*Procedures During Screening Process:
This study will involve recruitment of individuals who have experienced a severe stroke
as well as patients with similar neurological weakness from the inpatient setting,
outpatient clinics, as well as day rehabilitation sites through The Rehabilitation
Institute of Chicago and Northwestern Memorial Hospital.
Members of the research team will perform the initial screening of potential subjects.
These clinicians will determine study eligibility based on the inclusion and exclusion
criteria provided by Ekso Bionics in accordance with the medical recommendations of Dr.
Todd Kuiken.
Potential subjects will be asked questions regarding their medical history and current
level of function. If the subject meets the criteria, researchers will then provide the
subject with a consent form. The researchers will discuss the objectives, study protocol,
and the risks and benefits of the study with each subject. The subjects will be given
time to review the form and ask any questions about the study.
Once each subject has provided informed consent, he or she will undergo a screening
process to assess joint range of motion, muscular strength (via manual muscle test), and
any spasticity present (via Modified Ashworth Scale). These measures will be used to
determine subject qualification based on inclusion and exclusion criteria. Vital signs
(including heart rate, blood pressure and oxygen saturation) will be assessed at
baseline, after each session, and during sessions as needed based on subject's signs and
symptoms. Oxygen saturation and heart rate will be monitored using a pulse oximeter.
Blood pressure will be assessed with a manual blood pressure cuff and stethoscope.
*Procedures During Treatment:
Sessions will begin with donning the Ekso device to ensure a proper fit. A physical
therapist will check the subject for proper alignment of joints with the device and check
for areas of increased pressure between the device and body. If necessary, additional
padding will be added to ensure safety and comfort or the device configuration will be
modified. During the initial sessions, skin checks will be more frequent as padding is
customized, after which they will occur at the end of each session.
After the pre-session measures, the participant will be attached to a suspension device
(Guldman overhead lift) and guarded by facility clinical/Ekso Bionics staff to ensure
participant safety. Each participant will undergo measurement, sizing, and donning of the
Ekso device in addition to skill training. Each participant will then be instructed in
proper use of the Ekso device and progressed through a series of weight shifting,
balance, and walking skill sets. Participants will be scheduled for an initial screening
session and up to 26 follow-up training sessions and assessments after the 9th, 18th, and
26th session. A follow-up assessment will also take place 3 months after the 26th
training session. The amount of sessions provided will be dependent upon compatibility
with device, ability to tolerate device use, and ability to safely ambulate using the
device. A participant will continue with each phase of the study as deemed appropriate by
research staff:
Phase 1 (1-9 training sessions): Each subject will be instructed in regards to
optimal postural alignment and weight shifting strategies to walk more efficiently
in the device. The subject will complete balance and weight shifting tasks to
improve standing balance and initiation of stepping in the device. Each subject will
participate in 90 minute gait training sessions with an emphasis multi-directional
weigh shifting, balance, and initial walking tasks in the device.
Phase 2 (10-18 training sessions): Each subject will continue with gait training in
the Ekso device utilizing training protocols developed to achieve progression with
walking from maximum-assist, tethered walking towards a greater level of
independence including non-tethered walking in the device. An assessment of gait
speed, among other functional measures, will take place during the 18th session.
Each subject's gait speed will determine the type of training that he or she will
receive during the sessions 19-26.
Phase 3 (19-26 training sessions): Subjects with a walking speed <.4m/sec will
continue with Ekso device gait training for 4 weeks at a rate of 2 sessions per
week. Subjects with a walking speed of >.4m/sec will continue with traditional
physical therapy treatment for 4 weeks at a rate of 2 sessions per week. Both types
of training sessions will focus on improving overall balance, walking distance,
walking speed, & confidence with over ground walking.
