biomimetics

Article
Automatic Assist Level Adjustment Function of a Gait Exercise
Rehabilitation Robot with Functional Electrical Stimulation for
Spinal Cord Injury: Insights from Clinical Trials
Ryota Kimura 1, * , Takahiro Sato 1 , Yuji Kasukawa 2 , Daisuke Kudo 2 , Takehiro Iwami 3
and Naohisa Miyakoshi 1

1 Department of Orthopedic Surgery, Akita University Graduate School of Medicine, Akita 010-8543, Japan;
twrofwsh0930@outlook.com (T.S.); miyakosh@doc.med.akita-u.ac.jp (N.M.)
2 Department of Rehabilitation, Akita University Hospital, Akita 010-8543, Japan;
kasukawa@doc.med.akita-u.ac.jp (Y.K.); dkudo@doc.med.akita-u.ac.jp (D.K.)
3 Department of Systems Design Engineering, Faculty of Engineering Science, Akita University Graduate
School of Engineering Science, Akita 010-8502, Japan; iwami@gipc.akita-u.ac.jp
* Correspondence: rkimura@med.akita-u.ac.jp; Tel.: +81-18-884-6148

Abstract: This study aimed to identify whether the combined use of functional electrical stimulation
(FES) reduces the motor torque of a gait exercise rehabilitation robot in spinal cord injury (SCI)
and to verify the effectiveness of the developed automatic assist level adjustment in people with
paraplegia. Acute and chronic SCI patients (1 case each) performed 10 min of gait exercises with and
without FES using a rehabilitation robot. Reinforcement learning was used to adjust the assist level
automatically. The maximum torque values and assist levels for each of the ten walking cycles when
walking became steady were averaged and compared with and without FES. The motor’s output
torque and the assist level were measured as outcomes. The assist level adjustment allowed both the
motor torque and assist level to decrease gradually to a steady state. The motor torque and the assist
Citation: Kimura, R.; Sato, T.; levels were significantly lower with the FES than without the FES under steady conditions in both
Kasukawa, Y.; Kudo, D.; Iwami, T.; cases. No adverse events were reported. The combined use of FES attenuated the motor torque of a
Miyakoshi, N. Automatic Assist Level gait exercise rehabilitation robot for SCI. Automatic assistive level adjustment is also useful for spinal
Adjustment Function of a Gait cord injuries.
Exercise Rehabilitation Robot with
Functional Electrical Stimulation for Keywords: spinal cord injury; functional electrical stimulation; rehabilitation robot; reinforcement
Spinal Cord Injury: Insights from learning; assistive level
Clinical Trials. Biomimetics 2024, 9, 621.
https://doi.org/10.3390/
biomimetics9100621

Academic Editor: Rafhael Milanezi 1. Introduction

de Andrade Worldwide, approximately 15.4 million people have been living with spinal cord injury
Received: 8 September 2024
(SCI). SCI is a major cause of long-term disability, accounting for over 4.5 million years of
Revised: 6 October 2024
life lived with disability in 2021 [1]. Many of these injuries are reported to result from high-
Accepted: 12 October 2024 energy trauma, such as motor vehicle accidents and falls. In contrast, the number of cases
Published: 13 October 2024 of incomplete SCI due to low-energy trauma from falls on level surfaces in older adults
is increasing in Japan [2]. In particular, in the case of incomplete paralysis, appropriate
assistance is needed in rehabilitation, in accordance with motor learning theory, depending
on the recovery process of motor paralysis. A basic premise of motor learning is that of
Copyright: © 2024 by the authors. high-volume repetition and task-oriented training. Treatments based on this premise have
Licensee MDPI, Basel, Switzerland. become a major focus of research on the recovery of motor function in central nervous
This article is an open access article
system disorders such as spinal cord injury and stroke [3,4]. For high-frequency training,
distributed under the terms and
robotic rehabilitation can provide more extensive training while compensating for the
conditions of the Creative Commons
patient’s lost functions and reducing the burden on supporting medical staff.
Attribution (CC BY) license (https://
Neuromodulation techniques, such as functional electrical stimulation (FES), are
creativecommons.org/licenses/by/
important tools in restorative neurology [5]. FES can noninvasively activate paralyzed
4.0/).

Biomimetics 2024, 9, 621. https://doi.org/10.3390/biomimetics9100621 https://www.mdpi.com/journal/biomimetics

Biomimetics 2024, 9, 621 2 of 8

muscles or muscle groups through electrodes placed on the skin. Depending on whether
the upper or lower motor neurons are damaged, stimulation directly activates the motor
nerves or muscle fibers. Nerve stimulation relies on intact peripheral nerves and neural
signal processing in the intact portion of the spinal cord below the lesion [6]. Kralj et al. [7]
developed an FES method and system to facilitate ambulation in individuals with spinal
cord injury. Furthermore, FES has been used in combination with ankle–foot orthosis [8]
and hip–knee–ankle–foot orthosis [9]. There have also been several reports of the addition
of FES into gait training rehabilitation robots [10,11], and it has been reported to reduce the
electric motor torque of an exoskeletal assistive walking robot [12]. A systematic review
and network meta-analysis has also indicated that FES was the most effective treatment for
improving walking velocity and distance in incomplete spinal cord injury [13]. Furthermore,
combining FES with a robot resulted in exercise with less muscle fatigue than FES alone [14],
making hybrid FES–robot training a viable option for prolonged exercise. As a result, the
use of a gait rehabilitation robot with FES improves the range of motion of the joints, the
muscle strength and the ability to walk [15,16]. Robot-assisted training with FES appears
to support the recovery of residual function after SCI and has been observed to lead to
improvements in motor function and strength in the lower extremities [17]. Previously,
we developed a gait training rehabilitation robot with FES [18] and confirmed that the
robot’s torque was reduced by using FES in pseudo paraplegics [19]. In addition, a function
for automatically adjusting the level of assistance using reinforcement learning has been
developed, and its effectiveness in healthy subjects has been confirmed [20].
It is unknown whether using FES in combination with a gait training rehabilitation
robot reduces motor torque in people with paraplegia with spinal cord injury. Moreover,
there are currently no devices that automatically adjust the level of assistance. This study
aimed to verify whether concurrent use of FES reduces the motor torque of a gait exercise
rehabilitation robot in SCI and the effectiveness of the developed automatic assist level
adjustment in people with paraplegia.

2. Materials and Methods

Patients with paraparesis were recruited from our institution. Paraparesis was defined
as those with SCI because of trauma. The inclusion criteria were as follows: (1) inability to
walk unaided; (2) recognition of the significance of this research and participation in the
research of their own free will; and (3) written informed consent after explanation in the
informed consent document. The exclusion criteria were as follows: (1) inability to follow
the therapist’s instructions, (2) conditions in which exercise load leads to deterioration of
physical condition, (3) severe joint contractures or deformities, and (4) other movement
limitations for any reason.
Patients performed 10 min of gait exercises with and without FES using a rehabilitation
robot. The robot’s exoskeleton was designed based on the hip–knee–ankle–foot orthosis
for paraplegia. The trunk, thigh, and lower leg were secured with belts. An ankle-foot
orthosis (RAPS, Tomei Brace, Seto, Japan) was used for the ankle joint, allowing for angle
adjustment based on the patient’s spasticity. The actuators driving the hip and knee joints
were equipped with encoders, enabling the acquisition of joint angle data. Although
the entire exoskeleton weighed 40 kg, it did not affect the patient during use owing to
the weight being offset by a counterweight. The orthosis could be adjusted in length
to fit each patient’s thigh and lower leg. The patients were lifted, and their weight was
supported by a rehabilitation lift (SP-1000, Moritoh, Ichinomiya, Japan); following this,
they were walked under this condition on a treadmill (8.1T, JohnsonHealth Tech Japan,
Tokyo, Japan). Bilateral quadriceps and hamstrings were stimulated using FES (Dynamid,
DM2500, Minato Medical Science, Osaka, Japan) (Figure 1). The quadriceps, primarily the
rectus femoris, were stimulated from mid-swing to mid-stance during the robotic gait cycle.
The stimulation point was located at the motor point, identified by palpation of the anterior
superior iliac spine and lateral femoral condyle. The hamstrings, mainly on the lateral side,
were stimulated from pre-swing to mid-stance, and the stimulation point was located at
Biomimetics 2024, 9, 621 3 of 8

the motor point identified by palpation of the sciatic tuberosity and the head of the fibula.
The exoskeleton system was pre-programmed using gait data from the joint angles of a
healthy individual. The system performs walking motions by changing the positions of the
hip and knee joints according to the gait data. The stimulus intensity was set to the lowest
stimulus (15–20 mA, 25 Hz) that produced joint movement, and the stimulus timing was
synchronized to the gait cycle [19].

Figure 1. Gait exercise rehabilitation robot. The robot has an exoskeleton, rehabilitation lift, treadmill,
and functional electrical stimulation (FES).

In this device, the motor drive was controlled by a computer to reproduce the walking
motion. The motor’s output torque (Nm) was proportional to the stiffness parameter, and
the range was divided into 50 parts, defined as the assist level. The higher the assistance
level, the greater the amount of assistance. Force control was used to control the motor, and
compliance control was used to vary the amount of assistance. The control Equation (1)
used for compliance control is shown below.
. ..
τ = K ·θ + C ·θ + I ·θ (1)

In the equation, K (Nm/deg) represents the stiffness; C (Nm/deg·s) represents the

viscosity; I (Nm/deg · s2 ) represents the inertia; θ (deg) represents the deviation between
. ..
the target joint angle and measured angle; θ (deg/s) and θ (deg/s2 ) represent first and
second derivative values of θ, respectively; and τ (Nm) is the motor torque. The equation
follows the equation of motion, and the first term indicates that the motor output increases
as the difference between the target joint angle and measured joint angle increases. In the
first term, the output torque is proportional to the stiffness parameter K, i.e., when the
stiffness parameter represented by K is large, the output torque increases; conversely, when
K is small, the output torque decreases. In this study, the ranges of stiffness, viscosity, and
inertia parameters were determined experimentally based on a previous study [16] and
the range of stiffness (K) was divided into 50 parts and defined as the assist level. The
assistance level provided feedback to the patient through data displayed on the computer
monitor placed in front of the robot.
Biomimetics 2024, 9, 621 4 of 8

Reinforcement learning was used to adjust the assist level automatically. The method
used was Q-learning, a type of off-policy temporal difference learning, and the ε-greedy
method was used to determine the policy [21]. In this study, the reinforcement learning
environment was defined as “the device and the entire subject wearing it”. The subject
was trained to select actions by choosing between three options: increasing, maintaining,
or decreasing the level of assistance. The subject was rewarded with angular error and
motor torque for each walking cycle. The ε-greedy method introduced a search rate ε
(0 ≤ ε ≤ 1) into the decision process and prevented the system from falling into a local
solution through exploration by selecting a random action with probability ε regardless of
the action value and an action corresponding to the maximum action value with probability
1 − ε. In the initial stages of learning, we increased the proportion of exploration by setting
ε to a large value and collecting knowledge. Then, in the advanced stages of learning,
we set ε to a small value so that the robot can select the optimal action by using the
collected knowledge. The Q-learning algorithm is an off-policy type and the aim was not
to optimize the policy, but to optimize the action state value function Q, which indicates
the effectiveness of actions, and to construct a decision-making standard that can select the
optimal action for the environment. The update equation for updating the Q value Q(st , at )
when action at is selected in state st is shown in Equation (2).

Q(st , at ) ← Q(st , at ) + α(γ + γ · maxQ(st+1 , at+1 ) − Q(st , at )) (2)

In Equation (2), s represents the state, a represents the action selected in state s,
α(0 ≤ α ≤ 1) represents the learning coefficient, r represents the reward obtained as a result
of the action, γ(0 ≤ γ ≤ 1) represents the discount rate, and maxQ(st + 1 , at + 1 ) represents the
maximum Q value of the actions that can be selected in the next action. The action value
function Q for selecting action a in a given state s is expressed as Q(s, a). The Equation (2)
means that if the value of the reward r, obtained as a result of the action, is positive,
then the value of Q(s, a) is increased, and if the reward is negative, the value of Q(s, a) is
decreased. By repeating the process of taking actions and updating the Q value using the
Equation (2), it becomes possible to proceed with learning about the Q value. In addition,
in the Equation (2), the state s, action a, and reward r represent variables that are brought
about by interaction with the environment, so there was no need to adjust the parameters.
The parameters that had be adjusted here were the learning coefficient α and the discount
rate γ. The actions that the agent could take were classified as increasing, maintaining,
or decreasing the assist level, and the corresponding Q values were set for each. Because
the ε-greedy method was used here to determine the policy, the action corresponding to
the largest Q value among each of these was selected, while a random action was selected
with probability ε, and the Q value was updated according to the reward obtained from the
environment as a result. By repeating this process, the Q values were updated to minimize
the reward r obtained, thereby reducing the discrepancy between the joint angle and motor
torque during the walking cycle. This allowed the assist level to be adjusted to an optimal
level for the patient.
The walking speed was set at 0.8 km/h. The maximum torque values and assist levels
for each of the 10 walking cycles when walking became a steady condition were averaged
and compared with and without FES. All statistical analyses were conducted using EZR
(Saitama Medical Center, Jichi Medical University, Saitama, Japan) [22]. The motor torque
and assist level were compared using the paired t-test, with statistical significance set at
p < 0.05.
This study was approved by our institution’s ethics committee (approval number:
CRB2180005). All of the individuals voluntarily participated in the study and provided
written informed consent.

3. Results
The subjects were a patient with acute thoracic spinal cord injury (33-year-old man),
2 weeks after injury, American Spinal Injury Association (ASIA) Impairment Scale (AIS) C,
Biomimetics 2024, 9, 621 5 of 8

neurological level of injury (NLI) T12 without spasticity, and a patient with chronic thoracic
spinal cord injury (34-year-old man), 2 years after injury, AIS C, and NLI T11 with spasticity
(modified Ashworth scale: grade 2).
Assist level adjustment allowed both the motor torque and assist level to decrease
gradually to a steady state. Each value reached a steady state between 60 and 120 s. The
motor torque was significantly lower with the FES than without the FES under steady
conditions in both cases (Table 1). Furthermore, the assist levels were significantly lower
with FES than without FES in both cases (Table 2).
The electrical stimulation delivered via the FES did not cause any adverse effects, such
as pain, and did not lead to any adverse events associated with robotic gait exercises.

Table 1. Motor torque.

Case 1 Case 2
(Nm)
FES (−) FES (+) p FES (−) FES (+) p
Hip
18.6 ± 1.5 16.6 ± 1.7 0.0237 17.9 ± 1.2 8.7 ± 1.2 <0.001
Right
Hip
18.1 ± 1.4 16 ± 1.6 0.0181 14.7 ± 1.3 11.9 ± 1.7 <0.001
Left
Knee
20.3 ± 1.8 13.1 ± 1.5 <0.001 15.4 ± 1.2 13.4 ± 1.6 0.0047
Right
Knee
19.2 ± 1.4 17.1 ± 1.9 0.0226 18.4 ± 1.5 12.2 ± 1.3 <0.001
Left

Table 2. Assist levels.

Case 1 Case 2
(Nm)
FES (−) FES (+) p FES (−) FES (+) p
Hip
28.5 ± 0.5 26.5 ± 0.5 <0.001 42.9 ± 0.3 30.9 ± 0.7 <0.001
Right
Hip
24.1 ± 0.6 23.4 ± 0.7 0.0445 38.9 ± 0.3 30.9 ± 0.3 <0.001
Left
Knee
30.8 ± 0.4 23.9 ± 0.3 <0.001 25.4 ± 0.5 20.6 ± 0.5 <0.001
Right
Knee
29.5 ± 0.5 17.5 ± 0.5 <0.001 33.9 ± 0.3 21.4 ± 0.5 <0.001
Left

4. Discussion
The combined use of FES attenuated the motor torque of the gait exercise rehabilitation
robot for spinal cord injury. Furthermore, automatic adjustment of the assistance level using
reinforcement learning proved to be effective in gait exercises for patients with spinal cord
injuries, and the combined use of FES attenuated the assistance level. It was shown that
the automatic assist level adjustment system could be used in conjunction with the torque
generated by the FES. This suggests that the intrinsic muscle activity generated by FES
reconstructed some of the torque required for walking (Figure 2). In conventional robotic
gait training, the gait is reconstructed by combining the robot torque with the patient’s
muscle torque; the use of FES in conjunction may help attenuate the robot torque.
Biomimetics 2024, 9, 621 6 of 8

Figure 2. The motor torque. Conventional robots were constructed using the robot’s torque and their
own muscle’s torque in order to prove the torque required for walking. Motor torque is attenuated by
the combined use of functional electrical stimulation (FES). Furthermore, the required motor torque
decreases as the patient’s muscle torque improves.

In functional electrical stimulation therapy (FEST), three factors are crucial: the patient,
FES, and the therapist [23]. A phase I randomized control trial (RCT) has revealed that
locomotion function improved significantly more with FEST than a non-FEST controlled
intervention [24]. The therapist could be replaced by a robot. Regarding the combination
of FES and gait rehabilitation robots, we have reported that the smoothness of movement
was not lost even when FES was used in combination [18], and that the robot torque was
reduced by pseudo-paraplegia [19]. The present study builds on these previous reports and
extends them by demonstrating that the combined use of a gait rehabilitation robot and FES
reduces the motor torque of the robot in SCI. In order to substantiate the clinical efficacy
of FEST when utilizing robots, it is necessary to conduct RCTs; for example, to compare
FEST with FES monotherapy. Furthermore, the potential of combining robotics and FES in
rehabilitating patients with disorders affecting the central nervous system remains to be
fully validated. Future validation is needed because robotic rehabilitation is expected to be
integrated with brain–computer interface (BCI) [24] in the future.
Although machine learning and reinforcement learning in exoskeletal rehabilitation
robots have previously been studied and reported on [25–27], this is the first report of their
combination with FES for SCI. The automatic and appropriate adjustment of task difficulty
according to the degree of paralysis is an effective rehabilitation tool from the perspective
of motor learning [28]. Furthermore, the patients did not experience any discomfort during
gait, and no adverse events were observed. Further research is required to ascertain the
clinical efficacy of this system’s rehabilitative intervention.
The integration of FES into the robot resulted in a reduction in the torque of the
motor. This could ultimately result in a reduction in power consumption and size. The
large size of conventional gait rehabilitation robots has been a substantial barrier to their
implementation in a broader range of settings. It is of paramount importance to reduce
the size of the robot if the objective of achieving the generalization of robotic rehabilitation
is to be met. The incorporation of artificial muscles may prove an efficacious solution
to these challenges [29]. Given that the concurrent use of an exoskeleton-type robot and
a treadmill represents a safe method for gait training rehabilitation, it is imperative to
reduce the size of each to promote the overall effectiveness of robotic rehabilitation. As
FES reduces the torque generated by the robot’s motor, it seems reasonable to employ FES
to reduce the overall size of the robot. Consequently, the treadmill size can be reduced,
thereby increasing compatibility with the treadmills that are commonly used. This may, in
turn, facilitate the implementation of gait training rehabilitation robots in a wide range of
applications, including the prevention of disabilities in the aging population. From this
study, clinicians should consider combining FES with a gait rehabilitation robot, including
the clinical efficacy of FES in SCI.
Biomimetics 2024, 9, 621 7 of 8

This study has several limitations. First, it included only two cases, but data were
available for both acute and chronic cases. The automatic assistance level adjustment
system proved useful in both cases. However, further validation of the clinical effects of
rehabilitation with a sufficient number of patients is needed. Second, the walking speed
and FES settings were fixed; further verification of the variations caused by changes in
speed and FES settings is needed.

5. Conclusions
The combined use of a gait rehabilitation robot and FES reduced the robot’s motor
torque in SCI, and automatic assist level adjustment through reinforcement learning was
effective in people with paraplegia. The clinical outcomes need to be evaluated.

Author Contributions: Conceptualization, R.K.; methodology, R.K. and T.S.; software and
hardware, T.I.; formal analysis, R.K.; investigation, T.S.; writing—original draft preparation, R.K.;
writing—review and editing, Y.K., D.K. and N.M.; supervision, N.M.; project administration, R.K.;
funding acquisition, R.K. All authors have read and agreed to the published version of the manuscript.
Funding: This study was partly supported by the JSPS KAKENHI (Grant No. 23K16600) and the
Japan Orthopaedics and Traumatology Research Foundation (Grant No. 474).
Institutional Review Board Statement: The study was conducted in accordance with the Declaration
of Helsinki, and approved by our institution’s ethics committee (approval number: CRB2180005). All
of the individuals voluntarily participated in the study and provided written informed consent.
Data Availability Statement: Data are contained within the article. Contact the author for addi-
tional data.
Acknowledgments: We thank Sumito Musaka, Atsuko Harata, Yasufumi Yamaji, Tetsuya Yamauchi,
Daiki Miura, Kai Maeda, Kaname Sasaki, Cao Yu, and Kota Odanagi for developing the rehabilitation
robot. We thank Kazutoshi Hatakeyama, Motoyuki Watanabe, and Tomohiro Suda, for rehabilitation
assistance and ideas for equipment development.
Conflicts of Interest: The authors declare no conflicts of interest.

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