Asymmetry measures
Walking
on the rehabilitative shoe may benefit gait symmetry. All participants
improved step length symmetry after training, and the average change in
step length symmetry found in our study is similar to that shown in a
study focused on gait symmetry during split-belt treadmill (SBT)
training [
37].
Four participants improved DLS symmetry; the two that did not improve
were the severely impaired participant (initial gait velocity of 9.0
cm/s) and the highly functional participant (initial gait velocity of
113.5 cm/s). Although these two did not respond with a DLS asymmetry
change, participant 3 improved step length asymmetry and had a
substantial decrease on the TUG, and participant 6 improved on the 6MWT
and had a substantial increase in gait velocity. For comparison, related
studies show no change in DLS symmetry following SBT training [
37,
38].
Our results suggest that over-ground gait training using the
rehabilitative shoe could provide an additional benefit to the recovery
of DLS symmetry for some individuals after stroke.
The literature
does not provide estimates of the clinical relevance of gait asymmetry
measures while walking over ground, but does provide some spatiotemporal
measures for treadmill walking [
39]. However, gait asymmetry has been associated with balance [
40,
41]
and is considered a major cause of future degenerative issues with
hips, knees, and backs for stroke survivors with gait hemiparesis [
42,
43].
Functional measures
Walking
on the rehabilitative shoe may help individuals with hemiparetic stroke
improve their functional walking. Two of the participants’ gait
velocity increased beyond a substantial meaningful change (≥ 14 cm/s),
two other participants’ gait velocity increased beyond a small
meaningful change (≥ 6 cm/s), and the remaining two improved less than
these ranges. These ranges are based on people 30 to 150 days post
stroke [
35,
44].
One participant improved gait velocity beyond the clinically meaningful
change of ≥ 16 cm/s that another study reported for people less than 60
days post stroke [
45].
All the participants in our study were more than one year post stroke,
which is much greater than the groups reported in these studies. Another
important measure is that two out of three participants who were
initially categorized as household ambulators (i.e., gait velocity of &l; 40 cm/s) became limited community ambulators (i.e., gait velocity
of 40–80 cm/s) after training [
5]; these two participants were 5 and 10 years post stroke
All participants who were assessed improved on the TUG, and two of them improved beyond the MDC of − 3.5 sec [
36].
Although all five participants assessed improved the distance walked in
the 6MWT following training, none of them surpassed the smallest
minimal clinically important difference (MCID) of 34 m reported by Fulk
and He [
46].
The four-week training with only 6 hours total walk time may not be
long enough for each participant to show a meaningful change in aerobic
capacity. Continued daily use of the device for a longer time coupled
with concomitant exercise may help them further increase aerobic
capacity over time.
Subjective evaluations
At
the conclusion of the training and post-testing, we discussed the
device and therapy with each participant and family member (if present).
All the participants were generally positive about it. One participant
was very encouraged by the amount of improvement she had following the
training. Her thoughts are summarized by the two following statements:
“I walked into church last week without a cane for the first time [since
my stroke].” Her husband followed up by stating: “Her confidence
walking around the house has increased dramatically since she started
walking on the shoe.” Another participant stated: “I am able to walk
faster and my knee moves and my toes have started to move. And those are
a couple of things that didn’t happen before.” A video interview with
one of the participants is available [
47].
Therapeutic mechanisms
The
device presented is unlike any known existing rehabilitation therapies
and is thought to function through a combination of mechanisms. These
mechanisms likely benefit each individual uniquely since stroke presents
in different ways. For example, all the participants showed a shorter
stance phase with the paretic side compared to the nonparetic side, but
three of the participants (1, 2, & 6) had a shorter step length with
the paretic side. Although these three participants showed a smaller
improvement in step length asymmetry, participant 1 showed the largest
double limb support asymmetry improvement and participants 2 and 6
showed the largest gait velocity improvements. Encouraging more use of
the paretic foot likely had a larger benefit to these participants.
These unique benefits suggest that our device may have a heterogenous
set of mechanisms that can benefit a wide set of stroke patients’
specific gait impairments. Further, all of our participants benefitted
from this treatment, which is different than some of the SBT studies
that show no gait symmetry improvements, especially step length
symmetry, in approximately 40% of participants [
37,
38]. Below are details on some the mechanisms we believe cause our device to help correct gait.
Asymmetric Motion:
Both the presented device and the SBT cause one foot to move backward
faster than the other. In SBT training, the gait asymmetry of the
patient is increased by having two treads move at different speeds so
that the patient must compensate to stay moving on the treadmill. When
the belts are returned to the same speed, the patient will retain the
“adjusted”, now more symmetric, gait on the treadmill [
37,
48].
Our presented device moves the foot backward relative to the paretic
foot, much like the motion of the fast tread of a SBT. Both the SBT and
our device beneficially change step length symmetry, but only our device
shows improvements in double limb support symmetry. This additional
gait benefit is likely due the device attaching to the foot, which
allows training in an over-ground context.
Context Awareness:
The corrected walking patterns from existing therapeutic methods, such
as treadmills, do not completely transfer to over-ground walking because
the dynamic and sensorimotor aspects of walking over ground are
distinctly different than walking on a treadmill [
22,
28,
49,
50].
Research has indicated that only about 60% of the gait correction from
walking on a split-belt treadmill transfers to walking over ground in
individuals with stroke [
51].
When
walking over ground, an individual has complete control over velocity,
whereas the treadmill speed limits one’s ability to change velocity.
Another important difference is the amount of visual flow: on a
treadmill, the scene is not moving, so there are no visual cues
reinforcing the forward motion that would be present when walking over
ground. Since walking is highly context dependent [
25,
51–
54],
these visual cues indicating a different context may prevent the
learned patterns on the treadmill from being expressed during
over-ground walking. Our device allows over-ground walking in the
environment of daily activities. A user of our device experiences a
congruent dynamic optical/visual flow as opposed to an individual on a
SBT, who typically views a static scene that is incongruent to training
movements.
Cueing: The benefits of this device may also
arise from the multiple cues produced by the device that guide the user
through their gait. The first cue is that the nonparetic foot height is
decreasing after first contact in stance; a second cue is that the
nonparetic foot begins moving backward during the transition to stance.
These cues start before the paretic leg transitions from stance, which
provides a set of cues that possibly indicate the type of step to take
with the paretic leg. For example, the first cue may induce more weight
bearing on the paretic leg at mid-stance, while the second cue may
foster earlier toe off of the paretic leg at terminal stance.
Encouraging Paretic Leg:
The device can also increase the relearning of the paretic leg by
reducing the effective output of the nonparetic leg by generating a
backward motion. The motion induced by the device encourages the wearer
to increase the use of their paretic leg. This effect is similar to the
idea of Constraint Induced Movement Therapy [
15,
16].
By slightly destabilizing their nonparetic leg, the user will naturally
start to spend more time on their paretic side, which may help to
foster those abilities and confidence in using that side of their body.
Home Rehabilitation:
The literature has continued to show that patients are dissatisfied
with their options for training after they are discharged from the
rehabilitation hospital/clinic [
55–
59]. Moreover, most individuals with stroke prefer a home-based approach for their initial rehabilitation [
60].
The ability to train at home enables individuals to more frequently
rehabilitate themselves, which leads to better results in motor
relearning [
61] and can maintain individuals’ ability to perform activities of daily living [
62,
63].
Our device has the potential to be used in the home setting, which
could reduce the costs and increase the access as well as the amount of
rehabilitation.
There are open questions related to the frequency
of training, the length of each session, and how many weeks the training
should continue. The intensity of the training during each session can
also be customized by adjusting the spiral wheel to make the generated
backward motion longer and/or faster. This customization could also be
adjusted at regular intervals to keep a constant intensity level. Future
studies will evaluate how to optimize the therapy further.
Safety
is vital, particularly during home care. Using the device independently
in a safe way is being evaluated in a separate home-based trial. In the
study presented here, we found that participants became comfortable
with the device within the first three sessions and needed little or no
assistance after that. Out of the over 400 bouts of walking in our
study, the attending PT only provided physical assistance twice due a
perceived need for patient support. As such, we expect that home-based
therapy could be provided for many patients after they complete a few
sessions in the clinic and become qualified for home-use. The specific
requirements of being eligible for home-use are being evaluated and will
be discussed further once the larger home-based study is complete.
Limitations
A
limitation to this study is that only six participants were evaluated. A
study with a larger sample size will provide more details about how
these effects generalize across different stroke gait patterns. Another
limitation is that this study did not have a matched control group to
compare to standard physical therapy or simply walking for a similar
amount of time [
64]. Despite these limitations, the initial results are promising and suggest that further study is warranted.