CADTH ISSUES IN EMERGING
HEALTH TECHNOLOGIES
INFORMING DECISIONS ABOUT NEW HEALTH TECHNOLOGIES
ISSUE
SEPT
141
2015
ReWalk:
Robotic
Exoskeletons
for Spinal
Cord Injury
Author: James Murtagh, BBA, MHA, FACHE
Disclaimer: CADTH Issues in Emerging Health Technologies is a series of bulletins describing health technologies that are not yet used (or widely diffused) in Canada. The
contents are based on information from early experience with the technology; however, further evidence may become available in the future. These summaries are not
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Cite as: ReWalk: robotic exoskeletons for spinal cord injury. Ottawa: CADTH; 2015 Sep. (CADTH issues in emerging health technologies; issue 141)
Contact [email protected] with inquiries about this notice or legal matters relating to CADTH services.
ISSN: 1488-6324
CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES
2
Summary
•ReWalk is a powered exoskeleton — an external brace-like, lower-limb orthotic device.
•ReWalk may allow adults with mobility impairment to stand, sit, walk, turn, and navigate stairs.
•Four small, uncontrolled studies suggest that the supervised use of ReWalk is safe.
•ReWalk costs US$71,600 for a personal device and US$85,500 for an institutional device, with
additional annual service fees. The lifespan of the device is approximately five years.
•ReWalk may lead to an increase in the need for health care aids.
•ReWalk may represent an important advance for those with mobility impairment whose
condition imposes substantial physiological and psychological burdens.
•Larger comparative studies are needed to understand the potential impact of ReWalk and
similar devices in rehabilitation and community settings.
The Technology
ReWalk (ReWalk Robotics, Marlborough, Massachusetts) is a
powered gait orthosis for lower-limb mobility-impaired adults. It
is also sometimes referred to as an exoskeleton — a term that
generally describes a variety of supportive, brace-like orthotic
devices that are external to the body.1
Two variants of the ReWalk device are commercially available:
an adjustable model intended for multiple users in rehabilitation
settings and a customized version for use by individual users at
home or in the community. Although other robotic exoskeletons
are commercially available, ReWalk is the first such device
approved for personal use in North America.
ReWalk consists of fitted, metal braces that support each leg and
part of the upper body. With joints running parallel to the hip, knee,
and ankle, ReWalk is considered a full lower-limb orthosis. Unlike
mechanical orthoses, ReWalk incorporates battery-powered
bilateral hip and knee joint motors, a computerized control system,
and a wireless remote control worn on the wrist. In addition to
walking, the device also facilitates standing from a sitting position,
sitting from a standing position, and navigating stairs.
Regulatory Status
Walking is initiated through minor trunk motions and changes
in the centre of gravity, which are detected by a torso-mounted
sensor. A software algorithm analyzes input from the sensor and
generates pre-set hip and knee movements in alternating legs
that result in stepping. Crutches are required to provide stability.2
In the United States, the ReWalk institutional-use system was
registered by the Food and Drug Administration (FDA) in 2011
and the personal-use system was issued a marketing clearance
in June 2014. The personal-use system is to be used under the
supervision of a trained companion, and navigation of stairs is
CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES
ReWalk was licensed by Health Canada as a Class II device
(#91986) in September 2013. However, in December 2014,
Health Canada reclassified the ReWalk device as a Class I
device (John Hamilton, ReWalk Robotics, Marlboro, MA:
personal communication, 2015 April 3). It now holds a Medical
Devices Establishment Licence (#6595) as a Class I device.3
3
Components of
ReWalk system.
Computer
and Batteries
Tilt Sensor
Pelvic Support
Motors, Gears
and Software
Shoe Insert
Image courtesy of ReWalk Robotics
CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES
4
not an approved use in the US.4 The FDA clearance decision for
the personal-use system requires the manufacturer to complete
a post-marketing study, including a registry to capture adverse
events, and to assess the adequacy of its training program for
users.4 Although the US approval did not specify ReWalk as only
for use in adults, the weight of the prosthesis, and the height and
weight restrictions for the user, suggest it is designed for adults.5
Standing and walking have
been shown to produce
positive physiological and
psychological effects for
individuals with paraplegia.
In February 2015, the FDA issued a rule making all powered
exoskeletons Class II devices.6 Class II devices are considered
higher risk than Class I devices and require greater regulatory
controls to provide reasonable assurance of safety and
effectiveness prior to US marketing.
Patient Group
Although lower-limb impairment can arise in a wide variety of
clinical circumstances, ReWalk is specifically approved in the US
for use by individuals with paraplegia due to spinal cord injury
(SCI) at levels T7 (seventh thoracic vertebra) to L5 (fifth lumbar
vertebra). It may also be used with higher-level injuries (T4 to T6)
in rehabilitation settings.4
To use ReWalk, individuals must have hand, arm, and shoulder
function. Contraindications include a history of neurological
injuries other than SCI, severe spasticity, significant
contractures, unstable spine, and unhealed limb or pelvic
fractures. Concurrent medical issues such as infection,
cardiovascular or respiratory conditions, or pressure sores also
rule out the use of the device.4
Published prevalence and incidence estimates for SCI in
Canada vary widely, as does the detail available regarding the
origin and severity of SCI. SCIs can have traumatic origins
(e.g., accidents, falls, violence) or non-traumatic origins (e.g.,
infections, tumours, vascular diseases) and the consequences
CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES
can be quadriplegia or paraplegia. SCIs are further classified as
complete or incomplete depending on whether there is a total or
partial motor and/or sensory deficit below the level of the injury.
A recent report estimated the number of Canadians living with
SCI in 2010 at 85,556; of this total, an estimated 48,243 (56%)
were individuals with paraplegia. Of those SCIs resulting in
paraplegia, 40% (19,232) were associated with trauma, while
the balance (29,011) had non-traumatic origins.7 No information
is presented concerning the number of complete versus
incomplete injuries. The annual incidence for SCIs is estimated
at 3,675, the majority (58%) of which are non-traumatic SCIs.
Non-traumatic SCIs are expected to grow significantly as the
population ages. Prevalence and annual incidence are expected
to grow to 121,000 and 5,000 respectively by 2020.7
The inability to walk is associated with an increased risk for
osteoporosis, cardiovascular disease, pressure ulcers, muscular
spasticity, and contractures. Other potential complications
include chronic pain and urinary, sexual, and digestive
dysfunction.8,9 According to one study, individuals with SCI
are hospitalized 2.6 times more often, require 2.7 times more
physician contacts, and use 30 times more home care services
than the non-SCI population.10,11 Standing and walking have
been shown to produce positive physiological and psychological
effects for individuals with paraplegia.8
Current Practice
Individuals with paraplegia have a number of locomotion
options available to them, including wheelchairs, orthoses, and
neuroprosthetic functional electrical stimulation systems.1 All
of the options have some limitations. The wheelchair remains
the most common mode of locomotion for people with
paraplegia. While they provide users with mobility that allows
them to perform many activities of daily living, wheelchairs are
limited by numerous architectural and environmental barriers,
their risk of causing shoulder and arm injuries, and the height
restrictions for eye-to-eye interaction with non-SCI adults. More
importantly, by not allowing the user to put weight on his or her
legs, wheelchairs do not mitigate the adverse clinical conditions
associated with SCI.12
Mechanical (non-powered) orthoses have been used to support
standing and walking in some individuals with paraplegia. These
5
Table 1: Study Participant Injury Level and Degree of Impairment
ReWalk FDA-Approval Status
Injury Level
Number of Study Participants
Complete
Not approved
C7
Rehab settings
Personal/community use
Incomplete
1
C8
2a
T1
1
T2
2
T3
1
T4
4
T5
2
T6
1
T7
4
T8
2
T9
3
T10
5
T11
2
T12
3
1
C = cervical (neck); L = lumbar;
T = thoracic.
One of these injuries is
described as a C8-T8 injury
and the other as a C8-T2 injury.
a
Benson et al.18 include one
patient with an L1 spinal cord
injury, which is a deviation
from their inclusion criteria of
C7-T12.
b
L1
1b
Table 2: Walking Performance Measures for ReWalk
Study Author
Timed Up-and-Go
(Mean sec ± SD;
Range)
6-Minute Walk
Distance (Mean
m ± SD; Range)
6-Minute Walk
Velocity (Mean
m/sec ± SD; Range)
10-Metre Walk
Time (Mean
sec ± SD; Range)
10-Metre Walk
Velocity (Mean
m/sec ± SD; Range)
Zeilig et al.15
(n = 6)
101 ± 27.3 sec.;
72 to 156
47 ± 20.8 m;
18 to 72
0.131 ±
0.063 m/sec.;a
0.050 to 0.200 b
66 ± 22.3 sec.;
42 to103
0.168 ±
0.058 m/sec.;a
0.097 to 0.238
Esquenazi et al.12
(n = 11)
N/A
77.5 ± 44.9 m;a
10.8 to 150.4
0.216 ±
0.126 m/sec.;a
0.03 to 0.42
88.7 ± 114.0 sec.;a
22.0 to 325.0
0.251 ±
0.145 m/sec.;a
0.03 to 0.45
Benson et al.18
(n = 5)
48.8 ± 8.7 sec.;a
39 to 59
140.8 ± 41.1 m;a
91 to 174
0.391 ±
0.114 m/sec.;a
0.253 ± 0.483 b
24.4 ± 3.4 sec.;a
22 to 30
0.415 ±
0.051 m/sec.;a
0.333 to 0.455 b
Yang et al.19
(n = 12)
N/A
129.0 ± 70.9 m;a
46.3 to 255.9
0.359 ±
0.197 m/sec.;a
0.13 to 0.71
36.5 ± 21.9 sec.;a
14.0 to 78.0
0.379 ±
0.196 m/sec.;a
0.13 to 0.71
m = metres; N/A = not available; SD = standard deviation; sec = seconds.
Walking velocity and/or mean and SD were calculated using published individual participant outcome data.
a
b
All numbers are presented to one decimal place, unless the authors did not report to the decimal place.
CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES
6
devices are often challenging to put on and take off, and they
are widely recognized as requiring high energy expenditure
on the part of users. Upper-limb overuse is also a risk with
these devices. Published reports show that users abandon the
use of these orthoses at high rates.12,13 Functional electrical
stimulation has also been used successfully but is known to
quickly induce muscle fatigue.12
years. The time since injury ranged between one and 24 years.
Regarding impairment, most participants had complete SCIs
(91%), with the majority (57%) of the injuries located between
the T7 and L1 vertebrae. Table 1 summarizes the injury level
and degree of impairment in the study participants. The choice
of walking performance measures was similar across the four
studies, and those results are summarized in Table 2.
Additional gait-training options exist within rehabilitation
facilities, such as treadmill systems, some of which incorporate
powered exoskeletons. However, the inability to receive or
continue the therapy at home may limit the frequency and
intensity of walking.14
The training programs varied across the studies ― in particular,
by the number of training sessions and their intensity.
Participants in the study by Zeilig et al. trained on a level surface,
with the goal of walking 100 metres unassisted before walking
performance was measured. Training sessions averaged 50
minutes, and an average of 13.7 sessions (range 7 to 24) were
required to meet the 100-metre goal.15 Esquenazi et al. did not
define a required performance threshold, but they also deferred
performance measurement until the conclusion of the program.
Participants trained for 60 to 90 minutes for an average of 24
sessions (range 13 to 26).12
The Evidence
Six small observational studies published as medical journal
reports12,15-19 and a conference presentation/research report14
make up the available evidence base on the ReWalk technology.
Two reports16,17 focus primarily on the mechanics of walking
(e.g., body motion, weight distribution) with the ReWalk device,
while six address, directly or incidentally, safety and/or walking
performance.12,14-16,18,19 Among the reports, three14,17,19 include
overlapping study populations (i.e., reporting on the same patients),
thus leaving four studies of primary relevance to this report.12,15,18,19
All of the relevant studies received financial or in-kind support
from the device manufacturer. The study size at enrolment
ranged from eight to 14 participants (n = 44) and none included
a comparator therapy or device.
Inclusion and exclusion criteria were similar across the studies.
Men and women with SCI and weighing less than 100 kilograms
were eligible for enrolment. Females were required to not be
pregnant and not be lactating. Individuals with a history of
neurological disorders other than SCI, as well as those with
concurrent medical conditions (e.g., infections, circulatory
or respiratory disease), unhealed or recent (within the past
two years) lower extremity fractures, psychopathology, or
other cognitive issues were excluded. All but one study15 also
had similar exclusion criteria related to osteoporosis, severe
spasticity, range of motion, and contractures.
Participants who completed the studies (n = 35) were
predominately male (83%) and ranged in age from 18 to 64
CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES
Benson et al. measured performance at multiple points during
the training period. Training sessions lasted 120 minutes and
were intended to occur twice per week over a 10-week period.
The mean number of weeks to achieve 20 sessions was 19
(range 10 to 31).18 Participants in the study by Yang et al. initially
trained for 60 minutes, but this time increased to 120 minutes
as participant tolerance permitted. The average number of
training sessions was 55 (range 12 to 120).19
Although all study participants were able to walk using the
ReWalk device, the ability to perform the different tests varied.
Two studies reported that participants did not achieve a level of
proficiency to support functional daily use or fell just short of the
proficiency required to be mobile in the community setting.12,15
The basis for these conclusions is not clear, but one study
noted that the number of training sessions was not sufficient
to support the skill development necessary to achieve more
rapid walking.15 The other study noted that it was difficult for
participants to manage changes in walking surfaces and deal
with heavy foot traffic.12 Benson et al. described the ambulatory
improvements in participants with complete SCIs as profound,
but they also reported that no participants achieved walking
velocities close to those necessary to safely cross a road.18
In contrast, Yang et al. noted that seven of 12 participants in their
study were able to walk at a velocity of greater than or equal to
7
Images courtesy of ReWalk Robotics
0.40 m/sec., a speed they characterized as sufficient for limited
community ambulation.19 Velocity may ultimately be correlated to
the SCI level. Zeilig et al. found that performance was influenced
by the location of the SCI.15 Participants with lower-level injuries
(to thoracic vertebrae T9 to T12) walked longer distances than
those with higher-level injuries (to thoracic vertebrae T5 to T7).
In the 10-metre walk test, participants with lower-level injuries
walked significantly faster than those with higher injuries.15
Similar but less specific observations were made in two
additional studies,12,19 but others caution that variation in walking
speed is not entirely explained by injury level.16
Overall, the studies offer limited insight into the use of the
ReWalk device in situations other than walking on even surfaces.
The training program offered by Benson et al. incorporated
navigating obstacles and stairs, as well as other activities of
daily living performed in an upright position. The published study
offers no details regarding participant performance in these
sub-categories of activity other than noting that four of the five
participants who completed the training program were able to
navigate stairs and an obstacle course.18 Some additional insight
may be gleaned from Spungen et al.,14 whose study population is
a subset of the population in the study by Yang et al.19
Spungen et al. examined participants’ ability to perform an
extensive list of primary and secondary standing or walking
skills. In addition to basic skills such as standing, sitting, use of
the remote wristband, and walking, the authors also assessed
the ability to stop walking on command, manoeuvre to a wall to
rest, walk on carpet, and other irregular surfaces, as well as to
navigate electric doors, elevators, revolving doors, and stairs. All
CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES
seven participants in the study were able to transfer into and out
of the device, but six individuals required assistance to put on
shoes. Five participants were able to independently use the wristmounted control device and four were able to independently
retrieve an object from overhead while standing in the device.
All participants achieved standing and walking skills within
15 training sessions, although three participants still required
minimal assistance (with the trainer placing one hand on
the user) to moderate assistance (with the trainer having
both hands on the user). The skills needed to use stairs were
acquired by all four participants who attempted this task within
25 training sessions, but all required moderate assistance. The
ability to arrest one’s gait, manoeuvre to a wall to rest, and
navigate a push-button door either independently or with
assistance was achieved by all participants. Independent or
assisted walking on carpet was accomplished by four of the six
participants who attempted the task; and on outdoor surfaces,
four out of the five who attempted this task were successful.
Navigating elevators and revolving doors was attempted by
four and three participants respectively, and all were successful
without assistance.14
In terms of tolerance and satisfaction, participants in two
studies were generally positive about the training. Some
studies reported positive impacts on pain and spasticity, but
not all studies reported positive impacts on bowel or bladder
function.12,15 In one study, the authors noted that positive
findings cannot be unequivocally attributed to the device.12
Another study indicated that most participants reported a slight
increase in pain after using the exoskeleton and that, overall,
8
the device did not meet participant expectations regarding
perceived benefits and impact on quality of life.18 Two studies
concluded that larger trials are needed to confirm the efficacy
of the device or address other outstanding questions.15,18 As
to the feasibility of larger trials, one study reported significant
challenges in recruiting participants.18 Although the recruitment
difficulties are not attributed to any single issue, the time
commitment associated with training is mentioned. Pre- or
post-enrolment withdrawal for logistical reasons (e.g., time
availability, transportation, work relocation) were reported in
three studies.15,18,19 Of 36 eligible participants in the study by
Benson et al., 16 opted not to enrol because of limited interest
in committing to a 10-week training program.18 This study also
noted 19 interruptions in the training program stemming from
participant logistical issues.
Adverse Events
No serious adverse events, including death and hospitalization,
were reported in the ReWalk studies. Esquenazi et al. reported
skin abrasions in areas of contact with the device, lightheadedness, or lower-limb swelling in five users.12 Yang et al.
reported 13 episodes of mild skin abrasions, all of which were
successfully resolved with padding and equipment adjustments.19
Benson et al. reported a high incidence of skin issues. Five
grade 1 skin aberrations occurred in three participants, and 10
grade 2 aberrations occurred in five participants. All of the skin
aberrations resulted in interruptions to the training program, and
two participants were forced to withdraw because of recurring
skin issues. An additional study participant was required to
withdraw because of what the authors describe as a nearserious fracture of a bone in the ankle.18
No falls were reported in any of the studies, but Esquenazi et al.
mentioned instances where users lost their balance and either
saved themselves from falling or were stabilized by staff.12 The
same authors also reported instances where the device misfired
and failed to step, a situation that might lead to an adverse event.
This deficiency has reportedly been addressed by the manufacturer.
Benson et al. cautioned that the continuous expert supervision
characteristic of clinical environments may underestimate the real
risk of falls and fractures in community settings.18
CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES
Administration and Cost
ReWalk is currently used primarily in rehabilitation centres.
Published trials have targeted training frequency of two to three
times per week, for periods of up to 120 minutes. Spungen et
al. have shown that basic standing and walking skills can be
acquired in 15 training sessions or less, but other skills may not be
acquired by some users even after 25 sessions.14 Regarding the
physiological benefits that might be associated with using ReWalk,
no data on its effects on this type of outcome have been published.
The institutional version of ReWalk is priced at US$85,500. A
2.5 day training program for four clinicians and two technicians
costs an additional US$4,000. The device comes with a two-year
warranty, after which an annual service contract costs US$8,000
per year. The contract includes servicing three times per year.
The personal-use system costs US$71,600 and the post-warranty
service contract costs US$4,000 per year. The life expectancy
of the device is five years (Loren Wass, ReWalk Robotics,
Marlborough, MA: personal communication, 2015 Mar 12).
Anecdotal evidence suggests that powered exoskeletons may
reduce staffing requirements in rehabilitation settings.20 Whether
this observation extends to all powered exoskeletons and all
rehabilitation settings, especially those already using treadmill
systems incorporating a powered gait orthosis, is unknown.
Concurrent Developments
In addition to ReWalk, three other robotic exoskeletons are
commercially available in Australia, Europe, Japan, and/or
North America. Although similar in purpose, the devices vary
in appearance, size, and other factors, such as the presence or
absence of functional electrical stimulation. Only one of the other
devices is currently marketed for personal use. At least eight
powered exoskeletons are reported to be under development,
including one by Canadian company Bionik Laboratories.21
Advances in power supplies, microprocessors, sensors, and other
components are expected to result in changes to the appearance
and capabilities of powered exoskeletons in the future. Further
developments, such as direct brain interfaces, may lead to even
more sophisticated devices. Despite these potential advances,
wheelchairs are likely to remain the most important mobility
technology for people with SCI for at least the next decade.1
9
Rate of Technology Diffusion
Implementation Issues
Powered exoskeletons, including ReWalk, are in the early stages
of diffusion. The three vendors whose public reporting includes
sales figures have approximately 560 devices in use worldwide.
A single vendor (Cyberdyne, Tsukuba, Ibaraki Prefecture, Japan)
has reportedly sold 363 devices in Japan.
It is unlikely that the ReWalk device or similarly powered
exoskeletons face any policy or reimbursement barriers to their
diffusion into publicly funded rehabilitation centres in Canada.
The ReWalk device and some competitor devices are already in
place in a small number of facilities. Other related but stationary
technologies ― such as treadmill gait-training systems, some of
which incorporate powered exoskeletons ― are also becoming
more common.23 The challenge facing public sector service
providers is in determining the appropriate place for ReWalk
within the rehabilitation technology continuum and its relative
effectiveness. In the absence of comparative studies, these
questions are difficult to answer.
As of early 2015, ReWalk Robotics reported 99 devices in service
worldwide, with sales increasing threefold in 2014 compared with
2013. There are currently two ReWalk devices in Canada: one at
the University of Alberta and another at a private, not-for-profit
rehabilitation centre in Nova Scotia (Loren Wass, ReWalk Robotics,
Marlborough, MA: personal communication, 2015 Mar 12).
ReWalk may represent an
important advance for some
mobility-impaired individuals
whose condition imposes
substantial physiological and
psychological burdens.
Ekso Bionics (Richmond, California) has 96 devices in use
worldwide,20 including five in Canada. The devices at Canadian
sites include two at public facilities in Vancouver, one in
Edmonton, and one in London, as well as one at a private facility
in London (Heidi Darling, Ekso Bionics, Richmond, CA; personal
communication, 2015 Mar 10).
A Rex Bionics (Auckland, New Zealand) exoskeleton is in use at
Able Bionics, in London, Ontario.22
There are no significant barriers to the diffusion of powered
exoskeletons in Canadian health care facilities other than
awareness and cost. Diffusion of personal-use devices will be
affected by cost and/or public reimbursement practices.
The situation is more complex in relation to the placement of
personal-use devices in the community. There are significant
knowledge gaps regarding the role of powered exoskeletons
in community settings: will they primarily extend rehabilitation
capabilities to the home and will they fundamentally change the
ability of persons with SCI to move around their communities?
Clear evidence has yet to emerge regarding many questions,
including who is most likely to benefit from the technology,
how long it can be comfortably worn, and what is the rate
at which users might abandon the technology? ReWalk and
other exoskeletons are very costly relative to wheelchairs, but
currently there is no indication they can replace wheelchairs
or positively affect public funding arrangements for mobility
devices that are already in place. In addition, the life expectancy
of the ReWalk device is relatively short, virtually matching that of
wheelchairs, thus eliminating the need for any major extension
of the replacement cycle currently supported by payers.
Despite these barriers to implementation, payers need to
be aware that robotic exoskeletons may be an important
advance for a portion of a population whose condition imposes
significant physiological and psychological burdens.
Expanded indications for use may also influence diffusion. Most
vendors see the market for this type of technology expanding
beyond SCI and rehabilitation (estimated to be the smallest
markets in the US). Other conditions, such as stroke, may offer
larger marketing opportunities. Industry reports estimate the
powered exoskeleton market may grow to US$1.9 billion by 2020.20
CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES
10
References
1. Boninger M, French J, Abbas J, Nagy L, Ferguson-Pell M, Taylor SJ,
et al. Technology for mobility in SCI 10 years from now. Spinal Cord.
2012;50(5):358-63.
2. Esquenazi A. New bipedal locomotion option for individuals with thoracic
level motor complete spinal cord injury. Journal of the Spinal Research
Foundation. 2013;8(1):26-8.
3. Health Canada. Medical Devices Establishment Licence Listing [Internet].
Ottawa: Health Canada. ReWalk; Licence No. 6595; 2012 [cited 2015
May 26]. Available from: http://webprod5.hc-sc.gc.ca/el-le/start-debuter.
do?lang=eng
4. U.S. Food and Drug Administration. FDA allows marketing of first wearable, motorized device that helps people with certain spinal cord injuries
to walk [Internet]. Silver Spring (MD): The Administration; 2014 Jun 26.
[cited 2015 Mar 17]. Available from: http://www.fda.gov/NewsEvents/
Newsroom/PressAnnouncements/ucm402970.htm
5. U.S. Food and Drug Administration. Evaluation of automatic class III
designation (De Novo) for Argo Rewalk™ [Internet]. Silver Spring (MD): The
Administration; 2014. [cited 2015 May 26]. Available from: http://www.
accessdata.fda.gov/cdrh_docs/reviews/den130034.pdf
6. Medical devices; physical medicine devices; classification of the powered
exoskeleton. Final order. Fed Regist [Internet]. 2014 Feb 24 [cited 2015
Mar 18];80(36):9600-3. Available from: http://www.gpo.gov/fdsys/pkg/FR2015-02-24/pdf/2015-03692.pdf
7. Farry A, Baxter D. The incidence and prevalence of spinal cord injury in
Canada: overview and estimates based in current evidence [Internet]. Vancouver: Rick Hansen Institute; 2010 Dec. [cited 2015 Mar 17]. Available
from: http://www.urbanfutures.com/spinal-injury Jointly published with
the Urban Futures Institute.
8. Arazpour M, Bani MA, Hutchins SW. Reciprocal gait orthoses and powered
gait orthoses for walking by spinal cord injury patients. Prosthet Orthot
Int. 2013 Feb;37(1):14-21.
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