Arad Lajevardi-Khosh1, Ben Tresco2, Ami Stuart3, Sarina Sinclair3, Matt Ackerman1, Erik Kubiak4, Tomasz Petelenz1, Robert Hitchcock1. 1. Department of Bioengineering, University of Utah, Salt Lake City, UT, USA. 2. Department of Chemistry, University of Utah, Salt Lake City, UT, USA. 3. Department of Orthopaedics, University of Utah Hospitals and Clinics, Salt Lake City, UT, USA. 4. Department of Orthopaedics, University of Nevada Las Vegas, Las Vegas, NV, USA.
Abstract
Introduction: Ambulation can be used to monitor the healing of lower extremity fractures. However, the ambulatory behavior of tibia fracture patients remains unknown due to an inability to continuously quantify ambulation outside of the clinic. The goal of this study was to design and validate an algorithm to assess ambulation in tibia fracture patients using the ambulatory tibial load analysis system during recovery, outside of the clinic. METHODS: Data were collected from a cyclic tester, 14 healthy volunteers performing a 2-min walk test on the treadmill, and 10 tibia fracture patients who wore the ambulatory tibial load analysis system during recovery. RESULTS: The algorithm accurately detected 2000/2000 steps from simulated ambulatory data. During the 2-min walk test, step counts derived from the algorithm and treadmill showed a strong correlation (r2>0.98) to the visual ("actual") step count. Applying the algorithm to continuous data from tibia fracture patients revealed qualitative differences in gait between the initial and later stages of recovery. Additionally, a relatively large standard deviation (≤3000 steps) in the daily average step count indicated a variety of patient ambulatory behaviors. CONCLUSION: The algorithm reported in this study can assess the ambulatory activity of tibia fracture patients during the recovery period.
Introduction: Ambulation can be used to monitor the healing of lower extremity fractures. However, the ambulatory behavior of tibia fracture patients remains unknown due to an inability to continuously quantify ambulation outside of the clinic. The goal of this study was to design and validate an algorithm to assess ambulation in tibia fracture patients using the ambulatory tibial load analysis system during recovery, outside of the clinic. METHODS: Data were collected from a cyclic tester, 14 healthy volunteers performing a 2-min walk test on the treadmill, and 10 tibia fracture patients who wore the ambulatory tibial load analysis system during recovery. RESULTS: The algorithm accurately detected 2000/2000 steps from simulated ambulatory data. During the 2-min walk test, step counts derived from the algorithm and treadmill showed a strong correlation (r2>0.98) to the visual ("actual") step count. Applying the algorithm to continuous data from tibia fracture patients revealed qualitative differences in gait between the initial and later stages of recovery. Additionally, a relatively large standard deviation (≤3000 steps) in the daily average step count indicated a variety of patient ambulatory behaviors. CONCLUSION: The algorithm reported in this study can assess the ambulatory activity of tibia fracture patients during the recovery period.
The tibia is the most commonly fractured long bone.[1] Tibia fractures can be caused by
both low impact (i.e. walking, fall from standing) and high impact mechanisms of
injury (i.e. sports injury, motor vehicle accident).[2] Complications such as delayed
healing or non-union occur in 13–60%[3,4] of cases and place additional
burden on the patient because they prolong the recovery period and are associated
with significant pain.[5] It is well known that fracture healing is highly dependent
on the mechanical environment,[6] which is the magnitude and type
of load experienced by the fractured bone. Under-loading has been shown to result in
impeded bone formation and over-loading conditions have resulted in dislocation of
the bone fragments.[7-9] In order to
promote bone healing, the standard of care instructs patients to gradually increase
load applied to the injured limb from no-load to full-load conditions,[10] during
recovery which typically lasts 6–12 weeks or more.[11] Moreover, the ability of a
patient to bear weight on the injured limb is a commonly used clinical factor to
assess fracture healing.[12]One method to analyze the ability of a patient to bear weight is through the
assessment of gait.[13] In general, ambulation is a basic component of various
daily activities and quantification of ambulation can provide important information
regarding an individual's functional capacity. In 2012, Macri et al.[13] used video
assessment to grade the gait of tibia fracture patients on a scale of 1–4 and found
that a patient's ability to ambulate was correlated to the healing stage of the
fractured bone. Patients with a higher score were able to ambulate normally, while
patients with a lower score had difficulties ambulating. However, this qualitative
measure of ambulation is time consuming, limited by subjectivity, and requires
clinical visits for data points. An objective, out-of-clinic method to quantify
ambulation may provide clinicians with a more practical tool to monitor fracture
healing. However, monitoring progress in fracture healing outside of the clinical
environment has been difficult due to unknown patient behaviors such as the number
of steps taken,[14] the actual amount of loading[15] and time spent wearing a
rehabilitative boot. The lack of a reliable method to continuously monitor the type
and magnitude of loading is one of the main reasons why quantifying the mechanical
environment experienced by lower extremity fractures has been difficult.In an attempt to quantify the mechanical environment experienced by an injured lower
extremity, several technologies have been developed. One set of devices is underfoot
load monitoring systems which measure force underneath the foot. These systems have
been limited by inadequate sensor performance including hysteresis, non-linearity,
drift, short recording time ( < 24 h), and/or high cost.[16-19] These limitations have led to
a paucity of continuous, out-of-clinic underfoot load data from lower extremity
fracture patients. Apart from underfoot load monitoring systems, several specialized
research tools such as implantable microelectromechanical sensors and instrumented
internal fixators have been developed.[20-22] However, these tools are
limited to certain fracture types, are invasive due to the need for surgical
implantation and retrieval and some require clinical visits for data
acquisition.While the aforementioned load monitoring devices can measure the magnitude of
loading, these systems are generally not designed to measure ambulation. An
exception is the OpenGo insole which measures the amount of active time spent by
ankle fracture patients for a duration of six weeks.[23] It is unclear, however, if the
amount of time spent active, refers to dynamic or static activities. Activity
monitors that are designed for consumer fitness and wellness tracking have also been
used to quantify ambulation with varying results. The most popular wearable device,
the Fitbit, has been shown to underestimate the number of steps taken at a slow,
moderate, and brisk walking speeds on a treadmill.[24] Diaz et al. reported
underestimations in step counts of up to 3% for hip worn FitBit models and up to 23%
for wrist worn FitBit models. In another study with healthy volunteers walking both
indoors and outdoors, devices such as the Nike+ Fuel Band, Jawbone Up,
and Tractivity showed poor accuracy at slow walking speeds by underestimating the
number of footsteps by 35.39 ± 21.17%, 10.08 ± 8.04%, and 10.92 ± 16.26%
respectively.[25] Due to their varying accuracies, these devices may not be
appropriate to use to accurately quantify ambulation in lower extremity fracture
patients. Quantifying ambulation requires a reliable and accurate methodology to
detect footsteps—including footsteps during the early recovery period where the
underfoot loads are low. Therefore, there is a need for a reliable, robust and
affordable tool to measure ambulation during recovery which may allow for new
insights into tibia fracture healing and equip care providers with data to guide
improved healing outcomes.In previous studies by our group, a robust underfoot load measuring device, the
Ambulatory Tibia Load Analysis System (ATLAS), was developed and shown to overcome
many of the current technological limitations in long-term limb load monitoring such
as sensor linearity, drift, and duration of recording time outside of the
clinic.[26] The ATLAS consists of three separate piezoresistive pressure
sensors with two sensors positioned under the medial and lateral metatarsal heads,
and one sensor under the heel.[27] The sensors are integrated
into a controlled ankle movement (CAM) walker, which is worn by the patient.The goal of this study was to develop an algorithm to count steps from underfoot load
data from the ATLAS in order to assess ambulation in tibia fracture patients as they
are recovering, both during the initial healing phase as well as late stage healing.
In this study, we developed an automated step counting algorithm to accurately and
reliably determine the number of steps from ATLAS underfoot loading data.
Verification of the step counting algorithm was performed in the laboratory using a
cyclic loading device and software generated loading curves. Validation was
performed with healthy volunteers wearing an ATLAS instrumented CAM walker boot
during a 2-min walking test (2MWT) on a Noraxon Scifit treadmill. The accuracy of
the step counting algorithm was compared to a visual step count and treadmill
generated step count. Subsequently, the step counting algorithm was used to assess
ambulation in 10 tibia fracture patients.
Materials and methods
The study was conducted at the University Orthopedic Center and the Department of
Bioengineering at the University of Utah, according to the protocol reviewed and
approved by the University of Utah IRB. Healthy volunteers (ref IRB 81249) and tibia
fracture patients (ref IRB 61719) provided informed written consent to participate
in these studies. Unless otherwise specified, all software programs were run with
default or recommended settings from a 2.66 GHz Intel Core i7 Windows OS desktop
machine equipped with 16 GB of RAM.
Algorithm description
All of the data analyzed by the algorithm consisted of the sum of the three
sensors of the ATLAS. The ATLAS continuously records underfoot loading, and
therefore the data contain information about both ambulation and other
activities, such as static loading and momentary loading (e.g. required to
maintain balance, “shuffling” at the early stage of recovery, etc.). Thus, an
algorithm is necessary to filter data associated with non-ambulatory events in
order to count steps. The algorithm was developed and informed by analyzing
partial and full weight-bearing waveforms from the first three patients in this
study. The initial analysis of this data revealed that steps taken by tibia
fracture patients in a walking boot often deviated from the healthy gait, which
has been previously reported in healthy volunteers simulating partial weight
bearing.[28] In order to overcome the challenge of counting steps
based on irregular loading patterns, we developed an algorithm with three
conditions. The desired function of the algorithm was to first detect the heel
or forefoot contact with the ground by looking for a maximum load value and then
detect when the foot discontinued contact with the ground by looking for a
minimum load value. In addition, the algorithm was designed to disregard quickly
occurring maxima that may have occurred due to a variety of events such as
balancing or shuffling during the numerous weeks of recording data. Underfoot
load data that met all three conditions of the algorithm were counted as
footsteps.The first condition of the algorithm was to detect a heel or forefoot strike by
identifying local maxima based on a threshold. From observations with our
initial data, it was quickly determined that a fixed threshold system was unable
to compensate for the dynamic nature of weight-bearing progression over the many
weeks of using the CAM Walker. In order to determine a dynamic threshold, we
sampled data from the first three patients in the study to determine the
relationship regarding the threshold (differences between local maxima and
minima) and the corresponding peak loads (maxima). These variables were sampled
at time points during the early, middle, and late periods of recovery. Linear
regression analysis revealed a slope value of 40% which indicated that
differences between maxima and minima were approximately 0.4 times the peak load
value. Thus, we set our threshold to be at least 40% of the daily average peak
load. Because the average load increases over time, thresholding with respect to
individual days allows for the capture of steps taken from partial
weight-bearing to full weight-bearing conditions. Peak load values (foot strike)
greater than or equivalent to the threshold were passed on to the second
condition of the algorithm for further filtering.The second condition of the algorithm was to disregard peak loads that occurred
too quickly to be associated with ambulation. The fast gait for humans ages
20–49 is approximately 2.48 ± .12 steps/s.[29] It is unlikely that a
lower limb fracture patient would exceed this rate. Therefore, the condition was
set that if two maxima occurred at a frequency faster than 1.3 steps/s, the
lower amplitude maximum would be disregarded. This condition was designed to
remove peaklets that occurred as the recovering patients attempted to ambulate,
balance, shuffle and perform other daily activities. The remaining peak loads
were then passed on to the third condition of the algorithm to determine the
final step count.Finally, the third condition of the algorithm was to detect the swing phase of
gait by detecting a local minimum. During normal gait, the foot strike with the
ground is preceded and followed by foot swing. This scenario is represented in
the underfoot load data by a maximum value surrounded on both sides by two
minima values. In order to account for the irregular gait of tibia fracture
patients, we also needed to detect abnormal steps such as when the foot begins
in the air, strikes the ground and then the patient balances on that foot. In
this case, the underfoot load data would by represented by a minimum value
followed by a maximum value. In order to capture both of these types of steps,
the algorithm was designed to disregard maxima that were not preceded or
followed by a minimum of less than 20% of patient body weight within 1 s. Using
the ALTAS system in the laboratory, we found that the baseline value of the
system could shift up to 10% based on how tightly the walking boot straps were
fastened. To account for the variability in strap tightness due to patients
donning and doffing the boot each day, we doubled the observed 10% value as a
safety factor.
Laboratory hardware and software verification
In order to simulate steps from patients, a cyclic loading system was designed.
The system consists of three pneumatic cylinders controlled using a National
Instruments LabView (Labview 2013, http://www.ni.com/labview/) system programmed for step
simulation. The Labview software allows for customization of the number of
loading cycles, time loaded or unloaded, and input waveform. In this simplified
system, each strike of the disk piston on the ATLAS represents a step.Additionally, a test waveform was created to represent underfoot load data. A
piecewise sine wave consisting of four segments was programmed using MATLAB.
Each segment contained varying frequency, amplitude, and/or offset values in
order to simulate different walking conditions. The segments were designed to
determine whether or not the algorithm could indeed filter miscellaneous
activities in the loading data. The equation used to construct the waveform is
presented in equation (1)
Study procedure
A total of 14 healthy volunteers (6 males, 8 females, age range 21–63 years)
participated in the treadmill walking validation study. Each subject was fitted
with the ATLAS instrumented CAM walker boot (right leg). Each trial consisted of
a 2MWT on a Noraxon Scifit treadmill at a speed of 1.12 m/s. This speed was
similar to speeds used in previous treadmill studies[30,31] but slightly decreased to
minimize potential difficulties in ambulation with the walking boot. While each
patient walked, treadmill and ATLAS data were recorded. Each test was video
recorded in order to collect a manual step count for each trial. Step counts
recorded by the ATLAS and treadmill were compared to the number of steps
determined by manually counting steps captured on the video, which was used as
the reference for each trial. Steps determined by ATLAS were calculated by the
ATLAS step counting algorithm and step counts from the treadmill were calculated
by the Noraxon treadmill software. Each participant performed the test
twice.Data sets from tibia fracture patients were obtained from a study at the
University of Utah Orthopaedic Center. Ten tibia fracture patients (6 males 4
females, age range 20–55 years) were recruited from this institution. Each
patient was fitted with an ATLAS system that integrates with the clinically
prescribed MaxTrax CAM walking boot. Each patient was instructed in the study
procedures by a member of the clinical team.
ATLAS data
Data analysis was performed in MATLAB 2014a (Mathworks, www.mathworks.com). The objective of data analysis was to
generate a loading curve, to identify individual steps and to determine step
statistics from ATLAS-recorded underfoot load data. All of the ATLAS data
analyzed by the algorithm consisted of the sum of the underfoot load from the
three sensors (1 underneath the heel and 2 underneath the forefoot). Loading
values obtained from patients were normalized for the patient's body weight from
the beginning of the study. Step count data from the treadmill, ATLAS and video
records were tabulated for each trial and average and standard deviation values
were computed. The data were plotted, and correlation coefficients (linear
regression) were calculated.
Results
Laboratory hardware verification
The total load recorded by ATLAS during a 10-s interval from the cyclic load test
is shown in Figure 1.
Five peak loads are observed with a baseline value between each maximum. The
five asterisks indicate the five maxima values that were detected by the
algorithm and interpreted as steps. The step counting algorithm detected 2000
out of 2000 cycles that were programmed for this experiment.
Figure
1.
Representative 10-s interval of ATLAS data
during the cyclic loading test. Asterisks indicate maxima detected
by the step counting algorithm. The number of cycles during this
interval, 5, matches the number of “steps” detected by the ATLAS
algorithm.
Representative 10-s interval of ATLAS data
during the cyclic loading test. Asterisks indicate maxima detected
by the step counting algorithm. The number of cycles during this
interval, 5, matches the number of “steps” detected by the ATLAS
algorithm.
Laboratory verification using simulated loading curves
A sine wave with varying amplitudes and frequencies was created to simulate
various walking conditions is shown in Figure 2. The number of steps detected by
different conditions of the algorithm as well as the number of steps detected by
the algorithm as a whole is also shown. When individual conditions of the
algorithm were used, percent errors of 50% or greater were observed. The testing
demonstrated that all three components of the step counting algorithm are
necessary in order to obtain the correct number of steps.
Figure
2.
Simulated steps detected from an artificial
waveform representing ambulation. The four subplots used different
peak detection conditions: (A) constant small threshold, (B) first
condition of the algorithm, (C) first and second conditions of the
algorithm, (D) all three conditions of the algorithm. Asterisks at
the waveform peaks indicate the detected simulated steps. (a)
Indicates number of maxima expected, (b) maxima detected, and (c)
percent error. Only the combination of all three conditions of the
algorithm resulted in the correct step count.
Simulated steps detected from an artificial
waveform representing ambulation. The four subplots used different
peak detection conditions: (A) constant small threshold, (B) first
condition of the algorithm, (C) first and second conditions of the
algorithm, (D) all three conditions of the algorithm. Asterisks at
the waveform peaks indicate the detected simulated steps. (a)
Indicates number of maxima expected, (b) maxima detected, and (c)
percent error. Only the combination of all three conditions of the
algorithm resulted in the correct step count.
Validation of step counting software using treadmill
During the 2MWT, the treadmill, ATLAS, and video count detected footsteps of
89 ± 9 steps, 91 ± 10 steps, and 91 ± 10 steps, respectively. Figure 3 shows the
correlation between the calculated number of steps from each device with respect
to the actual number of steps derived from video analysis. The number of steps
as detected by the ATLAS had the highest correlation with the actual number of
steps taken with an r[2] value of 0.989. The number of steps as calculated by
treadmill was also highly correlated to the actual number of steps with an
r[2]
value of 0.984.
Figure
3.
ATLAS step count is highly correlated to the
actual step count. The highest correlation with the reference values
was recorded for the ATLAS (r[2] = 0.989), with
the treadmill following closely (r[2] = 0.984).
ATLAS step count is highly correlated to the
actual step count. The highest correlation with the reference values
was recorded for the ATLAS (r[2] = 0.989), with
the treadmill following closely (r[2] = 0.984).
Continuous recovery data
In this section, examples of the application of the step counting algorithm in
two patients are discussed. Figure 4 shows 28 days of continuous loading data obtained in tibia
fracture Patient 1. The load values for this patient begin 17 days after surgery
when the patient was first instructed to wear the ATLAS. During the first two
weeks of ATLAS use, loading values never exceeded 50% of the patient's
bodyweight. However, after additional weeks of recovery, this patient was weight
bearing at nearly 90% of their bodyweight. Inset graphs (A) and (B) represent
the differences in ambulation that occur over time. The underfoot load while
ambulating is irregular and variable 9 days after surgery, but becomes more
patterned and consistent 42 days after surgery.
Figure 4.
Progressive nature of
weight bearing during the rehabilitation period of a tibia fracture
patient. The patient began wearing the boot 17 days after surgery.
Insert (a) shows a 10-s segment of data from day 26, and insert (b)
shows a 10 s segment of data from day 40.
Progressive nature of
weight bearing during the rehabilitation period of a tibia fracture
patient. The patient began wearing the boot 17 days after surgery.
Insert (a) shows a 10-s segment of data from day 26, and insert (b)
shows a 10 s segment of data from day 40.Practical application of the step counting algorithm to patient data is shown in
Figures 5 and 6. In Figures 5 and 6, asterisks indicate steps detected by
the algorithm. Figure 5
shows the total underfoot load during a 10-s period from the early stage of
healing. The data appear disordered and only one step was detected during this
period. During the first 5 s of this data, the total underfoot load varies
irregularly from 8% of body weight to approximately 11% of body weight. This
results in numerous peaklets (local maxima) which lack the loading profile
typically seen during ambulation in a walking boot. In contrast, the 10 s of
data from the late stage of healing shown in Figure 6 depict loading values which
relatively consistently varied from 6% of body weight to 66%. In this case, six
steps were detected from the dynamically varying data and the overall profile of
loading during each step is similar in magnitude and duration. The six steps in
Figure 6 all contain
the same pattern of two peaklets, representing loading of the heel and forefoot
sensors during each step, while the single step detected in Figure 5 has several peaklets during the
step. Overall, there are qualitative differences in the nature of ambulation and
loading values between the early and late stages of healing.
Figure
5.
Example of irregular loading pattern at
relatively low percentage of bodyweight during the early stage of
rehabilitation. This graph shows the percentage of loading
normalized to body weight over a 10-s interval. Examples of peaklets
resulting from behavior that does not appear to be ambulation are
denoted by dashed arrows. The algorithm disregarded the peaklets and
detected a single step, denoted by the (*), in this portion of the
data.
Figure
6.
Example of regular load pattern at a
relatively high percentage of bodyweight during the late stage of
rehabilitation. This 10-s interval of data shows the relatively
consistent and patterned waveform seen in most patients during the
late stages of healing. Overall, the features of the waveform are
similar to that normal ambulation in a walking boot. The (*) above
the peak indicates the six steps detected by the algorithm in this
portion of the data.
Example of irregular loading pattern at
relatively low percentage of bodyweight during the early stage of
rehabilitation. This graph shows the percentage of loading
normalized to body weight over a 10-s interval. Examples of peaklets
resulting from behavior that does not appear to be ambulation are
denoted by dashed arrows. The algorithm disregarded the peaklets and
detected a single step, denoted by the (*), in this portion of the
data.Example of regular load pattern at a
relatively high percentage of bodyweight during the late stage of
rehabilitation. This 10-s interval of data shows the relatively
consistent and patterned waveform seen in most patients during the
late stages of healing. Overall, the features of the waveform are
similar to that normal ambulation in a walking boot. The (*) above
the peak indicates the six steps detected by the algorithm in this
portion of the data.An overview of the number of steps taken per day by 10 patients (mean, SD) is
shown in Figure 7. The
large standard deviation values (up to ∼3000 steps/day) indicate the diversity
of patient behavior during partial weight-bearing rehabilitation. Overall, there
appears to be an increase in the mean number of steps taken per day during the
first five to six weeks after surgery. After this time period, the mean number
of steps taken per day intermittently increases and decreases. Despite the lack
of a continuing trend, the mean number of steps per day is generally greater
than 1000 steps per day after two weeks of recovery as compared to the first two
weeks.
Figure
7.
Average number of footsteps taken per day by
10 patients. Large standard deviations indicate a wide variety of
patient ambulatory behavior. The number of steps taken per day tends
to increase during the first five weeks and is followed by
intermittent increases and decreases.
Average number of footsteps taken per day by
10 patients. Large standard deviations indicate a wide variety of
patient ambulatory behavior. The number of steps taken per day tends
to increase during the first five weeks and is followed by
intermittent increases and decreases.
Discussion
Ambulation may be an influential factor in the healing of lower extremity fractures
and could also be used as a monitoring tool to measure the progression of fracture
healing.[13,32] However, the ambulatory behavior of tibia fracture patients
remains unknown due to an inability to continuously and reliably quantify ambulation
outside of a clinical setting. Our goal was to develop an algorithm to assess
ambulation in tibia fracture patients, outside of the clinic, during recovery in a
CAM walker. Our results indicated that a reliable algorithm to count steps from
ATLAS underfoot load data was developed and validated. To the best of our knowledge,
this is the first report on the out-of-clinic ambulatory behavior of tibia fracture
patients from the first day of recovery in a CAM walker to the day a clinician
determined that the fracture was healed and the CAM boot was no longer needed.The accuracy and reliability of the algorithm were verified using hardware and
software in the laboratory to simulate two simplified models of ambulation. When a
cyclic loading system was used to simulate ambulation, the algorithm correctly
identified all of the simulated steps (Figure 1). Similarly, when a loading waveform
containing data representing both footsteps and miscellaneous activities was input
into the algorithm, the algorithm filtered out extraneous activities and correctly
identified the simulated steps (Figure 2). These experiments indicated that the algorithm could reliably
identify footsteps in simplified models of ambulation. In addition, validation
testing was performed on healthy volunteers. Our results showed that the algorithm
derived step count had a high correlation (r[2] = 0.989) with the actual number
of steps taken as determined by a manual video count (Figure 3), indicating that the algorithm
could accurately detect steps taken in a CAM walker boot during walking. Comparing
the accuracy of our device to common commercial devices, the accuracy of our step
counting algorithm is greater than that of the wrist worn FitBit Flex, but similar
to the hip worn FitBit One. Previous validation and reliability studies performed on
a treadmill have shown that step counts from the FitBit Flex and Fitbit One are
moderately correlated (0.77 ≤ r[2] ≤ 0.85)[24] and highly
correlated (0.97 ≤ r[2] ≤ 0.99),[33,34] respectively, to the manual step count.The collection of continuous, out-of-clinic, underfoot load data from tibia fracture
patients revealed specific patient behavior and provided insight into the
progressive nature of weight bearing over time (Figure 4). While previous studies have
captured discrete changes in weight bearing,[35,36] this study provided the first
continuous picture of weight bearing during a period of 28 days. From day 17 to day
45, there was an overall nonlinear increase in weight bearing. Within that period,
there were consecutive days where the increase in weight bearing was followed by a
sudden decrease as seen in days 21 to 22 and days 34 to 35. One explanation for this
behavior may be that the patient over-loaded the injured limb leading to pain which
is reflected by the subsequent decrease in weight bearing. When the weight-bearing
data were analyzed with a time scale in seconds, ambulatory behavior was revealed
(Figure 4(a) and
(b)).Application of the step counting algorithm to data obtained continuously by the ATLAS
system qualitatively showed that ambulation during the initial stages of recovery
(Figure 5) differed from
ambulation in later stages of recovery (Figure 6). While the loading curve in Figure 5 contained varying
maxima values, the loading curve in Figure 6 appeared to be regular with consistent maxima values. The
variance in initial loading (Figure
5) may be due to the patient continuously adjusting the amount of load on
the injured limb due to pain (such as shuffling) or attempting to partially weight
bear while using crutches. Previous studies have also found a difference in gait in
the initial stages of recovery compared to the later stages of recovery.[13,37] However, the
aforementioned studies were performed on an animal model or assessed gait at
discrete time points, in a clinical setting. Thus, results from these studies may
not be representative of patient community ambulatory behavior. Our results may be
more representative of actual patient ambulation since they were based on
measurements obtained continuously, outside of a clinical setting. Since new
literature has pointed towards a correlation between the quality of gait and
fracture healing,[13] clinicians may be able to utilize the step counting algorithm
to gain objective insight into continuous, personalized fracture healing.Our overall assessment of ambulatory behavior revealed much variance in the number of
steps taken between patients during recovery. We believe this is the first report of
a continuous step count for tibia fracture patients obtained outside of a clinical
setting. A general increase in the daily step count was observed (Figure 7) for the first five
weeks of use followed by intermittent increases and decreases during the following
three weeks. One possible explanation for this behavior is that a subset of patients
may have been non-compliant and wore the ATLAS instrumented CAM walker less
consistently once they were able to ambulate comfortably without the CAM walker
(around week 5). In addition, there was a large standard deviation for each data
point in this group of 10 patients. This variance between patients underscores the
fact that patients have different behaviors and may respond differently to
prescribed rehabilitative protocols. Instead of a standardized protocol for given
fracture types,[10] individualized rehabilitative protocols based on ambulatory
data obtained by the algorithm may optimize healing outcomes. Despite a paucity of
data on patient ambulation during recovery outside of a clinical setting, our
findings are similar to the most current results in the literature. While Braun
et al.[23] only performed measurements for a total of six weeks, they also
observed that the average time spent active by a group of 10 ankle fracture patients
increased overtime and that there was a relatively large standard deviation in the
time spent active. Time spent active may include ambulation by both the healthy limb
and the injured limb. However, literature has shown that loading and ambulation on
the injured limb promote healing[36,38] and therefore time spent
active may be an imprecise measure of ambulation experienced by the injured limb.
Further studies with an increased number of patients may reveal how ambulation
affects healing and allows for scientifically derived activity suggestions to
promote fracture healing.One of the limitations of this study was that validation of the step counting
algorithm was only performed with healthy subjects for a trial duration of 2 min.
The 2MWT is commonly used to determine ambulatory capacity of unhealthy individuals,
due to the practicality and efficiency of the test.[39,40] While there is no established
protocol for validation of a step counting system, previous studies have used
walking durations of 1–3 min.[41-43] As a result, the authors
decided the 2MWT was a feasible protocol to validate the step counting algorithm.
Another limitation is our inability to report on ambulation when patients are
non-compliant and do not wear the ATLAS. It is possible that a recovering patient
can take numerous steps without wearing ATLAS, which would not be detected by the
algorithm. While we cannot control the compliance of patients, we can continuously
monitor the underfoot load and speculate when patients do not wear the ATLAS based
on long periods of no loading. In other words, the ATLAS system could also be used
as a tool to measure patient compliance. Lastly, we did not give wearable sensors to
the tibia fracture patients during the recovery period. However, it is important to
note that no activity monitor has been validated in a tibia fracture patient model
and as a result we would have been unable to make objective comparisons between our
device and one that is not intended for this purpose. In addition, prescribing
activity monitors to tibia fracture patients is not part of the current standard of
care, whereas the CAM walker boot is commonly prescribed by orthopaedic clinicians.
While prescribing the use of an activity monitor may have been a major change to
established protocols, integration of the ATLAS into the sole of the CAM Walker was
a minimal modification to the current post-surgical standards.In summary, the algorithm reported here provided a means to assess patient ambulation
and may be used in the future to connect patients and care providers to guide
therapy and monitor rehabilitation. We have shown that our algorithm can be applied
to ATLAS underfoot load data to continuously count the number of steps taken and
provided an assessment of the ambulatory behavior of tibia fracture patients. The
algorithm revealed a qualitative difference in gait during the initial stages of
recovery compared to the later stages of recovery. Additionally, a relatively large
variance in daily ambulation within a group of 10 patients over a six-week period
was observed, suggesting differences in ambulatory behavior. In the future, the
ambulatory behavior of patients, as derived by our algorithm, may be used by
clinicians to develop personalized healing regimens, which could allow patients to
resume their normal activities more quickly and lower surgical revision rates.
Future studies correlating radiographic measures of healing, such as the RUST
score,[44] to ambulation may also provide additional evidence for the use
of ambulation as a measure for fracture healing.
Authors: Randal C Foster; Lorraine M Lanningham-Foster; Chinmay Manohar; Shelly K McCrady; Lana J Nysse; Kenton R Kaufman; Denny J Padgett; James A Levine Journal: Prev Med Date: 2005 Sep-Oct Impact factor: 4.018