Original article  309
Early body weight-supported overground walking training
in patients with stroke in subacute phase compared to
conventional physiotherapy: a randomized controlled
pilot study
Stefano Brunellia, Marco Iosaa, Francesca Romana Fuscoa, Carmelo Pirrib,
Claudia Di Giuntab, Calogero Fotib and Marco Traballesia
Among the new rehabilitation strategies aimed at
improving independent walking after stroke, the body
weight-support training allows an early and controlled
ambulatory training. To date, most available studies are
based on treadmill body weight-support (BWS) training
and involve patients with chronic stroke sequelae. In
contrast, the effects of a BWS training performed on the
ground in patients with subacute hemiparesis (stroke
within 4 weeks), with significant gait deficiencies, is
unknown. The primary aim of this study was to evaluate
the efficacy of a rehabilitative program that combines
conventional approach with an early overground
body weight-support training, in terms of recovery of
independent walking focussing on patients with subacute
stroke. The secondary aim was to evaluate the impact of
body weight-support also on functional mobility, overall
disability, and gait endurance. A total of 37 participants
were enrolled and randomized to experimental group
or control group for the baseline evaluations. In the
experimental group, body weight-supported overground
walking was added to conventional physiotherapy
for 4 weeks. The outcome measurements used were:
Functional Ambulation Classification (FAC), Rivermead
Introduction
There is a growing interest for innovative rehabilitation
interventions aimed at restoring independent walking
in stroke patients. Thus, improving functional activity
(Teasell et  al., 2003; Paolucci et  al., 2008), social partici-
pation, and perceived quality of life (Langhammer et al.,
2008) would be a great achievement, particularly consid-
ering that only about 75% of the patients admitted for
acute care are able to walk 3 months post-stroke (Wade
et al., 1987).
Among strategies to retrain gait and balance performance
after stroke, body weight-support (BWS) systems appear
to be a promising approach (Hesse et al., 1995; Trueblood,
2001; Sullivan et al., 2002; Manning and Pomeroy, 2003;
Hesse, 2008; Combs-Miller et al., 2014). However, in order
to better understand the results of clinical trials, it is cru-
cial to take into account whether BWS training was per-
formed on treadmill or overground, and whether patients
0342-5282 Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
Copyright © 2019 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Mobility Index, Barthel Index, and the 6-minute Walk Test.
At the evaluation 1 week after the end of the intervention
period, experimental group reached a statistically
significant increase of independent walking as detected by
FAC (experimental group: 3 vs. control group: 2, P < 0.01).
No differences were observed by the other evaluation
outcome measures. We conclude that BWS training may
be more effective than conventional therapy alone in
improving walking autonomy in persons with subacute
stroke. International Journal of Rehabilitation Research
42:309–315 Copyright © 2019 Wolters Kluwer Health, Inc.
All rights reserved.
International Journal of Rehabilitation Research 2019, 42:309–315
Keywords: body weight-support training, functional ambulation category,
gait, rehabilitation, stroke
a
Fondazione Santa Lucia, Scientific Institute for Research and Healthcare,
Operative Unit 4. and  bPhysical and Rehabilitation Medicine, Tor Vergata
University of Rome, Rome, Italy
Correspondence to Stefano Brunelli, MD, Operative Unit 4, Fondazione Santa
Lucia, Scientific Institute for Research and Healthcare, Rome 00179, Italy
Tel: +39 0651501844; fax: +39 065032097; e-mail: s.brunelli@santalucia.it
Received 13 March 2019 Accepted 20 June 2019
were in a subacute or in chronic stage. About treadmill
training, a recent review found that this treatment does
not significantly improve the ability of patients after
stroke to walk independently (Mehrholz et  al., 2017).
Moreover, treadmill training (with and without BWS)
seems to be more useful to improve walking ability in
patients who can walk after stroke, but not those who had
worse impairment (Mehrholz et al., 2017). We should also
consider that the requirements for walking on treadmill
are different from those for overground walking, mainly
in propulsion and balance control, but also in terms of
visual flow stimuli (Hesse et  al., 1999; Lee and Hidler,
2008).
Only few studies (Miller et  al., 2002; Sousa et  al., 2011;
Gama et  al., 2017) examined the effects of BWS over-
ground training in stroke, and no studies examined the
early post-stroke phase.
DOI: 10.1097/MRR.0000000000000363
310  International Journal of Rehabilitation Research  2019, Vol 42 No 4
Moreover, subacute patients with stroke may have dif-
ferent therapeutic goals than chronic patients, in terms
of body weight distribution between lower limbs, trunk
stabilization, and balance control (Van Peppen et  al.,
2004). For example, in subacute stroke phase, an early
BWS walking training can be crucial in avoiding acciden-
tal falls when the subjects can hardly bear their full body
weight (Visintin et  al., 1998), and in enhancing patients
confidence in performing more demanding therapeutic
exercises, thus taking advantage of the inherent flexibil-
ity of neural system in the subacute phase. Finally, few
studies have also investigated the effects of treadmill
(Combs et  al., 2010) or overground (Gama et  al., 2017)
BWS on overall disability and there are insufficient data
to determine beneficial effects on quality of life or activ-
ities of daily living (Mehrholz et  al., 2017). For these
reasons, the primary purpose of this pilot study was to
investigate the effects of an early overground BWS train-
ing in terms of recovery of walking ability in patients
with stroke in subacute phase, compared to standard gait
training. The secondary aim was to evaluate the effect
of this trial on general mobility, overall disability, and
walking endurance. It was hypothesized that overground
BWS training would have shown short-term advantages
over conventional gait training due to an earlier and safe
walking practice.
Methods
The study took place in an Institute for Research
Hospitalization and Health Care for Neurorehabilitation.
We screened all inpatients with recent stroke during
their first week of hospitalization, that were consecu-
tively admitted to our rehabilitation unit for a period of
18 months.
Inclusion/exclusion criteria
Inclusion criteria were as follows: subacute hemipare-
sis (within 4 weeks from the ischaemic or haemorrhagic
stroke onset) with significant gait deficiency measured
by Functional Ambulation Classification (FAC < 2); first-
stroke survivors: adult (age between 40 and 85 years);
ability to reach and maintain the standing position at par-
allel bars for at least 30 seconds (even with the help of the
physiotherapist), cardiovascular stability, confirmed brain
lesions by tomography or MRI.
Exclusion criteria included the presence of other dis-
abling comorbidities that compromises walking train-
ing (such as dyspnoea or severe osteoarthritis), severe
spasticity limiting the movement of the lower limbs
(Ashworth > 3), sacral skin lesions and inability to under-
stand the required motor task.
The study was designed as a prospective randomized
trial with two parallel groups. After recruitment, all partic-
ipants were randomly allocated (according to a comput-
er-generated centrally-located list) into the experimental
group (EG) treated with BWS overground gait training
Copyright © 2019 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
using LiteGait, or the control group (CG) treated with
conventional gait training. Detailed information related
to the study aims and procedures was provided to the
participants and written consent was obtained. The
study was approved by the local independent Ethics
Committee.
Outcome measures
The primary outcome measure was walking ability
(assessed by Functional Ambulation Classification),
whereas secondary outcomes were functional mobility
[Rivermead Mobility Index (RMI)], disability in activi-
ties of daily living [Barthel Index (BI)], and gait endur-
ance [6-minute Walk Test (6mWT)].
Walking ability was collected each week, during the
intervention period, whereas all other measures were
only completed at baseline (admission) and 1 week after
training period. All assessments were performed by the
same assessor, a physician blind to the group allocation.
The Functional Ambulation Classification (FAC) scale
is a six-point scale which rates the gait ability: (0) the
patient cannot walk or requires help of two or more peo-
ple; (1) the patient requires firm continuous support from
one person who helps with carrying weight and with
balance; (2) the patient needs intermittent or continu-
ous light touch to assist balance or coordination; (3) the
patient requires verbal supervision or standby help from
one person without physical contact; (4) the patient can
walk independently on level ground, but requires help
on stairs, inclined or uneven surfaces; and (5) the patient
can walk independently (Holden et al., 1984).
The RMI includes 15 mobility items with dichotomous
(yes = 1/no = 0) answers. Thus, the cumulative score may
range from 0 to 15, with a higher score indicating better
patient mobility (Collen et al., 1991).
The Modified BI is a 10-item ordinal scale that covers
mobility and self-care domains; scores range from 0 (total
dependence in ADL) to 100 (complete independence)
(Shah et al., 1989).
In 6mWT, the participants were instructed to walk at a
comfortable speed covering as much distance as possible
in 6 minutes back and forth on a 30 m long linear course
through the hospital corridors (Flansbjer et al., 2005). The
6mWT was only evaluated at discharge, as it could not be
performed at admission for patients with FAC 0 and 1.
Interventions
Both groups underwent two 40-minute sessions of phys-
iotherapy per day, 5 days per week for 4 weeks as in a
previous study (Husemann et al., 2007). All patients per-
formed the first daily session of standard physiotherapy,
focussed on the facilitation of movements on the paretic
side and upper-limb exercises, and exercises for improv-
ing balance, standing, sitting, and transferring tasks.
 Overground BWS walking training in subacute stroke Brunelli et al.  311
In the second session the CG was trained in exercises
for trunk stabilization, weight transfer to the paretic leg
and conventional assisted overground walking (with or
without parallel bars) with task-specific walking orien-
tated leg exercises promoting of normal movement and
function, controlling of muscle tone and compensations
(National Clinical Guideline for Stroke, 5th edition,
2016). Where necessary, the patient was helped by one
or two therapists and walking aids. Conversely, the EG
performed, during the second session, BWS gait training
with LiteGait. The EG session included about 20 min-
utes dedicated to patient’s preparation (due to impair-
ment’s severity two therapists were needed to settle most
patients in the harness) and parameters setting as already
reported in the previous similar RCT study (Morone et al.,
2011). Foot orthoses were used in both groups as needed.
The LiteGait (Mobility Research, Tempe, Arizona, USA;
http://www.litegait.com) is an electromechanical stand-
alone support system designed for practicing overground
and treadmill walking. It consists of a frame on wheels
from which the patient can be supported via an overhead
harness, through a four-buckle system with a two-point
attachment. The harness provides good support fitting
Fig. 1
Body weight-support walking training with the Lite Gait device.
Copyright © 2019 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
around the trunk and the legs (Crompton et  al., 2001)
(Fig. 1).
Once the standing position was reached, a BWS mech-
anism, that is regulated by a remote control and oper-
ated through a monitor, calculated the relief to be given
to the patient during walking. To standardize the initial
amount of BWS to give each patient, his/her FAC value
were followed. Considering that very weak patients may
need more BWS and the range is typically up to 50%
(Crompton et  al., 2001), it was established that if the
patient had FAC = 0, the BWS was equal to 50% of the
body weight; if FAC = 1 the BWS was 30% and if FAC = 2
the BWS was 10%. During the training session, the BWS
was adjusted in relation to patient comfort, possibility of
performing the swing phase and sufficiently bear weight
on the paretic side.
During BWS training the physiotherapists helped
patients with verbal cueing and manual guidance of
lower extremity to work on the repetitiveness of the
movements, on the pace of the step, on the length of the
step, on the length of the support base, on the loading
phase, and on the oscillation phase. Speed of ambulation
during BWS training was determined by the participant’
motor skills, and the physiotherapists assisted them by
moving and steering the Lite Gait. The patients were
given a maximum of four breaks, of 3 minutes each, as
needed to minimize exacerbation of tone and fatigue.
Initially, two physiotherapists assisted the patient’s
gait; with further improvement, less and less help was
required. Session after session participants progressively
showed an increase in tolerance and walking endurance,
gradually eliminating the breaks.
Statistical analysis
Data were reported with mean and SD if obtained from
continuous measures and with median and quartiles if
related to ordinal measures such as clinical scale scores.
To determine the statistical differences between EG
and CG, parametric statistics (two-tailed Student’s t-test)
was used for continuous outcome measures (6mWT) and
non-parametric statistics (Chi-square test) was used for
ordinal outcome measures (scale scores, all evaluated at
admission and discharge). The Mann–Whitney U-test, a
non-parametric test for the analysis of the repeated meas-
ures variance, was used to compare the two groups.
Results
Two hundred sixteen patients with stroke were evalu-
ated in the enrolment period, all of which were admitted
into our rehabilitation ward after being transferred for
an acute care department. Out of these patients, 37 met
the inclusion criteria and were enrolled in the study. The
exclusion reasons were (n = 199): FAC ≥ 2 (n = 50), not
able to reach the standing position (n = 45), presence of
comorbidities (n = 28), recurrent stroke (n = 15), cognitive
312  International Journal of Rehabilitation Research  2019, Vol 42 No 4

impairment (n = 11), age > 80 (n = 4), severe spasticity Table  1 shows the homogeneity of the initial sam-
(n  =  3), and more than one reason (n  =  31). Moreover ple: no significant differences between groups were
six patients declined to participate in the study. The found at baseline for the investigated variables (FAC,
EG included 16 patients, whereas the CG 21 patients. RMI, and BI) neither for age or time since the onset
The mean total age of the whole sample analysed was of stroke.
70 ± 10.74 years, the time since stroke was 19 ± 15.8 days,
As showed in the flowchart (Fig. 2), during the period of
48% were males, 51% left hemisphere lesion and a prev-
the investigation there were three drop-outs: one patient
alence of ischaemic stroke (67%).
from EG and two from CG. Thus, the final sample was 15
Table 1  Demographic and clinical features of experimental group
EG and 19 CG, respectively.
and control group at enrolment time
EG CG P value All measures showed significant improvements in both
groups at the last evaluation 1 week after the last BWS
Age (years) 69.64 (10.88) 72.05 (10.08) 0.51
Time since stroke at 16.07 (11.42) 14.63 (7.58) 0.66
overground walking training (EG: z  >  3, P  <  0.002 and
hospitalization (days) CG: z > 3.4, P < 0.002: same values for FAC, RMI, and
FAC 0.14 (0.36) 0.26 (0.56) 0.58 BI). Regarding FAC, evaluation scale (Fig. 3), at the time
RMI 1.71 (1.93) 2.00 (2.16) 0.79
BI 14.35 (14.62) 14.42 (15.72) 0.68 of entry into the study, the average score ranged around 0
for both groups. Both groups showed a continuous walk-
Values are expressed as mean (±SD).
BI, Barthel Index; CG, control group; EG, experimental group; RMI, Rivermead
ing improvement among the enrolment period, but EG
Mobility Index. presented a more evident improvement after the third

Fig. 2

CONSORT flowchart diagram.

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 Overground BWS walking training in subacute stroke Brunelli et al.  313

Fig. 3

Mean values of functional ambulation classification (FAC) weekly values in the two groups among the enrolment period (0 = baseline; 1 = starting
Lite Gait training for EG; 2, 3, 4 = weekly evaluation; 5 = end of Lite Gait training; 6 = evaluation at discharge). EG, experimental group.

Fig. 4 Table 2  Mean value (±SD) of evaluation tools of experimental

group and control group at the end of the study
Evaluation tools EG CG P value

RMI 5.78 (1.84) 5.21 (3,61) 0.45

BI 58.92 (22.91) 57.15 (29.84) 0.95
6mWT 139.14 (60.27) 116.36 (73.79) 0.34

6mWT, 6-minute Walk Test; BI, Barthel Index; CG, control group; EG, experimen-
tal group; RMI, Rivermead Mobility Index.

At the end of the enrolled period, 1 week after the end

of the intervention period, the FAC median value of EG
was three, with a range going from 2 to 4; whereas the
median value of CG was two, with a range between 0 and
3. The difference between the two groups was statisti-
cally significant (u = 122.0, P < 0.01) (Fig. 4).
The differences between the two groups regarding RMI,
BI, and 6mWT were not significant: all the data are
reported in Table 2.

Box and whiskers plot of FAC results. The boxes represent the range
between first and third quartiles, and the bold line in the boxes the
median value. The whiskers represent the minimum and maximum with
the exception of data considered outliers (those more than 1.5 times
the interquartile range out of the box).
week of BWS training, as showed in Fig. 3. None of the
enrolled patients interrupted the training due to rejec-
tion or side effects.
Discussion
As shown by the overall scores, both groups progres-
sively improved their general functional conditions at
the end of the enrolled period. There was an increase in
their skills in walking capability (FAC), global mobility,
balance (RMI), and in everyday life activities (BI). The
improvement of FAC score was statistical significantly
greater for EG in comparison to CG. At the final evalua-
tion, the EG obtained a median FAC score of three (that
means ‘ambulation with supervision’), compared to the

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314  International Journal of Rehabilitation Research  2019, Vol 42 No 4
CG who presented FAC value of two (‘walking assisted
by physical assistance’). This significant result, although
minimal in terms of numbers, has a major impact on the
required care load during walking for these patients in
the first stages of rehabilitation. The benefit of BWS
is that walking can be initiated sooner in patients who
may not be able to otherwise walk. Moreover, BWS is a
safer environment to begin walking (Nilsson et al., 2001).
Besides, BWS training allows controlled repetition of a
high number of steps, where sensitive afferences repre-
sent an important stimulus for the activation of neuro-
plasticity processes, which are pivotal for motor recovery
(Hornby et al., 2011).
Regarding the secondary aim of our study, the lack of sta-
tistical significance between the two groups with respect
to functional mobility and overall disability (evaluated
by RMI and BI), is not surprising. Indeed, this is proba-
bly due to the fact that both assessment scales also take
into consideration aspects that are not strictly related
to walking. In particular, RMI evaluates the patient’s
mobility in different situations of daily life and not
specifically in walking; moreover, RMI requires a high
level of balance and mobility in most items (Antonucci
et  al., 2002). The BI admission and discharge scores of
our sample are similar to those reported in a previous
study (Pinedo et  al., 2014). However, BI also measures
independence in personal care, sphincter control, and
autonomy in movements related to the functionality of
the upper limb. Such functions were not influenced by
BWS training, because BI assesses independency also
in several other activities and because the steps on the
scale are fairly large, so it is not very sensitive to small
changes as one point of difference in FAC (Kasner, 2006).
No differences were observed between the two groups at
the 6mWT. An aspect to be considered when analysing
the results is that four patients of the CG were able to
perform only a few steps to the parallel bars. It means
that they could not perform the 6mWT, whereas only one
EG patient was unable to walk. This data greatly affects
the statistic results, possibly overestimating the CG
group results. The study was conducted on patients in
the subacute phase who had a severe degree of disability
at the entrance with a BI average score of about 14/100,
and an important disability also at discharge, with an
average score of about 58/100. Indeed, a robotic-assisted
gait device (like Lokomat) treadmill would be more
appropriate for patients so severely affected, mainly to
reduce the workload of therapists (Hesse, 2008). The use
of overground training with LiteGait has been reported
more suitable for patients who were no longer severely
disabled (Hesse, 2008). However, our study led to the
observation of a more beneficial effect of the overground
training with LiteGait compared to conventional walk-
ing training even in patients with severe impairment.
The beneficial effects of overground BWS walking
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training in spatiotemporal and kinematics parameters of
the gait were reported by Gama et  al. (2017): the ame-
lioration in stride symmetry and length of paretic limb
can be explained by different strategies in locomotor
control that a subject has when walking on the ground
compared to the treadmill. In our overview of literature,
we found conflicting results being reported also in stud-
ies about subacute patients. A better outcome in terms
of ambulation and autonomy of walking was recorded in
patients treated with BWS (Ada et al., 2010). Conversely,
Dean et al. (2010) failed to show a significant difference
between BWS and traditional therapy in terms of stride
length and velocity, whereas they observed a difference
in distance walked. Both studies, however, were con-
ducted using treadmill. The poor efficacy of treadmill
training has already been reported by Mehrholz et  al.
(2017) in which they reported that the treadmill training
did not increase the chances of walking independently
compared with other physiotherapy interventions.
Overground BWS affords a very safe treatment environ-
ment for the patient, facilitating balance and coordina-
tion. Such early training translates into a better autonomy
during ambulation, which was our primary aim for this
study. However, we could not demonstrate a significant
influence on overall mobility and disability which was our
secondary aim.
The main limitation of this study is lack of a follow-up.
It would have been important to evaluate if differences
between the two groups were stable over time. Secondly,
the sample size of this pilot study was small; therefore,
the findings may be difficult to generalize beyond the
sample group of this study.
Lastly, the two groups did not receive the same amount
of physiotherapy. The active walking training for EG was
20 minutes less than CG because of BWS setting. We
might hypothesize that, with a full training of 40 minutes,
the EG could have reach better results.
Conclusion
An early gait training with BWS during overground walk-
ing in persons with stroke in the subacute phase may
improve walking autonomy at discharge after an inpa-
tient hospitalization. No differences were observed in
terms of BI, RMI, and 6mWT. The treatment was well
accepted by patients. This training strategy might be
adopted for gait rehabilitation after stroke. Further stud-
ies are needed to investigate if increasing BWS training
intensity may led to a better improvement of rehabilita-
tion outcomes and to assess whether the results obtained
are maintained over time.
Acknowledgements
Conflicts of interest
There are no conflicts of interest.
 Overground BWS walking training in subacute stroke Brunelli et al.  315
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