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Annals of Clinical and Medical
Case Reports
Case Report ISSN 2639-8109 Volume 9
T Oshima1*
, M Toda1*
and T Chin1,2*
1
Department of Orthopaedic Surgery, Hyogo Rehabilitation Center Hospital, 1070 Akebono-cho, Nishi-ku, Kobe, Hyogo, Japan
2
Robot Rehabilitation Center, Hyogo Institute of Assistive Technology, 1070 Akebono-cho, Nishi-ku, Kobe, Hyogo, Japan
Walking Rehabilitation Using Hybrid Assistive Limb (HAL) and Computer-Controlled
Long-Leg Orthosis (C-Brace) for an Individual with Chronic Incomplete Spinal Cord
Injury: A Case Report
*
Corresponding author:
Takaaki Chin,
Department of Orthopaedic Surgery, Hyogo Rehabil-
itation Center Hospital, 1070 Akebono-cho, Nishi-ku,
Kobe, Hyogo, Japan and Robot Rehabilitation Center,
Hyogo Institute of Assistive Technology, 1070
Akebono-cho, Nishi-ku, Kobe, Hyogo, Japan,
E-mail for t_chin@hwc.or.jp
Received: 08 Sep 2022
Accepted: 20 Sep 2022
Published: 25 Sep 2022
J Short Name: ACMCR
Copyright:
©2022 T Chin. This is an open access article distributed
under the terms of the Creative Commons Attribution Li-
cense, which permits unrestricted use, distribution, and
build upon your work non-commercially
Citation:
T Chin, Walking Rehabilitation Using Hybrid Assistive
Limb (HAL) and Computer-Controlled Long-Leg Ortho-
sis (C-Brace) for an Individual with Chronic Incomplete
Spinal Cord Injury: A Case Report. Ann Clin Med Case
Rep. 2022; V9(16): 1-6
http://www.acmcasereport.com/ 1
1. Abstract
Many individuals with spinal cord injury (SCI) hope to restore
walking function irrespective of their impairment. We present a
case with chronic incomplete cervical SCI who could regain com-
munity ambulation by gait training with hybrid assistive limb
(HAL), followed by fitting and training of microprocessor-con-
trolled knee ankle foot orthosis (C-Brace). The walking and bal-
ance ability continuously improved in the course of rehabilitation.
The combination therapy of HAL and C-Brace could be a novel,
effective therapeutic strategy for walking rehabilitation in chronic
incomplete SCI patients.
2. Background
Spinal cord injury (SCI) can cause severe quadriplegia or paraple-
gia and can significantly negatively affect the physical and mental
health of patients [1,2]. Traditionally, therapies for SCI that caused
complete or incomplete paralysis have primarily involved rehabil-
itation practices focused on patients’remaining physical functions.
Many people with SCIs return to their local communities by reac-
quiring their Activity of Daily Living (ADL) functionality to the
extent they can and making use of assistive devices, such as wheel-
chairs [3]. At the same time, it has been reported that irrespective
of the severity of their paralyses, a large number of SCI patients
hope to reacquire the ability to walk. Thus, the improvement of
SCI patients’paralysis and the reacquisition of their ability to walk
remain important unsolved issues in this field [4]. In recent years,
reports detailing the efficacy of rehabilitation practices involving
robotic technology for patients with neurological impairments (in-
cluding SCI) have become more common [5,6]. Hybrid Assistive
Limb (HAL) robot is a wearable cyborg device which detects
movement signals at the wearer’s hip and knee joints and provides
assistive force to aid them in walking (Figure 1a). Reports indicate
that HAL is effective in improving chronic SCI patients’ walking
ability, and thus is an important therapeutic strategy to consider
when rehabilitating an individual’s walking ability [6-8]. How-
ever, there are certain problems with HAL rehabilitation therapy.
HAL is large and quite heavy, and the patient cannot equip or put
on HAL alone. Furthermore, while HAL can be used in walking
practice on flat ground, it is very difficult to adapt it for use out-
doors, climbing or descending stairs, and on sloped surfaces. As a
result, HAL can only be used inside rehabilitation facilities and is,
for all intents and purposes, impossible to use in local community
spaces. For this reason, it is very difficult for patients that rely on
HAL to reacquire real-world walking ability. These problems at-
tendant upon HAL-reliant rehabilitation therapy represent the lim-
itations of the technology [9]. A new therapeutic strategy, which
can both maintain the walking ability improvement effects made
possible by HAL training and can enable the acquisition of walk-
ing ability for local community settings, is sorely needed. One pos-
sible candidate for this strategy is C-Brace computer-controlled
http://www.acmcasereport.com/ 2
Volume 9 Issue 16 -2022 Case Report
long-leg orthosis. Compared to HAL, C-Brace is more compact,
lighter, and can be put on by the patient alone quite easily (Fig-
ure 2). C-Brace can be equipped and used outdoors, up and down
stairs, on sloped surfaces, and in many other environments. It as-
sists the wearer in walking stably and works to prevent falls [10-
11]. C-Brace should allow patients to maintain the walking ability
improvement they obtained through HAL training while also serve
as a promising means for wearers to realize walking ability usable
in local community spaces. However, there are no reports to date
on the use of C-Brace for SCI patients. There are also no reports
of rehabilitation therapies that combine HAL and C-Brace training
for SCI patients. Here, we report a case wherein a chronic cervical
SCI patient for whom conventional rehabilitation therapy did not
work received walking training using the HAL device, followed by
C-Brace use. Ultimately, this patient was able to regain the practi-
cal walking ability necessary to navigate local community spaces.
This study was carried out in accordance with the Declaration of
Helsinki and received the approval of the Hyogo Rehabilitation
Center Hospital’s Ethics Committee. Written consent was obtained
from the patient.
3. Case Presentation
A 38-y-old male suffered from incomplete cervical SCI due to a
car accident. After initial treatment at a tertiary emergency hos-
pital, he was transferred to a general rehabilitation hospital 1 mo
later. He was admitted to our hospital, which specializes in SCI
rehabilitation, 5 mo after the injury developed. The patient’s im-
pairment at admission to our hospital was as follows: American
Spinal Cord Injury Association Impairment Scale (AIS) D, Inter-
national Standards for Neurological and Functional Classification
of Spinal Cord Injury (ISNCSCI) score [12], upper limbs 45 (left
24, right 21), lower limbs 41 (left 25, right 16), neurological level
of injury (NLI) C8, sensory level of injury C5, Berg Balance Scale
(BBS) 48 [13], and WISCI-Ⅱ score 15 (can walk 10 m using one
Lofstrand crutch and right rear strut ankle foot orthosis) [14]. For
1 mo, the patient underwent conventional rehabilitation therapy
(physical therapy/occupational therapy for 80 min/d, 5 d/week,
along with individual exercises), but almost no improvement in
physical function or balance capabilities was observed. Further-
more, no improvement in LEMS or WISCI-Ⅱ scores was observed
(Table 1). Given these results and the fact that an additional 6 mo
had passed since the patient’s injury, we judged that improvement
in the patient’s paralysis caused by cervical SCI had plateaued,
and, thus, decided to introduce HAL training.
3.1. HAL Functions, Training Protocol, and Evaluation Meth-
ods
HAL is a wearable cyborg device that detects and provides me-
chanical assistance for movement impulses at the hip and knee
joints of the wearer. The floor reaction force sensors in the “shoe”
part of the device and the myoelectric potential signals detected by
skin-contact electrodes are analyzed to assist the wearer’s intended
walking movement (Figure 1a) [15,16]. The hip/knee unit consists
of an angle sensor and an actuator. In terms of methods to control
these separate units, HAL can be operated in two modes. In the cy-
bernic voluntary control (CVC) mode, the device analyzes move-
ment impulses from signals collected by electrodes at the user’s
skin surface and controls its parts in accordance with the user’s
voluntary movements. In the cybernic autonomous control (CAC)
mode, the device largely controls itself, enabling it to complete the
user’s movement patterns even when biopotential signals at the
skin surface are insufficient or incomplete. The training for this
case was performed in CVC mode because the myoelectric signals
detected by its surface electrodes were sufficient to properly ma-
nipulate the HAL device. The strength of support was adjusted by
a physiotherapist in accordance with the walking ability of the pa-
tient while wearing HAL. As training progressed and the patient’s
walking ability improved, the amount of support was reduced.
The protocol was as follows: 24 sessions of HAL training were
held twice a week for 12 wk. During the HAL training period, reg-
ular physiotherapy was performed in the same way as it was before
the introduction of the HAL. The contents of the HAL training
were as follows: each session lasted 45 min; 15 min for equipping
the HAL, 25 min of walking training (6 min of walking in the
training room and 3 min of rest, each set repeated thrice), and 5
min for HAL removal. During the training, a doctor was present in
case of an emergency, the patient used a wheeled walker to prevent
falls, and the patient was accompanied by two physiotherapists
(Figure 1b). Another physiotherapist was present as a timekeeper
and to measure vital signs (heart rate, blood pressure, and blood
oxygen saturation).
The following items were measured: 10 m walking test (10MWT,
comfortable speed and max speed), 6 min walking test (6MD)
[17], and the BBS. Finally, to measure balance ability in ADL
movements, the Activity-Balance Confidence Scale (ABC scale)
was used [18]. The ABC scale involves self-rating one’s confi-
dence during each performance of 16 ADL movements (such as
walking up and down stairs) from 0% to 100%; we calculated the
mean of these 16 ratings.
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Volume 9 Issue 16 -2022 Case Report
3.2 Progress after HAL Training, Function and Manufacture
of the C-Brace, and Suitability
After 3 mo of HAL training, the patient’s walking and balance
abilities improved (Table 2). However, the extensor strength of the
right knee muscles was still weak at the Manual Muscle Testing
(MMT) 3 level, and hyperextension of the right knee was observed
when the patient walked with the right ankle foot orthosis. He was
able to walk indoors on level ground in a stable manner, but was
unstable on slopes, stairs, and rough terrain, and was afraid of fall-
ing. A wheelchair was required for him to move about outdoors.
Therefore, we decided to adapt the C-Brace to maintain the im-
proved walking ability by achieved by using HAL and to acquire
practical walking ability in the community. C-Brace consists of
a carbon fiber thigh/lower leg shell made for each patient and a
uniaxial knee joint with a computer-controlled hydraulic damper
connected to it (Figure 2). The knee joint has a built-in angle sen-
sor and an angular velocity sensor. Carbon fiber struts connect the
lower leg shell to the foot parts. The knee joint computer controls
the knee joint hydraulic damper. This structure allows the device
to control the user’s entire walk cycle in real time [10]. However,
C-Brace cannot assist its user via reading signals collected from
surface electrodes like the HAL can. C-Brace was molded and
manufactured by a prosthetist, and the patient’s suitability for the
device was confirmed by a doctor.
Figure: 1a: Hybrid Assistive Limb (HAL) robot is a wearable cyborg device which detects movement signals at the wearer’s hip and knee joints and
provides assistive force to aid them in walking.
Figure 1b: The contents of the HAL training were as follows: each session lasted 45 min; 15 min for equipping the HAL, 25 min of walking training (6
min of walking in the training room and 3 min of rest, each set repeated thrice), and 5 min for HAL removal. During the training, a doctor was present
in case of an emergency, the patient used a wheeled walker to prevent falls, and the patient was accompanied by two physiotherapists.
Table 1: Physcial funcation and WISCI - ⅠⅠ.
Before HAL
traning
After 3 months HAL
training
After 3 months
C - Barce
After 6 Months
C- brace
UEMS total 44 47 47 47
LEMS total 41 42 42 42
WISCI - II 15 15 15 15
UEMS: upper extremity motor score
LEMS: lower extremity motor score
WISCI-ⅠⅠ: Walking Index for Spinal Cord Injury ⅠⅠ
http://www.acmcasereport.com/ 4
Volume 9 Issue 16 -2022 Case Report
Table 2: Gait and balance abilities.
Before
HAL
training
After 3
months AHL
training
After 3
months
C-Brace
After 6
months
C-Brace
10MWT CWS (ms) 0.40 0.75 0.80 1.14
10MWT MWS (ms) 0.52 1.15 1.19 1.33
6MD (m) 195 284 360 424
BBS 48 50 50 53
ABC scale (%) 56.3 62.5 65.6 67.5
10MWT: 10-meter walk test
CWS: comfortable walking speed
MWS: maximum walking speed
6MD: 6- minute walking distance
BBS: Berg balance scale
ABC scale: Activate-Balance Confidence Scale
Figure 2: C-Brace consists of a carbon fiber thigh/lower leg shell made for each patient and a uniaxial knee joint with a computer-controlled hydraulic
damper connected to it.
3.3. C-Brace Training Protocol and Progress
The patient underwent C-Brace training four times a week for 6
mo. As was done during HAL training, normal physiotherapy ses-
sions were continued throughout. C-Brace training protocol. Each
session was 30 min long. For the first 3 mo, the patient focused on
walking training using C-Brace, with three sets of 6 min of flat-
found walking training and 3 min of rest between sets. During the
first few sessions, the patient used a walker to prevent falling, but
after it was confirmed that he could walk safely, he was permit-
ted to walk with Lofstrand crutches. For the last 3 mo, the patient
underwent applied training on uneven ground, stairs, and sloped
surfaces. After 6 mo of training, the patient acquired the ability to
walk stably while wearing C-Brace in all environments necessary
for daily life, including rough terrain, stairs, and slopes (Figure 3).
He was also able to walk continuously for more than 1000 m. The
patient’s walking and balance ability further improved through
C-Brace training (Table 2). The patient is currently preparing to
return to work as a postal worker.
Figure 3: After 6 mo of training, the patient acquired the ability to walk stably while wearing C-Brace in all environments necessary for daily life,
including rough terrain, stairs, and slopes.
http://www.acmcasereport.com/ 5
Volume 9 Issue 16 -2022 Case Report
4. Discussion
In a patient with chronic incomplete SCI, the application of
C-Brace training after HAL-based walking training led to the fur-
ther improvement of walking and balance ability, reduced fear of
falling during daily living activities, and acquisition of practical
walking ability in local community spaces. The training results of
this case make it clear that walking training using HAL was ef-
fective in improving walking and balance ability. Previous reports
also indicated that HAL was effective in improving the walking
ability in patients with spinal cord disorders whose conditions did
not improve with conventional rehabilitation treatment [6,9,19].
These improvements are believed to be related to motor learn-
ing and dose-dependent plasticity in the central nervous system
[3,20,21]. Our results are in agreement with these findings and
suggest that HAL training is quite effective. However, HAL is a
training device and is suitable only for use in training contexts; as
such, it cannot be used in patients’ daily lives. In addition, it has
been reported that after HAL training is completed, walking ability
can decline again if HAL training is not continued [9]. In order to
maintain the walking ability improvement effect obtained after the
completion of HAL training, and to acquire practical walking in
the local community, orthoses and walking aids that compensate
for patients’ remaining dysfunctions are necessary. In other words,
walking training with HAL alone is not sufficient for the rehabil-
itation of practical walking in community spaces for people with
SCI. In this case, use of C-Brace allowed the patient to maintain
the improvements in their walking and balance ability that they
achieved with HAL training and to even achieve further improve-
ment (Table 2). It has been reported that C-Brace maintains better
control of the knee joint during both the stance and swing phases,
compared to conventional long-leg orthoses, and better enables us-
ers to walk on stairs and sloped surfaces naturally [10,11]. In this
case, we believe that the knee joint stability during walking pro-
vided by the C-Brace contributed to the maintenance of the effects
of HAL training and further improvement in the patient’s walking
ability. Establishing an effective rehabilitation treatment strategy
for gait disorders in people with chronic myelopathy is an impor-
tant clinical issue. In recent years, cell-based spinal cord regen-
erative medicine has attracted attention. It has been reported that
spinal cord regeneration therapy using these cells cannot achieve
functional and ability improvement alone, especially in chronic
SCI, and that it is necessary to use this approach in combination
with rehabilitation therapy [22]. However, effective rehabilitation
treatment has not yet been fully established in the context of regen-
erative medicine for SCI. The HAL training followed by C-Brace
training that we have reported here is likely a promising new ther-
apeutic strategy for walking rehabilitation in chronic SCI patients.
5. Conclusion
We experienced a case in which HAL and C-Brace training proved
effective as practical walking reacquisition therapy at the local
community level for a patient with chronic incomplete cervical
SCI associated with ambulatory impairment. The combination of
HAL and C-Brace technologies is a novel, effective therapeutic
strategy for walking rehabilitation in chronic SCI patients. Further
proof with additional cases is necessary for verification of these
results.
References
1. Wyndaele M, Wyndaele JJ. Incidence, prevalence and epidemiology
of spinal cord injury: What learns a worldwide literature survey?
Spinal Cord. 2006.
2. Toda M, Nakatani E, Omae K, Fukushima M, Chin T. Age-specific
characterization of spinal cord injuries over a 19-year period at a
Japanese rehabilitation center. PLoS One. 2018.
3. Behrman AL, Bowden MG, Nair PM. Neuroplasticity After Spinal
Cord Injury and Training: An Emerging Paradigm Shift in Rehabili-
tation and Walking Recovery. Phys Ther. 2006.
4. Ditunno PL, Patrick M, Stineman M, Ditunno JF. Who wants
to walk? Preferences for recovery after SCI: a longitudinal and
cross-sectional study. Spinal Cord. 2008; 46(7): 500.
5. Tefertiller C, Pharo B, Evans N, Winchester P. Efficacy of rehabili-
tation robotics for walking training in neurological disorders:A re-
view. J Rehabil Res Dev. 2011.
6. Aach M, Cruciger O, Sczesny-Kaiser M. Voluntary driven exoskel-
eton as a new tool for rehabilitation in chronic spinal cord injury: A
pilot study. Spine J. 2014.
7. Kawamoto H, Taal S, Niniss H. Voluntary motion support control of
Robot Suit HAL triggered by bioelectrical signal for hemiplegia. In:
2010 Annual International Conference of the IEEE Engineering in
Medicine and Biology Society, EMBC’. 2010.
8. Kubota S, Nakata Y, Eguchi K. Feasibility of rehabilitation training
with a newly developed wearable robot for patients with limited mo-
bility. Arch Phys Med Rehabil. 2013.
9. Jansen O, Schildhauer TA, Meindl RC. Functional outcome of neu-
rologic-controlled HAL-exoskeletal neurorehabilitation in chronic
spinal cord injury: a pilot with one year treatment and variable treat-
ment frequency. Glob spine J. 2017; 7(8): 735-743.
10. Pröbsting E, Kannenberg A, Zacharias B. Safety and walking ability
of KAFO users with the C-Brace® Orthotronic Mobility System,
a new microprocessor stance and swing control orthosis. Prosthet
Orthot Int. 2017.
11. Hobusch GM, Hasenöhrl T, Pieber K. A novel mechanotronic ortho-
sis enables symmetrical gait kinematics in a patient with a femoral
nerve palsy–a case study. Disabil Rehabil Assist Technol. 2018.
12. Devivo MJ, Biering-Sørensen F, New P, Chen Y. Standardization of
data analysis and reporting of results from the International Spinal
Cord Injury Core Data Set. Spinal Cord. 2011.
13. Downs S. The Berg Balance Scale. J Physiother. 2015.
14. Dittuno PL, Dittuno JF. Walking index for spinal cord injury (WIS-
CI II): Scale revision. Spinal Cord. 2001.
15. Kawamoto H, Sankai Y. Power assist method based on Phase Se-
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Volume 9 Issue 16 -2022 Case Report
quence and muscle force condition for HAL. Adv Robot. 2005.
16. Sankai Y. HAL: Hybrid assistive limb based on cybernics. In:
Springer Tracts in Advanced Robotics. 2010.
17. Van Hedel HJA, Wirz M, Dietz V. Standardized assessment of walk-
ing capacity after spinal cord injury: The European network ap-
proach. In: Neurological Research. 2008.
18. Miller WC, Deathe AB, Speechley M. Psychometric properties of
the activities-specific balance confidence scale among individuals
with a lower-limb amputation. Arch Phys Med Rehabil. 2003.
19. Cruciger O, Schildhauer TA, Meindl RC, et al. Impact of locomotion
training with a neurologic controlled hybrid assistive limb (HAL)
exoskeleton on neuropathic pain and health related quality of life
(HRQoL) in chronic SCI: a case study*. Disabil Rehabil Assist
Technol. 2016.
20. Hubli M, Dietz V. The physiological basis of neurorehabilitation -
Locomotor training after spinal cord injury. J Neuroeng Rehabil.
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21. Wall A, Wall A, Borg J, Borg J, Palmcrantz S, Palmcrantz S. Clinical
application of the hybrid assistive limb (Hal) for gait training – A
systematic review. Front Syst Neurosci. 2015.
22. Tashiro S, Nakamura M, Okano H. The prospects of regenerative
medicine combined with rehabilitative approaches for chronic spi-
nal cord injury animal models. Neural Regen Res. 2017.

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Walking rehabilitation using Hybrid Assistive Limb and C-Brace for an individual with chronic incomplete spinal cord injury: a case report

  • 1. Annals of Clinical and Medical Case Reports Case Report ISSN 2639-8109 Volume 9 T Oshima1* , M Toda1* and T Chin1,2* 1 Department of Orthopaedic Surgery, Hyogo Rehabilitation Center Hospital, 1070 Akebono-cho, Nishi-ku, Kobe, Hyogo, Japan 2 Robot Rehabilitation Center, Hyogo Institute of Assistive Technology, 1070 Akebono-cho, Nishi-ku, Kobe, Hyogo, Japan Walking Rehabilitation Using Hybrid Assistive Limb (HAL) and Computer-Controlled Long-Leg Orthosis (C-Brace) for an Individual with Chronic Incomplete Spinal Cord Injury: A Case Report * Corresponding author: Takaaki Chin, Department of Orthopaedic Surgery, Hyogo Rehabil- itation Center Hospital, 1070 Akebono-cho, Nishi-ku, Kobe, Hyogo, Japan and Robot Rehabilitation Center, Hyogo Institute of Assistive Technology, 1070 Akebono-cho, Nishi-ku, Kobe, Hyogo, Japan, E-mail for t_chin@hwc.or.jp Received: 08 Sep 2022 Accepted: 20 Sep 2022 Published: 25 Sep 2022 J Short Name: ACMCR Copyright: ©2022 T Chin. This is an open access article distributed under the terms of the Creative Commons Attribution Li- cense, which permits unrestricted use, distribution, and build upon your work non-commercially Citation: T Chin, Walking Rehabilitation Using Hybrid Assistive Limb (HAL) and Computer-Controlled Long-Leg Ortho- sis (C-Brace) for an Individual with Chronic Incomplete Spinal Cord Injury: A Case Report. Ann Clin Med Case Rep. 2022; V9(16): 1-6 http://www.acmcasereport.com/ 1 1. Abstract Many individuals with spinal cord injury (SCI) hope to restore walking function irrespective of their impairment. We present a case with chronic incomplete cervical SCI who could regain com- munity ambulation by gait training with hybrid assistive limb (HAL), followed by fitting and training of microprocessor-con- trolled knee ankle foot orthosis (C-Brace). The walking and bal- ance ability continuously improved in the course of rehabilitation. The combination therapy of HAL and C-Brace could be a novel, effective therapeutic strategy for walking rehabilitation in chronic incomplete SCI patients. 2. Background Spinal cord injury (SCI) can cause severe quadriplegia or paraple- gia and can significantly negatively affect the physical and mental health of patients [1,2]. Traditionally, therapies for SCI that caused complete or incomplete paralysis have primarily involved rehabil- itation practices focused on patients’remaining physical functions. Many people with SCIs return to their local communities by reac- quiring their Activity of Daily Living (ADL) functionality to the extent they can and making use of assistive devices, such as wheel- chairs [3]. At the same time, it has been reported that irrespective of the severity of their paralyses, a large number of SCI patients hope to reacquire the ability to walk. Thus, the improvement of SCI patients’paralysis and the reacquisition of their ability to walk remain important unsolved issues in this field [4]. In recent years, reports detailing the efficacy of rehabilitation practices involving robotic technology for patients with neurological impairments (in- cluding SCI) have become more common [5,6]. Hybrid Assistive Limb (HAL) robot is a wearable cyborg device which detects movement signals at the wearer’s hip and knee joints and provides assistive force to aid them in walking (Figure 1a). Reports indicate that HAL is effective in improving chronic SCI patients’ walking ability, and thus is an important therapeutic strategy to consider when rehabilitating an individual’s walking ability [6-8]. How- ever, there are certain problems with HAL rehabilitation therapy. HAL is large and quite heavy, and the patient cannot equip or put on HAL alone. Furthermore, while HAL can be used in walking practice on flat ground, it is very difficult to adapt it for use out- doors, climbing or descending stairs, and on sloped surfaces. As a result, HAL can only be used inside rehabilitation facilities and is, for all intents and purposes, impossible to use in local community spaces. For this reason, it is very difficult for patients that rely on HAL to reacquire real-world walking ability. These problems at- tendant upon HAL-reliant rehabilitation therapy represent the lim- itations of the technology [9]. A new therapeutic strategy, which can both maintain the walking ability improvement effects made possible by HAL training and can enable the acquisition of walk- ing ability for local community settings, is sorely needed. One pos- sible candidate for this strategy is C-Brace computer-controlled
  • 2. http://www.acmcasereport.com/ 2 Volume 9 Issue 16 -2022 Case Report long-leg orthosis. Compared to HAL, C-Brace is more compact, lighter, and can be put on by the patient alone quite easily (Fig- ure 2). C-Brace can be equipped and used outdoors, up and down stairs, on sloped surfaces, and in many other environments. It as- sists the wearer in walking stably and works to prevent falls [10- 11]. C-Brace should allow patients to maintain the walking ability improvement they obtained through HAL training while also serve as a promising means for wearers to realize walking ability usable in local community spaces. However, there are no reports to date on the use of C-Brace for SCI patients. There are also no reports of rehabilitation therapies that combine HAL and C-Brace training for SCI patients. Here, we report a case wherein a chronic cervical SCI patient for whom conventional rehabilitation therapy did not work received walking training using the HAL device, followed by C-Brace use. Ultimately, this patient was able to regain the practi- cal walking ability necessary to navigate local community spaces. This study was carried out in accordance with the Declaration of Helsinki and received the approval of the Hyogo Rehabilitation Center Hospital’s Ethics Committee. Written consent was obtained from the patient. 3. Case Presentation A 38-y-old male suffered from incomplete cervical SCI due to a car accident. After initial treatment at a tertiary emergency hos- pital, he was transferred to a general rehabilitation hospital 1 mo later. He was admitted to our hospital, which specializes in SCI rehabilitation, 5 mo after the injury developed. The patient’s im- pairment at admission to our hospital was as follows: American Spinal Cord Injury Association Impairment Scale (AIS) D, Inter- national Standards for Neurological and Functional Classification of Spinal Cord Injury (ISNCSCI) score [12], upper limbs 45 (left 24, right 21), lower limbs 41 (left 25, right 16), neurological level of injury (NLI) C8, sensory level of injury C5, Berg Balance Scale (BBS) 48 [13], and WISCI-Ⅱ score 15 (can walk 10 m using one Lofstrand crutch and right rear strut ankle foot orthosis) [14]. For 1 mo, the patient underwent conventional rehabilitation therapy (physical therapy/occupational therapy for 80 min/d, 5 d/week, along with individual exercises), but almost no improvement in physical function or balance capabilities was observed. Further- more, no improvement in LEMS or WISCI-Ⅱ scores was observed (Table 1). Given these results and the fact that an additional 6 mo had passed since the patient’s injury, we judged that improvement in the patient’s paralysis caused by cervical SCI had plateaued, and, thus, decided to introduce HAL training. 3.1. HAL Functions, Training Protocol, and Evaluation Meth- ods HAL is a wearable cyborg device that detects and provides me- chanical assistance for movement impulses at the hip and knee joints of the wearer. The floor reaction force sensors in the “shoe” part of the device and the myoelectric potential signals detected by skin-contact electrodes are analyzed to assist the wearer’s intended walking movement (Figure 1a) [15,16]. The hip/knee unit consists of an angle sensor and an actuator. In terms of methods to control these separate units, HAL can be operated in two modes. In the cy- bernic voluntary control (CVC) mode, the device analyzes move- ment impulses from signals collected by electrodes at the user’s skin surface and controls its parts in accordance with the user’s voluntary movements. In the cybernic autonomous control (CAC) mode, the device largely controls itself, enabling it to complete the user’s movement patterns even when biopotential signals at the skin surface are insufficient or incomplete. The training for this case was performed in CVC mode because the myoelectric signals detected by its surface electrodes were sufficient to properly ma- nipulate the HAL device. The strength of support was adjusted by a physiotherapist in accordance with the walking ability of the pa- tient while wearing HAL. As training progressed and the patient’s walking ability improved, the amount of support was reduced. The protocol was as follows: 24 sessions of HAL training were held twice a week for 12 wk. During the HAL training period, reg- ular physiotherapy was performed in the same way as it was before the introduction of the HAL. The contents of the HAL training were as follows: each session lasted 45 min; 15 min for equipping the HAL, 25 min of walking training (6 min of walking in the training room and 3 min of rest, each set repeated thrice), and 5 min for HAL removal. During the training, a doctor was present in case of an emergency, the patient used a wheeled walker to prevent falls, and the patient was accompanied by two physiotherapists (Figure 1b). Another physiotherapist was present as a timekeeper and to measure vital signs (heart rate, blood pressure, and blood oxygen saturation). The following items were measured: 10 m walking test (10MWT, comfortable speed and max speed), 6 min walking test (6MD) [17], and the BBS. Finally, to measure balance ability in ADL movements, the Activity-Balance Confidence Scale (ABC scale) was used [18]. The ABC scale involves self-rating one’s confi- dence during each performance of 16 ADL movements (such as walking up and down stairs) from 0% to 100%; we calculated the mean of these 16 ratings.
  • 3. http://www.acmcasereport.com/ 3 Volume 9 Issue 16 -2022 Case Report 3.2 Progress after HAL Training, Function and Manufacture of the C-Brace, and Suitability After 3 mo of HAL training, the patient’s walking and balance abilities improved (Table 2). However, the extensor strength of the right knee muscles was still weak at the Manual Muscle Testing (MMT) 3 level, and hyperextension of the right knee was observed when the patient walked with the right ankle foot orthosis. He was able to walk indoors on level ground in a stable manner, but was unstable on slopes, stairs, and rough terrain, and was afraid of fall- ing. A wheelchair was required for him to move about outdoors. Therefore, we decided to adapt the C-Brace to maintain the im- proved walking ability by achieved by using HAL and to acquire practical walking ability in the community. C-Brace consists of a carbon fiber thigh/lower leg shell made for each patient and a uniaxial knee joint with a computer-controlled hydraulic damper connected to it (Figure 2). The knee joint has a built-in angle sen- sor and an angular velocity sensor. Carbon fiber struts connect the lower leg shell to the foot parts. The knee joint computer controls the knee joint hydraulic damper. This structure allows the device to control the user’s entire walk cycle in real time [10]. However, C-Brace cannot assist its user via reading signals collected from surface electrodes like the HAL can. C-Brace was molded and manufactured by a prosthetist, and the patient’s suitability for the device was confirmed by a doctor. Figure: 1a: Hybrid Assistive Limb (HAL) robot is a wearable cyborg device which detects movement signals at the wearer’s hip and knee joints and provides assistive force to aid them in walking. Figure 1b: The contents of the HAL training were as follows: each session lasted 45 min; 15 min for equipping the HAL, 25 min of walking training (6 min of walking in the training room and 3 min of rest, each set repeated thrice), and 5 min for HAL removal. During the training, a doctor was present in case of an emergency, the patient used a wheeled walker to prevent falls, and the patient was accompanied by two physiotherapists. Table 1: Physcial funcation and WISCI - ⅠⅠ. Before HAL traning After 3 months HAL training After 3 months C - Barce After 6 Months C- brace UEMS total 44 47 47 47 LEMS total 41 42 42 42 WISCI - II 15 15 15 15 UEMS: upper extremity motor score LEMS: lower extremity motor score WISCI-ⅠⅠ: Walking Index for Spinal Cord Injury ⅠⅠ
  • 4. http://www.acmcasereport.com/ 4 Volume 9 Issue 16 -2022 Case Report Table 2: Gait and balance abilities. Before HAL training After 3 months AHL training After 3 months C-Brace After 6 months C-Brace 10MWT CWS (ms) 0.40 0.75 0.80 1.14 10MWT MWS (ms) 0.52 1.15 1.19 1.33 6MD (m) 195 284 360 424 BBS 48 50 50 53 ABC scale (%) 56.3 62.5 65.6 67.5 10MWT: 10-meter walk test CWS: comfortable walking speed MWS: maximum walking speed 6MD: 6- minute walking distance BBS: Berg balance scale ABC scale: Activate-Balance Confidence Scale Figure 2: C-Brace consists of a carbon fiber thigh/lower leg shell made for each patient and a uniaxial knee joint with a computer-controlled hydraulic damper connected to it. 3.3. C-Brace Training Protocol and Progress The patient underwent C-Brace training four times a week for 6 mo. As was done during HAL training, normal physiotherapy ses- sions were continued throughout. C-Brace training protocol. Each session was 30 min long. For the first 3 mo, the patient focused on walking training using C-Brace, with three sets of 6 min of flat- found walking training and 3 min of rest between sets. During the first few sessions, the patient used a walker to prevent falling, but after it was confirmed that he could walk safely, he was permit- ted to walk with Lofstrand crutches. For the last 3 mo, the patient underwent applied training on uneven ground, stairs, and sloped surfaces. After 6 mo of training, the patient acquired the ability to walk stably while wearing C-Brace in all environments necessary for daily life, including rough terrain, stairs, and slopes (Figure 3). He was also able to walk continuously for more than 1000 m. The patient’s walking and balance ability further improved through C-Brace training (Table 2). The patient is currently preparing to return to work as a postal worker. Figure 3: After 6 mo of training, the patient acquired the ability to walk stably while wearing C-Brace in all environments necessary for daily life, including rough terrain, stairs, and slopes.
  • 5. http://www.acmcasereport.com/ 5 Volume 9 Issue 16 -2022 Case Report 4. Discussion In a patient with chronic incomplete SCI, the application of C-Brace training after HAL-based walking training led to the fur- ther improvement of walking and balance ability, reduced fear of falling during daily living activities, and acquisition of practical walking ability in local community spaces. The training results of this case make it clear that walking training using HAL was ef- fective in improving walking and balance ability. Previous reports also indicated that HAL was effective in improving the walking ability in patients with spinal cord disorders whose conditions did not improve with conventional rehabilitation treatment [6,9,19]. These improvements are believed to be related to motor learn- ing and dose-dependent plasticity in the central nervous system [3,20,21]. Our results are in agreement with these findings and suggest that HAL training is quite effective. However, HAL is a training device and is suitable only for use in training contexts; as such, it cannot be used in patients’ daily lives. In addition, it has been reported that after HAL training is completed, walking ability can decline again if HAL training is not continued [9]. In order to maintain the walking ability improvement effect obtained after the completion of HAL training, and to acquire practical walking in the local community, orthoses and walking aids that compensate for patients’ remaining dysfunctions are necessary. In other words, walking training with HAL alone is not sufficient for the rehabil- itation of practical walking in community spaces for people with SCI. In this case, use of C-Brace allowed the patient to maintain the improvements in their walking and balance ability that they achieved with HAL training and to even achieve further improve- ment (Table 2). It has been reported that C-Brace maintains better control of the knee joint during both the stance and swing phases, compared to conventional long-leg orthoses, and better enables us- ers to walk on stairs and sloped surfaces naturally [10,11]. In this case, we believe that the knee joint stability during walking pro- vided by the C-Brace contributed to the maintenance of the effects of HAL training and further improvement in the patient’s walking ability. Establishing an effective rehabilitation treatment strategy for gait disorders in people with chronic myelopathy is an impor- tant clinical issue. In recent years, cell-based spinal cord regen- erative medicine has attracted attention. It has been reported that spinal cord regeneration therapy using these cells cannot achieve functional and ability improvement alone, especially in chronic SCI, and that it is necessary to use this approach in combination with rehabilitation therapy [22]. However, effective rehabilitation treatment has not yet been fully established in the context of regen- erative medicine for SCI. The HAL training followed by C-Brace training that we have reported here is likely a promising new ther- apeutic strategy for walking rehabilitation in chronic SCI patients. 5. Conclusion We experienced a case in which HAL and C-Brace training proved effective as practical walking reacquisition therapy at the local community level for a patient with chronic incomplete cervical SCI associated with ambulatory impairment. The combination of HAL and C-Brace technologies is a novel, effective therapeutic strategy for walking rehabilitation in chronic SCI patients. Further proof with additional cases is necessary for verification of these results. References 1. Wyndaele M, Wyndaele JJ. Incidence, prevalence and epidemiology of spinal cord injury: What learns a worldwide literature survey? Spinal Cord. 2006. 2. Toda M, Nakatani E, Omae K, Fukushima M, Chin T. Age-specific characterization of spinal cord injuries over a 19-year period at a Japanese rehabilitation center. PLoS One. 2018. 3. Behrman AL, Bowden MG, Nair PM. Neuroplasticity After Spinal Cord Injury and Training: An Emerging Paradigm Shift in Rehabili- tation and Walking Recovery. Phys Ther. 2006. 4. Ditunno PL, Patrick M, Stineman M, Ditunno JF. Who wants to walk? Preferences for recovery after SCI: a longitudinal and cross-sectional study. Spinal Cord. 2008; 46(7): 500. 5. Tefertiller C, Pharo B, Evans N, Winchester P. Efficacy of rehabili- tation robotics for walking training in neurological disorders:A re- view. J Rehabil Res Dev. 2011. 6. Aach M, Cruciger O, Sczesny-Kaiser M. Voluntary driven exoskel- eton as a new tool for rehabilitation in chronic spinal cord injury: A pilot study. Spine J. 2014. 7. Kawamoto H, Taal S, Niniss H. Voluntary motion support control of Robot Suit HAL triggered by bioelectrical signal for hemiplegia. In: 2010 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBC’. 2010. 8. Kubota S, Nakata Y, Eguchi K. Feasibility of rehabilitation training with a newly developed wearable robot for patients with limited mo- bility. Arch Phys Med Rehabil. 2013. 9. Jansen O, Schildhauer TA, Meindl RC. Functional outcome of neu- rologic-controlled HAL-exoskeletal neurorehabilitation in chronic spinal cord injury: a pilot with one year treatment and variable treat- ment frequency. Glob spine J. 2017; 7(8): 735-743. 10. Pröbsting E, Kannenberg A, Zacharias B. Safety and walking ability of KAFO users with the C-Brace® Orthotronic Mobility System, a new microprocessor stance and swing control orthosis. Prosthet Orthot Int. 2017. 11. Hobusch GM, Hasenöhrl T, Pieber K. A novel mechanotronic ortho- sis enables symmetrical gait kinematics in a patient with a femoral nerve palsy–a case study. Disabil Rehabil Assist Technol. 2018. 12. Devivo MJ, Biering-Sørensen F, New P, Chen Y. Standardization of data analysis and reporting of results from the International Spinal Cord Injury Core Data Set. Spinal Cord. 2011. 13. Downs S. The Berg Balance Scale. J Physiother. 2015. 14. Dittuno PL, Dittuno JF. Walking index for spinal cord injury (WIS- CI II): Scale revision. Spinal Cord. 2001. 15. Kawamoto H, Sankai Y. Power assist method based on Phase Se-
  • 6. http://www.acmcasereport.com/ 6 Volume 9 Issue 16 -2022 Case Report quence and muscle force condition for HAL. Adv Robot. 2005. 16. Sankai Y. HAL: Hybrid assistive limb based on cybernics. In: Springer Tracts in Advanced Robotics. 2010. 17. Van Hedel HJA, Wirz M, Dietz V. Standardized assessment of walk- ing capacity after spinal cord injury: The European network ap- proach. In: Neurological Research. 2008. 18. Miller WC, Deathe AB, Speechley M. Psychometric properties of the activities-specific balance confidence scale among individuals with a lower-limb amputation. Arch Phys Med Rehabil. 2003. 19. Cruciger O, Schildhauer TA, Meindl RC, et al. Impact of locomotion training with a neurologic controlled hybrid assistive limb (HAL) exoskeleton on neuropathic pain and health related quality of life (HRQoL) in chronic SCI: a case study*. Disabil Rehabil Assist Technol. 2016. 20. Hubli M, Dietz V. The physiological basis of neurorehabilitation - Locomotor training after spinal cord injury. J Neuroeng Rehabil. 2013. 21. Wall A, Wall A, Borg J, Borg J, Palmcrantz S, Palmcrantz S. Clinical application of the hybrid assistive limb (Hal) for gait training – A systematic review. Front Syst Neurosci. 2015. 22. Tashiro S, Nakamura M, Okano H. The prospects of regenerative medicine combined with rehabilitative approaches for chronic spi- nal cord injury animal models. Neural Regen Res. 2017.