Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA
Phase: NA
Conditions: Cerebrovascular Accident (CVA), Stroke, Hemiplegia
Sponsor: Parker Hannifin Corporation

PHIND_CVA01 
 
Parker Hannifin Corporation 
 
 
Protocol Date: Oct 25, 2016 
 
                                                                                                       Revision: NA 
 Confidential 
 
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Study Title: 
Evaluating the Indego Exoskeleton for Persons with Hemiplegia Due to CVA 
Study Number: 
PHIND_CVA01 
Product Name: 
Indego® 
Study Phase: 
510 K 
Indication: 
Current FDA approval for persons with Spinal Cord Injury (T4 and lower). 
This study to provide safety results to the FDA for potential approval for persons 
with hemiplegia due to CVA (Cerebral Vascular Accident) 
Investigators: 
Multi-center:  Shepherd Center (GA), Cedar Sinai Medical Center (CA), Rusk 
Rehabilitation (NY), Sheltering Arms (VA), St Charles Hospital (NY), Craig 
Hospital (CO), Kessler Foundation (NJ), Rehabilitation Institute of Chicago 
(Shirley Ryan AbilityLab, IL) and TIRR Memorial Hermann (TX) 
Sponsor and 
Monitor 
Parker Hannifin Corporation 
Human Motion and Control 
1390 E. Highland Rd 
Macedonia OH 44056-2310 
 
Sponsor Contact: 
Achilleas Dorotheou 
Parker Hannifin 
VP Business Development 
Head, Human Motion & Control 
Office  (216) 896 2044 
Email: adorotheou@parker.com 
Shepherd Center 
Principal 
Investigator 
Donald Peck Leslie, MD 
Medical Director, Shepherd Center 
2020 Peachtree RD, NW 
Atlanta, GA 30309 
Email: donald_leslie@shepherd.org 
Parker Hannifin 
Principal 
Investigator 
Ryan Farris, PhD 
Engineering Manager, Human Motion and Control 
Office (216) 896-3335 
Email: ryan.farris@parker.com 
 
Original Protocol: 
25 October 2016 
Revisions: 
NA 
 
 
Confidentiality Statement 
The concepts and information contained herein are considered proprietary and will not be disclosed in whole 
or in part without the expressed written consent of Parker Hannifin Corporation. 
 
 

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Protocol Date: Oct 25, 2016 
 
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PHIND_CVA01 
 
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Protocol Date: Oct 25, 2016 
 
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INDEGO  (Figure 1. Page 8) 
The Indego exoskeleton was approved for use by the FDA in February of 2016 with individuals with spinal cord 
injury (SCI) at levels T4 and below for rehabilitation use, and for T7 and below for personal use in the home and 
community. Shepherd Center was instrumental in leading the multi-site clinical trials that led to the Indego FDA 
approval for persons with SCI. 
 
Shepherd Center, in collaboration with Vanderbilt University and Parker Hannifin Corporation, has also led the 
clinical research efforts for use of Indego for persons with hemiparesis resulting from cerebrovascular accident 
(CVA) since 2012.   
 
A publication from our earliest work using Indego with persons with CVA  (Shepherd RRC project #510) can be 
found here:  S. A. Murray, K. H. Ha, C. Hartigan, and M. Goldfarb, "An assistive control approach for a lower-
limb exoskeleton to facilitate recovery of walking following stroke," Neural Systems and Rehabilitation 
Engineering, IEEE Transactions on, vol. 23, pp. 441-449, 2015. Shepherd Center Principal Investigator was 
Donald Peck Leslie, MD 
 
A second manuscript from an Indego trial for persons with CVA conducted in 2015 and 2016 as a collaborative 
effort between Shepherd Center, Vanderbilt University and Parker Hannifin Corporation (Shepherd RRC Project 
#660) has been submitted but not yet accepted for publication. A full copy of the manuscript is attached in this 
IRB submission: Spencer A. Murray, Student Member, IEEE, Clare Hartigan, Casey Kandilakis, Elizabeth Sasso, 
and Michael Goldfarb, Member, IEEE “A Preliminary Crossover Study of Exoskeleton Control Methodologies for 
Gait Rehabilitation Post-Stroke”. Shepherd Center Principal Investigator was Donald Peck Leslie, MD 
 
The Indego User Mauual is attached in this submission. In addition, videos and other Indego information can be 
found at www.Indego.com 
 
 
STUDY SYNOPSIS 
 
Primary Objective:  
 
• 
To demonstrate that the Indego® device is safe to use as a gait training intervention for persons with 
hemiplegia due to CVA.  
 
Results of this multi-site study to include 40 subjects will be submitted to the FDA as part of a 510K Parker 
Hannifin submission to seek FDA approval for Indego use with persons following stroke. 
 
 
Hypothesis:  
 
• 
Indego can be safely used as a gait training intervention for persons with hemiplegia due to CVA for 
persons with mild, moderate or severe stroke. 
• 
Indego can be safely used as a gait training intervention for persons with hemiplegia due to CVA for 
persons with acute (less than 2months), sub- acute (2-6 months) and chronic (greater than 6 months) 
onset. 
• 
Following six Indego sessions, persons with hemiplegia due to CVA may show improvements in mobility 
when comparing pre- training measurements to post-training measurements. 
 

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Protocol Date: Oct 25, 2016 
 
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Study Design:  
 
Forty subjects in total will be enrolled across nine clinical sites: Shepherd Center (GA), Cedar Sinai Medical 
Center (CA), Rusk Rehabilitation (NY), Sheltering Arms (VA), St Charles Hospital (NY), Craig Hospital (CO), 
Kessler Foundation (NJ), Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab, IL) and TIRR Memorial 
Hermann (TX). Subjects will be seen three times per week for two weeks. 
 
Up to five subjects are expected to be enrolled at Shepherd Center. 
 
 
Session Content 
Session Duration 
Session 1 
Consent  
Initial Evaluation and Fit 
2 hours 
Session 2 
Indego Training Sessions 
1 hour  
 
Session 3 
Session 4 
Session 5 
Session 6 
Indego Training Session 
Final  Evaluation 
2 hours 
 
 
Study duration for each individual enrolled is two weeks. If a session is missed, attempts must be made to 
reschedule within the same week. The maximum amount of time the protocol may be interrupted or extended (due 
to illness, weather, other) is two weeks. The number of study visits remains the same. 
 
Shepherd Center will be provided with an Indego® kit for the duration of the trial. This kit will include small 
(short), medium and large (tall) hardware components, all necessary padding options, and 2 hand held IPod touch 
operator controllers. Parker will provide “on call” engineering support.   
 
Enrollment for PHIND_CVA01 will be on a rolling basis so that each site can enroll any number of subjects until 
the total subject number across sites reaches forty. Should a subject not complete all study sessions, an additional 
subject will be added to replace the person who did not complete the study. Data for persons who did not 
complete all sessions for the study will be analyzed separately.  
 
Subjects may be enrolled from inpatient, day program, outpatient, post rehabilitation programs, or from home.  
Researchers will not attempt to have an equal representation among “programs” of when the subject was enrolled. 
However, the sponsor will attempt to have a mix of acute, sub acute and chronic conditions.  
 
In addition, enrollment will be monitored based on severity of motor involvement using the Fugl-Meyer Motor 
Assessment (FMA).  The maximum FMA score is 100 (Upper Extremity maximum score = 66 and Lower 
Extremity maximum score =34). The FMA will be scored by the physical therapist at the time of the Initial 
Evaluation.  
 
• 
Mild = FMA Total Motor Score greater than 79 
• 
Moderate = FMA Total Motor Score 56-79 
• 
Severe = FMA Total Motor Score 36-55 
• 
*Very Severe = FMA Total Motor Score 0-35. 
(Duncan, Goldstein, Horner, Landsman, Samsa and Matchar 1994) 
 
*Sponsor does not anticipate enrolling persons in the Very Severe FMA Category; subjects must be able to 
walk 14 meters or 46 feet with the assistance of one to two persons to qualify for study participation. 

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Study subjects will serve as their own control. This will be accomplished by gathering baseline historical data 
from the medical record.  In addition, multiple baseline assessments will be done during session one to establish 
each subject’s current strength, functional status and mobility at the time of enrollment. 
 
 
INCLUSION CRITERIA 
• 
18 years and older 
• 
Height 5’1” to 6’3” (acceptable height may vary depending on femur length) 
• 
Weight 250 lbs. or less 
• 
History of one sided ischemic or hemorrhagic stroke with resultant hemiparesis 
• 
Ability to walk 14 meters or 46 feet with the assist of 1-2 persons 
• 
Manual Muscle Test (MMT)  4/5 in at least one Upper Extremity (UE) 
• 
No restrictions on time since stroke (acuity), but all subjects need to be cleared by MD for locomotor 
training 
• 
No other known brain abnormalities or neurological diseases /disorders 
• 
Has never been treated for a stroke in the past 
• 
Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for 
safe gait. 
• 
Skin intact where interfaces with the Indego device 
• 
Modified Ashworth Scale for spasticity 3 or less in the lower extremities 
• 
Absence of complicating physical or mental conditions as determined by MD that would preclude the 
individual from safely participating in gait training  
• 
Must be able to follow directions and communicate basic needs, demonstrated by a MMSE (Mini Mental 
Status Exam) score of 18 or greater 
 
EXCLUSION CRITERIA 
• 
Failure to meet all inclusion criteria 
• 
Pregnancy 
• 
Colostomy bag  
• 
Uncontrolled / untreated hyper- or hypotension 
 
 
MEASURES 
• 
Function 
o Mini Mental Status Exam (MMSE) 
o Fugl – Meyer Assessment (to be assessed during PT evaluation only, for stratifying severity of 
stroke) 
o Spasticity: Modified Ashworth Scale (MAS) 
▪ 
Bilateral upper and lower extremities 
o Strength  
▪ Manual Muscle Test (MMT) of upper and lower extremities 
• 
Strength will be tested even if the subject presents with MAS 0-3. The potential 
influence or  limitation of the MAS score will be reflected in session notes  
 
• 
Activity (to be assessed WITHOUT Indego; Indego will be used during gait training only, not 
during mobility measures) 
o Functional Ambulation Category (FAC) 
o Fast Gait speed (as measured during the 10 Meter Walk Test with 14 Meter Track) 
 
 

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Protocol Date: Oct 25, 2016 
 
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SESSION DATA 
Within each of the six sessions, the following parameters will be also monitored and recorded:  
• 
Medications 
• 
Skin Integrity – Pre/Post each session 
• 
Vital signs – Pre/Post each session 
• 
Pain – FLACC scale (Face, Legs, Activity, Cry, Consolability scale with pictorial images) 
• 
Functional Ambulation Category (FAC)  
• 
Adverse Events 
o Subject 
o Device 
o Falls 
• 
Comments on Spasticity (Formal MAS only during sessions one and six) 
 
SESSION GUIDELINES 
• 
Therapists will make all attempts not to affect the subject’s functional performances on mobility 
measures, however patient safety is priority. Levels of assistance provided to the subject will be recorded. 
• 
Indego sessions should be scheduled to avoid fatigue and to work in collaboration with other inpatient or 
outpatient therapies. 
• 
One study session allowed per day  
• 
Concurrent therapies are allowed, but therapists should take into account adequate rest for the subject in 
the event they have other appointments the same day. 
• 
A fall is defined as “An unintentional change in position coming to rest on the ground, floor, or onto the 
next lower surface (e.g. onto a bed, chair or bedside mat). The fall may be witnessed, reported by another 
person, or identified when the user is found on the ground. Falls include any fall whether it occurred at 
home or out in the community. Falls are not a result of an overwhelming external force (e.g., the user is 
pushed by another person). An intercepted fall occurs when the user would have fallen if he or she had 
not caught him or herself, or had not been intercepted by another person—this is still considered a fall “ 
Definition provided by FDA to Parker Hannifin on July 20, 2016  based on Centers for Medicare and 
Medicaid Service guidelines. 
 
EXPECTED TIMELINE TO COMPLETE 40 SUBJECTS ACROSS SIX SITES: 
• 
40 subjects for 2 week intervention = 80 weeks/6 sites = 13 weeks per site (3.25 months)  
• 
Depending on site enrollment, total study duration should last roughly 8 months. 
 
 
EFICACY ENDPOINTS   
Primary Endpoint:  
• 
To show that the Indego® device is safe and potentially effective at providing gait training intervention for 
persons with hemiplegia due to CVA. 
 
Supportive and Exploratory:  
• 
Assess vital sign and skin 
• 
Assess pain 
• 
Assess impact of Indego training related to mobility measures.  
• 
Assess changes in spasticity  
 
 
SAFETY MEASURES 
• 
Subjects must meet all inclusion criteria and posses none of the exclusion criteria 
• 
Subjects must have medical clearance to participate prior to consenting process. 
• 
Vital signs will be taken before and after each session 

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• 
Skin checks will take place before and after each session 
• 
An Indego® certified PT will be present for all sessions. 
• 
Sponsor will provide “on call” engineering support for the duration of the study. 
• 
The six clinical sites chosen for the study are all experts in the field of neurological rehabilitation. 
• 
All Subject Adverse Events and Serious Adverse Events will be documented, reported and followed to 
resolution. 
• 
All device related adverse events to include device malfunctions pertaining to the device hardware, 
software or hand held controller interface will be documented, reported and followed to resolution. 
 
 
STATISTICAL MEASURES 
Forty subjects must complete all sessions for the study to be concluded. If any subject is unable to complete all 
sessions, their data will be analyzed separately and reported as a sub set to the main report. 
 
A total sample size of 40 participants and over 200 Indego training sessions for this study will yield reasonable 
statistical power in determining the safety of the device and potential differences between pre- and post-test 
values, one-sample means tests, and Pearson correlation coefficients.  When conducting matched pairs t-tests for 
pre- and post-test differences, 40 participants will yield a power of 0.87, with an alpha level of 0.05 and an effect 
size of 0.50, an effect size value that falls within the medium range according to Cohen (1998).   
 
Cohen, Jacob. Statistical Power Analysis for the Behavioral Sciences.  Hillsdale (NJ): Lawrence Erlbaum 
Associates, Inc.; 1998.    
 
Descriptive analyses will also be reported for medical history, severity and onset of CVA, subject evaluation 
measures, gait characteristics and subject/device adverse events. 
 
 
RATIONALE 
The following is paraphrased from S.A. Murray’s dissertation “Development and assessment of a control 
approach for a lower-limb exoskeleton for use in gait rehabilitation post stroke.” Vanderbilt University, 2016:1 
 
CVA is one of the leading causes of chronic disability in the United Stated.  There are an estimated 6.6 million 
people having survived a cerebrovascular accident (CVA) and an estimated 610,000 first-incident CVAs 
occurring each year in the United States[1]. Restoration of gait functionality is often a high priority during 
rehabilitation in patients with lower-limb hemiparesis [2, 3].  This has thereby caused many  to develop 
robotically-assisted gait-training devices in recent years. 
  
While results vary in the highly-heterogeneous population of stroke patients, a recent meta-analysis found that 
electromechanically-assisted rehabilitation devices may improve the likelihood that a patient will recover the 
ability to walk independently [4]. Many control approaches have been proposed and described for the control of 
these robotic devices [5-15]. These control strategies can be roughly categorized as either a “trajectory-based 
controlled” or “non-trajectory-based controlled” type. Trajectory-based controllers dictate the spatiotemporal 
nature of joint movement; non-trajectory based controllers do not. Examples of the latter include force tunnels 
around the desired trajectory [8, 12, 14], teach-and-replay impedance based control strategies to generate subject-
specific trajectories [16], and model-based strategies to target specific portions of the gait cycle [9, 17].   
 
The following is paraphrased from S.A. Murray et. al 2019, currently in preparation for publication1 
 
A trajectory control approach can offer functional advantages relative to a non-trajectory control approach, such 
as the ability to consistently reproduce healthy gait kinematics, provide full movement assistance, and provide 
                                                          
1 Note: These points of clarification added on April 17, 2019. 

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early therapy to subjects who may otherwise be non-ambulatory. Despite these potential advantages, researchers 
hypothesize that a trajectory-based control approach may allow patients to assume a passive role within the 
device, since the device is, in essence, providing full coordination and effort associated with movement.  It is 
well-known that increased patient participation results in improved outcomes [18, 19], and therefore recovery is 
more likely if the machine promotes active rather than passive patient participation.  
 
Thus, despite the advantages of a trajectory-based controller, researchers hypothesize that a non-trajectory-based 
control approach would place increased responsibility for coordination and movement on the patient, and would 
therefore require greater engagement, and thus presumably result in improved functional outcomes.  
 
Use of Indego for the proposed study is a non-trajectory based controller approach. Use of the Indego controller 
for persons with stroke has been safely utilized in the following studies, previously approved by Shepherd Center 
Research Review Committee: 
 
• 
Project #510:  i-Step Long-Leg Orthosis (3 subjects with CVA enrolled. Study  has been closed) 
• 
Project #660:  Engineering Assessment of the Indego® Software Controllers – Parker #ENG1 (8 subjects 
with CVA currently enrolled. Study remains active) 
 
In previous Shepherd RRC approved studies, gait parameters were controlled and manipulated by Vanderbilt or 
Parker Engineers thought a tethered cord from the Indego device to a laptop computer. For the proposed study, 
the gait parameters will be manipulated by the physical therapist through an IPod controller connected wirelessly 
to Indego using Bluetooth. 
 
To date there have been no serious adverse events of falls using the Indego with persons with. No sites other than 
Shepherd Center have completed research using the Therapy Mode controller that was designed for persons with 
stroke and other neurological disorders.  
 
The proposed study will allow a greater number of subjects and participating sites to evaluate the safety of the 
Therapy Mode Indego controller and assist in data collection for potential approval through the Parker 510 K 
submission by the FDA to use the Indego as a gait training tool for persons with hemiplegia due to stroke. 
 
 
 
 
  (Figure 1) Indego® ; total weight 26 pounds, 5 modular components, powered 
assist at the hip and knee joints, carbon fiber ankle foot orthoses is passive. 
 
 
 
 
 

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 (Figure 2) Subject training in the Indego with PT assist and tethered control cord. In 
the proposed study the tethered cord will not be present, rather an Ipod touch will be used to communicate 
the subject settings to the Indego device through wireless Bluetooth. 
 
 
 
Clinicians will have the option to modify 5 different groups of subject settings through the wireless Bluetooth 
Ipod touch controller: 
1. Joint Neutrals, 
2. Gravity Compensation 
3. Stance Support 
4. Swing Support 
5. Feedback.  
 
Each of these 5 main categories is adjustable for the right and/or left sides of the body.  
  
                                                
 
 
Joint Neutrals: Pressing the “Reset Neutrals” buttons will cause Indego to capture the current position of each 
joint and treat this stored angle as the joint’s neutral position (i.e. Indego will treat the stored position as though it 
were zero degrees of flexion or extension at each joint). This permits Indego to automatically calibrate itself to 
adjust for slight misalignment between the user and the Indego, or to adjust for users who walk with joint angles 
that differ from the anticipated. 
 
Gravity Compensation: Reduces the weight of the user’s leg (i.e. making the user’s limb seem lighter during 
gait). The percentage of the user’s limb weight to be accounted for may be varied independently for each leg by 
adjusting the position of the Left Leg Support and Right Leg Support sliders. The amount of compensation is 
represented on a scale of 0 to 100 percent in 10 percent increments. Changing the support level adjusts the support 
for both upper- and lower leg compensation. 
 
Stance Support: Stabilizes the stance limb by providing resistance to excessive knee flexion or hyperextension. 
 

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Protocol Date: Oct 25, 2016 
 
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Swing Support: Provides an additional push at the hip or knee joints when gravity compensation is insufficient to 
achieve the desired joint excursion during swing. Flexion assistance becomes active as soon as the Indego detects 
that the user is attempting to take a step, and remains active until either the duration of the flexion assistance 
passes, or the user begins to extend the knee. Extension assistance is provided once the knee begins to extend, and 
lasts until the knee achieves adequate extension or until heel strike is detected. 
 
Feedback: Provides audio feedback in order to signal to the user and clinician that the user achieved a desired 
step length. When heel strike is detected, Indego calculates the length of the step. If the step met or exceeded the 
goal step length the iPod will produce an audible chime. 
 
The Indego Dashboard provides objective information during and following each therapy session, 
including: the current state, the number of steps taken, total session time, walking time, battery level, power 
limiting level, stride length, step symmetry, and gait speed during a session. 
 
 
 
 
 
REFERENCES 
[1] 
D. Mozaffarian, E. Benjamin, and A. Go, "Heart disease and stroke statistics-2015 update: a report from the American Heart 
Association," Circulation, 2014. 
[2] 
R. W. Bohannon, A. W. Andrews, and M. B. Smith, "Rehabilitation goals of patients with hemiplegia," International Journal of 
Rehabilitation Research, vol. 11, pp. 181-184, 1988. 
[3] 
J. Mehrholz, B. Elsner, C. Werner, J. Kugler, and M. Pohl, "Electromechanical‐assisted training for walking after stroke," The 
Cochrane Library, 2013. 
[4] 
J. Mehrholz and M. Pohl, "Electromechanical-assisted gait training after stroke: a systematic review comparing end-effector and 
exoskeleton devices," Journal of rehabilitation medicine, vol. 44, pp. 193-199, 2012. 
[5] 
H. Kawamoto, H. Kandone, T. Sakurai, R. Ariyasu, Y. Ueno, K. Eguchi, and Y. Sankai, "Development of an assist controller with 
robot suit HAL for hemiplegic patients using motion data on the unaffected side," in Engineering in Medicine and Biology Society 
(EMBC), 2014 36th Annual International Conference of the IEEE, 2014, pp. 3077-3080. 
[6] 
A. Mokhtarian, A. Fattah, and S. K. Agrawal, "A novel passive pelvic device for assistance during locomotion," in Robotics and 
Automation (ICRA), 2010 IEEE International Conference on, 2010, pp. 2241-2246. 
[7] 
A. Nilsson, K. S. Vreede, V. Häglund, H. Kawamoto, Y. Sankai, and J. Borg, "Gait training early after stroke with a new 
exoskeleton–the hybrid assistive limb: a study of safety and feasibility," Journal of neuroengineering and rehabilitation, vol. 11, 
p. 92, 2014. 
[8] 
H. Vallery, A. Duschau-Wicke, and R. Riener, "Generalized elasticities improve patient-cooperative control of rehabilitation 
robots," in Rehabilitation Robotics, 2009. ICORR 2009. IEEE International Conference on, 2009, pp. 535-541. 
[9] 
J. F. Veneman, R. Kruidhof, E. E. G. Hekman, R. Ekkelenkamp, E. H. F. Van Asseldonk, and H. van der Kooij, "Design and 
Evaluation of the LOPES Exoskeleton Robot for Interactive Gait Rehabilitation," Neural Systems and Rehabilitation Engineering, 
IEEE Transactions on, vol. 15, pp. 379-386, 2007. 
[10] 
D. Zanotto, P. Stegall, and S. K. Agrawal, "ALEX III: A novel robotic platform with 12 DOFs for human gait training," in Robotics 
and Automation (ICRA), 2013 IEEE International Conference on, 2013, pp. 3914-3919. 

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Page 11 of 11 
[11] 
D. Zanotto, P. Stegall, and S. K. Agrawal, "Adaptive assist-as-needed controller to improve gait symmetry in robot-assisted gait 
training," in Robotics and Automation (ICRA), 2014 IEEE International Conference on, 2014, pp. 724-729. 
[12] 
S. K. Banala, K. Seok Hun, S. K. Agrawal, and J. P. Scholz, "Robot Assisted Gait Training With Active Leg Exoskeleton (ALEX)," 
Neural Systems and Rehabilitation Engineering, IEEE Transactions on, vol. 17, pp. 2-8, 2009. 
[13] 
R. Riener, L. Lünenburger, I. Maier, G. Colombo, and V. Dietz, "Locomotor training in subjects with sensori-motor deficits: an 
overview of the robotic gait orthosis lokomat," Journal of Healthcare Engineering, vol. 1, pp. 197-216, 2010. 
[14] 
M. Bortole, A. Venkatakrishnan, F. Zhu, J. C. Moreno, G. E. Francisco, J. L. Pons, and J. L. Contreras-Vidal, "The H2 robotic 
exoskeleton for gait rehabilitation after stroke: early findings from a clinical study," Journal of neuroengineering and 
rehabilitation, vol. 12, p. 1, 2015. 
[15] 
L. Marchal-Crespo and D. J. Reinkensmeyer, "Review of control strategies for robotic movement training after neurologic injury," 
Journal of NeuroEngineering and Rehabilitation, vol. 6, 2009. 
[16] 
J. L. Emken, S. J. Harkema, J. A. Beres-Jones, C. K. Ferreira, and D. J. Reinkensmeyer, "Feasibility of Manual Teach-and-Replay 
and Continuous Impedance Shaping for Robotic Locomotor Training Following Spinal Cord Injury," Biomedical Engineering, 
IEEE Transactions on, vol. 55, pp. 322-334, 2008. 
[17] 
R. Ekkelenkamp, J. Veneman, and H. van der Kooij, "LOPES: selective control of gait functions during the gait rehabilitation of 
CVA patients," in Rehabilitation Robotics, 2005. ICORR 2005. 9th International Conference on, 2005, pp. 361-364. 
[18] 
E. J. Lenze, M. C. Munin, T. Quear, M. A. Dew, J. C. Rogers, A. E. Begley, and C. F. Reynolds, "Significance of poor patient 
participation in physical and occupational therapy for functional outcome and length of stay," Archives of physical medicine and 
rehabilitation, vol. 85, pp. 1599-1601, 2004. 
[19] 
E. J. Lenze, M. C. Munin, T. Quear, M. A. Dew, J. C. Rogers, A. E. Begley, and C. F. Reynolds III, "The Pittsburgh Rehabilitation 
Participation Scale: reliability and validity of a clinician-rated measure of participation in acute rehabilitation," Archives of physical 
medicine and rehabilitation, vol. 85, pp. 380-384, 2004. 
[20] 
S. A. Murray, K. H. Ha, C. Hartigan, and M. Goldfarb, "An assistive control approach for a lower-limb exoskeleton to facilitate 
recovery of walking following stroke," Neural Systems and Rehabilitation Engineering, IEEE Transactions on, vol. 23, pp. 441-
449, 2015. 
[21] 
R. J. Farris, H. A. Quintero, and M. Goldfarb, "Preliminary Evaluation of a Powered Lower Limb Orthosis to Aid Walking in 
Paraplegic Individuals," Neural Systems and Rehabilitation Engineering, IEEE Transactions on, vol. 19, pp. 652-659, 2011. 
[22] 
C. Hartigan, C. Kandilakis, S. Dalley, M. Clausen, E. Wilson, S. Morrison, S. Etheridge, and R. Farris, "Mobility outcomes 
following five training sessions with a powered exoskeleton," Topics in spinal cord injury rehabilitation, vol. 21, pp. 93-99, 2015.