recruit Veterans with chronic motor incomplete SCI who are ambulatory 
and able to advance their limbs without assistance. We will include participants with a range of 
initial functional walking ability evaluated by walking speed (half of the participants preferred 
walking speed will be < 0.5 m/s at enrollment). Thus, the target population for this trial is the 
considerable proportion of individuals with iSCI who would benefit from the advancement of 
interventions that can improve dynamic walking balance. 
Protocol Overview 

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Participants will be stratified by gait speed (half of the participants will have a preferred 
over ground gait speed ≥ 0.5 m/s and half of participants will have a preferred over ground gait 
speed < 0.5 m/s) and then randomized into two locomotor intervention groups:  
 
The Control group will receive high intensity locomotor training performed on a treadmill 
[60].  
 
The Experimental group will receive high intensity locomotor training performed on a 
treadmill in a  movement amplification environment created by the Agility Trainer.  
 
We will conduct clinical outcome measures to assess changes in functional gait and 
balance and quality of life. We will conduct quantitative laboratory assessments to evaluate 
changes in dynamic balance and associated gait patterns. Finally, to assess if the effects of 
locomotor training impact participation in walking activities outside of the laboratory/clinical 
setting, we will 
measure 
daily 
steps taken in 
the home and 
community.  
 
To 
ensure that gait 
and balance are 
stable prior to 
beginning 
the 
intervention, we 
will measure 10 m walk speed and Berg Balance Scale score during an initial Screen. These two 
measures will be repeated a week later during the Baseline (BSL) assessment session to ensure 
the participant’s initial performance is stable. If measures are not stable, measures will be 
repeated a week later. If measures do not stabilize after three-weeks of testing, the participant 
will not be enrolled in the training intervention. Clinical outcome measures and laboratory 
assessments will be performed at four time points (BSL, Mid, Post, and Follow Up) 
encompassing the 20-session training intervention (Figure 7). Average number of steps taken in 
the home and community environment will be estimated from data recorded during 1-week 
periods occurring at three time points corresponding with BSL, Post, and at the 3-month Follow 
Up. (Figure 7). 
Locomotor Training Interventions 
 
We will conduct all locomotor training interventions in the Human Agility Laboratory. All 
training will be directed by a licensed physical therapist. Training for each intervention group will 
be conducted on a large commercial treadmill - belt width 1.39 m (Tuff Tread, Willis, TX) providing 
space to perform side steps and small lateral maneuvers [82]. For safety, participants will wear a 
trunk harness attached to a passive overhead safety support. Support straps will be adjusted to 
allow unrestricted travel across the treadmill and will not provide bodyweight support. During 
locomotor training, participants will wear a heart-rate monitor, to provide continuous feedback to 
the physical therapist on the intensity of the training, and an activity monitor, to measure number 
of steps during the session. For the Experimental group, the training equipment will also include 
the Agility Trainer to produce the movement amplification environment.  
 
The locomotor training intervention will include 20 sessions (2 to 3 times per week). Each 
training session will last up to 60-minutes. The objective each session is for the participant to 
complete a total of 45-minutes of treadmill walking. The additional time each session will be used 
as needed for setup and rest breaks.  
Figure 7. Timeline of the 22 to 26 week schedule for assessments and locomotor 
training intervention. The length of each individual study segment is indicated. 

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Control group: Participants randomized to the Control group will complete high intensity 
gait training on a treadmill. The protocol is based on evidence demonstrating that for individuals 
with iSCI high intensity training based on heart rate (HR) and perceived exertion (RPE) [83] 
resulted in significantly greater increases in treadmill and over ground walking speeds than lower 
intensity training interventions [60]. The goal of each session will be to achieve 40-minutes of 
stepping practice within a desired range for HR and RPE. We will continuously adjust training 
parameters to maintain a target HR between 70 and 80% of estimated age-predicted HR reserve. 
We will calculate HR reserve at follows: 
 
 
HR reserve = (HR maximum – HR resting) + HR resting 
 
We will estimate HR maximum [84] as: HR maximum = (208 – (0.7 x age)). If target heart 
rate zones cannot be achieved during training, we will use RPE as a secondary measure of 
intensity. We will target a rating of 15 “hard” to 17 “very hard” on the 20-point RPE rating scale 
during training.  
 
Every training session will begin and end with a 2.5-minute warmup and cool down 
respectively. During these periods, individuals will perform straight treadmill walking. Target heart 
rate during these periods will be between 50 and 65% of HR reserve. The 40-minute body of the 
training session will be divided into four 10-minute segments. Two of the 10-minute segments will 
consist of Speed-training. The objective during Speed-training will be to achieve the highest 
possible speed during straight-forward treadmill walking while maintaining the target HR and RPE. 
The other two 10-minute segments will consist of Balance-training. The objective during the 
Balance-training segments will be to maximize repetitions of forward treadmill walking while 
introducing additional challenges to dynamic balance. We will utilize the following tasks to 
challenge dynamic balance: 
1) Lateral Stepping Maneuvers. We will draw a chalk line down the center of the treadmill. 
During forward walking the physical therapist will cue the participant to move from one side 
of the chalk line to the other. Task difficultly will be increased by increasing the frequency 
of lateral maneuvers performed. 
2) Head Turns. Participants will perform cued vertical and horizontal head turns while 
maintaining forward walking. Task difficulty will be progressed by increasing the magnitude 
and duration of the head turns. 
3) Obstacle negotiation. Participants will be tasked with stepping over small objects during 
forward walking. Task difficulty will be progressed by increasing the size and frequency of 
obstacles. 
 
Within the clinical decision-making framework (described below) combinations of the 
balance challenging tasks will be selected to; avoid repeated failures (loss of balance requiring 
physical assist from physical therapist to recover), achieve the appropriate heart rate and RPE, 
and consider the participant’s tolerance/needs. At the physical therapist’s discretion participants 
will be provided with hand-held assist as necessary to safely-perform the desired stepping tasks. 
Our goal will be to minimize any external support provided to the participants. Seated or standing 
rest breaks will be permitted as needed. Brief rest breaks will naturally occur during transitions 
between segments. We will monitor the individual and cumulative rest break time each session. 
We will set goals to decrease the individual and cumulative duration of rest breaks over the course 
of the training intervention. 
 
The order of the individual 10-minute Speed- and Balance-training segments will be 
alternated within a session. We will alter which segment type (Speed- or Balance-training) is 
presented first from session-to-session. 
 
Experimental group: The locomotor training protocol described for the Control group will 
be used for the Experimental group with one exception. The Experimental group will perform all 

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Speed- and Balance-training within the movement amplification environment. The objective for 
the Experimental group will be to progressively increase the movement amplification gain within 
and across sessions to increase the challenge for the participant to control their lateral COM 
motion. The gain of the movement amplification environment will be initially set very low (25 Nms-
1). When a participant can successfully ambulate in the low intensity movement amplification field 
without repeated failures (loss of balance requiring physical assist from physical therapist to 
recover), we will incrementally increase the gain of the field by (5 Nms-1). We will continue to 
increase the gain until we reach a maximum gain of 55 Nms-1 dictated by the current Agility Trainer 
hardware and software. 
 
Clinical Decision-Making: To ensure consistency of the intervention between 
participants, a simple clinical decision-making protocol will be used to guide the physical 
therapist’s decisions about when to change intervention parameters. First the physical therapist 
will determine: is the participant able to accomplish the immediate walking task? Second, the 
physical therapist will determine: is HR and RPE in the target zone? 
 
 
We recognize that there is an interaction between the two decision-making trees. 
Specifically, increasing balance-challenges may increase the cardiovascular demands of walking, 
and increasing walking speed may increase the challenge to maintain dynamic balance. Based 
on our goal to provided targeted dynamic balance training, we will prioritize successful 
accomplishment of the task and stress progression of the dynamic balance demands (elimination 
of any handheld assist, progression of movement amplification gains, and progression of the 
balance-challenging tasks). We realize that for lower functioning participants prioritizing the 
balance challenging components of walking may result in HR and RPE below the target threshold. 
However, our pilot testing found that we were able to consistently adjust the movement 
Is the participant able to accomplish the immediate walking task? 
The immediate walking task during Speed-training is straight-forward walking. The task during Balance-
training is straight-forward walking + an additional balance challenge. The physical therapist will 
determine that the participant is able to successfully accomplish the task if; the participant is able to 
make positive reciprocal steps without limb collapse or loss of balance requiring assistance for 1-minute 
of walking.  
 
If successful. First reduced or eliminate any handheld assistance. Next, if applicable, increase 
movement amplification gain by 5 Nms-1 (up to 10 Nms-1 above the participant’s pervious highest 
gain within a single session or a maximum of 55 Nms-1). Finally, if applicable, increase the 
challenge of the balance-training task. Reevaluate every minute. 
 
If unsuccessful. First, if applicable, decrease the challenge of the balance-training task. Next, 
if applicable, decrease the movement amplification gain by 5 Nms-1 (to a minimum of 25 Nms-
1). Finally, provide handheld assist as needed to perform the task successfully. Reevaluate 
every minute. 
Is HR and RPE in the target zone? 
Once the participant is able to successfully accomplish the walking task then the treadmill speed should 
be adjusted to achieve the desired HR and RPE.  
 
If HR and RPE are below the target zone. Increase treadmill speed by 0.1-0.3 mph. 
Reevaluated every 30 seconds.  
 
If HR and RPE are above the target zone. Decrease treadmill speed by 0.1-0.3 mph (treadmill 
speed should not go below the speed used during the session’s warmup period). Reevaluated 
every 30 seconds. If HR and RPE remain above the target zone upper limit, then give a rest 
break. 

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amplification gains, balance-challenging tasks, and walking speeds in a manner that consistently 
placed individuals in the target HR and RPE zone. 
Documentation of Intervention 
A research assistant will be present at every session to assist the physical therapist and 
document the following events at every training session. Specifically, we will record:  
Vital signs before, during, and after training;  
Total time walking within the 60-minute session;  
Total number of steps (StepWatch, Modus, Washington DC);  
Walking speeds;  
Number of times physical assistance (from the physical therapist or overhead safety support) 
was provided to prevent fall (fall defined as inability to recover loss of balance without physical 
assistance);  
Specific balance-challenging tasks practiced each session;  
Movement Amplification environment gains (if applicable); and  
Exertion and workload - monitored via heart rate and the 6-20 RPE scale throughout the 
session.  
Assessment of Locomotor Training Effects 
Clinical Outcome Measures 
 
We will collect clinical outcome measures at four time points (BSL, Mid, Post, and Follow 
Up) surrounding the training intervention. Study personnel performing the clinical assessments 
will be blinded to the intervention. We will first collect demographic information and a brief medical 
history including: 
 
Demographic variables: age, gender, date of birth (BSL only) 
 
Date of spinal cord injury, level of injury, and cause of injury (BSL only) 
 
Current and past medical history (BSL only) 
 
Current medications 
 
Current ambulatory ability in the home and community including any assistive devices 
used during ambulation 
 
Self-reported number of falls in the past year (BSL only) 
 
Self-reported number of falls since previous assessment (Mid, Post, and Follow Up only) 
 
Next, we will collect data using measures that span each level of the International 
Classification of Function, Disability, and Health (body structure and function, activity, and 
participation), utilizing a combination of performance based and self-report measures. First, the 
type of SCI will be classified using the Lower Extremity Motor Score (LEMS) portion of the 
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) [85].  The 
LEMS assess strength of five muscle groups representing neurological levels L2 to S1. We will 
also perform manual muscle tests of hip abductor strength which is important for controlling lateral 
motions.  
 
We will use several clinical outcome measures to identify functional changes in gait-
related balance. We will use the Walking Index for Spinal Cord Injury II (WISCI II). The WISCI 
II evaluates the amount of physical assistance needed for gait after SCI. The WISCI II has 
excellent reliability and validity in the chronic iSCI population [86]. The WISCII has also been 
found to have a strong correlation with measures of balance [30]. The Functional Gait 
Assessment (FGA) is a ten-item test that evaluates dynamic balance and postural stability during 
gait [87]. Unpublished data from a study we conducted suggests the FGA is both valid and reliable 

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for assessing walking balance in individuals with iSCI [88]. The 10 Meter Walk Test (10MWT) is 
a simple measurement of an individual's average walking speed. Research indicates there is a 
correlation between walking speed and balance; walking speeds below 0.48 m/s are in large part 
due to balance issues over long distances [89]. Gait speed will be measured at self-selected 
(instruction: “walk at your normal comfortable pace”), fastest-possible speed (instruction: “as fast 
as you safety can”). The Activities-Specific Balance Confidence (ABC) scale is a self-report 
measurement of an individual’s confidence while performing numerous postural and ambulatory 
activities. The ABC is a reliable and valid measure of balance confidence in individuals with iSCI 
who ambulate in the community [90]. The Balance Evaluations Systems Test (BESTest) is 
used to assess balance impairments across six different domains of postural control. We will 
specifically use the reactive balance item from the BESTest to assess changes in the capacity to 
react to fore-aft, and lateral perturbations [91]. The Berg Balance Scale (BBS) is a 14-item 
measure that assesses static balance [29]. The test has excellent validity and reliability data for 
in individuals with AIS D, however in higher functioning individuals the test suffers from a ceiling 
effect. As the test does not assess dynamic balance it is recommend to be used in conjunction 
with additional measures, such as 10MWT [92].  
 
Finally, we will measure the intervention’s potential impact on quality of life. We will utilize 
an abbreviated version of The World Health Organization Quality of Life scale (WHOQOL-
BREF) [93]. The WHOQOL-BREF is a 26-item self-report quality of life assessment focusing on 
areas such as physical, psychological, social and environmental health. Two of the three 
participants in our case series investigating the effect of locomotor training performed in a 
movement amplification environment reported substantial improvements in bowel/bladder and 
sexual function following training. This is consistent with a pervious locomotor training study [94] 
that also found improvements in bladder function. These improvements may be attributable to 
neuroplasticity or biomechanical demands related to pelvic floor and core musculature 
involvement in dynamic balance during locomotion. We will use the International Consultation 
on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ- UI SF) a 4-item self-
report of urinary incontinence to document changes in bladder function [95].  
Laboratory Assessments 
 
We will perform laboratory assessments to make quantitative measures of changes in 
dynamic balance during walking. Specifically, we will quantify the ability of participants to control 
their whole-body COM motion during treadmill walking and measure associated stepping 
mechanics. We will collect kinematic data as participants perform walking on an oversized 
treadmill (Tuff Tread, Willis, TX). We will record 3D coordinates of 40 reflective markers placed 
on the trunk, pelvis and lower limbs using a 12-camera motion capture system (Qualisys, 
Gothenburg Sweden).The participant will not be allowed to use any assistive devices (canes, 
walkers, handrails, or manual assistance) with the exception of any passive ankle-foot orthoses 
they would typically wear during community ambulation. All walking will be performed at the 
participant’s preferred treadmill speed (identified at the beginning of each Laboratory Assessment 
testing session through a staircase method of increasing and decreasing the treadmill speed until 
desired speed is confirmed through verbal feedback). For the Mid, Post, and Follow Up 
assessments, walking will be performed at both the current preferred treadmill speed (if preferred 
treadmill speed has changed with training) and at the preferred treadmill speed identified during 
BSL.  
 
Participants will perform a series of 2-minute long walking trials performed at both their 
current preferred walking speed and matched to their preferred walking speeded identified during 
BSL. Two walking trials at each speed will be used to identify participant’s preferred walking 
characteristics. During these trials, participants will be instructed to walk as they feel most 
comfortable. No additional external support or feedback will be provided during these trials. Two 
additional walking trials at each speed will be used to assess the ability of the participant to control 

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their lateral COM motion during walking. During these walking trials, participants will perform the 
Lane Width Optimization Test. The order of all trials will be randomized. Participants will rest 
for at least 2 minutes between trials. Additional rest time will be provided as need. 
  
 
We will post-process and analyze data from the walking trials to assess COM motion and 
stepping characteristics. Kinematic marker data will be processed using Visual3D (C-Motion, 
Germantown, MD) and a custom MATLAB (Mathworks, Natick, MA) program. Marker data will be 
gap-filled and low-pass filtered (Butterworth, 6 Hz cut-off frequency). Time of initial foot contact 
(IC) and toe-off (TO) events will be identified for each step based on fore-aft positions of the 
calcaneus and 2nd metatarsal markers. Medio-lateral COM position will be calculated in Visual3D 
as the center of the Visual3D model’s pelvis. To characterize medio-lateral control of the COM 
during all walking trials we will identify peak lateral COM Speed and lateral COM Excursion 
each stride. COM velocity will be calculated as the derivative of COM position. Peak lateral COM 
Speed will be identified as the maximum absolute COM velocity between ipsilateral initial contact 
events, and lateral COM Excursion will be calculated as the difference between the maximum 
and minimum lateral COM positions per stride. To assess how control was instituted, we will 
examine step width, step length, step time, and minimum lateral margin of stability (MOS) 
each step using established methods [82].  
Daily Stepping  
 
We will assess the amount of daily stepping in the home and community during three 1-
week periods. Daily stepping will be measured and recorded using a StepWatch4 (Modus, 
Edmonds, WA) activity monitor. The device has a battery life of 35 days and will record individual 
stepping data on the resolution of seconds. The device has been found to be accurate and reliable 
for measuring stepping activity in individuals with iSCI [96] and has been used successfully to 
assess daily stepping in individual with iSCI [31, 97]. During each assessment period, the 
microprocessor-based accelerometer will be worn around the ankle during all waking hours 
(except bathing) for seven continuous days. We will only analyze data on days that the StepWatch 
has been worn for at least 90% of waking hours. Research suggests that stable measures of 
walking activity in adults with iSCI can be obtained by averaging step count values from any 2-
day period in a week [97]. Our primary measure of daily stepping will be the total number of 
steps taken per day averaged across the 7-day period. We will also measure changes in activity 
level using two secondary measures, the number of minutes of the day with at least one step, 
and percent of a 24-hour day with no walking. 
Research Team, Organization, Management, and Communications 
 
All members of the research team will meet as a group on a quarterly basis to review 
progress, discuss research-related issues, and to identify upcoming goals. Three smaller sub-
groups will meet on a weekly-basis. The sub-groups will include a clinical research team who are 
responsible for administering and documenting the training intervention, a laboratory research 
team who are responsible for collection, analysis, and processing of laboratory assessments and 
daily stepping records, and an administrative team responsible for recruitment, IRB-related 
issues, purchasing, and equipment maintenance. Meeting notes will be recorded and saved in a 
shared online folder where they can be accessed and reviewed by the study team members. 

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Time Line 
 
We will spend the first quarter of 
the study finalizing administrative issues, 
and standardizing training procedures. 
Once in place, we will begin recruiting 
and enroll participants. We will have 2-3 
participants involved in the training 
interventions at a time. We will time study 
enrollments to limit disruptions during 
high travel/vacation periods (winter holidays). We will stagger start times in the intervention, so 
data collection periods and step tracking periods are spread out. 
 
 Description of risks to participants and of how anticipated risk 
will be minimized. 
Potential Risks 
 
All participants will engage in a high intensity locomotor training intervention. The greatest 
risks participants will face are comparable to risks associated with other intense cardiovascular 
exercise and gait rehabilitation programs. Specifically, the potential risks to participation include: 
 
Cardiovascular difficulties and fatigue resulting from high intensity walking. 
 
Musculoskeletal injuries resulting from falls and/or stumbles during treadmill walking.  
 
Fear of falling that may be brought on by the training environment that is designed to 
challenge balance. 
 
Discomfort from the pelvic harness which fits snuggly around the waist and is used to 
transmit forces to the pelvis from a cable-driven robotic device. 
 
Emotional or psychological discomfort created by the personal nature of some of the 
medical history questions, clinical outcome measures, and record of daily stepping activity. 
 
Protections Against Risk 
   
We will continuously monitor participants for any evidence of adverse or unanticipated 
events during experimental testing and training sessions. In order to minimize cardiovascular risks 
during experimental testing and training we will monitor heart rate, blood pressure, and perceived 
exertion to determine if exercise should be stopped. Participants will also be allowed to stop and 
rest at any time. We will also monitor participants for any trips, slips, stumbles, or missteps during 
walking trials. Should any occur, we will stop testing to examine the participant for orthopedic 
injury prior to resuming testing. All participants will also be attached to a safety system consisting 
of a modified parachute harness attached to an overhead support that will prevent participants 
from falling more than several inches if they stumble when walking. All robotic equipment will have 
emergency shut-off switches that will be accessible to both the participant and research personnel 
during testing that will turn off the robotic device immediately when pushed. Hard stops and robotic 
controls will prevent participants from experiencing applied forces greater than a predetermined 
magnitude, or on certain areas (boundary’s) of the treadmill belt. Research staff will continually 
interact with participants to monitor for any evidence of adverse or unanticipated events during 
testing. Before leaving the laboratory, participants will be reminded that they have the contact 
information for the PI and research staff (included in their copy of the informed consent form), and 
they will be encouraged to contact us immediately should they experience any adverse or 
Quarter 1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
IRB Approvals X
Manual of Study Procedures X
Training of Study Personnel X
Participant Recruitment
X
X
X
X
X
X
X
X
X
X
X
X
Lab Assessments / Clinical Measures
X
X
X
X
X
X
X
X
X
X
X
X
X
Stepping Assessments
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Training Interventions
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Manuscript Preparation
X
X
X
X
X
X
X
X
X
X
X
X
X
Grant Preparations
X
X
X
Year 1
Year 2
Year 3
Year 4
Timeline
Tasks

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unanticipated events that may have been in any way related to their participation in the research 
study. We will also take the specific following steps to minimize risk to participants. 
 
Cardiovascular Risks 
Participants might experience cardiovascular difficulties during the high intensity treadmill 
training intervention. We will monitor heart rate (HR) and blood pressure (BP) along with an 
ensemble of information from all participants to minimize cardiovascular risk. Dependent on the 
location and severity of the SCI, innervation of the sympathetic nervous system may be disrupted, 
which can affect the HR–VO2 relationship. Because of this, clear guidelines for prescribing and 
stopping exercise for individuals with SCI based on BP and HR values have not been established 
as they have for neurologically-intact individuals. We will monitor BP and HR and use this 
information in conjunction with other guidelines provided by the American College of Sports 
Medicine for indications to terminate exercise. Specifically, we will stop exercise if any of the 
following signs are observed: 
 
Suspicion of a myocardial infarction or acute myocardial infarction (heart attack) 
 
Onset of moderate-to-severe angina (chest pain) 
 
Drop in systolic blood pressure (SBP) below standing resting pressure or drop in SBP 
with increasing workload accompanied by signs or symptoms 
 
Signs of poor perfusion (circulation or blood flow), including pallor (pale appearance to 
the skin), cyanosis (bluish discoloration), or cold and clammy skin 
 
Severe or unusual shortness of breath 
 
CNS (central nervous system) symptoms (e.g., ataxia (failure of muscular 
coordination), vertigo (an illusion of dizzying movement), confusion) 
 
Serious arrhythmias (abnormal heart rhythms) (e.g. second / third degree AV block, 
atrial fibrillation with fast ventricular response, increasing premature ventricular 
contractions or sustained ventricular tachycardia) 
 
Participant's request to stop 
    After testing is complete, we will check heart rate and blood pressure of all participants to 
ensure that these measures have returned to baseline levels before participants leave the 
laboratory. We will continually interact with participants to monitor for any evidence of adverse or 
unanticipated events during this time.  
 
 
Fatigue  
Walking on the treadmill is exercise and may cause individuals to become fatigued. 
Participants will be given regular scheduled rest periods throughout the experiment and training. 
However, they may request additional rest at any point during experiments and locomotor training 
sessions. 
 
Musculoskeletal Injury, Risk of Falling, and Fear of Falling 
Participants might trip and fall while walking which could result in musculoskeletal injury such 
as an ankle sprain. To minimize this risk, participants will wear a harness that will prevent them 

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from falling more than several inches if they were to trip or stumble during walking. Participants 
will also be given time to accommodate to walking on a treadmill. The treadmill and Agility Trainer 
both have emergency shut-off “kill” switches to rapidly disengage the devices at any time. The 
emergency shut down switches will be easily accessible to both the physical therapist and the 
participant. 
 
Discomfort due to Forces applied to the Pelvic Harness   
 
We will use a padded hip belt and offer all participants additional padding as desired to 
minimize any discomfort. In addition, the Agility Trainer has a number of safety features that limit 
the magnitude of force that can be applied to participants, including mechanical stops to ensure 
the device does not move participants beyond their normal range of motion and emergency shut 
off switches that will be within research of both participants and researchers during testing. Also, 
we will very gradually increase the magnitude of force the device applies to participants and 
continually monitor participants’ responses so that the magnitude of the applied forces does not 
exceed the individual’s ability. Finally, the pelvic harness (Barry USA Inc., Delaware) is well 
padded and was designed to comfortably suspend circus trapeze performers. 
 
Emotional Discomfort 
Some of the questions we ask may be upsetting, or participants may feel uncomfortable 
answering them. If they do not wish to answer a question, they may skip it and go to the next 
question. 
 
Availability of Emergency Services 
All assessments and training sessions will be conducted at the Northwestern University 
Feinberg School of Medicine. In the event of an emergency, this facility is equipped to provide 
immediate care to participants. In addition, a physical therapist will be present during all 
experimental and training sessions. The physical therapist will continually monitor the 
cardiopulmonary condition of the participant and attend to any immediate health-related issues. 
 
Potential Benefit of the Proposed Research to the Participant and Others 
The overarching goal of this project is to assess the effects of a novel intervention, locomotor 
training performed in a movement amplification environment, on dynamic balance and 
participation in walking-related activities in individuals with iSCI. Recent scientific research [64, 
65] has provided an evidence-based framework for motivating the development of tools able to 
create the movement amplification training environment examined in the proposed research. 
Locomotor training performed on a treadmill is frequently administered in clinical settings and is 
well-accepted because it provides a safe and straightforward method of intensely training many 
of the important components of walking while not requiring much space or complex equipment. 
However, treadmill training alone is limited because it lacks a balance-specific component. If 
outcomes from the proposed research are successful, the supplementation of treadmill-based 
locomotor training with a movement amplification environment could dramatically improve the 
capacity of treadmill training to enhance dynamic balance. The movement amplification 

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environment has the potential to transform an ordinary treadmill into a dynamic environment 
where people with iSCI can receive safe, challenging, and customized locomotor balance training. 
Overall, this proposal has the potential to dramatically enhance how gait rehabilitation is delivered 
and, most importantly for Veterans recovering from iSCI, the intervention may provide a means 
to significantly improve components of their walking effected by balance. 
Several clinical gait rehabilitation breakthroughs have often been spawned from research 
originally developed for individuals with SCI (e.g. body weight supported treadmill training [98], 
robotic assisted gait training [99]). Similarly, we believe the tools and training procedures 
developed within the current proposal have broad applications that extend far beyond those 
recovering from SCI. The approach we are using has the potential to benefit a wide range of 
impaired populations that experience balance-related deficits (i.e. stroke, TBI, lower-limb 
amputee, older adults). The development of tools to enhance dynamic balance may also benefit 
non-impaired populations in specific professions that require excellent balance such as war 
fighters, search and rescue teams, and athletes. Thus, outcomes from the proposed research 
may provide the ground work to develop dynamic-balance related interventions for a broad range 
of applications.  
All participants in the proposed study will receive high intensity locomotor training under the 
supervision of an experienced clinician. The benefits of exercise in the iSCI population can 
improve physical and emotional well-being [100]. In addition, there is strong evidence that 
locomotor training can improve walking speed, and endurance [3, 60, 101]. This intervention will 
also target the enhancement of dynamic balance during walking. As such, individuals enrolled in 
the proposed study may improve aspects of their health and functional walking ability. However, 
as this is an experimental study, it possible that participants may not improve their own walking 
ability by participating. The risks of participating are similar to that involved when participating in 
any physical therapy intervention aimed at improving gait. 
 
Importance of the Knowledge to be gained 
For people with SCI, balance deficits negatively impact elements of walking critical for 
participation in mobility-related activities. We hypothesize that for individuals with iSCI locomotor 
training performed in a movement amplification environment will substantially improve dynamic 
balance and participation in walking activates. Currently, many clinically-accepted gait 
rehabilitation practices including body weight supported treadmill training are likely sub-optimal 
for teaching locomotor balance because they lack effective balance-specific training components. 
Presently, there is an absence of evidence-based clinical tools to address this shortcoming. 
Outcomes from this project will enhance our understanding of how individuals with iSCI learn 
dynamic balance. This study will investigate a motor learning paradigm – amplification of an 
individual’s own movements – that has shown promise for teaching control of upper extremity 
movements of individuals with neurologic injury [64, 65]. This project will extend this paradigm to 
train dynamic balance during walking. If successful outcomes from this study will provide a 
foundation for development of new technologies that can be used to apply movement 
amplification type environments to current gait rehabilitation practices used within the VA clinical 
setting. 

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In addition, our general understanding of how locomotor training interventions impact 
participation in walking-related activities of individuals with iSCI is poor [96]. This study will provide 
quantitative measures on how locomotor training, and locomotor training that includes a targeted 
dynamic balance component influence participation in walking activities. Frequently reported 
clinical outcome measures, such as 10-meter walk speed or 6-minute walk distance are valuable 
for understanding an individual’s function, but these measures taken in a laboratory or clinic 
setting are not sufficient to gage participation. As technology to assess participation using simple 
wearable devices has advanced, it is important that researchers include measures of participation 
when evaluating locomotor training interventions. Research suggests that dynamic balance is a 
primary determinate of walking activity in individuals with iSCI. Currently it is unknown if 
engagement in training interventions targeting balance will be effective for improving participation 
in walking activities. Outcomes from this study will fill this void in our knowledge and provide data 
that will be essential for developing normative standards for changes in walking participation 
following locomotor training interventions. 
 
 Provide description of the study population (delineate all 
categories of subjects – patients, providers, family members, 
employees, etc.). Include anticipated enrollment numbers 
 
We aim to enroll 46 Veterans and non-Veterans with chronic motor incomplete SCI who 
are ambulatory. We will include participants with a range of initial functional walking abilities 
evaluated by walking speed (half the participants’ walking speed will be < 0.5 m/s at the start of 
the study). All potential study participants will be screened to ensure they meet the study 
inclusion/exclusion criteria. 
 
Participation in this study is open to all individuals who meet the inclusion exclusion criteria 
for participation. Participation will be open to people of all racial and ethical backgrounds, gender, 
and sexual orientation. Minorities and female participants will be actively recruited and their 
representation in the study is anticipated to match population demographics. Specifically, we 
anticipate that the ethnic and racial diversity of our participants will match the composition of the 
greater Chicago metropolitan area. In 2010 the United States Census Bureau reported the 
population of Chicago had the following ethnic and racial composition: 
 
Hispanic or Latino (of any race) 29% 
 
Not Hispanic or Latino 71% 
 
American Indian and Alaska Native 0.5% 
 
Asian 5% 
 
Native Hawaiian and Other Pacific Islander 0.0% 
 
Black or African American 33% 
 
White 45% 
 
By gender, 80% of individuals with SCI are male. As such we anticipate that the male to 
female ratio of participants in this study will be 80% male and 20% female. This study will not 
include individuals under 18 years of age or vulnerable populations. Women of childbearing 
potential will not be excluded, although women who are pregnant will be excluded because of 
pregnancy-related body changes on balance. 

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 Include rationale for including or excluding certain 
populations – in particular vulnerable populations. 
Participation in this study is open to all individuals who meet the inclusion exclusion 
criteria for participation. 
 
 As applicable, provide information on any added protections 
for vulnerable populations.  
This study will not recruit or enroll vulnerable populations. 
 
5.2 Recruitment Methods 
 State how many subjects will be needed.  
We will enroll 46 participants with iSCI in the study. 
 
 Describe when, where, how and by whom potential subjects 
will be identified and recruited.  
We will enroll 46 participants with iSCI in the study. Veterans will be recruited from the Spinal 
Cord Injury Service at Edward Hines Jr. VA Hospital. During the last three years the Hines Spinal 
Cord Injury Service treated 553 unique patients with SCI. We will work with a highly experienced 
clinical coordinator at the Edward Hines Jr. VA Hospital to recruit participants from this facility. 
Ms. Jelinek has established a strong professional relationship with the clinical staff from the Spinal 
Cord Injury Service to identify, contact, and screen potential study participants. Ms. Jelinek has 
been involved with multiple SCI related studies in the past, including studies run by the PI of the 
proposed study. Her familiarity working with the target study population and their clinical providers 
will be an asset to the proposal. We anticipate that the pool of eligible participants available 
through the Edward Hines Jr. VA Hospital may not be sufficient to meet our full enrollment 
objective.  
As needed, additional Veteran and non-Veteran participants will be recruited through the 
Shirley Ryan AbilityLab. The Shirley Ryan AbilityLab maintains the Clinical Neuroscience 
Research Registry a database of interested, potential study volunteers with SCI. The Registry is 
populated through referrals from associated inpatient and outpatient physical therapy clinics of 
the Shirley Ryan AbilityLab and through postings at clinics, support groups, and SCI 
organizations. The volunteer database currently has 475 volunteers with up-to-date-contact 
information. Of these volunteers greater than 215 individuals identify that they are able to walk in 
therapy, home or the community. Individuals registered in the database have consented to 
allowing researchers to contact them directly to discuss opportunities to participate in ongoing 
research projects. Dr. Kahn, a co-Investigator on this proposal, jointly oversees the maintenance 
and population of the volunteer database. She will ensure that the study team receives access to 
the database. In addition, the Shirley Ryan AbilityLab treats ~140 SCI inpatients and 225 SCI 

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outpatients a year. Collectively, the potential pool of study participants available between the 
Edward Hines Jr. VA Hospital and the Shirley Ryan AbilityLab will be more than adequate to meet 
the requirements for the proposed trial. 
 
 Describe materials that will be used to recruit subjects, e.g., 
advertisements.  Include materials as an appendix or separate 
attachment. 
 
We will employ a multi-faceted approach to recruiting and enrolling 46 individuals with iSCI 
needed for this study. 
 
First we will recruit veterans with spinal cord injury from the Spinal Cord Injury Service at 
Edward Hines Jr. VA Hospital. We will recruit individuals using the following means. 
 
Ms. Jelinek will contact clinical staff from the Spinal Cord Injury service. These 
individuals will be provided with a recruitment flyer attached. Clinical staff will be 
asked to post and/or provide the recruitment flyer to potential participants. The fly 
directs potential participants to contact the study PI and research staff by phone or 
mail. 
 
Recruitment flyers will be posted in the Spinal Cord Injury Service at the Edward 
Hines Jr. VA Hospital. Interested individuals will be directed to contact the study PI 
and research staff by phone or mail. 
 
 
Second, additional veteran and non-veteran subjects with incomplete spinal cord injury 
will be recruited through the Clinical Neuroscience Research Registry, a database of interested, 
potential study volunteers with SCI, which is maintained by the Shirley Ryan AbilityLab  
 
Individuals registered in the database have consented to allowing researchers to 
contact them directly to discuss opportunities to participate in ongoing research 
projects. Dr. Kahn and approved study personal will call qualified individuals from the 
database to discuss participation in the study. 
 
Recruitment flyers will be posted in the lobby of the Shirley Ryan AbilityLab and on 
SCI outpatient floors. Interested individuals will be directed to contact the study PI 
and research staff by phone or mail. 
 
Third, the PI will reach out to the Paralyzed Veterans of America local chapter and the Illinois 
Spinal Cord Injury Association. The PI will request to present the study in person at upcoming 
meetings and will ask if the study flyer can be distributed to members either through the 
organization’s print or web-based newsletter. Interested individuals will be directed to contact the 
study PI and research staff by phone or mail.  
Fourth, study information will be posted on http://www.clinicaltrials.gov/. Interested individuals 
will be directed to contact the study PI and research staff by phone or mail. 
Finally, a recruitment will be posted on the PI’s laboratory website. Interested individuals will 
be directed to contact the study PI and research staff by phone or mail. 

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 Describe any payments to subjects, including the amount, 
timing (at the end of the study or pro-rated for partial study 
participation), method (e.g., cash, check, gift card), and 
whether subjects will experience a delay in receiving the 
payment. 
All participants will receive a stipend of $25 for visits including laboratory assessments and 
clinical outcome measures or $20 for visits that include participation in the locomotor training 
intervention. Participants will also receive vouchers for parking. 
 
5.3 Informed Consent Procedures 
 
 Indicate if informed consent will be obtained and/or if you are 
requesting a waiver of informed consent or waiver of 
documentation of informed consent.  If the research involves 
multiple phases, specify for which phases of the research the 
waiver(s) is being requested and/or the informed consent will 
be sought. 
 
Approved study team members will obtain informed written consent from all 
participants in the study. 
 Describe who will be obtaining informed consent, if applicable, 
and any circumstances that may need to be addressed (e.g. 
subjects with impaired decision making ability and the use of a 
legally authorized representative, etc.) 
Approved study team members will obtain informed written consent from all participants in the 
study. All participants will receive a copy of the informed consent form. Potentially eligible 
participants will have the study described to them verbally, either in person or over the phone 
before they are scheduled for any study-related testing sessions. Upon arrival at the first in-person 
study-related testing session, potential subjects will be provided with a detailed oral explanation 
of the study by an approved study-personnel. The oral explanation will use statements from the 
consent form and be performed in the laboratory or in another private room with only the 
participant and investigators present. Participants will be asked; 
 
“Do you understand what is being asked of you in this study?”  
 
“Do you have any questions regarding this procedure or study?” 
 
Participants will be given the opportunity to ask questions during the consent process. 
Participants will have the option to have a family member present during the consent process. 
Individuals who are; not yet adults, cognitively impaired adults, and adults unable to provide 
informed consent, will not be recruited for this study.  

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 If applicable, indicate how local site study personnel will be 
trained regarding human subjects protections requirements 
and how to obtain and document informed consent. 
 
All study personnel will complete CITI training and the Hines VA required TMS 
training regarding human subjects protections. Prior to administering informed consent 
all new study personnel will first observe a senior study personnel obtaining informed 
consent. New personnel will also meet with senior study personnel to review the 
informed consent process and associated administrative procedures.  
 
5.4 Inclusion/Exclusion Criteria 
 
 Describe the criteria that determine who will be included in or 
excluded from the study.  
Inclusion/Exclusion Criteria 
 
Inclusion criteria: a) age 18 to 80 years; b) medically stable with medical clearance from 
physician to participate; c) neurologic level of the spinal cord injury between C1-T10 with 
American Spinal Injury Association (ASIA) Impairment Scale (AIS) C or D; d) more than 6 
months since initial injury; e) passive range of motion of the legs within functional limits and not 
restricting the ability to engage in locomotor training; f) able to ambulatory 10 m with no physical 
assistance, use of assistive devices, such as a single cane or rolling walker, and use of braces 
that do not cross the knee joint, such as an ankle-foot orthosis, are permitted.  
 
Exclusion criteria: a) excessive spasticity in the lower limbs as measured by a score of > 3 on 
the Modified Ashworth Scale on all test muscle groups; b) inability to tolerate 30 minutes of 
standing; c) severe cardiovascular and pulmonary disease; d) history of recurrent fractures or 
known orthopedic problems in the lower extremities (i.e. heterotopic ossification); e) 
concomitant central or peripheral neurological injury (i.e. traumatic head injury or peripheral 
nerve damage in lower limbs); f) inability to provide informed consent due to cognitive 
impairments; g) presence of unhealed decubiti or other skin compromise; h) enrollment in 
concurrent physical therapy or research involving locomotor training; i) use of braces/orthotics 
crossing the knee joint; j) known pregnancy. 
 
5.5 Study Evaluations 
 
 Describe all evaluations to be conducted (including screening; 
tests/questionnaires that will be administered; any procedures 
that subjects will be required to complete) and data collection 
methods.  Include materials as an appendix or separate 
attachment. 

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The following data will be recorded directly from participants.  
 
Demographic and Medical History 
After providing written informed consent, all potential participants will undergo a screening for 
inclusion and exclusion criteria. We will then collect demographic information and a brief medical 
history from participants who meet all inclusion and exclusion criteria. The information collected 
will include; age, gender, date of SCI, level of injury, cause of injury, current medications, current 
ambulatory ability in the home and community, use of any assistive devices, and self-reported 
falls in the past year. 
Clinical Outcome Measures 
Clinical Outcome measures will be performed by a clinician at four time points during the 
intervention. We will collect data using measures that span each level of the International 
Classification of Function, Disability, and Health (ICF) (body structure and function, activity, and 
participation), utilizing a combination of performance based and self-report measures. The 
measures we will use include: the Lower Extremity Motor Score (LEMS) portion of the 
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), manual 
muscle tests of hip abductor strength, the Walking Index for Spinal Cord Injury (WISCI II), the 
Functional Gait Assessment (FGA), the 10 meter walk test (10MWT), the Activities-Specific 
Balance Confidence scale (ABC), the reactive balance test items from the Balance Evaluations 
Systems Test (BESTest), the Berg Balance Scale (BBS), the World Health Organization Quality 
of Life scale (WHOQOL-BREF) and the International Consultation on Incontinence 
Questionnaire-Urinary Incontinence Short Form (ICIQ- UI SF). 
Laboratory Assessments 
Laboratory Assessments of dynamic balance during walking will be made at four time points 
during the intervention. Specifically, we will collect kinematic data as participants perform treadmill 
walking. To assess COM and stepping kinematics we will record 3D coordinates of 40 reflective 
markers placed on the trunk, pelvis and lower limbs using a 12-camera motion capture system 
(Qualisys, Gothenburg Sweden). 
Stepping Activity in the Home and Community 
 
We will assess the amount of daily stepping in the home and community during three one-
week periods. Daily stepping will be measured and recorded using a StepWatch4 (Modus, 
Edmonds, WA) activity monitor. The device has a battery life of 35 days and will record individual 
stepping data on the resolution of seconds. During each assessment period, the microprocessor-
based accelerometer will be worn around the ankle during all waking hours (except bathing). Our 
primary measure of daily stepping will be the total number of steps taken per day averaged across 
each assessment period. Secondary measures used to quantify changes in activity level include; 
the number of minutes of the day with at least one step, and percent of a 24-hour day with no 
walking. 
Performance during Individual Locomotor Training Sessions 

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We will collect data from participants to document the details of every locomotor training 
session. The data we will collect include; vital signs before, during and after training, exertion and 
workload - monitored via heart rate and the 6-20 point RPE scale monitored throughout the 
training session, and number of steps taken during the training session. 
 
Participant perception of training effects  
We will assess the perceived changes of participants following high intensity locomotor 
training in both training and control group to understand the effects of our training intervention. 
This semi-structured interview will have open ended questions and predetermined prompts used 
to determine the subjective impact of our training intervention on participants perceived balance 
confidence, walking capacity, everyday life and other changes that were noted as following 
participation in this intervention. This interview will be performed 3 months after training is 
completed. During the interview, questions will be asked by a researcher not involved in training 
interventions. The interview will take about 15 to 30 minutes. Interview performed will be audio 
recorded and transcribed by our researchers. 
5.6 Data Analysis 
 
 Provide sample size determination and analysis (include 
anticipated rate of screen failures, study discontinuations, lost 
to follow-up etc.). 
 
Our primary measure to assess dynamic balance during walking is the Lane Width 
Optimization Test. The test challenges participants to maintain their medio-lateral COM position 
within a target lane during treadmill walking. If successful, the difficulty of the task becomes 
progressively more difficult by continuingly narrowing the width of the target lane until the 
participant is unable to maintain the target position. The lateral COM excursion per stride during 
the narrowest lane width achieved provides a quantitative measure of dynamic balance 
during gait. A reduction in the minimum lateral COM excursion following training would indicate 
improved dynamic balance during gait.  
 
We performed a power analysis to determine the minimum sample size required to detect 
significant changes in dynamic balance using the lane width optimization test. To estimate the 
population variability, we used data from 13 individuals with iSCI, having similar characteristics to 
the target population, performing unassisted treadmill walking [102]. We found that typical lateral 
COM excursion per stride during preferred speed treadmill walking was 0.083 ± 0.014 m (mean 
± standard deviation). To estimate effect size, we used pre- and post-intervention data from three 
individuals with iSCI who received 16-18 high intensity locomotor training sessions performed in 
the movement amplification environment. Following the intervention, these individuals improved 
dynamic balance (decreased their lateral COM motion excursion during walking) by 32-36%. To 
detect a 20% difference in improvements in dynamic balance between training groups we will 
need a sample size of 7 individuals per group at α = 0.05 and a power of 80%. We plan to enroll 
46 individuals. A recent locomotor training intervention using individuals with iSCI, conducted by 
one of our study team members at a nearby facility, lost 12% of their participants to drop out [60]. 
With a conservative estimate that we will lose 20% of participants to drop out, an initial enrollment 
of 46 individuals would yield 14 high functioning and 14 low functioning participants (stratified 
based on the gait speed). This number, double that estimated by the power analysis, should be 
sufficient to assess training effects on dynamic balance. 
We plan to enroll 46 participants with iSCI in the trial. Veterans will be recruited from the Spinal 
Cord Injury Service at Edward Hines Jr. VA Hospital. During the last three years, the Hines Spinal 

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Cord Injury Service saw 553 unique patients with SCI. Our research team includes a highly 
experienced clinical coordinator located at the Edward Hines Jr. VA Hospital. Ms. Jelinek will work 
with clinicians in the Spinal Cord Injury Service to identify, contact, and screen potential study 
participants. As needed, additional Veteran and non-Veteran participants will be recruited through 
the Shirley Ryan AbilityLab. The Shirley Ryan AbilityLab maintains the Clinical Neuroscience 
Research Registry a database of interested, potential study volunteers with SCI. Of these 
volunteers greater than 215 individuals identify that they are able to walk in therapy, home or the 
community. Dr. Kahn, a co-Investigator on this proposal, jointly oversees the volunteer database 
and will ensure access. Collectively, the potential pool of participants available between the 
Edward Hines Jr. VA Hospital and the Shirley Ryan AbilityLab will be more than adequate to meet 
the requirements for the proposed trial. 
 
 Describe how, where and by whom the data will be analyzed. 
 
The PI, research physical therapist, research engineers, and biostatistician will work 
collaboratively to analyze the data. The data will be analyzed at Northwestern University. 
 
Specific Aim 1: To test if our primary measure, changes in dynamic balance during 
walking, is different between the two groups following the two interventions, we will compare 
changes in participants’ COM lateral excursion during the lane width optimization test across the 
four assessment periods (BSL, Mid, Post, Follow Up) and between intervention groups (Control 
and Experimental). To account for the correlation that arises from measuring multiple data points 
within each participant over time (i.e. data measured from the mid- assessment period from a 
specific participant will bear more resemblance to data measured from the BSL- assessment 
period from the same participant than a different participant) we propose to model the primary 
outcome using a linear mixed effects model. We will use an indicator variable for the group 
assignment, i.e. 1=Experimental, 0=Control, to test for the effect of intervention while controlling 
for potential confounders such as initial walking speed, severity and location of the SCI, spasticity, 
and age. The strength of the linear mixed effects models is that it can accommodate multiple data 
points from a single participant and can also handle missing data when data is missing at random. 
We will apply a similar strategy for fitting a secondary analysis to examine changes in preferred 
walking characteristics (average and variability of step width, step length, and minimum lateral 
MOS) and outcome measures (10 MWT, FGA, ABC etc.) across the four assessment periods and 
between intervention groups. We will transform the variables, such as log-transformation, as 
needed to meet the model assumption of normality. 
 
Specific Aim 2: To test if our primary measure, changes in steps per day, are different 
following the two interventions, we will compare changes in participants’ average steps per day 
across the three assessment periods (BSL, Post, Follow Up) and between intervention groups 
(Control and Experimental). Similar to the methods proposed above, we will model the primary 
outcome using a linear mixed effects model. We will use an indicator variable for the group 
assignment, i.e. 1=intervention, 0=control, to test for the effect of intervention while again 
controlling for potential confounders such as initial walking speed, severity and location of spinal 
cord injury, spasticity, and age. 

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5.7 Withdrawal of Subjects 
 
 Describe any anticipated circumstances under which subjects 
will be withdrawn from the research without their consent.  
It is unlikely that participants will be withdrawn from the study without their consent. 
However, there are circumstances that we would withdraw a participant. 
 
We will withdraw a participant from the study if we identify that their participation 
is putting their health at risk.  
 
We will withdraw a participant from the study if they miss scheduled study 
appointment visits without a valid excuse or fail to notifying study team members of their 
absence. We will provide participants with a warning prior to withdrawal. 
 
We will withdraw a participant from the study if we learn that they were dishonest 
when answering our screening (inclusion/exclusion) questionnaire. 
 
We will withdraw a participant from the study if they arrive for study procedures 
while under the influence of illegal drugs or alcohol. 
 
 Describe the consequences of a subject's decision to 
withdraw from the research and the procedures for orderly 
termination of participation by the subject (e.g., the subject 
contacting the investigator for an end-of-study visit). 
Participation in this study is voluntary. All participants have the option to choose not to 
participate in the study or to withdraw from the study at any time without penalty, 
consequences or loss of VA or other benefits. 
 
 Describe procedures if a subject is withdrawn or withdraws 
from the intervention portion of the study but agrees to 
continue in the follow-up phases or for safety outcome 
purposes. 
We will not perform follow-up testing with any participant that withdraws or is withdrawn 
from the study. 
6.0 
Reporting 
 
 Include procedures for reporting unanticipated problems, serious 
adverse events, and protocol deviations. 
 

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Any unanticipated deaths will be reported to both the Hines IRB and the Northwestern 
University IRB within 24 hours of becoming aware of them. Any serious adverse events will be 
reported to the Hines IRB and Northwestern IRB within 48 hours of becoming aware of the event. 
All unanticipated adverse events or unanticipated problems involving risks to research 
participants or study personal will be reported to the Hines IRB and Northwestern University IRB 
within 48 hours. Any adverse event directly or indirectly related to the study, such as loss of 
confidentiality or emotional trauma, will also be reported to the Hines IRB and the Northwestern 
University IRB. Privacy and Data security breaches will be reported to the Hines ISO and 
Northwestern University ISO immediately. 
 
 Include information about whether the study has a Data Monitoring 
Committee and if so, how often it will meet. 
 
Dr. Gordon and Dr. Kahn will jointly be responsible for carrying out the Data Safety Monitoring 
Plan. The decision to have Drs. Gordon and Kahn monitor safety of the trial was based on the 
simplicity and limited size of the proposed project. Specifically, the following factors were 
considered - the proposed study is low risk, Drs. Gordon and Kahn are not blinded to the study 
interventions, the study involves less than 40 total participants, and experimental testing and 
training sessions will be conducted at a single location.   
7.0 
Privacy and Confidentiality 
 
 Describe whether the study will use or disclose subjects’ Protected 
Health Information (PHI).  
 
The study will collect PHI from study participants.  
 
 Describe the steps that will be taken to secure the data (e.g., training, 
authorization of access, password protection, encryption, physical 
controls, Certificates of Confidentiality, and separation of identifiers 
and data) 
 
All participants will be given a secret identification code. All experimental data collected from 
participants will be identified only with this identification code. Data that link the participant to the 
identification code will kept in a locked file cabinet.  
All hard data recorded from this study will be stored in a locked file cabinet. All electronic data 
from this study will be coded. A complete copy of all original data will be stored in secure folders on both 
the Hines VA and Northwestern University servers. Only approved study-team members will be given 
access to data stored on the servers.  

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Participants’ responses to questionnaires, and medical history questions and clinical testing 
will be recorded by hand by authorized study personnel. These forms will be identified strictly by 
the participant’s secret identification code. This data will be entered into Microsoft Excel 
Spreadsheets run on an encrypted VA computer by authorized study personnel. This data too will 
only be identified using the participant’s identification code. When not in use by authorized study 
personnel, all hardcopies of these forms will be locked in a secure file cabinet in the PI’s office 
located at:  
 
 
645 N Michigan Ave, Suite 1119, Chicago IL 60610. 
The file cabinet will be accessible by the PI and approved study personnel. If authorized 
personnel leave the research team, their access to data will be terminated. 
Electronic data collected from motion analysis cameras, load cells, step monitors, heart rate 
monitors, and other analogue devices will be de-identified. This data will be labeled with the 
participant’s secret identification code. The data will be stored on hard drives and processed in 
Visual 3-D, MATLAB, and LabVIEW on secure encrypted computers located at:   
 
 
645 N Michigan Ave, Suite 1147, Chicago IL 60610.  
Audio recordings from the interview to understand participants’ perception will also be de-
identified and stored on secured computers at the above location. The electronic data will be 
accessible only by the PI and approved study personnel. 
Data will be stored for 6 years after completion of the study. Only the PI and sub-investigators 
will have access to the data during this time. The study team members who collect hard copy data 
during the experiment will be responsible for receipt and transmission of the data from the 
laboratory to a locked filing cabinet. A digital copy of all original data collected for the project will 
be transferred to a secure Hines VA server. A VA-approved encrypted flash drive issued to an 
authorized member of the study team will be used to transfer data from the Northwestern server 
to a secure study folder on the Hines VA server. Only an authorized study team member 
 
will have access to the encrypted flash drive and study data. The authorized member of 
the study team will maintain possession of the flash drive at all times. Once the data are 
transferred, the data on the flash drive will be erased. 
If unauthorized use, disclosure, transmission, removal, theft, loss or destruction of VA 
research-related protected health information (PHI) should occur, in accordance with VA Policy, 
within one hour of becoming aware of the unauthorized use, disclosure, transmission, removal, 
theft, loss or destruction of VA research-related PHI, a member of the research team will report 
the incident to the ACOS for Research, the facility ISO, and the facility PO.   
 
 If data and biological specimens will be banked, specify. 
 
Data and biological specimens will not be banked. 
8.0 
Communication Plan (for multi-site studies) 

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This is not a multi-site study.   
9.0 
References 
 
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