Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Clinical Setting (SC140121 Study 1)

Study Outline Study 1, as described herein, will assess the three hypotheses, i.e., health
benefit, neurological recovery, and mobility benefits, in the context of regular dosing of
exoskeleton walking in a clinical setting. These studies will be conducted at three study
sites, Vanderbilt University Medical Center in Nashville TN, the James A. Haley Veterans
Hospital in Tampa FL, and the Mayo Clinic in Rochester MN. All study sites will conduct an
identical study protocol. The study will involve 24 non-ambulatory and poorly-ambulatory
individuals with incomplete and complete SCI (i.e., 8 subjects at each site). In this study,
"poorly ambulatory" is defined as persons with functional independence measure (FIM) gait
score of 2 to 6 who may be able to walk short distances with or without braces and stability
aid, or may be able to walk with assistance of one person, but whose primary means of
mobility is a manual or power-operated wheelchair. Of the 24 individuals, half will be
individuals with motor-complete injuries (i.e., American Spinal Injury Association Injury
Scale, AIS, A or B), and half with motor-incomplete injuries (i.e., AIS C or D). As described
subsequently in the Study Procedures section, the study will assess the therapeutic and
functional effects of exoskeleton walking over an 8-week period of treatment, where the
treatment consists of 3 walking sessions per week, each approximately 1.5 hours in duration
for a total of 24 walking sessions. Therapeutic effects will be assessed via a number of
measurements recorded primarily at study start, at the 4-week study midpoint, at the 8-week
completion of treatment, and in a follow-up session, 8 weeks following the conclusion of
treatment. Among the primary measurements to be used to assess secondary health benefits are
dual-energy X-ray absorptiometry scans (DXA) to assess bone mineral density (BMD); Modified
Ashworth scale (MAS) ratings and Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) to
assess effect on spasticity; body mass to assess BMI; and a self-report questionnaire to
assess effect on pain, spasticity, bowel and bladder function, skin, and well-being.
Neurological effects for non-ambulatory subjects will be assessed via neurological
examination and the functional reach (FR) test. Neurological effects for poorly-ambulatory
subjects will additionally be assessed via the Functional Independence Measure gait score
(FIM-G), the Walking Index for Spinal Cord Injury II (WISCI-II), the Ten Meter Walk Test
(10MWT), and the Timed Up and Go (TUG) test, all measured while the subject is not wearing
the exoskeleton. The level of mobility provided by the exoskeleton for both motor-complete
and motor-incomplete injuries will be assessed by use of the FIM-G, WISCI-II, 10MWT,
Six-Minute Walk Test (6MWT), TUG test, and Borg Rating of Perceived Exertion (BRPE), all
measured while the subject is wearing the exoskeleton.

Inclusion Criteria:

- Age 18 years or older.

- Size and limb proportions capable of fitting in the exoskeletal device :

- Height between 1.55 m (5 ft, 1 in) and 1.92 m (6 ft, 3 in).

- Femur length between 37.5 cm (15 in) and 43.125 cm (17.25 in).

- Body mass no greater than 114 kg (250 lb).

- Non-ambulatory or poorly-ambulatory. In this study, "non-ambulatory" is defined as a
person who cannot walk, or is classified with a Functional Independence Measure (FIM)
Gait score 1; "poorly ambulatory" is defined as a person with FIM Gait 2- 6, who may
be able to walk short distances with or without braces or stability aid, or may be
able to walk with assistance of one person, but whose primary means of mobility is a
manual or power-operated wheelchair.

- Sufficient upper extremity strength and coordination to balance using a appropriate
stability aids, such as a rolling walker or forearm crutches, during exoskeleton
walking.

- Present with SCI and NLI C5 or lower, with AIS A, B, C or D (as per the International
Standard for Neurological Classification of SCI, ISNCSCI), who are non-ambulatory or
poorly ambulatory.

- Chronic SCI: at least 6 months post-injury, and preferably post-injury more than 1
year.

- Sufficient bone health for walking with full weight-bearing without undue risk of
fracture, as determined by each subject's personal medical doctor, and approved by
each site's medical supervisor.

- Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower
extremities within functional limits for safe gait and use of appropriate assistive
device/stability aid.

- Skin intact where interfacing with robotic device.

- MAS for spasticity score 3 or less in lower extremities.

- Blood pressure and heart rate within established guidelines for locomotor training:

- At rest: systolic 150 mmHg or less, diastolic 90 mmHg or less, heart rate 105 bpm or
less.

- During exercise: systolic 180 mmHg or less, diastolic 105 mmHg or less, heart rate 145
bpm or less.

- Ability to tolerate an upright standing position for 20 min, passive or active,
without being lightheaded or having a headache.

- Sufficient responsiveness to FES in the quadriceps, hamstrings, tibialis anterior, and
gastrocnemius, as defined by MMT in response to stimulation of 3 or greater on a
5-point MMT scale. Note that this is specifically for Study 2, but is included in
Study 1 in order to economize study resources regarding enrollment, training, and
assessment, as previously discussed.

- Access to a wireless internet connection. Note that is required only for Study 3, but
is included in Study 1 in order to economize study resources regarding enrollment,
training and assessment, as previously discussed.

Exclusion Criteria:

- Heterotopic ossification that, in the opinion of the site medical supervisor, would
place the subject at undue risk for fracture.

- Inability to follow instructions.

- Colostomy bag.

- Women who are pregnant or attempting to become pregnant during the course of the
study. Note that a pregnancy test will be required and must be negative for all women
prior to enrolling in the study, and will be additionally required and must be
negative every four weeks during the course of the study protocol.

- Any disease, concomitant injury, or condition that interferes with the performance or
interpretation of the protocol- specified assessments.

- Insufficient availability to complete study.

- Any other issue which, in the opinion of the investigators or medical supervisor, make
the subject unsuitable for study participation.