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The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation: A systematic review

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Objective: This review examines the utility of current active, powered, wearable lower limb exoskeletons as aids to rehabilitation in paraplegic patients with gait disorders resulting from central nervous system lesions. Methods: The PRISMA guidelines were used to review literature on the use of powered and active lower limb exoskeletons for neurorehabilitative training in paraplegic subjects retrieved in a search of the electronic databases PubMed, EBSCO, Web of Science, Scopus, ProQuest, and Google Scholar. Results: We reviewed 27 studies published between 2001 and 2014, involving a total of 144 participants from the USA, Japan, Germany, Sweden, Israel, Italy, and Spain. Seventy percent of the studies were experimental tests of safety or efficacy and 29% evaluated rehabilitative effectiveness through uncontrolled (22%) or controlled (7%) clinical trials. Conclusions: Exoskeletons provide a safe and practical method of neurorehabilitation which is not physically exhausting and makes minimal demands on working memory. It is easy to learn to use an exoskeleton and they increase mobility, improve functioning and reduce the risk of secondary injury by reinstating a more normal gait pattern. A limitation of the field is the lack of experimental methods for demonstrating the relative effectiveness of the exoskeleton in comparison with other rehabilitative techniques and technologies.
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NeuroRehabilitation xx (20xx) x–xx
DOI:10.3233/NRE-151265
IOS Press
1
Review Article1
The effectiveness of powered, active lower
limb exoskeletons in neurorehabilitation:
A systematic review
2
3
4
Stefano Federicia,, Fabio Melonia, Marco Bracalentiaand Maria Laura De Filippisb
5
aDepartment of Philosophy, Social & Human Sciences and Education, University of Perugia, Italy6
bNIHR MindTech Healthcare Technology Co-operative, Institute of Mental Health, Jubilee Campus,
Nottingham, UK
7
8
Abstract.9
OBJECTIVE: This review examines the utility of current active, powered, wearable lower limb exoskeletons as aids to rehabil-
itation in paraplegic patients with gait disorders resulting from central nervous system lesions.
10
11
METHOD: The PRISMA guidelines were used to review literature on the use of powered and active lower limb exoskeletons
for neurorehabilitative training in paraplegic subjects retrieved in a search of the electronic databases PubMed, EBSCO, Web of
Science, Scopus, ProQuest, and Google Scholar.
12
13
14
RESULTS: We reviewed 27 studies published between 2001 and 2014, involving a total of 144 participants from the USA, Japan,
Germany, Sweden, Israel, Italy, and Spain. Seventy percent of the studies were experimental tests of safety or efficacy and 29%
evaluated rehabilitative effectiveness through uncontrolled (22%) or controlled (7%) clinical trials.
15
16
17
CONCLUSIONS: Exoskeletons provide a safe and practical method of neurorehabilitation which is not physically exhausting
and makes minimal demands on working memory. It is easy to learn to use an exoskeleton and they increase mobility, improve
functioning and reduce the risk of secondary injury by reinstating a more normal gait pattern. A limitation of the field is the lack
of experimental methods for demonstrating the relative effectiveness of the exoskeleton in comparison with other rehabilitative
techniques and technologies.
18
19
20
21
22
Keywords: Powered active lower limb exoskeleton, paraplegic patients, gait disorders, central nervous system lesions, neurore-
habilitation, systematic review, PRISMA
23
24
1. Introduction25
Gait disorders, classified in ICD-10 as “abnormalities26
of gait and mobility” (code R26), involve a reduction in
27
autonomy and the ability to move independently. Gait
28
disorders can result from central nervous system (CNS)
29
lesions caused by, for example, spinal cord injury (SCI),
30
cerebrovascular accident (CVA), cerebral palsy (CP),
Address for correspondence: Stefano Federici, Piazza G. Ermini
1, Perugia, 06123, Italy. Tel.: +39 3473769497; Fax: +39
0759660141; E-mail: stefano.federici@unipg.it.
or infectious diseases. When gait disorders severely 31
distort or completely abolish normal gait pattern and 32
functions (ICF, codes b770.3; b770.4) the patient is 33
usually forced to rely on a wheelchair for mobility 34
and will often require the support of a caregiver (Play- 35
ford, 2015). Over time patients may develop secondary 36
complications such as hypertension, osteoporosis, and 37
bedsores. These comorbidities severely limit an indi- 38
vidual’s ability to carry out activities of daily living 39
as well as restricting social participation, and affecting 40
quality of life and mood (Suzuki et al., 2005). 41
1053-8135/15/$35.00 © 2015 – IOS Press and the authors. All rights reserved
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2S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation
A new neurorehabilitation therapy which is different
42
from classical therapeutic techniques has been devel-43
oped. It is referred to as neurorobotic or neuroprosthetic
44
training and uses robotic devices such as the exoskele-45
ton (Moreno et al., 2011).46
Spungen et al. (2013) stated that robotics-assisted,47
powered exoskeletons represented a relatively new
48
technology that had been shown to be a safe and effec-
49
tive method of helping individuals with motor-complete
50
paraplegia to stand and walk. Exoskeletons enable51
paralyzed individuals to overcome environmental bar-
52
riers that cannot be tackled in a wheelchair, such as
53
stairs.54
Initially, exoskeletons were used in gait disorder
55
rehabilitation to facilitate recovery of upper limb move-56
ment (Chaigneau, Arsicault, Gazeau, & Zeghloul,57
2008). The first generation of lower limb exoskele-58
tons were passive ones (Rahman et al., 2006)—i.e.,
59
the exoskeleton moves the patient’s body on a pre-60
defined trajectory, regardless of what the patient is61
doing (Nef & Riener, 2012). Researchers observed that
62
users’ hip, pelvis, and leg motor patterns remained
63
unchanged when they wore a robotic gait-assisting pas-64
sive exoskeleton (Kao, Lewis, & Ferris, 2010; Lee65
et al., 2014) that reduced the muscular effort required66
(Mooney, Rouse, & Herr, 2014). This finding led to the67
development of the first active exoskeletons (Quintero,68
Farris, & Goldfarb, 2012) that enabled patients move
69
together with the robot in the desired direction (Nef &70
Riener, 2012).
71
Exoskeletons have been used to assist patients with
72
SCI by restoring their functional abilities (Spungen73
et al., 2013), to enhance the strength and muscular
74
endurance of personnel taking part in military oper-
75
ations (Herr, 2009), and to enabled disabled people76
to participate in sport: at the 2015 Rome marathon77
two paraplegic patients ran one kilometer wearing an78
exoskeleton (Fondazione Santa Lucia, 2015). Unlike
79
the human skeleton, an exoskeleton supports body80
weight externally, allowing the user to stand com-81
pletely upright, move autonomously, and to strengthen
82
and improve coordination of voluntary movements of83
the lower limbs. This technology has greater ecologi-84
cal validity than other neurorobotic techniques such as85
robotic-assisted gait training, because patients wearing86
an exoskeleton can walk and move autonomously for87
long periods of time, and on a wide range of walking88
surfaces. Exoskeletons can also be used in a wider range89
of environments; they can be used in the workplace or90
at home, as well as in a rehabilitation space, and to help91
patients perform activities of daily living.
1.1. Purpose 92
The aim of this systematic review was to examine 93
the rehabilitative capacity of current models of active, 94
powered lower limb exoskeletons when used in para- 95
plegic patients with gait disorders resulting from central 96
nervous system lesions caused by, for example, SCIs or 97
CVAs. 98
2. Method 99
This study followed the checklist in the Pre- 100
ferred Reporting Items for Systematic Reviews and 101
Meta-Analyses (PRISMA) statement (www.prisma- 102
statement.org) (Liberati et al., 2009; Moher, Liberati, 103
Tetzlaff, Altman, & The, 2009). 104
2.1. Eligibility criteria 105
We considered English-language journal articles, 106
conference papers, and conference proceedings which 107
focused on the neurorehabilitative training of para- 108
plegic subjects using powered or active lower limb 109
exoskeletons. Studies were excluded from the analy- 110
sis if they focused on unpowered, passive, or upper 111
limb exoskeletons, were based on healthy subjects, or 112
on non-rehabilitative uses of the exoskeleton. 113
2.2. Information sources 114
Relevant publications were retrieved from searches 115
of the PubMed, EBSCO, Web of Science, Scopus, 116
ProQuest, and Google Scholar electronic databases, 117
and identified by inspecting the reference lists of rele- 118
vant review articles, editorials, and handbooks (Bogue, 119
2009; Carpino, Accoto, Tagliamonte, Ghilardi, & 120
Guglielmelli, 2013; del-Ama et al., 2012; D´
ıaz, Gil, 121
&S
´
anchez, 2011; Dietz, Nef, & Rymer, 2012; Dietz & 122
Ward, 2015; Dollar & Herr, 2007, 2008; Esquenazi & 123
Packel, 2012; Ferris, Sawicki, & Domingo, 2005; Herr, 124
2009; Hong et al., 2013; Keller & Veneman, 2013; 125
Koceska & Koceski, 2013; Low, 2011; Mohammed, 126
Amirat, & Rifai, 2012; Moreno et al., 2011; Norhafizan, 127
Ghazilla, Kasi, Taha, & Hamid, 2014; Pennycott, Wyss, 128
Vallery, Klamroth-Marganska, & Riener, 2012; Jos´
eL. 129
Pons, 2010; Jos´
e L Pons & Torricelli, 2014; Viteck- 130
ova, Kutilek, & Jirina, 2013; Wall, Borg, & Palmcrantz, 131
2015; Yan, Cempini, Oddo, & Vitiello, 2015). The last 132
search was run on May 20, 2015.
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S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation 3
2.3. Search
133
We used the following search terms in all fields: (leg134
OR (lower AND (limb* OR extremity OR body))) AND135
(power* OR active) AND (aid OR assist* OR rehab*136
OR climb stair*) AND (exoskeleton* OR wearable
137
robot*) AND (stroke* OR spinal cord* OR paraplegia*138
OR paralysis* OR disab*).139
2.4. Study selection
140
A standardized protocol was used to determine eli-
141
gibility for inclusion in the review. Publications were
142
assessed independently by authors F. M. and M. B., who
143
were blind to authorship. The first screening was based
144
on the Abstracts of publications. A further selection
145
was made after reading the full text of the articles. Dis-146
agreements were resolved by discussion between the
147
reviewers.
148
2.5. Data collection process
149
Relevant data were extracted from the included pub-150
lications using a specially developed a data extraction151
sheet, which was piloted on ten randomly selected152
included studies and refined accordingly. Data were
153
extracted from the included studies by M.B. and154
checked by F. M. Disagreements were resolved by dis-
155
cussion between the authors.156
2.6. Data items157
We extracted the following information about158
included studies: (1) year of publication; (2) country159
where the study was conducted; (3) study design (exper-160
imental trial, controlled or uncontrolled clinical trial);
161
(4) brand of exoskeleton used; (5) sample inclusion cri-
162
teria; (6) sample size; (7) sample type (SCI, stroke, not
163
available); (8) measures used in the study; (9) research164
field; (10) publication type (journal article, conference
165
proceedings, etc.).166
3. Results
167
3.1. Study selection
168
The number of hits retrieved from each electronic
169
database is given in parentheses: EBSCO (284), Web170
of Science (88), Scopus (91), ProQuest (1119), PubMed171
(16), Google Scholar (448); a total of 2,046 publi-172
cations. Inspection and assessment of the references 173
of relevant review articles, editorials, and handbooks 174
resulted in the inclusion of an additional 24 publi- 175
cations. The search was limited to English language 176
publications and retrieved 1,795 unique records, of 177
which 1,738 were discarded after screening of the 178
Abstracts because they did not focus on our review 179
topic. The full texts of the remaining 57 publications 180
were examined in more detail. Thirty studies did not 181
meet the inclusion criteria and were excluded from the 182
analysis because the samples comprised healthy par- 183
ticipants or data about participants and experimental 184
design were not reported in the full text. 185
The final sample comprised 27 full-text publications. 186
The process by which we selected publications for 187
inclusion in this systematic review is synthesized in a 188
flow diagram based on PRISMA (Fig. 1) (Liberati et al., 189
2009). 190
3.2. Study characteristics 191
All 27 studies included in the review investigated 192
the use of active, powered lower limb exoskeletons 193
in neurorehabilitation or clinical trials in patients with 194
gait disorders. Table 1 summarizes the results of the 195
included studies according to the ten data items (see 196
sub-section 2.6) extracted from each reviewed study. 197
The included studies were published between 2001 198
and 2014 at a constant annual rate and involved a total of 199
144 participants, of whom only 4% (n= 6) were healthy 200
subjects enrolled in a control group (Sylos-Labini et al., 201
2014). The remaining participants (96%) were enrolled 202
in experimental groups comprising patients with strokes 203
(n= 51, 35%) (Kawamoto et al., 2010; Nilsson et al., 204
2014; Stein, Bishop, Stein, & Wong, 2014; Watan- 205
abe, Tanaka, Inuta, Saitou, & Yanagi, 2014), SCIs 58% 206
(n= 83) (Aach et al., 2013, 2013; Belforte, Gastaldi, & 207
Sorli, 2001; Bishop, Stein, & Wong, 2012; Esquenazi, 208
Talaty, Packel, & Saulino, 2012; Farris, Quintero, & 209
Goldfarb, 2011, 2012; Farris et al., 2014; Kolakowsky- 210
Hayner, 2013; Neuhaus et al., 2011; Quintero et al., 211
2012; Sczesny-Kaiser et al., 2013; Spungen et al., 2013; 212
Strausser & Kazerooni, 2011; Strausser, Swift, Zoss, 213
& Kazerooni, 2010; Sylos-Labini et al., 2014; Talaty, 214
Esquenazi, & Brice˜
no, 2013; Tsukahara, Hasegawa, 215
& Sankai, 2009; Tsukahara, Kawanishi, Hasegawa, & 216
Sankai, 2010; Zeilig et al., 2012), or gait disorders of 217
unspecified etiology (n= 4, 3%) (Ikehara et al., 2011; 218
Mori, Okada, & Takayama, 2006; Sanz-Merodio, Ces- 219
tari, Arevalo, & Garcia, 2012). 220
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4S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation
Fig. 1. Four-phase flow diagram of the systematic review according to PRISMA.
Fifty-one percent (n= 74) of all participants were221
recruited in the USA (Bishop et al., 2012; Esquenazi et222
al., 2012; Farris et al., 2011, 2012, 2014; Kolakowsky-223
Hayner, 2013; Neuhaus et al., 2011; Quintero et al.,
224
2012; Spungen et al., 2013; Stein et al., 2014; Strausser
225
& Kazerooni, 2011; Strausser et al., 2010; Talaty et al.,
226
2013); 19% (n= 28) in Japan (Ikehara et al., 2011;
227
Kawamoto et al., 2010; Mori et al., 2006; Tsukahara
228
et al., 2009, 2010; Watanabe et al., 2014); 11% (n= 16)
229
in Germany (Aach et al., 2013, 2014; Sczesny-Kaiser230
et al., 2013); 6% (n= 8) in Sweden (Nilsson et al.,
231
2014); 4% (n= 6) in Israel (Zeilig et al., 2012); 3%232
(n= 5) in Italy (Belforte et al., 2001; Sylos-Labini et al.,233
2014); and 0.7% (n= 1) in Spain (Sanz-Merodio et al.,234
2012).
235
Fifty-six percent (n= 15) of the publications were
236
journal articles (Aach et al., 2014; Belforte et al., 2001;
237
Bishop et al., 2012; Esquenazi et al., 2012; Farris et al.,
238
2011, 2014; Mori et al., 2006; Nilsson et al., 2014; Quin-
239
tero et al., 2012; Stein et al., 2014; Sylos-Labini et al.,
240
2014; Tsukahara et al., 2010; Watanabe et al., 2014;241
Zeilig et al., 2012) (Kolakowsky-Hayner, 2013); 37% 242
(n= 10) were conference papers or conference proceed- 243
ings (Farris et al., 2012; Ikehara et al., 2011; Kawamoto 244
et al., 2010; Neuhaus et al., 2011; Sanz-Merodio et al., 245
2012; Spungen et al., 2013; Strausser & Kazerooni, 246
2011; Strausser et al., 2010; Talaty et al., 2013; Tsuka- 247
hara et al., 2009); and 7% (n= 2) were book chapters 248
(Aach et al., 2013; Sczesny-Kaiser et al., 2013). 249
Fifty-six percent (n= 15) of the included publications 250
related to medical research (Aach et al., 2013, 2014; 251
Bishop et al., 2012; Esquenazi et al., 2012; Kawamoto 252
et al., 2010; Kolakowsky-Hayner, 2013; Neuhaus et al., 253
2011; Nilsson et al., 2014; Sczesny-Kaiser et al., 2013; 254
Spungen et al., 2013; Stein et al., 2014; Sylos-Labini 255
et al., 2014; Talaty et al., 2013; Watanabe et al., 2014; 256
Zeilig et al., 2012), and 44% (n= 12) to engineering 257
research (Belforte et al., 2001; Farris et al., 2011, 2012, 258
2014; Ikehara et al., 2011; Mori et al., 2006; Quintero et 259
al., 2012; Sanz-Merodio et al., 2012; Strausser & Kaze- 260
rooni, 2011; Strausser et al., 2010; Tsukahara et al., 261
2009, 2010). 262
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S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation 5
Table 1
Summary of the included studies
Studies in
alphabetic
order
Country Study
design
Exoskeleton Sample inclusion
criteria
Sample size Sample type Measures∗∗ Research field Publication
Type
Aach et al.,
2013
Germany Uncontrolled
Clinical Trial
HAL NA 4 SCI OBSERVATION
MEASURES: Walking
distance; walking
speed; walking time on
treadmill. OUTCOME
MEASURES: 10MWT;
TUG; WISCI II.
Medicine Book Section
Aach et al.,
2014
Germany Uncontrolled
Clinical Trial
HAL 1) Traumatic SCI with chronic
incomplete (ASIA B/C/D)
or complete paraplegia
(ASIA A) after lesions of
the conus medullaris/cauda
equine with zones of partial
preservation;
2) Motor functions of hip
and knee extensor and flexor
muscle groups to be able to
trigger the exoskeleton.
8 SCI CLINICAL MEASURES:
Lower extremity
circumferences
OUTCOME
MEASURES: 10MWT;
TUG; 6MWT; WISCI
II; LEMS; Ashworth
scale.
Medicine Journal Article
Belforte,
Gastaldi, &
Sorli, 2001
Italy Experimental
Trial
ARGO
(Advanced
Reciprocating
Gait
Orthosis)
NA 1 SCI OBSERVATION
MEASURES: Rotations
and applied torques for
each joint; kinematic
magnitudes and
exchanged forces.
Engineering Journal Article
Bishop, Stein,
& Wong,
2012
USA Uncontrolled
Clinical Trial
Tibion Bionic
Technologies
NA 1 SCI OUTCOME
MEASURES: 6MWT;
BBS; TUG; 10MWT.
Medicine Journal Article
Esquenazi,
Talaty,
Packel, &
Saulino, 2012
USA Experimental
Trial
ReWalk 1) 18 to 55 years of age;
2) Motor-complete cervical
(C7-8) and thoracic
(T1-T12) SCI;
3) Male and nonpregnant,
nonlactating woman;
4) At least 6 months after
injury;
5) Regular use of a
Reciprocating Gait Orthosis
(RGO) or KAFOs or able to
stand using a standing
device;
6) Height 160 to 190 cm
7) Weight <100 kg
12 SCI OBSERVATION
MEASURES: distance
walked in 6 minutes;
time spent to cover 10
meters. OUTCOME
MEASURES: 6MWT;
10MWT.
Medicine Journal Article
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6S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation
Table 1
(Continued)
Studies in
alphabetic
order
Country Study
design
Exoskeleton Sample inclusion
criteria
Sample size Sample type Measures∗∗ Research
field
Publication Type
Farris et al.,
2014
USA Experimental
Trial
Vanderbilt lower
limb
exoskeleton,
knee–ankle–foot
orthoses
(KAFOs).
NA 1 SCI OUTCOME MEASURES:
10MWT; TUG; 6MWT.
Engineering Journal Article
Farris, Quintero,
& Goldfarb,
2011
USA Experimental
Trial
Vanderbilt lower
limb
exoskeleton
NA 1 SCI OBSERVATION
MEASURES: Hip and
knee joint angle
trajectories during
walking; average
walking speed.
Engineering Journal Article
Farris, Quintero,
& Goldfarb,
2012
USA Experimental
Trial
Vanderbilt lower
limb
exoskeleton.
NA 1 SCI OBSERVATION
MEASURES: knee joint
torque
Engineering Conference
Proceedings
Ikehara et al.,
2011
Japan Experimental
Trial
Walking
Assistance
Device
NA 2 NA OBSERVATION
MEASURES: video
recording of subjects’
walking.
Engineering Conference
Proceedings
Kawamoto
et al., 2010
Japan Experimental
Trial
HAL NA 1 Stroke OBSERVATION
MEASURES: knee joint
angle
Medicine Conference
Proceedings
Mori, Okada, &
Takayama,
2006
Japan Experimental
Trial
ABLE system NA 1 NA OBSERVATION
MEASURES: time
response of the angles
and electric currents of
each joint.
Engineering Journal Article
Neuhaus et al.,
2011
USA Experimental
Trial
MINA 1) Traumatic SCI with chronic
incomplete (ASIA B/C/D) or
complete paraplegia
(ASIA A);
2) WISCI level 9 or higher.
2 SCI OBSERVATION
MEASURES:
conversation with the
user during walking.
Medicine Conference
Proceedings
Nilsson et al.,
2014
Sweden Uncontrolled
Clinical Trial
HAL 1) Time since stroke onset
of <7 weeks;
2) Able to sit on a bench
with/without supervision at
least five minutes;
3) Unable to walk
independently;
4) Sufficient postural control;
5) Ability to understanding
instruction;
6) Body size compatible
with the HAL suit.
8 Stroke OBSERVATION
MEASURES: walking
speed. OUTCOME
MEASURES: NIHSS;
FM-LE; BBS; TUG;
10MWT; S-COVS; FAC;
FES(S); BI; FIM; VAS.
Medicine Journal Article
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S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation 7
Quintero,
Farris, &
Goldfarb,
2012
USA Experimental
Trial
Vanderbilt
lower limb
exoskeleton
NA 1 SCI OUTCOME
MEASURES: TUG.
Engineering Journal Article
Sanz-Merodio,
Cestari,
Arevalo, &
Garcia, 2012
Spain Experimental
Trial
ATLAS NA 1 NA OBSERVATION
MEASURES: joint
angles
Engineering Conference
Proceedings
Sczesny-Kaiser
et al., 2013
German Uncontrolled
Clinical Trial
HAL NA 4 SCI OUTCOME
MEASURES: fMRI;
EMG.
Medicine Book Section
Spungen,
Asselin,
Fineberg,
Kornfeld, &
Harel, 2013
USA Uncontrolled
Clinical Trial
ReWalk 1) 18 to 65 years of age;
2) Motor-complete
paraplegia (T1 to T12);
3) Greater than 6 months
elapsed since the SCI;
4) Height 160 to 190 cm;
5) Weigh <100kg.
7 SCI OBSERVATION
MEASURES: walking
speed.
Medicine Conference
Paper
Stein, Bishop,
Stein, &
Wong, 2014
USA Controlled
Clinical Trial
Bionic Leg 1) Single stroke (ischemic or
hemorrhagic) causing
significant leg weakness
and gait alterations at
least 6 months before
study entry;
2) Stroke confirmation
through CT or MRI;
3) Independence in
household ambulation
with or without facilitator.
20 Stroke OUTCOME
MEASURES: 10MWT;
TUG; 6MWT; 5XSST;
Romberg’s test; EFAP;
BBS; CAFE 40.
Medicine Journal Article
Strausser &
Kazerooni,
2011
USA Experimental
Trial
eLEGS NA 5 SCI OBSERVATION
MEASURES: knee
angle; time practicing.
Engineering Conference
Proceedings
Strausser, Swift,
Zoss, &
Kazerooni,
2010
USA Experimental
Trial
Human
Universal
Load Carrier
(HULC)
NA 4 SCI OBSERVATION
MESURES: video
recording of subjects’
walking.
Engineering Conference
Proceedings
Sylos-Labini
et al., 2014
Italy Experimental
Trial
MindWalker
Exoskeleton
1) 18 to 45 years of age;
2) Traumatic/non-
traumatic SCI;
3) At least 5 months after
injury;
4) Complete lesion
below T7;
5) Inability to ambulate;
6) MMSE score >26.
10 SCI OBSERVATION
MEASURES: joint
angles and torques.
OUTCOME
MEASURES: EMG.
Medicine Journal Article
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8S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation
Table 1
(Continued)
Studies in
alphabetic
order
Country Study
design
Exoskeleton Sample inclusion
criteria
Sample size Sample type Measures∗∗ Research field Publication
Type
Talaty,
Esquenazi, &
Brice˜
no,
2013
USA Experimental
Trial
ReWalk 1) Joint integrity/absence
of fractures that prevent
walking;
2) Standing alone also
with facilitator; 3) A
complete neurological
evaluation to assess motor
and physiological
functioning; 4) Absence
of osteoporosis (BMD
>–2.5) at the right limb
femoral neck and the L2
to L4 spine.
12 SCI CLINICAL MEASURES:
isometric muscle
strength.
OBSERVATION
MEASURES: video
recording of subjects’
walking; walking speed.
OUTCOME
MEASURES: EMG.
Medicine Conference
Proceedings
Tsukahara,
Hasegawa, &
Sankai, 2009
Japan Experimental
Trial
HAL NA 1 SCI OBSERVATION
MEASURES: knee
joint angle.
Engineering Conference
Proceedings
Tsukahara,
Kawanishi,
Hasegawa, &
Sankai, 2010
Japan Experimental
Trial
HAL NA 1 SCI OBSERVATION
MEASURES: knee
joint angle.
Engineering Journal Article
Watanabe,
Tanaka,
Inuta, Saitou,
& Yanagi,
2014
Japan Controlled
Clinical Trial
HAL 1) Hemiparesis resulting
from unilateral ischemic
or hemorrhagic stroke;
2) Time since stroke onset
of <6 months.
22 Stroke CLINICAL MEASURES:
Isometric muscle
strength.
OBSERVATION
MEASURES:
maximum walking
speed. OUTCOME
MEASURES: FAC;
TUG; 6MWT; SPPB;
FM-LE.
Medicine Journal Article
Zeilig et al.,
2012)
Israel Experimental
Trial
ReWalk 1) 16 to 70 years of age;
2) Weight <100kg;
3) Height from 155
to 200 cm;
4) Complete motor
impairment C7–C8 or
T1–T12;
5) At least 6 months since
injury;
6) Regular user of a RGO
or therapeutic standing
frame.
6 SCI OBSERVATION
MEASURES: distance
walked in 6 minutes.
OUTCOME
MEASURES: 10MWT;
TUG.
Medicine Journal Article
NA = Not available: In the study inclusion criteria were not reported. All the measures’ abbreviations are explained in the Table 2. ∗∗See Table 2 for the measure reference details.
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S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation 9
Seventy percent (n= 19) of the publications were
263
reports of experimental testing of the safety or efficacy264
of a particular device (Belforte et al., 2001; Esquenazi
265
et al., 2012; Farris et al., 2011, 2012, 2014; Ikehara et266
al., 2011; Kawamoto et al., 2010; Kolakowsky-Hayner,267
2013; Mori et al., 2006; Neuhaus et al., 2011; Quin-268
tero et al., 2012; Sanz-Merodio et al., 2012; Strausser
269
& Kazerooni, 2011; Strausser et al., 2010; Sylos-Labini
270
et al., 2014; Talaty et al., 2013; Tsukahara et al., 2009,
271
2010; Zeilig et al., 2012); 22% (n= 6) were uncontrolled272
clinical trials evaluating the rehabilitative effectiveness
273
of a specific device in the context of a specific condition
274
(Aach et al., 2013, 2014; Bishop et al., 2012; Nilsson275
et al., 2014; Sczesny-Kaiser et al., 2013; Spungen et
276
al., 2013); and 7% (n= 2) were controlled clinical trials277
evaluating the rehabilitative effectiveness of a specific278
device in the context of a specific condition (Stein et al.,279
2014; Watanabe et al., 2014).
280
Three types of indicators or data were used in the281
included studies:282
Clinical indicators were used to characterize
283
baseline functioning e.g. isometric muscle284
strength (hip flexion and extension, knee flexion
285
and extension, trunk flexion and extension,
286
ankle dorsi-/plantar flexion) and lower extremity287
circumferences.
288
Outcome indicators (standardized tests, neuro-289
physiological or neuroimaging techniques) were290
used to evaluate treatment effectiveness.291
Observational data on participants’ functioning292
whilst they were wearing the exoskeleton e.g. knee293
joint angle or torque, video recordings of a partici-
294
pant walking, hip and knee joint angle trajectories
295
during walking, time spent practicing, distance
296
walked in a certain time period, etc.
297
Table 2 provides details of the indicators and the298
studies in which they were used.299
In the following sub-sections we review the evi-300
dence relating to the 14 different exoskeletons (Hybrid301
Assistive Limb, HAL; ReWalk; Vanderbilt Lower Limb
302
Exoskeleton; Human Universal Load Carrier, HULC;303
MINDWALKER Exoskeleton; Advanced Reciprocat-304
ing Gait Orthosis, ARGO; Walking Assistance Device;305
eLEGS; X1 Robotic Exoskeleton, MINA; ATLAS;306
ABLE system; Tibion Bionic Technologies; Bionic307
Leg; Ekso). We consider the type of device, partici-308
pant inclusion criteria, study objectives, indicators, and309
intervention outcomes. Because of the variability in310
study design, sample type, nature of intervention, and311
outcome indicators we evaluated the included studies312
through separate qualitative syntheses for each device 313
rather than carrying out a meta-analysis. 314
Hybrid Assistive Limb (HAL). Eight publications 315
reported on the HAL exoskeleton developed by 316
Tsukuba University, Japan and the robotics company 317
Cyberdyne (Aach et al., 2013, 2014; Kawamoto et al., 318
2010; Nilsson et al., 2014; Sczesny-Kaiser et al., 2013; 319
Tsukahara et al., 2009, 2010; Watanabe et al., 2014) 320
(Table 1). 321
The studies involved 49 participants, of whom 16 322
were enrolled in Germany, 8 in Sweden, and 25 in 323
Japan. Most of these subjects (n= 31) had hemiparesis 324
after a stroke; the remainder had a SCI at the T10 level 325
resulting in complete paraplegia (n= 10) or incomplete 326
paraplegia (n= 8). The most studies specified these 327
inclusion criteria for participants: experienced stroke or 328
SCI less than seven weeks before the start of the study; 329
able to sit on a bench for at least five minutes with or 330
without supervision; unable to walk independently due 331
to paresis of lower limbs with/without somato-sensory 332
impairment and with/without spasticity; sufficient pos- 333
tural control to maintain an upright, standing position 334
with aids and/or manual support; the ability to under- 335
stand training instructions and written and oral study 336
information and the capacity to give informed consent; 337
sufficient motor function in the hip and knee extensor 338
and flexor muscle groups to trigger the exoskeleton; 339
body size compatible with the HAL suit. 340
In all eight studies, the main goal was to evaluate 341
the device in terms of safety, feasibility, and ability to 342
increase the motor skills of patients with chronic com- 343
plete or incomplete paraplegia. Secondary goals were 344
variable: production of standing-up and sitting motion 345
support systems for completely paraplegic patients 346
(Tsukahara et al., 2009, 2010), and in another study 347
to develop and test a method of controlling volun- 348
tary motion using bioelectrical signals generated by the 349
patient (Kawamoto et al., 2010). Two studies conducted 350
in Germany in 2103 investigated the effectiveness of the 351
HAL device (Aach et al., 2013; Sczesny-Kaiser et al., 352
2013). Aach et al. (2013, 2014) evaluated initial func- 353
tional rehabilitation of gait using the supported active 354
ROM mode of HAL. Sczesny-Kaiser et al. (2013) eval- 355
uated cortical excitability and plastic changes after a 356
three-month period of treadmill training supported by 357
HAL. Nilsson et al. (2014) assessed the safety and fea- 358
sibility of the HAL exoskeleton in a European sample. 359
Watanabe et al. (2014) compared the effectiveness of 360
the single-leg version of the HAL with conventional gait 361
training in a sample of Japanese patients with sub-acute 362
stroke. 363
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10 S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation
Table 2
Summary of the measures adopted in the studies included, ordered by largest to smallest frequency of use
Measure Abbreviation Frequency Measure Study where the Measures’
Type measure was administered References
Timed-Up-and-Go test TUG 9 outcome measure Aach et al., 2013. Podsiadlo & Richardson, 1991.
Aach et al., 2014.
Bishop et al., 2012.
Farris et al., 2014.
Nilsson et al., 2014.
Quintero et al., 2012.
Stein et al., 2014.
Watanabe et al., 2014.
Zeilig et al., 2012.
10-Meter Walk Test 10MWT 8 outcome measure Aach et al., 2013. Peters, Middleton, Donley,
Aach et al., 2014. Blanck, & Fritz, 2014.
Bishop et al., 2012.
Esquenazi et al., 2012.
Farris et al., 2014.
Nilsson et al., 2014.
Stein et al., 2014.
Zeilig et al., 2012.
6-Minutes Walking Test 6MWT 6 outcome measure Aach et al., 2014. Reybrouck, 2003.
Bishop et al., 2012.
Esquenazi et al., 2012.
Farris et al., 2014.
Stein et al., 2014.
Watanabe et al., 2014.
Knee joint angle or torque / 6 observation measure Farris et al., 2011. /
Farris et al., 2012.
Kawamoto et al., 2010.
Strausser & Kazerooni, 2011.
Tsukahara et al., 2009.
Tsukahara et al., 2010.
Walking speed / 6 observation measure Aach et al., 2013. /
Farris et al., 2011.
Nilsson et al., 2014.
Spungen et al., 2013.
Talaty et al., 2013.
Watanabe et al., 2014.
Distance walked in a / 4 observation measure Aach et al., 2013. /
certain time period Esquenazi et al., 2012.
Kolakowsky-Hayner, 2013.
Zeilig et al., 2012.
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S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation 11
Berg Balance Scale BBS 3 outcome measure Bishop et al., 2012. Downs, Marquez,
Nilsson et al., 2014. & Chiarelli, 2013.
Stein et al., 2014.
Electromyography EMG 3 outcome measure Sczesny-Kaiser et al., 2013. Mohseni Bandpei
Sylos-Labini et al., 2014. et al., 2014.
Talaty et al., 2013.
Video recording / 3 observation measure Ikehara et al., 2011. /
of subject’s walking Strausser et al., 2010.
Talaty et al., 2013.
Ashworth Scale / 2 outcome measure Aach et al., 2014. Pandyan et al., 1999.
Kolakowsky-Hayner, 2013.
Fugl-Meyer assessment FM-LE 2 outcome measure Nilsson et al., 2014. Park & Choi, 2014.
for Lower Extremity Watanabe et al., 2014.
Functional Ambulation FAC 2 outcome measure Nilsson et al., 2014. Mehrholz, Wagner, Rutte,
Category Watanabe et al., 2014. Meissner, & Pohl, 2007.
Isometric muscle strength / 2 clinical measure Talaty et al., 2013. /
(hip/knee/trunk flexion and Watanabe et al., 2014.
extension, ankle dorsi-/
plantar flexion)
Time practicing / 2 observation measure Strausser & Kazerooni, 2011. /
Kolakowsky-Hayner, 2013.
Walking Index for SCI II WISCI II 2 outcome measure Aach et al., 2013. Ditunno et al., 2013.
Aach et al., 2014.
Assistive devices used / 1 observation measure Kolakowsky-Hayner, 2013. /
during ambulation
Barthel Index BI 1 outcome measure Nilsson et al., 2014. Cuesta-Vargas &
Perez-Cruzado, 2014.
Braden Scale for Predicting / 1 outcome measure Kolakowsky-Hayner, 2013. Bergstrom, Braden,
Pressure Sore Risk Laguzza, & Holman, 1987.
California Functional Evaluation 40 CAFE 40 1 outcome measure Stein et al., 2014. Fung et al., 1997.
Clinical Outcome Variable S-COVS 1 outcome measure Nilsson et al., 2014. Andersson & Franzen, 2015.
Scale, Swedish Version
Conversation with the / 1 observation measure Neuhaus et al., 2011. /
user during walking
Emory Functional EFAP 1 outcome measure Stein et al., 2014. Wolf et al., 1999.
Ambulation Profile
Falls-Efficacy Scale, FES(S) 1 outcome measure Nilsson et al., 2014. Hellstrom, Lindmark, &
Swedish Version Fugl-Meyer, 2002.
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12 S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation
Table 2
(Continued)
Measure Abbreviation Frequency Measure Study where the Measures’ References
Type measure was administered
Timed-Up-and-Go test TUG 9 outcome measure Aach et al., 2013. Podsiadlo & Richardson, 1991.
Five-Times-Sit- 5XSST 1 outcome measure Stein et al., 2014. Whitney et al., 2005.
to-Stand Test
Functional Independence Measure FIM 1 outcome measure Nilsson et al., 2014. Saji et al., 2015.
Functional Magnetic fMRI 1 outcome measure Sczesny-Kaiser et al., 2013. Buxton, 2013.
Resonance Imaging
Kinematic magnitudes and / 1 observation measure Belforte et al., 2001. /
exchanged forces
Level of functional / 1 clinical measure Kolakowsky-Hayner, 2013. /
mobility
Losses of balance / 1 observation measure Kolakowsky-Hayner, 2013. /
Lower extremity / 1 clinical measure Aach et al., 2014. /
circumference
Lower Extremity LEMS 1 outcome measure Aach et al., 2014. Shin, Yoo, Jung, & Goo, 2011.
Motor Score
National Institutes of NIHSS 1 outcome measure Nilsson et al., 2014. Yang, Zhang, & Gao, 2014.
Health Stroke Scale
Number of falls / 1 observation measure Kolakowsky-Hayner, 2013. /
Proprioception / 1 clinical measure Kolakowsky-Hayner, 2013. /
Range of motion / 1 clinical measure Kolakowsky-Hayner, 2013. /
Romberg’s Test / 1 outcome measure Stein et al., 2014. Agrawal, Carey, Hoffman,
Sklare, & Schubert, 2011.
Rotations and applied / 1 observation measure Belforte et al., 2001. /
torques for each joint
Short Physical SPPB 1 outcome measure Watanabe et al., 2014. Stookey, Katzel, Steinbrenner,
Performance Battery Shaughnessy, & Ivey, 2014.
Spasticity / 1 clinical measure Kolakowsky-Hayner, 2013. /
Step length / 1 observation measure Kolakowsky-Hayner, 2013. /
Subjective Pain Scale SPS 1 outcome measure Kolakowsky-Hayner, 2013. /
Time and level / 1 observation measure Kolakowsky-Hayner, 2013. /
of assistance
Time response of the / 1 observation measure Mori et al., 2006. /
angles and electric
currents of each joint
Upper and lower / 1 clinical measure Kolakowsky-Hayner, 2013. /
extremity motor function
Visual Analogue Scale VAS 1 outcome measure Nilsson et al., 2014. Reed & Van Nostran, 2014.
[EndNote codes for generating bibliography in ‘References’: (Agrawal, Carey, Hoffman, Sklare, & Schubert, 2011; Andersson & Franzen, 2015; Bergstrom, Braden, Laguzza, & Holman,
1987; Buxton, 2013; Cuesta-Vargas & Perez-Cruzado, 2014; Ditunno et al., 2013; Downs, Marquez, & Chiarelli, 2013; Fung et al., 1997; Hellstrom, Lindmark, & Fugl-Meyer, 2002; Mehrholz,
Wagner, Rutte, Meissner, & Pohl, 2007; Mohseni Bandpei et al., 2014; Pandyan et al., 1999; Park & Choi, 2014; Peters, Middleton, Donley, Blanck, & Fritz, 2014; Podsiadlo & Richardson,
1991; Reed & Van Nostran, 2014; Reybrouck, 2003; Saji et al., 2015; Shin, Yoo, Jung, & Goo, 2011; Stookey, Katzel, Steinbrenner, Shaughnessy, & Ivey, 2014; Whitney et al., 2005; Wolf et
al., 1999; Yang, Zhang, & Gao, 2014)].
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S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation 13
The clinical, observational, and outcome data used to
364
evaluate the effectiveness of HAL varied, for example365
Sczesny-Kaiser et al. (2013) used functional mag-
366
netic resonance imaging (fMRI) and electromyography367
(EMG) to evaluate cortical excitability and plastic368
changes after a three-month period of treadmill training369
supported by HAL.
370
Taken together, these studies provide convincing
371
evidence of the safety (Nilsson et al., 2014) and effec-
372
tiveness of HAL. Paraplegic patients’ functional ability373
to walk over ground improved (Aach et al., 2013,
374
2014) and the knee angle measured during leg flexion
375
increased (Kawamoto et al., 2010). Diagnostic imaging376
showed enhanced paired-pulse inhibition of somatosen-
377
sory evoked potentials in both hemispheres following378
median nerve stimulation at the wrist and reduced S1379
activation of the relevant area in both hemispheres after380
tactile stimulation of the index finger (Sczesny-Kaiser
381
et al., 2013). Finally, a gait training program using382
the single-leg version of HAL facilitated independent383
walking more effectivelythan conventional gait training
384
(Watanabe et al., 2014).
385
ReWalk. We found four papers in which the ReWalk386
exoskeleton (by ReWalk Robotics, Inc.) was tested387
(Esquenazi et al., 2012; Spungen et al., 2013; Talaty388
et al., 2013; Zeilig et al., 2012) (Table 1). These clini-389
cal trials involved 37 participants with complete SCIs390
of whom 30 were injured at the C7-T12 level and 7
391
at the T1-T12 level. All the patients were paraplegic;392
31 were recruited in the USA and 6 in Israel. The
393
inclusion criteria were: motor-complete cervical (C7-
394
8) or thoracic (T1-T12) SCI according to the American395
Spinal Injury Association (ASIA) guidelines (Ameri-
396
can Spinal Injury Association & International Medical
397
Society of Paraplegia, 2000); male sex or not being398
pregnant or lactating, age between 16 and 70 years;399
injury occurrence at least six months prior to enrolment400
in the study; regular use of reciprocating gait ortho-
401
sis (RGO) or knee-ankle-foot-orthosis (KAFOs); use402
of standing devices; and body size compatible with the403
ReWalk suit.
404
The main objectives of all studies were to assess405
the safety and tolerability of the ReWalk device.406
Various secondary objectives were also investigated,407
e.g. evaluation of the effectiveness of the ReWalk in408
enabling paraplegic patients to carry out routine ambu-409
latory functions (Esquenazi et al., 2012); investigation410
of inter-individual variability in walking kinematics411
(Talaty et al., 2013); evaluation of the number of train-412
ing sessions and level of assistance needed to achieve413
specific exoskeleton-assisted mobility skills such as414
standing, walking, and stair climbing; identification of 415
additional indoor and outdoor mobility skills critical to 416
successful use of ReWalk in the home or community 417
(Spungen et al., 2013). 418
Taken together, these eight studies demonstrated that, 419
using the ReWalk, paraplegic patients were able to 420
achieve a level of walking proficiency that was close 421
to that needed for limited ambulation in an urban com- 422
munity setting (Esquenazi et al., 2012; Spungen et al., 423
2013), for example, for a distance of 100 meters (Zeilig 424
et al., 2012), and that the device enabled fundamentally 425
symmetrical gait (Talaty et al., 2013). 426
Vanderbilt Lower Limb Exoskeleton was tested in 427
four studies carried out by a team of engineers from 428
Vanderbilt University, Nashville, Tennessee, chaired 429
by Quintero (Farris et al., 2011, 2012, 2014; Quintero 430
et al., 2012) (Table 1). These clinical trials involved 431
four paraplegic patients with motor- and sensory- 432
complete SCIs at the T10 level who were recruited in 433
the USA. 434
In their first study Farris et al. (2011) assessed the 435
impact on gait of providing assistive torque at both 436
hip and knee joints using the Vanderbilt lower limb 437
exoskeleton. A year later the research team imple- 438
mented and tested the exoskeleton’s stair ascending and 439
descending capabilities (Farris et al., 2012). Finally, 440
in 2014 they compared the mobility afforded by the 441
Vanderbilt exoskeleton and KAFOs, and the level of 442
exertion required to use the devices. The Vander- 443
bilt lower limb exoskeleton system enabled paraplegic 444
patients to walk faster (Farris et al., 2012, 2014), with 445
knee and hip joint amplitudes similar to those observed 446
in walking in people without a SCI (Farris et al., 447
2011). 448
Human Universal Load Carrier (HULC) was devel- 449
oped by Kazerooni and colleagues at Ekso Bionics, 450
USA. The HULC is designed to assist able-bodied indi- 451
viduals by powering knee extension movements so it is 452
unsurprising that only one study of its effectiveness met 453
our inclusion criteria (Strausser et al., 2010) (Table 1). 454
In this study the standard HULC, which has single- 455
acting hydraulic cylinders, was replaced with a version 456
with double-acting hydraulic cylinders that provided 457
powered flexion and extension at the knee, and the 458
bracing used in the standard device was augmented 459
to provide support for patients with limited leg and 460
torso muscle control. This clinical trial involved four 461
paraplegic patients with a motor-complete SCI at the 462
T5-T10 level who were enrolled in the USA. 463
The aim of the study was to establish whether an 464
exoskeleton developed for medical use would enable 465
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14 S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation
paraplegic people to lead a more active life and thus
466
reduce the incidence of secondary complications. The467
results confirmed that when adapted for medical use
468
the HULC exoskeleton is a safe and effective method469
of improving the mobility of people who are unable to470
walk unaided.471
MINDWALKER was developed in 2009 by a Euro-
472
pean Commission-funded consortium coordinated by
473
Ilzkovitz. We reviewed only one study related to the
474
project (Sylos-Labini et al., 2014) (Table 1), a clini-475
cal trial involving ten participants recruited in Italy; six
476
were healthy and four had a SCI at the T7-L1 level.
477
The aim of this study was to quantify muscle activ-478
ityduring MINDWALKER-aided walkingina sample of
479
intactand injured patients. The data collected were EMG480
activity, joint angles, and torques. In SCI patients, EMG481
activity in the upper limb muscles was augmented when482
using the MINDWALKER, although there was little leg
483
muscleactivity.Contrarytoexpectations,however, inthe484
neurologically intact subjects, leg muscle EMG activity485
was similar or greater during exoskeleton-assisted walk-
486
ing than during normal walking on a flat surface. EMG
487
waveformsvariedsignificantly across the differentwalk-488
ing conditions; variability was greatest in the hamstring489
muscles. Overall, the results are consistent with a non-490
linear reorganization of locomotor output when using491
this robotic walking device.492
Advanced Reciprocating Gait Orthosis (ARGO).
493
Only one study in our review tested the ARGO, pro-494
duced by RSLsteeper, in paraplegic patients (Belforte
495
et al., 2001) (Table 1). This was a clinical trial involving
496
one participant (single subject design) with a motor-497
complete SCI at the T3 level, and was carried out in
498
Italy. The report described the design and construction
499
of the ARGO and the experimental testing of its effects500
on locomotion in paraplegic subjects. It concluded that501
the device is ideal for rehabilitation, owing to its mod-502
ular structure and flexible approach to regulating gait
503
characteristics.504
Walking Assistance Device, a close-fitting walking505
assistance device with self-contained control systems,
506
is produced by Honda, Japan; it was developed and507
tested by a team of engineers led by Ikehara. Only one of508
their studies was eligible for the present review (Ikehara509
et al., 2011) (Table 1). This clinical study involved two510
participants with motor paralysis who were enrolled in511
Japan and it showed that the device could reproduce the512
power of kicking motions at ankle joints. Ikehara et al.513
(2011) claimed that persons using Walking Assistance514
Device may walk freely in both indoor and outdoor515
environments.516
eLEGS. In 2010 the Berkeley Robotics and Human 517
Engineering Laboratory, University of California, 518
directed by Kazerooni, presented the eLEGS exoskele- 519
ton developed by Strausser (Strausser & Kazerooni, 520
2011) (Table 1). 521
The clinical trial included in our review took place 522
in the USA. It tested whether the eLEGS device was 523
intuitive, and easy to learn to use in a sample of five 524
participants with no leg motion as a result of SCI or 525
ataxia. The indicators used were knee angle and time 526
spent practicing. The eLEGS human machine interface 527
(HMI) was found to be easy to use; all five sub- 528
jects quickly learnt how to use it. When walking in 529
the eLEGS the five participants had a longer interval 530
between heel lift and step than an able-bodied user. This 531
interval was shorter in experienced users: in users with 532
no experience with the device the average heel lift-to- 533
step interval was 0.859 seconds, whereas in experienced 534
users it was reduced to 0.590 seconds. 535
X1 Robotic Exoskeleton (MINA) was the outcome 536
of a collaboration between the Institute for Human and 537
Machine Cognition and the NASA Johnson Space Cen- 538
ter led by Neuhaus (Neuhaus et al., 2011) (Table 1). 539
The team carried out a clinical trial in the USA which 540
involved two participants with motor-complete SCIs 541
at the T10 level. The inclusion criteria stipulated an 542
ASIA impairment score of either A (complete) or B 543
(incomplete), and a Walking Index for Spinal Cord 544
Injury (WISCI) level 9 (9: ambulates with walker, 545
with braces and no physical assistance, 10 meters). 546
The paper presents an evaluation of the rehabilitative 547
value of the MINA exoskeleton. The cognitive effort 548
required to use MINA was evaluated qualitatively in 549
terms of how easily participants could converse with 550
the researchers whilst walking in the MINA device. 551
Static standing balance stability was assessed by ask- 552
ing participants to catch and throw a ball whilst standing 553
on both legs, using one crutch for balance. The results 554
indicated that MINA facilitated walking mobility in 555
paraplegics, allowing them to achieve speeds of up to 556
0.20 m/s. The MINA device is not physically taxing to 557
use and requires minimal cognitive effort. Cognitive 558
load was evaluated indirectly by measuring the propor- 559
tion of time for which a user was able to maintain a 560
conversation and maintain eye contact whilst walking 561
in the device. 562
ATLAS. The Centre for Automation and Robotics 563
in Spain developed the prototype of the ATLAS 564
exoskeleton to help a quadriplegic child to walk. The 565
development and main features of the device were 566
described by Sanz-Merodio et al. (2012) (Table 1). 567
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S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation 15
The clinical trial included in our review involved
568
one participant (single subject design), an eight-year-569
old quadriplegic Spanish girl. Experiments confirmed
570
that when using the device the participant was able to571
follow the gait pattern generated by the parameterized572
trajectory generator.573
ABLE. The ABLE system (Mori et al., 2006) was
574
designed and tested in the Department of Intelli-
575
gent Systems Engineering Ibaraki University, Japan
576
(Table 1).577
The clinical trial included our review involved one
578
participant (single subject design) with motor paraly-
579
sis and was carried out in Japan. Mori and colleagues580
developed “a standing style transfer system” for a per-
581
son with disabled legs. They compared this movement582
technique with their previous system (Mori, Takayama,583
Zengo, & Nakamura, 2004). The indicators used to eval-584
uate the device were response times, joint angles, and
585
power consumption of the device, corresponding with586
the torque of each joint. The participant succeeded in587
standing up with the aid of the device; a large arm force
588
was needed in the beginning, but not after the standing
589
motion had been initiated.590
Tibion Bionic Technologies. In 2013 Tibion Bionic591
Technologies was acquired by AlterG and the exoskele-592
ton tested by the team at Columbia University (Bishop593
et al., 2012) (Table 1) is now produced by AlterG. The594
clinical trial included in our review was carried out
595
in the USA and involved one participant (single sub-596
ject design) with motor-incomplete SCI at the C5-C6
597
level. The results suggested that the device is a practical
598
and useful supplement to standard physical therapy for599
incomplete SCI.
600
Bionic Leg, which is produced by the Californian
601
company AlterG, is a powered knee orthosis for patients602
with unilateral neurological or orthopedic conditions.603
It was tested in the Department of Rehabilitation604
and Regenerative Medicine, Columbia University Col-
605
lege of Physicians and Surgeons (Stein et al., 2014)606
(Table 1).607
The clinical trial included in our review involved 20
608
participants from the USA who had hemiparesis after609
a stroke. The main inclusion criterion for this study610
was having suffered a single stroke (ischemic or hem-611
orrhagic) which had caused significant leg weakness612
and alterations in gait alterations at least 6 months613
before entry to the study. The stroke had to have been614
confirmed using computed tomography or MRI. Partic-615
ipants for whom the clinical history indicated a single616
stroke whilst the imaging studies provided evidence617
of previous asymptomatic strokes were considered eli-618
gible for participation. Participants had to be capable 619
of independent ambulation in the home (with or with- 620
out the use of unilateral assistive devices or ankle or 621
foot orthoses); the study was designed to test how the 622
Bionic Leg restored mobility in the living environments 623
to stroke survivors. The results suggested that robotic 624
knee brace therapy for ambulatory stroke patients with 625
chronic hemiparesis delivered only modest additional 626
functional benefits when compared with an exercise- 627
only intervention. 628
Ekso. One publication reported on the Ekso exoskele- 629
ton developed by the robotics company Ekso Bionics 630
(Kolakowsky-Hayner, 2013) (Table 1). 631
This study involved seven participants with motor- 632
complete SCI and took place in the USA. The main 633
inclusion criterion was body size compatible with the 634
Ekso suit. The feasibility and safety of the device was 635
evaluated in a sample of SCI patients who had com- 636
pleted their initial SCI rehabilitation. The effects of 637
training with the device were evaluated in terms of time 638
tolerated, distance walked, and assistance needed whilst 639
in Ekso. The results suggested that Ekso is safe for 640
use by people with a complete thoracic SCI in a con- 641
trolled environment and may enhance mobility in those 642
without volitional lower extremity function. 643
4. Discussion and conclusions 644
We have reviewed the clinical effectiveness of var- 645
ious types of active, powered, wearable lower limb 646
exoskeletons for the rehabilitation of gait disorders 647
in paraplegic patients resulting from central ner- 648
vous system lesions caused by, for example, SCIs 649
or CVAs. 650
The most commonly studied exoskeletons were the 651
HAL (Aach et al., 2013, 2014; Kawamoto et al., 2010; 652
Nilsson et al., 2014; Sczesny-Kaiser et al., 2013; Tsuka- 653
hara et al., 2009, 2010; Watanabe et al., 2014), ReWalk 654
(Esquenazi et al., 2012; Spungen et al., 2013; Talaty 655
et al., 2013; Zeilig et al., 2012), and the Vanderbilt 656
lower limb exoskeleton (Farris et al., 2011, 2012, 2014; 657
Quintero et al., 2012). 658
Studies of exoskeleton use in neurorehabilitation 659
contexts have mostly evaluated the safety of the devices, 660
the physical and cognitive effort required to use them, 661
how easy it is to learn to use them and how effectively 662
they enhance patients’ gait. 663
The studies confirmed that the HAL, Tibion Bionic 664
Technologies, and Ekso devices were safe to use in con- 665
trolled environments, and with the assistance of expert 666
Uncorrected Author Proof
16 S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation
professionals (i.e., physiotherapists) (Bishop et al.,
667
2012; Kolakowsky-Hayner, 2013; Nilsson et al., 2014).668
We found no studies evaluating the effectiveness of
669
exoskeletons outside laboratory or clinical settings, and670
hence no evidence of their effectiveness in everyday671
living environments, for example for walking on rough672
surfaces such as a sidewalk or a staircase with uneven
673
steps.
674
The physical exertion involved in using exoskeletons
675
has been little studied. Neuhaus et al. (2011) measured676
users’ pulse rate, respiration rate, skin color, and perspi-
677
ration level when using the MINA device. Given that
678
we reviewed studies of the effectiveness of exoskele-679
tons for rehabilitation purposes, it is striking that only
680
one reported data on physical exertion. The target users681
of exoskeletons are patients who have suffered physical682
trauma, so future research should also evaluate device683
characteristics such as wearability and the relationship
684
between the weight of the device and the physical exer-685
tion required to use it.686
Information about the usability and cognitive load
687
associated with the exoskeleton was reported for MINA
688
(Neuhaus et al., 2011), Tibion Bionic Technologies689
(Bishop et al., 2012), and eLEGS (Strausser & Kaze-690
rooni, 2011). Cognitive load and usability were the691
only psychological variables investigated in the selected692
studies and in most cases data were based on sim-693
ple observations of user behavior rather than objective,
694
standardized instruments. The experimental set-up used695
by Neuhaus et al. (2011) was designed to measure users’
696
cognitive “effort”; however the analysis was limited
697
to qualitative indicators (ability to maintain eye con-698
tact and have a conversation with the evaluator whilst
699
walking in MINA). It has been argued that interna-
700
tional scientific literature on rehabilitation pays very701
little attention to personal factors (Meloni, Federici, &702
Stella, 2011; Meloni et al., 2012) and that, in partic-703
ular, it neglects the psychological variables involved
704
in matching people with assistive technology (Corradi,705
Scherer, & Lo Presti, 2012). At present there is little706
indication of psychological variables within biopsy-
707
chosocial approach to neurorehabilitation (Williams708
& Edwards, 2003). Psychological variables should be709
taken into account alongside biological and social710
variables when considering the effectiveness of tech-711
nological aids (Federici & Scherer, 2012).712
Almost all the studies we reviewed investigated713
gait enhancement, only the two studies carried out by714
Tsukahara et al. (2009, 2010) focused solely on device715
safety. The findings converged: all the exoskeletons,716
except the Bionic Leg, were reported to facilitate717
restoration of gait patterns comparable to normal walk- 718
ing on flat ground. Stein et al. (2014) found that 719
robotic therapy using Bionic Leg produced only modest 720
functional benefits comparable with those of a group 721
exercise intervention. Bishop et al. (2012) assessed a 722
unilateral prosthesis similar to the Bionic Leg, namely 723
the Tibion Bionic Technologies device which was 724
developed to provide assistance and training for patients 725
with unilateral neurological or orthopedic conditions. 726
They found that this robotic device was a practical, use- 727
ful adjunct to standard training; however unlike Stein 728
et al. (2014) they did not compare the performance of 729
the group using the exoskeleton with a control group. 730
In addition to the advantages noted, we consider that 731
all the exoskeletons could be considered as ecologi- 732
cal devices, namely usable in daily living environments 733
not only in a rehabilitation setting. Using an exoskele- 734
ton can improve patients’ autonomy; simply wearing 735
the device can enable them to walk independently. 736
No other neurorehabilitative or therapeutic technique 737
or technology offers such an extraordinary potential 738
gain in autonomy. However, given that it has not been 739
shown that exoskeletons are effective in home, work, 740
and daily living environments, their ecological poten- 741
tiality remains not experimentally verified. 742
Some limitations to the neurorehabilitative use of 743
exoskeletons must be noted. First, the wearability cri- 744
teria are too restrictive; they can only be used by 745
people in specific height and weight ranges (Esquenazi 746
et al., 2012; Nilsson et al., 2014; Spungen et al., 2013; 747
Sylos-Labini et al., 2014). Second, very complex and 748
specialized training is required to enable an individual 749
to use an exoskeleton autonomously at home. Third, 750
they are still extremely expensive devices and the cost 751
is not always covered by private or public healthcare 752
systems. For instance, most European health services 753
support the use of exoskeletons as part of rehabilita- 754
tion programs delivered in specialized medical centers, 755
but not private use in an individual’s home or work- 756
place. Fourth, there is a dearth of experimental evidence 757
demonstrating that exoskeletons are more effective than 758
other rehabilitative techniques and technologies. Our 759
sample included only two studies which adopted a ran- 760
domized clinical trial design comparing exoskeleton 761
use to conventional gait training (Stein et al., 2014; 762
Watanabe et al., 2014) and the results of these two 763
studies were contradictory. Fifth, none of the publica- 764
tions we reviewed analyzed users’ experiences with an 765
exoskeleton in activities of daily living. A final limita- 766
tion is the neglect of psychological factors; for instance 767
none of the studies we reviewed reported data on 768
Uncorrected Author Proof
S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation 17
psychological reactions to trauma (post-traumatic stress
769
disorder, depression, anxiety, perception of pain, body770
image perception, etc.) (McMillan, Williams, & Bryant,
771
2003) and their potential effect on acceptance and use772
of the exoskeleton.773
Conflict of interest774
The authors declare that there are no conflicts of775
interest or funding regarding publication of this paper.776
References777
Aach, M., Cruciger, O., Sczesny-Kaiser, M., Hoffken, O., Meindl,778
R. C., Tegenthoff, M., et al. (2014). Voluntary driven exoskele-779
ton as a new tool for rehabilitation in chronic spinal cord780
injury: A pilot study. Spine Journal,14(12), 2847-2853.
781
doi:10.1016/J.Spinee.2014.03.042
782
Aach, M., Meindl, R., Hayashi, T., Lange, I., Geßmann, J., Sander,
783
A., et al. (2013). Exoskeletal Neuro-Rehabilitation in Chronic784
Paraplegic Patients – Initial Results. In J. L. Pons, D. Torricelli, &785
M. Pajaro (Eds.), Converging Clinical and Engineering Research786
on Neurorehabilitation (pp. 233-236). Berlin, DE: Springer.787
Agrawal, Y., Carey, J. P., Hoffman, H. J., Sklare, D. A., & Schubert,
788
M. C. (2011). The modified Romberg Balance Test: Normative
789
data in U.S. adults. Otology and Neurotology,32(8), 1309-1311.790
doi:10.1097/MAO.0b013e31822e5bee
791
American Spinal Injury Association, & International Medical Society792
of Paraplegia (2000). International Standards for Neurological793
and Functional Classification of Spinal Cord Injury Patients.794
Chicago, IL: ASIA.795
Andersson, P., & Franzen, E. (2015). Effects of weight-shift train-796
ing on walking ability, ambulation, and weight distribution in797
individuals with chronic stroke: A pilot study. Topics in Stroke798
Rehabilitation. doi:10.1179/1074935715Z.00000000052799
Belforte, G., Gastaldi, L., & Sorli, M. (2001). Pneumatic active800
gait orthosis. Mechatronics,11(3), 301-323. doi:10.1016/S0957-801
4158(00)00017-9802
Bergstrom, N., Braden, B. J., Laguzza, A., & Holman, V. (1987).
803
The Braden Scale for Predicting Pressure Sore Risk. Nursing804
Research,36(4), 205-210.
805
Bishop, L., Stein, J., & Wong, C. K. (2012). Robot-aided gait train-806
ing in an individual with chronic spinal cord injury: A case807
study. Journal of Neurologic Physical Therapy,36(3), 138-143.808
doi:10.1097/NPT.0b013e3182624c87809
Bogue, R. (2009). Exoskeletons and robotic prosthetics: A review810
of recent developments. Industrial Robot,36(5), 421-427.811
doi:10.1108/01439910910980141812
Buxton, R. B. (2013). The physics of functional magnetic resonance813
imaging (fMRI). Reports on Progress in Physics,76(9), 096601.814
doi:10.1088/0034-4885/76/9/096601815
Carpino, G., Accoto, D., Tagliamonte, N. L., Ghilardi, G., &816
Guglielmelli, E. (2013). Lower limb wearable robots for phys-
817
iological gait restoration: State of the art and motivations.818
Methodology & Education for Clinical Innovation,21(2), 72-80.
819
Chaigneau, D., Arsicault, M., Gazeau, J. P., & Zeghloul, S. 820
(2008). LMS robotic hand grasp and manipulation planning (an 821
isomorphic exoskeleton approach). Robotica,26(2), 177-188. 822
doi:10.1017/S0263574707003736 823
Corradi, F., Scherer, M. J., & Lo Presti, A. (2012). Measuring the 824
Assistive Technology Match. In S. Federici & M. J. Scherer 825
(Eds.), Assistive Technology Assessment Handbook (pp. 49-65). 826
London, UK: CRC Press. 827
Cuesta-Vargas, A. I., & Perez-Cruzado, D. (2014). Relationship 828
between Barthel index with physical tests in adults with 829
intellectual disabilities. Springerplus,3(543). doi:10.1186/2193- 830
1801-3-543 831
del-Ama, A. J., Koutsou, A. D., Moreno, J. C., de-los-Reyes, 832
A., Gil-Agudo, ´
A., & Pons, J. L. (2012). Review of hybrid 833
exoskeletons to restore gait following spinal cord injury. Jour- 834
nal of Rehabilitation Research and Development,49(4), 497-514. 835
doi:10.1682/JRRD.2011.03.0043 836
D´
ıaz, I., Gil, J. J., & S´
anchez, E. (2011). Lower-Limb Robotic Reha- 837
bilitation: Literature Review and Challenges. Journalof Robotics,838
2011, 1-11. doi:10.1155/2011/759764 839
Dietz, V., Nef, T., & Rymer, W. Z. (Eds.). (2012). Neurorehabilitation 840
Technology. London, UK: Springer. 841
Dietz, V., & Ward, N. (Eds.). (2015). Oxford Textbook of Neuroreha- 842
bilitation. Oxford, UK: Oxford University Press. 843
Ditunno, J. F. J., Ditunno, P. L., Scivoletto, G., Patrick, M., Dijk- 844
ers, M., Barbeau, H., et al. (2013). The Walking Index for 845
Spinal Cord Injury (WISCI/WISCI II): Nature, metric proper- 846
ties, use and misuse. Spinal Cord,51(5), 346-355. doi:10.1038/sc. 847
2013.9 848
Dollar, A. M., & Herr, H. (2007). Active orthoses for the lower-limbs: 849
Challenges and state of the art. Paper presented at the 10th IEEE 850
International Conference on Rehabilitation Robotics, Noordwijk, 851
NL. 852
Dollar, A. M., & Herr, H. (2008). Lower Extremity Exoskele- 853
tons and Active Orthoses: Challenges and State-of-the-Art. 854
IEEE Transactions on Robotics,24(1), 144-158. doi:10.1109/ 855
TRO.2008.915453 856
Downs, S., Marquez, J., & Chiarelli, P. (2013). The Berg Balance 857
Scale has high intra- and inter-rater reliability but absolute relia- 858
bility varies across the scale: A systematic review. J Physiother,859
59(2), 93-99. doi:10.1016/S1836-9553(13)70161-9 860
Esquenazi, A., & Packel, A. (2012). Robotic-assisted gait train- 861
ing and restoration. American Journal of Physical Medicine 862
and Rehabilitation,91(11 Suppl 3), 217-227. doi:10.1097/ 863
PHM.0b013e31826bce18 864
Esquenazi, A., Talaty, M., Packel, A., & Saulino, M. (2012). The 865
ReWalk powered exoskeleton to restore ambulatory function 866
to individuals with thoracic-level motor-complete spinal cord 867
injury. American Journal of Physical Medicine and Rehabilita- 868
tion,91(11), 911-921. doi:10.1097/PHM.0b013e318269d9a3 869
Farris, R. J., Quintero, H. A., & Goldfarb, M. (2011). Prelim- 870
inary evaluation of a powered lower limb orthosis to aid 871
walking in paraplegic individuals. IEEE Transactions on Neu- 872
ral Systems and Rehabilitation Engineering,19(6), 652-659. 873
doi:10.1109/TNSRE.2011.2163083 874
Farris, R. J., Quintero, H. A., & Goldfarb, M. (2012, Aug 28- 875
Sep 1). Performance evaluation of a lower limb exoskeleton 876
for stair ascent and descent with Paraplegia. Paper presented 877
at the 34th Annual International Conference of the IEEE 878
Engineering in Medicine and Biology Society: EMBC 2012, 879
San Diego, CA. 880
Uncorrected Author Proof
18 S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation
Farris, R. J., Quintero, H. A., Murray, S. A., Ha, K. H., Har-
881
tigan, C., & Goldfarb, M. (2014). A preliminary assessment882
of legged mobility provided by a lower limb exoskeleton883
for persons with paraplegia. IEEE Transactions on Neu-884
ral Systems and Rehabilitation Engineering,22(3), 482-490.
885
doi:10.1109/TNSRE.2013.2268320886
Federici, S., & Scherer, M. J. (Eds.). (2012). Assistive Technology
887
Assessment Handbook. Boca Raton, FL: CRC Press.888
Ferris, D., Sawicki, G., & Domingo, A. (2005). Powered Lower Limb889
Orthoses for Gait Rehabilitation. Topics in Spinal Cord Injury890
Rehabilitation,11(2), 34-49. doi:10.1310/6GL4-UM7X-519H-
891
9JYD892
Fondazione Santa Lucia (2015, Mar 19). Maratona di Roma 2015, un893
esoscheletro hi-tech per tornare a correre. Retrieved from http://894
www.hsantalucia.it/modules.php?name=News&file=article&895
sid=989896
Fung, S., Byl, N., Melnick, M., Callahan, P., Selinger, A., Ishii,897
K., et al. (1997). Functional outcomes: The development of a898
new instrument to monitor the effectiveness of physical therapy.899
European Journal of Physical Medicine &Rehabilitation,7(2),900
31-41.901
Hellstrom, K., Lindmark, B., & Fugl-Meyer, A. (2002). The
902
Falls-Efficacy Scale, Swedish version: Does it reflect clinically903
meaningful changes after stroke? Disability and Rehabilitation,904
24(9), 471-481. doi:10.1080/09638280110105259905
Herr, H. (2009). Exoskeletons and orthoses: Classification, design906
challenges and future directions. Journal of Neuroengineering907
and Rehabilitation,6(1), 1-9. doi:10.1186/1743-0003-6-21
908
Hong, Y. W., King, Y.-J., Yeo, W.-H., Ting, C.-H., Chuah, Y.-D.,
909
Lee, J.-V., & Chok, E.-T. (2013). Lower extremity exoskeleton:910
Review and challenges surrounding the technology and its role911
in rehabilitation of lower limbs. Australian Journal of Basic and912
Applied Sciences,7(7), 520-524.913
Ikehara, T., Nagamura, K., Ushida, T., Tanaka, E., Saegusa, S.,914
Kojima, S., & Yuge, L. (2011, Jun 29-Jul 1). Development of915
closed-fitting-type walking assistance device for legs and evalua-916
tion of muscle activity. Paper presented at the IEEE International917
Conference on Rehabilitation Robotics: ICORR 2011, Zurich,918
CH.919
Kao, P.-C., Lewis, C. L., & Ferris, D. P. (2010). Invariant ankle920
moment patterns when walking with and without a robotic
921
ankle exoskeleton. Journal of Biomechanics,43(2), 203-209.922
doi:10.1016/j.jbiomech.2009.09.030923
Kawamoto, H., Taal, S., Niniss, H., Hayashi, T., Kamibayashi, K.,
924
Eguchi, K., & Sankai, Y. (2010, Aug 31-Sep 4). Voluntary motion925
support control of Robot Suit HAL triggered by bioelectrical
926
signal for hemiplegia. Paper presented at the 32nd Annual Inter-927
national Conference of the IEEE Engineering in Medicine and928
Biology Society: EMBC 2010, Buenos Aires, AR.929
Keller, T., & Veneman, J. (2013). Robotics for neurorehabilitation:930
Current state and future challenges. Applied Mechanics and Mate-931
rials,245, 3-8. doi:10.4028/ www.scientific.net/MM.245.3932
Koceska, N., & Koceski, S. (2013). Review: Robot Devices for Gait933
Rehabilitation. International Journal of Computer Applications,934
62(13), 1-8. doi:10.5120/10137-4279935
Kolakowsky-Hayner, S. A. (2013). Safety and Feasibility of using the936
EksoTM Bionic Exoskeleton to Aid Ambulation after Spinal Cord
937
Injury. Journal of Spine,S4(3), 1-8. doi:10.4172/2165-7939.S4-938
003
939
Lee, H. S., Song, J., Min, K., Choi, Y.-S., Kim, S.-M., Cho, S.-R., et al.940
(2014). Short-term effects of erythropoietin on neurodevelopment941
in infants with cerebral palsy: A pilot study. Brain and Develop- 942
ment,36(9), 764-769. doi:10.1016/j.braindev.2013.11.002 943
Liberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gøtzsche, 944
P. C., Ioannidis, J. P. A., & Moher, D. (2009). The PRISMA 945
Statement for Reporting Systematic Reviews and Meta-Analyses 946
of Studies That Evaluate Health Care Interventions: Expla- 947
nation and Elaboration. PLoS Medicine,6(7), e1000100. 948
doi:10.1371/journal.pmed.1000100 949
Low, K. H. (2011, Aug 3-5). Robot-assisted gait rehabilitation: 950
From exoskeletons to gait systems. Paper presented at the 951
Defense Science Research Conference and Expo: DSR 2011, 952
Singapore, SG. 953
McMillan, T. M., Williams, W. H., & Bryant, R. A. (2003). Post- 954
traumatic stress disorder and traumatic brain injury: A review of 955
causal mechanisms, assessment, and treatment. In H. Williams 956
& J. J. Edwards (Eds.), Biopsychosocial Approaches in Neurore- 957
habilitation: Assessment and Management of Neuropsychiatric, 958
Mood and Behavioural Disorders (pp. 149-164). Hove, UK: Psy- 959
chology Pres. 960
Mehrholz, J., Wagner, K., Rutte, K., Meissner, D., & Pohl, M. (2007). 961
Predictive validity and responsiveness of the functional ambu- 962
lation category in hemiparetic patients after stroke. Archives 963
of Physical Medicine and Rehabilitation,88(10), 1314-1319. 964
doi:10.1016/j.apmr.2007.06.764 965
Meloni, F., Federici, S., & Stella, A. (2011). The Psychologist’s 966
Role: A Neglected Presence in the Assistive Technology Assess- 967
ment Process. In G. J. Gelderblom, M. Soede, L. Adriaens, & 968
K. Miesenberger (Eds.), Everyday Technology for Independence 969
and Care: AAATE 2011 (Vol. 29, pp. 1199-1206). Amsterdam, 970
NL: IOS Press. 971
Meloni, F.,Federici, S., Stella, A., Mazzeschi, C., Cordella, B., Greco, 972
F., & Grasso, M. (2012). The Psychologist. In S. Federici & M. J. 973
Scherer (Eds.), Assistive Technology Assessment Handbook (pp. 974
149-177). Boca Raton, FL: CRC Press. 975
Mohammed, S., Amirat, Y., & Rifai, H. (2012). Lower-Limb 976
Movement Assistance through Wearable Robots: State of 977
the Art and Challenges. Advanced Robotics,26(1-2), 1-22. 978
doi:10.1163/016918611x607356 979
Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & The, P. G. 980
(2009). Preferred Reporting Items for Systematic Reviews and 981
Meta-Analyses: The PRISMA Statement. PLoS Medicine,6(7), 982
e1000097. doi:10.1371/journal.pmed.1000097 983
Mohseni Bandpei, M. A., Rahmani, N., Majdoleslam, B., Abdol- 984
lahi, I., Ali, S. S., & Ahmad, A. (2014). Reliability of 985
surface electromyography in the assessment of paraspinal 986
muscle fatigue: An updated systematic review. Journal of 987
Manipulative and Physiological Therapeutics,37(7), 510-521. 988
doi:10.1016/j.jmpt.2014.05.006 989
Mooney, L. M., Rouse, E. J., & Herr, H. M. (2014). Autonomous 990
exoskeleton reduces metabolic cost of human walking. Jour- 991
nal of Neuroengineering and Rehabilitation,11(151), 2-5. 992
doi:10.1186/1743-0003-11-151 993
Moreno, J., Ama, A., Reyes-Guzm´
an, A., Gil-Agudo, ´
A., Ceres, 994
R., & Pons, J. (2011). Neurorobotic and hybrid manage- 995
ment of lower limb motor disorders: A review. Medical and 996
Biological Engineering and Computing,49(10), 1119-1130. 997
doi:10.1007/s11517-011-0821-4 998
Mori, Y., Okada, J., & Takayama, K. (2006). Development of 999
a standing style transfer system “ABLE” for disabled lower 1000
limbs. IEEE/ASME Transactions on Mechatronics,11(4), 372- 1001
380. doi:10.1109/TMECH.2006.878558 1002
Uncorrected Author Proof
S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation 19
Mori, Y., Takayama, K., Zengo, T., & Nakamura, T. (2004). Devel-
1003
opment of straight style transfer equipment for lower limbs1004
disabled “ABLE”. Journal of Robotics and Mechatronics,16(5),1005
456-463.1006
Nef, T., & Riener, R. (2012). Three-Dimensional Multi-Degree-of-
1007
Freedom Arm Therapy Robot (ARMin). In V. Dietz, T. Nef, & W.1008
Z. Rymer (Eds.), Neurorehabilitation Technology (pp. 141-157).
1009
London, UK: Springer.1010
Neuhaus, P. D., Noorden, J. H., Craig, T. J., Torres, T., Kirschbaum,1011
J., & Pratt, J. E. (2011, Jun 29–Jul 1). Design and evaluation1012
of Mina: A robotic orthosis for paraplegics. Paper presented at
1013
the IEEE International Conference on Rehabilitation Robotics:1014
ICORR 2011, Zurich, CH.1015
Nilsson, A., Vreede, K. S., Haglund, V., Kawamoto, H., Sankai, Y.,1016
& Borg, J. (2014). Gait training early after stroke with a new1017
exoskeleton – the hybrid assistive limb: A study of safety and fea-1018
sibility. Journal of Neuroengineering and Rehabilitation,11(92),1019
1-10. doi:10.1186/1743-0003-11-921020
Norhafizan, A., Ghazilla, R. A. R., Kasi, V., Taha, Z., & Hamid, B.1021
(2014). A Review on lower-Limb Exoskeleton System for Sit1022
to Stand, Ascending and Descending Staircase Motion. Applied1023
Mechanics and Materials, 541-542, 1150-1155. doi:10.4028/
1024
www.scientific.net/AMM.541-542.11501025
Pandyan, A. D., Johnson, G. R., Price, C. I., Curless, R. H., Barnes,1026
M. P., & Rodgers, H. (1999). A review of the properties and1027
limitations of the Ashworth and modified Ashworth Scales as1028
measures of spasticity. Clinical Rehabilitation,13(5), 373-383.1029
Park, E. Y., & Choi, Y. I. (2014). Psychometric Properties of
1030
the Lower Extremity Subscale of the Fugl-Myer Assess-
1031
ment for Community-dwelling Hemiplegic Stroke Patients.1032
Journal of Physical Therapy Science,26(11), 1775-1777.1033
doi:10.1589/jpts.26.17751034
Pennycott, A., Wyss, D., Vallery, H., Klamroth-Marganska, V., &1035
Riener, R. (2012). Towards more effective robotic gait training1036
for stroke rehabilitation: A review. Journal of Neuroengineering1037
and Rehabilitation,9(65), 65. doi:10.1186/1743-0003-9-651038
Peters, D. M., Middleton, A., Donley, J. W., Blanck, E. L., & Fritz, S.1039
L. (2014). Concurrent validity of walking speed values calculated1040
via the GAITRite electronic walkway and 3 meter walk test in the1041
chronic stroke population. Physiotherapy Theory and Practice,1042
30(3), 183-188. doi:10.3109/09593985.2013.845805
1043
Playford, D. (2015). The International Classification of Functioning,1044
Disability, and Health. In V. Dietz & N. Ward (Eds.), Oxford1045
Textbook of Neurorehabilitation (pp. 3-7). Oxford, UK: Oxford
1046
University Press.1047
Podsiadlo, D., & Richardson, S. (1991). The timed “Up & Go”: A
1048
test of basic functional mobility for frail elderly persons. Journal1049
of the American Geriatrics Society,39(2), 142-148.1050
Pons, J. L. (2010). Rehabilitation Exoskeletal Robotics. IEEE1051
Engineering in Medicine and Biology Magazine,29(3), 57-63.1052
doi:10.1109/MEMB.2010.9365481053
Pons, J. L., & Torricelli, D. (Eds.). (2014). Emerging Therapies in1054
Neurorehabilitation. Berlin, DE: Springer-Verlag.1055
Quintero, H. A., Farris, R. J., & Goldfarb, M. (2012). A Method1056
for the Autonomous Control of Lower Limb Exoskeletons for1057
Persons With Paraplegia. Journal of Medical Devices,6(4), 1-6.1058
doi:10.1115/1.4007181
1059
Rahman, T., Sample, W., Jayakumar, S., King, M. M., Wee, J. Y.,1060
Seliktar, R., et al. (2006). Passive exoskeletons for assisting limb
1061
movement. Journal of Rehabilitation Research and Development,1062
43(5), 583-590. doi:10.1682/JRRD.2005.04.00701063
Reed, M. D., & Van Nostran, W. (2014). Assessing pain intensity 1064
with the visual analog scale: A plea for uniformity. Journal of 1065
Clinical Pharmacology,54(3), 241-144. doi:10.1002/jcph.250 1066
Reybrouck, T. (2003). Clinical usefulness and limitations of the 6- 1067
minute walk test in patients with cardiovascular or pulmonary 1068
disease. Chest,123(2), 325-327. doi:10.1378/chest.123.2.325 1069
Saji, N., Kimura, K., Ohsaka, G., Higashi, Y., Teramoto, Y., Usui, 1070
M., & Kita, Y. (2015). Functional independence measure scores 1071
predict level of long-term care required by patients after stroke: 1072
A multicenter retrospective cohort study. Disability and Rehabil- 1073
itation,37(4), 331-337. doi:10.3109/09638288.2014.918195 1074
Sanz-Merodio, D., Cestari, M., Arevalo,J. C., & Garcia, E. (2012, Dec 1075
11-14). A lower-limb exoskeleton for gait assistance in quadriple- 1076
gia. Paper presented at the IEEE International Conference on 1077
Robotics and Biomimetics: ROBIO 2012, Guangzhou, CN. 1078
Sczesny-Kaiser, M., H¨
offken, O., Lissek, S., Lenz, M., Schlaffke, 1079
L., Nicolas, V., et al. (2013). Neurorehabilitation in Chronic 1080
Paraplegic Patients with the HAL®Exoskeleton – Preliminary 1081
Electrophysiological and fMRI Data of a Pilot Study.In J. L. Pons, 1082
D. Torricelli, & M. Pajaro (Eds.), Converging Clinical and Engi- 1083
neering Research on Neurorehabilitation (pp. 611-615). Berlin, 1084
DE: Springer. 1085
Shin, J. C., Yoo, J. H., Jung, T. H., & Goo, H. R. (2011). Comparison 1086
of lower extremity motor score parameters for patients with motor 1087
incomplete spinal cord injury using gait parameters. Spinal Cord,1088
49(4), 529-533. doi:10.1038/sc.2010.158 1089
Spungen, A. M., Asselin, P., Fineberg, D. B., Kornfeld, S. D., & 1090
Harel, N. Y. (2013, Apr 15-17). Exoskeletal-Assisted Walking for 1091
Persons with Motor-Complete Paraplegia. Paper presented at the 1092
STO Human Factors and Medicine Panel (HFM) Symposium, 1093
Milan, IT. 1094
Stein, J., Bishop, L., Stein, D. J., & Wong, C. K. (2014). Gait training 1095
with a robotic leg brace after stroke: A randomized controlled 1096
pilot study. American Journal of Physical Medicine and Rehabil- 1097
itation,93(11), 987-994. doi:10.1097/PHM.0000000000000119 1098
Stookey, A. D., Katzel, L. I., Steinbrenner, G., Shaughnessy, 1099
M., & Ivey, F. M. (2014). The short physical performance 1100
battery as a predictor of functional capacity after stroke. Jour- 1101
nal of Stroke and Cerebrovascular Diseases,23(1), 130-135. 1102
doi:10.1016/j.jstrokecerebrovasdis.2012.11.003 1103
Strausser, K. A., & Kazerooni, H. (2011, Sep 25-30). The devel- 1104
opment and testing of a human machine interface for a mobile 1105
medical exoskeleton. Paper presented at the IEEE/RSJ Interna- 1106
tional Conference on Intelligent Robots and Systems: IROS 2011, 1107
San Francisco, CA. 1108
Strausser, K. A., Swift, T. A., Zoss, A. B., & Kazerooni, H. (2010, 1109
Sep 12-15). Prototype medical exoskeleton for paraplegic mobil- 1110
ity: First experimental results. Paper presented at the ASME 1111
2010 Dynamic Systems and Control Conference: DSCC 2010, 1112
Cambridge, MA. 1113
Suzuki, K., Kawamura, Y., Hayashi, T., Sakurai, T., Hasegawa, Y., 1114
& Sankai, Y. (2005, Oct 10-12). Intention-based walking support 1115
for paraplegia patient. Paper presented at the IEEE International 1116
Conference on Systems, Man and Cybernetics, Waikoloa, HI. 1117
Sylos-Labini, F., La Scaleia, V., d’Avella, A., Pisotta, I., Tamburella, 1118
F., Scivoletto, G., et al. (2014). EMG patterns during assisted 1119
walking in the exoskeleton. Frontiers in Human Neuroscience,1120
8(423), 1-12. doi:10.3389/fnhum.2014.00423 1121
Talaty, M., Esquenazi, A., & Brice ˜
no, J. E. (2013, Jun 24-26). Differ- 1122
entiating ability in users of the ReWalkTM powered exoskeleton: 1123
An analysis of walking kinematics. Paper presented at the IEEE 1124
Uncorrected Author Proof
20 S. Federici et al. / The effectiveness of powered, active lower limb exoskeletons in neurorehabilitation
International Conference on Rehabilitation Robotics: ICORR
1125
2013 Seattle, WA.1126
Tsukahara, A., Hasegawa, Y., & Sankai, Y. (2009, Jun 23-26).1127
Standing-up motion support for paraplegic patient with Robot1128
Suit HAL. Paper presented at the IEEE International Conference
1129
on Rehabilitation Robotics: ICORR 2009, Kyoto, JP.1130
Tsukahara, A., Kawanishi, R., Hasegawa, Y., & Sankai, Y. (2010).
1131
Sit-to-Stand and Stand-to-Sit Transfer Support for Complete1132
Paraplegic Patients with Robot Suit HAL. Advanced Robotics,1133
24(11), 1615-1638. doi:10.1163/016918610X5126221134
Viteckova, S., Kutilek, P., & Jirina, M. (2013). Wearable lower limb
1135
robotics: A review. Biocybernetics and Biomedical Engineering,1136
33(2), 96-105. doi:10.1016/J.Bbe.2013.03.0051137
Wall, A., Borg, J., & Palmcrantz, S. (2015). Clinical application1138
of the Hybrid Assistive Limb (HAL) for gait training-a sys-1139
tematic review. Frontiers in Systems Neuroscience,9(48), 1-10.1140
doi:10.3389/fnsys.2015.000481141
Watanabe, H., Tanaka, N., Inuta, T., Saitou, H., & Yanagi, H. (2014).1142
Locomotion Improvement Using a Hybrid Assistive Limb in1143
Recovery Phase Stroke Patients: A Randomized Controlled Pilot1144
Study. Archives of Physical Medicine and Rehabilitation,95(11),1145
2006-2012. doi:10.1016/J.Apmr.2014.07.002
1146
Whitney, S. L., Wrisley, D. M., Marchetti, G. F., Gee, M. A., Red-1147
fern, M. S., & Furman, J. M. (2005). Clinical measurement1148
of sit-to-stand performance in people with balance disorders:
Validity of data for the Five-Times-Sit-to-Stand Test. Physical 1149
Therapy,85(10), 1034-1045. 1150
Williams, H., & Edwards, J. J. (Eds.). (2003). Biopsychosocial 1151
Approachesin Neurorehabilitation: Assessment and Management 1152
of Neuropsychiatric, Mood and Behavioural Disorders. Hove, 1153
UK: Psychology Pres. 1154
Wolf, S. L., Catlin, P. A., Gage, K., Gurucharri, K., Robertson, R., 1155
& Stephen, K. (1999). Establishing the reliability and validity 1156
of measurements of walking time using the Emory Functional 1157
Ambulation Profile. Physical Therapy,79(12), 1122-1133. 1158
Yan, T., Cempini, M., Oddo, C. M., & Vitiello, N. (2015). Review 1159
of assistive strategies in powered lower-limb orthoses and 1160
exoskeletons. Robotics and Autonomous Systems,64, 120-136. 1161
doi:10.1016/j.robot.2014.09.032 1162
Yang, N., Zhang, B., & Gao, C. (2014). The baseline NIHSS score 1163
in female and male patients and short-time outcome: A study in 1164
young ischemic stroke. Journal of Thrombosis and Thrombolysis,1165
37(4), 565-570. doi:10.1007/s11239-013-0986-9 1166
Zeilig, G., Weingarden, H., Zwecker, M., Dudkiewicz, I., Bloch, A., 1167
& Esquenazi, A. (2012). Safety and tolerance of the ReWalk™ 1168
exoskeleton suit for ambulation by people with complete spinal 1169
cord injury: A pilot study.Journal of Spinal Cord Medicine,35(2), 1170
96-101. doi:10.1179/2045772312Y.0000000003 1171
... Their main objective is to restore the patient's gait based on motor learning techniques through the reproduction of gait patterns [31]. Several studies have shown the effectiveness and limitations of these devices in neurorehabilitation [22], [32], but not in traumatic injuries such as HF. ...
... Furthermore, experimental evidence comparing the use of exoskeletons and walkers for gait rehabilitation with other types of treatment, such as conventional therapy, is almost non-existent [32]. In the case of hip fracture, there are works describing case studies, but it is claimed that there is a shortage of studies with larger sample sizes and which also include differentiated control and intervention groups [29], [38]. ...
... Among the aforementioned indexes, there are clinical studies analyzing the efficacy of exoskeletons for gait rehabilitation that compute the Barthel index. However, these studies were conducted with patients with spinal cord injury and are therefore not comparable with this work [32]. We have found no studies with hip fracture patients using exoskeletons in their rehabilitation to compare these indexes. ...
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Hip fracture is one of the most common traumatisms associated with falls in the elderly, severely affecting the patient’s mobility and independence. In recent years, the use of robotic technology has proven to be effective in gait rehabilitation, especially for neurological disorders. However, there is a lack of research validating these devices for hip fracture in elderly patients. This paper presents the design and evaluation of a novel assistive platform for hip rehabilitation, SWalker, aimed at improving the rehabilitation of this condition. Functional validation of the SWalker platform was carried out with five healthy elderly subjects and two physiotherapists. Clinical validation was conducted with 34 patients with hip fracture. The control group ( $\text {n}=24$ , age $= 86.38\pm 6.16$ years, 75% female) followed conventional therapy, while the intervention group ( $\text{n}=10$ , age $= 86.80\pm 6.32$ years, 90% female) was rehabilitated using SWalker. The functional validation of the device reported good acceptability (System Usability Scale >85). In the clinical validation, the control group required 68.09±27.38 rehabilitation sessions compared to 22.60±16.75 in the intervention group ( $\text{p}< 0.001$ ). Patients in the control group needed 120.33±53.64 days to reach ambulation, while patients rehabilitated with SWalker achieved that stage in 67.11±51.07 days ( $\text{p}=0.021$ ). FAC and Tinetti indexes presented a larger improvement in the intervention group when compared with the control group ( $\text{p}=0.007$ and $\text{p}=0.01$ , respectively). The SWalker platform can be considered an effective tool to enhance autonomous gait and shorten rehabilitation therapy in elderly hip fracture patients. This result encourages further research on robotic rehabilitation platforms for hip fracture.
... Furthermore, the therapist can provide precise stimulation by controlling the hardware of the robot. Based on such repeatability and accuracy, the robot-assisted gait-training device affects the coordination between the lower extremities in the gait of hemiplegic patients, thereby affecting postural control and adaptation and improving the patient's gait [20,21]. Furthermore, the robot hardware allows control of the treadmill, harness system, and robot frame so that various techniques can be applied to the patient based on their needs [19]. ...
... Furthermore, the robot hardware allows control of the treadmill, harness system, and robot frame so that various techniques can be applied to the patient based on their needs [19]. Such a device can prevent fatigue and injuries in therapists and provide a wide range of gait-training environments for patients [13,20]. Furthermore, the robot offers effective treatment by providing precise, repetitive motions and a joint range of motion by controlling the robot's hardware [17,22]. ...
... There was a significant improvement in 10 MWT after the 6-week intervention in all robot groups (p < 0.05) but no significant difference was observed in the non-robot group (p > 0.05). Moreover, there was a significant difference in the changes in 10 MWT among the groups (F (3,20) = 21.93, p < 0.001). ...
Article
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This study investigated the effects of robot-assisted gait training with body weight support on gait and balance in stroke patients. The study participants comprised 24 patients diagnosed with stroke. Patients were randomly assigned to four groups of six: robot A, B, C, and non-robot. The body weight support (BWS) for the harness of the robot was set to 30% of the patient’s body weight in robot group A, 50% in robot group B, and 70% in robot group C. All experimental groups received robot-assisted gait training and general physical therapy. The non-robot group underwent gait training using a p-bar, a treadmill, and general physical therapy. The intervention was performed for 30 min a day, five times a week, for 6 weeks. All participants received the intervention after the pre-test. A post-test was performed after all of the interventions were completed. Gait was measured using a 10 m Walking test (10MWT) and the timed up and go (TUG) test. Balance was assessed using the Berg Balance Scale (BBS). Robot groups A, B, and C showed significantly better 10MWT results than did the non-robot group (p < 0.5). TUG was significantly shorter in robot groups A, B, and C than in the non-robot group (p < 0.5). The BBS scores for robot group A improved significantly more than did those for robot groups B and C and the non-robot group (p < 0.5), indicating that robot-assisted gait training with body weight support effectively improved the gait of stroke patients.
... La (ré)éducation, dès le plus jeuneâge en profitant de la plasticité cérébrale, est une des clés de la réussite de l'apprentissage permettant de reproduire une marche saine sur de longues distances. L'utilisation d'une assistance robotisée de type exosquelette, a montré qu'elle permettaità l'enfant d'acquérir une marche proche de celle de la marche saine après les phases d'apprentissage (Federici et al., 2015, Lajeunesse et al., 2015, Miller et al., 2016, Wall et al., 2015 pour certaines pathologies modérées. L'objectifà terme est de développer un prototype d'exosquelette personnalisé dont l'anthropométrie serait adaptéeà l'enfantétudié. ...
... Le couple obtenu T torsion a ensuiteété ajouté au couple calculé par TSID afin de déterminer couple d'impédance utilisé pour calculer l'accélération correspondantè a l'aide d'un algorithme de corps articulé (ABA) issu de la librairie Pinocchio(Carpentier et al., 2019 ; Carpentier et al., 2015 Carpentier et al., -2021 calculant la dynamique, c'est-à-dire les accélérations des articulations en fonction de l'état actuel et de l'actionnement du modèle. Cette fonction est mise en oeuvre en se basant surFeatherstone, 2014. ...
... Exoskeletons increase mobility, improve the limb's motor function, and restore the regular walking pattern [19]. Israel)-ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with spinal cord injury (SCI); REX (Rex Bionics PLC, London, UK)-mission is to develop technology in the field of autonomous mobile robotics, role in uprighting and walking training for patients with complete or incomplete C4-L5 injury; HAL (Hybrid Assistive Limb)-an exoskeleton for uprighting and training is walking; Ekso (Ekso Bionics, Richmond CA, USA)-an exoskeleton for training walking; Indego (Parker Hannifin, OH, USA)-The Indego is a powered hip-knee exoskeleton for gait training by motion. ...
... Exoskeletons increase mobility, improve the limb's motor function, and restore the regular walking pattern [19]. ...
Article
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Spinal cord injuries (SCIs) have major consequences on the patient's health and life. Voluntary muscle paralysis caused by spinal cord damage affects the patient's independence. Following SCI, an irreversible motor and sensory deficit occurs (spasticity, muscle paralysis, atrophy, pain, gait disorders, pain). This pathology has implications on the whole organism: on the osteoarticular, muscular, cardiovascular, respiratory, gastrointestinal, genito-urinary, skin, metabolic disorders, and neuro-psychic systems. The rehabilitation process for a subject having SCIs can be considered complex, since the pathophysiological mechanism and biochemical modifications occurring at the level of spinal cord are not yet fully elucidated. This review aims at evaluating the impact of robotic-assisted rehabilitation in subjects who have suffered SCI, both in terms of regaining mobility as a major dysfunction in patients with SCI, but also in terms of improving overall fitness and cardio-vascular function, respiratory function, as well as the gastrointestinal system, bone density and finally the psychosocial issues, based on multiple clinical trials, and pilot studies. The researched literature in the topic revealed that in order to increase the chances of neuro-motor recovery and to obtain satisfactory results, the combination of robotic therapy, a complex recovery treatment and specific medication is one of the best decisions. Furthermore, the use of these exoskeletons facilitates better/greater autonomy for patients, as well as optimal social integration.
... However, the outcomes attained with ambulatory exoskeletons are still controversial. Published studies and reviews show considerable differences among protocols, targeted populations and variables analyzed, in addition to the specific differences among exoskeletons (number of joints, type of actuators and controllers, among others) [3,4]. Recent research claims that robot-assisted walking arises from the interaction between the human body, driven by the central neural system (CNS) through the muscles, neural loops, reflex mechanisms and the mechanical structure of each exoskeleton, driven by the controller through the joint actuators and sensors [5]. ...
Article
Full-text available
Nowadays, robotic technology for gait training is becoming a common tool in rehabilitation hospitals. However, its effectiveness is still controversial. Traditional control strategies do not adequately integrate human intention and interaction and little is known regarding the impact of exoskeleton control strategies on muscle coordination, physical effort, and user acceptance. In this article, we benchmarked three types of exoskeleton control strategies in a sample of seven healthy volunteers: trajectory assistance (TC), compliant assistance (AC), and compliant assistance with EMG-Onset stepping control (OC), which allows the user to decide when to take a step during the walking cycle. This exploratory study was conducted within the EUROBENCH project facility. Experimental procedures and data analysis were conducted following EUROBENCH's protocols. Specifically, exoskeleton kinematics, muscle activation, heart and breathing rates, skin conductance, as well as user-perceived effort were analyzed. Our results show that the OC controller showed robust performance in detecting stepping intention even using a corrupt EMG acquisition channel. The AC and OC controllers resulted in similar kinematic alterations compared to the TC controller. Muscle synergies remained similar to the synergies found in the literature, although some changes in muscle contribution were found, as well as an overall increase in agonist-antagonist co-contraction. The OC condition led to the decreased mean duration of activation of synergies. These differences were not reflected in the overall physiological impact of walking or subjective perception. We conclude that, although the AC and OC walking conditions allowed the users to modulate their walking pattern, the application of these two controllers did not translate into significant changes in the overall physiological cost of walking nor the perceived experience of use. Nonetheless, results suggest that both AC and OC controllers are potentially interesting approaches that can be explored as gait rehabilitation tools. Furthermore, the INTENTION project is, to our knowledge, the first study to benchmark the effects on human-exoskeleton interaction of three different exoskeleton controllers, including a new EMG-based controller designed by us and never tested in previous studies, which has made it possible to provide valuable third-party feedback on the use of the EUROBENCH facility and testbed, enriching the apprenticeship of the project consortium and contributing to the scientific community.
... Modern wearable robotic exoskeletons are powerful emerging technologies that are versatile enough for personalized patient-centered care, can be specifically designed to deliver multicomponent exercise interventions, and have been extremely beneficial in neurologically impaired clinical populations [8,9]. However, the efficacy of robotic exoskeleton-based exercise intervention in a community setting is yet to be assessed in any population, especially the older adult population. ...
Article
Full-text available
Background Despite the benefits of physical activity for healthy physical and cognitive aging, 35% of adults over the age of 75 in the United States are inactive. Robotic exoskeleton-based exercise studies have shown benefits in improving walking function, but most are conducted in clinical settings with a neurologically impaired population. Emerging technology is starting to enable easy-to-use, lightweight, wearable robots, but their impact in the otherwise healthy older adult population remains mostly unknown. For the first time, this study investigates the feasibility and efficacy of using a lightweight, modular hip exoskeleton for in-community gait training in the older adult population to improve walking function. Methods Twelve adults over the age of 65 were enrolled in a gait training intervention involving twelve 30-min sessions using the Gait Enhancing and Motivating System for Hip in their own senior living community. Results Performance-based outcome measures suggest clinically significant improvements in balance, gait speed, and endurance following the exoskeleton training, and the device was safe and well tolerated. Gait speed below 1.0 m/s is an indicator of fall risk, and two out of the four participants below this threshold increased their self-selected gait speed over 1.0 m/s after intervention. Time spent in sedentary behavior also decreased significantly. Conclusions This intervention resulted in greater improvements in speed and endurance than traditional exercise programs, in significantly less time. Together, our results demonstrated that exoskeleton-based gait training is an effective intervention and novel approach to encouraging older adults to exercise and reduce sedentary time, while improving walking function. Future work will focus on whether the device can be used independently long-term by older adults as an everyday exercise and community-use personal mobility device. Trial registration This study was retrospectively registered with ClinicalTrials.gov (ID: NCT05197127).
... √ √ [21] Compliant joint mechanisms to ensure user's safety and comfort. √ √ [22] Application of wearable lower limb exoskeletons for rehabilitation of patients with gait disorders. ...
Article
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Wearableassistive devices such as passive exoskeletonhavebeen recognized as one of the effective solutions to assist people inindustrialwork, rehabilitation, elderly care, military and sports. Thedesign and development of a passive exoskeletonthat emphasizes on satisfying and fulfilling users’ requirements and users’ experience areessential to ensure the device remains competitive in the global market. Agood user experience of using an exoskeletonstimulates users’ satisfaction, as contemporary users are not only considering basic functional features but alsofascinated by perception values such as aesthetics and enjoyment. Themain purpose of this article is to review the critical factors that are influencing user experience before, during and after utilizing a passive exoskeleton. The authors had searched relevant articles from academic databases such as Google Scholar, Scopus and Web of Science as well as free Google search for the publicationperiod from 2001to 2021. Several search keywords were used such as ‘passive exoskeleton +user experience’, ‘passive exoskeleton + industry’, ‘passive exoskeleton + rehabilitation’, ‘passive exoskeleton + military’, ‘passive exoskeleton + sports’,‘passive exoskeleton + sit-stand’, and passive exoskeleton + walking’. This online search found that a total of 236 articles related to the application of passive exoskeleton in the area of industry, rehabilitation, military and sports. Out of this, 81 articles were identified as significant references and examined thoroughly to prepare the essence of this paper. Based on thesearticles, the authors revealed that the engineering design, usability, flexibility, safety and ergonomics, aesthetics, accessibility, purchase cost, after-sales service and sustainability are the critical factorsthatare influencing user experience whenemployingpassive exoskeleton.
... A associação com a terapia robótica talvez possa otimizar os resultados por proporcionar maior número de repetições nos movimentos realizados e complementar o treino funcional individualizado, atuando como importante método de neuroreabilitação. 9 O caso descrito é motivador para que estudos com um maior número de pacientes e com o enfoque no programa de reabilitação em modelo de internação sejam realizados. ...
Article
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There is little information in the medical literature on the rehabilitation of patients with GuillainBarre Syndrome (GBS). There are clinical studies that demonstrate the effectiveness of a rehabilitation program using an interdisciplinary team, but without well-defined protocols and only performed on an outpatient basis. This case report aims to describe the evolution of a patient with GBS during the intensive multidisciplinary inpatient rehabilitation program, discussing the therapeutic possibilities for rehabilitation of the disease
Chapter
Over the past decade, overground robotic exoskeletons have emerged as promising technologies that can be integrated into the rehabilitation process to help individuals maintain or regain neuromuscular health following neurological injury. Early studies suggest that individuals recovering from stroke, spinal cord injury, and other neurological conditions can benefit from the use of exoskeletons, either alone or as a complement to traditional rehabilitation strategies, to improve mobility and independence. Due to the broad range of impairments observed after neurological injury, clinicians should consider different types of exoskeletons to best suit the goals of each patient. The use of these exoskeletons as clinical tools also requires clinicians to understand how to operate and monitor the device, to identify which patient population(s) are appropriate and how they may benefit from the device in rehabilitation, and the limitations and safety measures required for each device. More research in this field, including large-scale clinical trials to assess the therapeutic benefits and limitations of exoskeletons, is required to achieve a greater understanding of how to optimize the use of these devices in the clinic and for personal mobility.
Article
In this study, we focused on the design and control of a single DoF laterally supported knee exoskeleton robot designed to improve the load-carrying and strength capacity of healthy individuals, especially soldiers and workers. First, a nonlinear second-order differential model of the robotic knee orthosis was produced. Then, a single degree of freedom exoskeleton robot was designed and manufactured. An interactive motion control method based on the relative angle measurement principle between the knee joint of the user and the exo-suit knee joint was proposed. The user’s knee joint motion is detected via an IMU sensor, and a controller was provided to allow the exo-suit to track the human knee joint in synchrony. In this study, a conventional PID, SMC, and moving surface SMC controllers were designed, and the controllers’ performance were tested in real-time experiments. The maximum tracking errors in the PID, SMC, and MSMC controllers were 2.631 ∘ , 1.578 ∘ , and 1.289 ∘ , respectively, and the average tracking time errors were 0.10, 0.08, and 0.06 s, respectively. In addition, the designed and produced knee orthosis weighs 2.5 kg, making it one of the lightest and most compact designs for use by healthy individuals. The knee orthosis was made of steel, and thus it is very durable for use in all kinds of terrain conditions (military, industrial, etc.). Experimental findings about the proposed design and control method are analyzed in the results and discussion section.
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Training leads to increased neuronal excitability, decreased inhibition and different types of neuronal plasticity. Most studies focus on cortical plastic changes after cerebral lesions or in healthy humans. In this study, we investigate cortical excitability and plastic changes after a three month period of HAL® exoskeleton supported treadmill training in patients with chronic incomplete spinal cord injury by means of electrophysiological measurements and functional magnetic resonance imaging. Here we report preliminary results of four patients.
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Systematic reviews and meta-analyses have become increasingly important in health care. Clinicians read them to keep up to date with their field [1],[2], and they are often used as a starting point for developing clinical practice guidelines. Granting agencies may require a systematic review to ensure there is justification for further research [3], and some health care journals are moving in this direction [4]. As with all research, the value of a systematic review depends on what was done, what was found, and the clarity of reporting. As with other publications, the reporting quality of systematic reviews varies, limiting readers' ability to assess the strengths and weaknesses of those reviews. Several early studies evaluated the quality of review reports. In 1987, Mulrow examined 50 review articles published in four leading medical journals in 1985 and 1986 and found that none met all eight explicit scientific criteria, such as a quality assessment of included studies [5]. In 1987, Sacks and colleagues [6] evaluated the adequacy of reporting of 83 meta-analyses on 23 characteristics in six domains. Reporting was generally poor; between one and 14 characteristics were adequately reported (mean = 7.7; standard deviation = 2.7). A 1996 update of this study found little improvement [7]. In 1996, to address the suboptimal reporting of meta-analyses, an international group developed a guidance called the QUOROM Statement (QUality Of Reporting Of Meta-analyses), which focused on the reporting of meta-analyses of randomized controlled trials [8]. In this article, we summarize a revision of these guidelines, renamed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses), which have been updated to address several conceptual and practical advances in the science of systematic reviews (Box 1). Box 1: Conceptual Issues in the Evolution from QUOROM to PRISMA Completing a Systematic Review Is an Iterative Process The conduct of a systematic review depends heavily on the scope and quality of included studies: thus systematic reviewers may need to modify their original review protocol during its conduct. Any systematic review reporting guideline should recommend that such changes can be reported and explained without suggesting that they are inappropriate. The PRISMA Statement (Items 5, 11, 16, and 23) acknowledges this iterative process. Aside from Cochrane reviews, all of which should have a protocol, only about 10% of systematic reviewers report working from a protocol [22]. Without a protocol that is publicly accessible, it is difficult to judge between appropriate and inappropriate modifications.
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Wearable robots are a class of mechatronic systems intended to exchange energy with the environment and the human body in order to attain performance augmentation as well as for assistive, prosthetic or rehabilitative purposes. In this scenario a safe physical human-robot interaction assumes a crucial role both from hardware and software points of view. Whereas the conventional design methodology is effective in several robotics fields, issues arise in the case of wearable robots. The goal of the authors is to develop a novel wearable robots design methodology exploiting the concept of embodied intelligence. The paper starts from the description of what is a wearable robot and what are the design objectives to achieve. Then a state of the art of lower limbs wearable robots is reported. The adoption of a novel design methodology based on embodied intelligence is finally described and motivated. In conclusion, an example of the application of these new methods to a nonanthropomorphic wearable robot for gait restoration is reported.
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Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users.Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement--a reporting guideline published in 1999--there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions.The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.
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