DONE
DONE
DONE
Objective To determine the effect of robotic-assisted gait training (RAGT) compared to conventional overground
training.
Methods Sixty patients with motor incomplete spinal cord injury (SCI) were included in a prospective,
randomized clinical trial by comparing RAGT to conventional overground training. The RAGT group received
RAGT three sessions per week at duration of 40 minutes with regular physiotherapy in 4 weeks. The conventional
group underwent regular physiotherapy twice a day, 5 times a week. Main outcomes were lower extremity motor
score of American Spinal Injury Association impairment scale (LEMS), ambulatory motor index (AMI), Spinal
Cord Independence Measure III mobility section (SCIM3-M), and walking index for spinal cord injury version II
(WISCI-II) scale.
Results At the end of rehabilitation, both groups showed significant improvement in LEMS, AMI, SCIM3-M,
and WISCI-II. Based on WISCI-II, statistically significant improvement was observed in the RAGT group. For the
remaining variables, no difference was found.
Conclusion RAGT combined with conventional physiotherapy could yield more improvement in ambulatory
function than conventional therapy alone. RAGT should be considered as one additional tool to provide
neuromuscular reeducation in patient with incomplete SCI.
INTRODUCTION
prognosis at 1-year post-injury [3,4]. enced RAGT. A total of 60 participants were enrolled and
However, successful gait training for SCI patients is randomly assigned to the RAGT group or conventional
costly. In addition, it requires space and skilled physio- group. Baseline measurements of outcome variables
therapists who can consider diverse aspects of physical were taken before they underwent intervention.
status of the patient. The main limitations of overground
walking ability for patients with SCI are reduced sensory- Robotic-assisted gait training system
motor coordination, spasticity, impaired balance [5], as The Lokomat system (Hocoma AG, Zurich, Switzerland)
well as muscle weakness. Practically, there are numerous included a treadmill, a body-weight support system, and
constraints in the provision of an individualized training two lightweight robotic actuators attached to subject’s
strategy. Various treatments have been attempted to fa- legs (Fig. 1). The speed of the treadmill could be adjusted
cilitate walking ability, such as robotic-assisted gait train- from 0 km/hr to approximately 3 km/hr. During treat-
ing (RAGT), for SCI patients. ments, velocity of the treadmill was fixed at 1.5 km/hr.
Recently implemented treatments have been focused At the beginning of the treatment, approximately 50% of
on enhancing the activity of spinal interneurons based each subject’s body weight was supported by the harness
on function of the central pattern generator by provid- system. During the following walking sessions, the body-
ing sensory-motor stimulation to optimize neural plas- weight support was reduced to the minimum as tolerated
ticity [6]. RAGT is also based on this strategy. It has the without substantial knee buckling or toe drag. Guidance
advantage of repeatedly conducting a pre-programmed force was maintained at 100%.
gait pattern. Several studies provide evidence that RAGT
promotes motor recovery and functional improvement Intervention
[7,8]. However, other studies demonstrated that there All patients assigned to each treatment group were
was no significant difference between RAGT and conven- treated with physical therapy in 4 weeks. The RAGT
tional therapy [9]. Several systematic reviews including group received RAGT with regular physiotherapy in the
a Cochrane review article [10-12] found that there was following schedule: 3 days with RAGT and 2 days with
insufficient evidence to determine the superiority of one regular treatment a week. On the day receiving RAGT,
gait training strategy over another. Further investigation patients performed one RAGT session with one regular
is needed to determine strategies that could result in the physiotherapy session. The overall session time of RAGT
best response and optimal training.
Participants
Between May 2012 and May 2014, all SCI patients ad-
mitted to the Department of Physical Medicine and Re-
habilitation of Severance Hospital were evaluated and
selected when they met the following inclusion criteria: 1)
non-progressive spinal cord lesion as a result of traumat-
ic or non-traumatic causes, 2) onset less than 6 months, 3)
classified by the ASIA impairment scale (AIS) as grade D
at entry, and 4) 20 to 65 years old. Exclusion criteria were
patients with pressure ulcers, severe limitation of range
of motion of the hips and knee joints, severe cognitive
impairment, or patients with pulmonary or heart dis-
ease requiring monitoring during exercise. Patients were Fig. 1. Lokomat, a robot-assisted gait training system,
also excluded if they had lower motor neuron lesion, consisted of robotic gait orthosis, body weight support,
such as cauda equina injury, or had previously experi- and treadmill.
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RAGT in iSCI
treatment was 1-hour, including set-up time. The actual The reasons for withdrawals were not associated with the
training time was 40 minutes. In the rest treatment days, study. Finally, a total of 53 participants were analyzed
subjects underwent regular physiotherapy twice a day in (Fig. 2). Demographic and injury data for each group
a 30-minute session. The control group underwent regu- along with baseline results are summarized in Table 1.
lar physiotherapy twice a day and 5 times a week using No significant difference was detected in age, sex, injury
Bobath principles. All subjects were allowed to partici- level, time course, or treatment periods. Therefore, the
pate in other treatments, such as occupational therapy or study groups were comparable.
functional electrical stimulation (FES), during the dura-
tion of the study. Muscular strength and gait abilities improvement du
ring study
Outcome measures There was no significant difference in baseline mea-
All participants were assessed within 48 hours of start- surement. At the end of the rehabilitation period, each
ing and the end of training period. The muscular strength group showed significant (p<0.05) recovery in muscular
of the lower limb was measured with ASIA lower extrem- strength according to the LEMS and the AMI scale. The
ity motor score subscale (LEMS; range 0 to 50) and the RAGT group showed more improvement in the AMI with
ambulatory motor index (AMI; range 0 to 30). The ability borderline significance (p=0.06). The AMI improved from
to walk was evaluated according to the outdoor and in- 21 (interquartile range [IQR], 10–30) to 25 (IQR, 15–30)
door mobility domain of the Spinal Cord Independence
Measurement III mobility section (SCIM3-M; range 0 to
30) and the walking index for spinal cord injury version II 456 individuals assessed
(WISCI-II). WISCI-II was a 20-item scale measuring the for eligibility
Statistical analysis
60 randomized patients
The general characteristics or baseline data were com-
pared between each group by using Student t-test (for
continuous variables) if data were normally distributed.
A Wilcoxon test was used for non-normally distributed 30 patients allocated to 30 patients allocated to
ordinal scale. The associations between qualitative treatment with RAGT conventional treatment
variables were assessed by c2-test. Within-group com- -1 RAGT+1 conventional -2 conventional treatment
treatment session per day,
parisons of treatment effects relative to baseline were sessions per day,
carried out with Wilcoxon signed-rank test. Between- 3 times a week
5 times a week
group comparisons were performed with Mann-Whitney -2 conventional treatment
U test. SPSS ver. 21.0 software (IBM SPSS Inc., Armonk, sessions per day,
NY, USA) was used for the statistical analyses. Statistical 2 times a week
significance was considered when p-value was less than
0.05.
3 withdrawals 4 withdrawals
RESULTS
27 patients analyzed 26 patients analyzed
Demographic data
Fig. 2. A total of 456 patients with spinal cord injury were
A total of 456 patients were assessed for eligibility, of
assessed from May 2012 to May 2014. A total of 60 patients
which 60 who met the inclusion criteria were enrolled in who had non-progressive spinal cord lesion elapsed less
this study. Seven withdrawals occurred, including three than 6 months were randomly allocated. RAGT, robotic-
in the RAGT group and four in the conventional group. assisted gait training.
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Ji Cheol Shin, et al.
12 DISCUSSION
Conventional
10 *
RAGT+conventional In this study, a SCI patient graded AIS-D showed sig-
8 nificant improvement in muscle strength and functional
recovery after an average of 4 weeks of treatment, with
WISCI-II
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RAGT in iSCI
Table 2. Muscular strength and gait abilities at entry and the end of the treatment
Conventional (n=26) RAGT+conventional (n=27)
a) p-valueb)
Entry End Variance p-value Entry End Variance p-valuea)
LEMS 33 (20–40) 37 (20–48) 4 (0–18) <0.001*** 31 (12–40) 37 (20–49) 6 (0–18) <0.001*** 0.24
AMI 23 (13–30) 26 (16–30) 2 (0–10) <0.001*** 21 (10–30) 25 (15–30) 4 (0–22) <0.001*** 0.06
SCIM3-M 6 (0–18) 9 (0–33) 3 (0–24) <0.001*** 4 (0–11) 10 (0–26) 6 (0–20) <0.001*** 0.13
WISCI-II 4 (0–16) 9 (0–20) 5 (0–20) <0.001*** 3 (0–14) 11 (0–19) 8 (0–17) <0.001*** 0.01*
Values are presented as median (interquartile range).
LEMS, lower extremity motor score; AMI, ambulatory motor index; SCIM3-M, mobility domain of the Spinal Cord In-
dependence Measurement-III; WISCI-II, walking index for spinal cord injury.
a)
For intragroup comparison, b)for intergroup comparison. *p<0.05, ***p<0.001.
have been impeded by the limitation of voluntary move- training could be more effective. Furthermore, partici-
ment. Movement variability is thought to be a critical pating in gait training without support has a significant
feature underlying motor learning [13]. A comparable potential to improve self-image and positive change of
study is needed. Secondly, the assessment tools may be emotion [24,25], regardless of the physical improvement
inappropriate. Walking ability should be measured based [26]. RAGT also improves confidence in walking perfor-
on both spatial and temporal parameters as well as kine- mance [21]. Considering the psychological benefits and
matics (joint range changes) and kinetics (moments and its effect from early intervention, RAGT might be con-
forces acting across joints). RAGT can significantly re- sidered for implementation before overground walking
duce neuromuscular abnormalities associated with spas- training.
ticity [14]. RAGT can also promote intralimb and inter- Our study had several limitations. The number of pa-
limb coordination and alter co-contraction between knee tients per group was relatively small with diverse etiolo-
and ankle antagonistic muscles [15]. Lastly, difference in gies. Only short-term outcome was evaluated. Long-
treatment duration could yield different outcomes. term follow-up was not assessed. Our results showed that
A recent study using a very intensive (3 hours per day, RAGT could be an effective supplement for gait training
5 times in a week for 2 weeks) training schedule for indi- in SCI patients. However, it did not afford a basis on
viduals did not result in changes in walking speed over which we could claim that this kind of training was better
ground [16]. Considering that RAGT was performed at than traditional technique. Nonetheless, this study adds
least 8 weeks in other studies and that those studies con- to the wealth of data necessary to determine appropriate
cluded that RAGT was more effective than conventional candidate, optimal timing, and the best protocol to de-
therapy [7,8], continuation may be more important than sign maximal efficacy of RAGT in SCI patients.
intensity or frequency of treatment to gain better out- In conclusion, RAGT combined with conventional
come. physiotherapy could yield more improvement in ambula-
In this study, 17 of 27 patients could not stand alone tory function than conventional treatment alone, there-
who needed more than two assistants to perform gait fore improving muscle strength and walking ability in
training. Fourteen of 27 patients started RAGT less than motor incomplete SCI patients. RAGT should be consid-
3 months after the onset of SCI, whereas previous stud- ered as one of the training methods to provide safe and
ies examined subacute [7,8] or chronic SCI patients [17- effective way to perform neuromuscular re-education for
21] who were able to use RAGT on their own without any SCI patients.
safety issues. Participants who started earlier after injury
(<4 weeks) showed significantly faster walking speeds CONFLICT OF INTEREST
and walking distance than those started later [22]. Pa-
tients who started training <6 months post-injury ended No potential conflict of interest relevant to this article
up with higher final walking scores than those who start- was reported.
ed >6 months post-injury [23]. Therefore, earlier walking
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Ji Cheol Shin, et al.
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Lopez-Blazquez R, Murillo N, et al. Gait training in the feeling states of people with spinal cord injury.
human spinal cord injury using electromechanical Spinal Cord 2007;45:112-5.
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tics. Arch Phys Med Rehabil 2012;93:404-12. Latimer A, Phillips SM, et al. Long-term body-weight-
24. Semerjian TZ, Montague SM, Dominguez JF, Davidian supported treadmill training and subsequent follow-
AM, de Leon RD. Enhancement of quality of life and up in persons with chronic SCI: effects on functional
body satisfaction through the use of adapted exercise walking ability and measures of subjective well-being.
devices for individuals with spinal cord injuries. Top Spinal Cord 2005;43:291-8.
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