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Gait & Posture 37 (2013) 564–569

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Gait & Posture


journal homepage: www.elsevier.com/locate/gaitpost

Design and validation of GCH System 1.0 which measures the weight-bearing
exerted on forearm crutches during aided gait
Gema Chamorro Moriana *, Jesús Rebollo Roldán, José Jesús Jiménez Rejano, Raquel Chillón Martı́nez,
Carmen Suárez Serrano
University of Seville, Faculty of Nursing, Physiotherapy and Podiatry, c/Avicena, s/n. C.P. 41009, Seville, Spain

A R T I C L E I N F O A B S T R A C T

Article history: Normally, when the patient’s functional recovery involves partial weight-bearing aided walking using
Received 25 November 2011 forearm crutches, it is not possible to control the amount of weight-bearing objectively that the
Received in revised form 4 July 2012 individuals carry out and its progression. This leads to significant errors in accuracy and, consequently,
Accepted 20 September 2012
complications and after effects in pathologies. To compensate for this deficiency, we have set out to
design and validate a measurement system and a computerized record of the loads exerted on Canadian
Keywords: crutches in aided walking as well as incorporating a mechanism for acoustic and visual biofeedback that
Gait
will inform the subject if said charges are correct, so that they are able correct their errors and avoid
Crutches
Biotechnology
problems in their recovery. We analyzed the validity and reliability of the system through a concordance
Validity study with the AMTI OR6-7-2000 force plate, extensively validated previously, while finding a
Reliability correlation coefficient of 0.99 with a significance (p < 0.001). We have designed and developed a
measurement system with a computerized record, analysis and wireless graphical display of real-time
data, incorporating a mechanism for acoustic and visual biofeedback to measure the loads exerted on
forearm crutches during aided walking. The device, called ‘‘GCH System 1.0’’ is a reliable and valid
instrument.
ß 2012 Elsevier B.V. All rights reserved.

1. Introduction hold up and the decrease in bone density, especially in fractures


[2], or loss of muscle mass which causes joint instability among
Gait training in patients with musculoskeletal injuries that other problems [1].
requires discharge to a lower limb tend to take place immediately These errors imply the need to use measurement systems that
so as to prevent loss of strength [1] and the onset of osteoporosis analyze and control the partial weight-bearing on injured
[2]. During the rehabilitation process a gradual increase in loads members, so that recurrence, such as an operated ruptured
aided by crutches [1,3] will be carried out until totally completing Achilles tendon and complications such as the sinking of a tibial
functional recovery. plateau in an osteoporotic knee or sequelae such as talar necrosis
Different authors [2,4–7] confirm that there are constant errors, caused by a prior bone edema [4,8]. However, existing systems are
in relation to partial discharges that the patient should do during deficient [4–7,9–12], as is detailed below.
gait training, both by deficiency or excess, the latter being the most Firstly, the traditional procedures of control and training based
frequent, and those involved in mainly the safety and patient on biofeedback, such as the scale [4,7,9] are not effective, as they
recovery. Isakov [6] determines that with the traditional methods control only static but not dynamic [4–7,9,10] weight-bearing. On
the patient loads more than 50% of the ideal quantity. These the other hand, force platforms [13] do determine the accuracy of
excesses can increase inflammation, pain, leakage of synovial fluid, the loads, but they are not feasible systems in gait recovery due to
amongst other problems in the premature stages of joint their complexity in their handling and the financial and spatial
pathology; and bone necrosis or cartilage damage after surgical resources they need [11].
implantation of autologous knee chondrocytes [4]. Charge defects Secondly, force platforms are more simple and portable systems
delay the patient’s functional recovery because of the osteoblastic that enable us to control the strength of the vertical ground
reaction during gait, even on uneven ground [6,8,12,13]. However,
they present drawbacks such as not allowing: the load control in
patients requiring some orthotic devices that is incompatible with
* Corresponding author. Tel.: +34 616439514; fax: +34 954486527.
E-mail addresses: gchamorro@us.es (G. Chamorro Moriana), jesusrebollo@us.es
normal shoes, the analysis of plantaris pressure on barefooted
(J.R. Roldán), jjjimenez@us.es (J.J.J. Rejano), raquelch@us.es (R.C. Martı́nez), patients or the control the amount of weight-bearing the patient
csuarez@us.es (C.S. Serrano). applies to each of the Canadian crutches.

0966-6362/$ – see front matter ß 2012 Elsevier B.V. All rights reserved.
http://dx.doi.org/10.1016/j.gaitpost.2012.09.018
G. Chamorro Moriana et al. / Gait & Posture 37 (2013) 564–569 565

Finally, there are patented tooled crutches [14–17] that 2.2. Study design
eliminate spatial barriers, transport problems and other disad- In a previous study, the quality of the measurement were analyzed once the
vantages pointed out but they are not commercialized as they do sensors were attached to the crutches, by means of applying calibrated weights,
not meet all the patient’s needs. thus showing that there was no significant difference between weight applied and
Consequently, this study established the following objectives: the GCH measurement (CCR = 1, Cronbach’s alpha = 1 with p value <0.001). System
measurements that were obtained were reproducible and reliable, a necessary
to design and validate the weight-bearing measurement system GCH condition prior to comparisons with other methods.
1.0, so as to know objectively the weight-bearing exerted by The present research consisted of a concordance study on the equivalence
patients on crutches during aided walking. This system will permit between the values obtained from a single variable (grip strength) in the same
patient’s biofeedback-based training [5,18,19] and the control, conditions and synchronously by two different methods of measurement [21]: the
applied force measurement system to a crutch or GCH System 1.0 and the
evaluation and analysis of weight-bearing progression to establish
previously validated AMTI OR6-7-2000 force platform.
clinical protocols [1].

2. Materials and methods 2.3. Variables study

2.1. GCH System 1.0 The variables analyzed were quantitative, as they referred to amounts of weight-
bearing or the difference among several measurements.
GCH System 1.0 is the coupling of a force sensor at the lower end of the Canadian
crutch, which is connected by a cable to a control box placed in the patient’s belt. - Variable 1: Vertical reaction force of the platform on the crutch measured by our
The box contains: battery power, signal amplifiers, two loudspeakers, a display, a system, named GCH. This variable is segregated in right GCH and left GCH,
data acquisition board that receives and digitalizes the analog signal from the expressions referring to each of the crutches used. Kilogram force (kg) is used as
sensor in millivolts and a radio frequency card that emits wireless data to a USB the unit of measure for GCH.
receiver connected to a computer. The hardware, through the display menu, - Variable 2: Vertical reaction force of the crutches on the platform which is calculated
provides two functions: by the AMTI platform. This variable is called platform and is divided into platform
1 and platform 2, as there are two used in our study. The measurement unit was
- The adjustment of zeros, which is done with the crutches vertically based on the kg.
ground, without a load, by pressing a button on the control box and waiting 5 s to - Variable 3: A third variable called difference was generated, which indicates the
record said load as zero. difference between the measurements carried out with the plates and those
- An acoustic and visual biofeedback system, independent of the computer, that performed with the GCH System 1.0. This variable is segregated into four:
allows the patient to train outside the treatment room. The researcher selects the platform 1 minus right CGH, platform 1 minus left GCH, platform 2 minus right
ideal load to be exerted on the crutches, allowing for a margin of error by excess or GCH and platform 2 minus left GCH1.
defect. If the patient does not reach the minimum load, the system emits a high
pitched sound and a red light, if it exceeds the upper margin, it emits severe beeps We only consider the axial force or Z component, because, clinically, we are
and a green light. Thus, the subject can self-correct their gait. The evaluator can interested in analyzing the peak load and its maintenance over time, and this is
also check the exact amount of load exerted by the subject in the graphs on the when the crutch is perpendicular to the ground. At present the components X and Y
computer and compare the loads of each crutch or their simultaneity. Graphs can are negligible, being assumed as measurement errors.
be offered to the subject by a cannon projector to provide an added visual
feedback.
2.4. Sample and participants

The set of measurements made during the gait by GCH System 1.0 and the force
An implementation program allows us to convert the millivolts into units of force platform, made up the sample subjects. Measurements were taken on 30
(Newton or kilograms force), the data recording, analysis and numerical and participants, 53.3% women [16] and 46.6% men [14], with an age range from 18
graphical display on the screen, in real-time, of the loads the subject performs to 60 years (mean = 32.03 years, DT = 9.38).
(Fig. 1). The sample size was obtained by means of the ‘‘Sample size 1.1’’ programme of
The software used, Moteview 2.0 allows us to record data with variable Medina Perez et al., where the number of measurements required was calculated.
frequencies from 0 to 10 Hz, of which 10 was chosen. Numerical data can be The data contributed to the program for said calculation were: a two-tailed
exported to an excel spreadsheet among other formats. To avoid saturation of data, hypothesis with an estimated value of the intra-class correlation coefficient of 0.8
we export and reset every 5 min. The software includes a calibration method, which and with a level of accuracy of 0.09. The required sample size was 89
must include data from the straight line provided by the certificate of quality of each measurements, but 90 were finally included so reaching a level of accuracy of
sensor used. 0.0895. The 90 observations come from calculating the force applied to the GCH
The measuring instrument invented in 2009, is registered with the Spanish System 1.0 in each of the 30 participants 3 times. Since we compared two crutches
Patent and Trademark Office (number P200901942) [20], while the international with two platforms, the 90 measurements were repeated 4 times thus obtaining a
expansion was carried out in 2010 (PCT/ES2010/000401). total of 360 observations.

Fig. 1. Graphical and numerical representations of the loads applied to the crutches through the Moteview instrumentation program 2.0.
566 G. Chamorro Moriana et al. / Gait & Posture 37 (2013) 564–569

The observed loads were variable (from 2.26 kg to 31.16 kg), since the subjects
were not given specific guidelines on the amount of weight-bearing to be applied to
the crutches during aided walking. Therefore, this was considered a probability
sampling.
Participants were selected in a non-probabilistic and convenience sampling.In-
clusion criteria
- Healthy subjects between 18 and 60 years of age with previous experience with
crutches.
- Presenting a normal gait, being asymptomatic at free cadence walking.
- Overcoming a simple test of static equilibrium, which consisted of maintaining
one’s balance for 30 s on each foot without major body movements [22].

Exclusion criteria for participants


- Those having an evident general coordination disorder and physical ability which
might distort the aided walking.

The subjects were informed about the study orally and signed a written consent
form.

2.5. Measurement of variables and data collection

Measurements made by the two systems during aided gait were calculated
simultaneously and under the same conditions. After a period of training and
familiarization of the gait requested from the participants, they performed a route
of 8.5 m, 10 times with each crutch. The aided gait with partial weight-bearing was
on two points, with a contra-lateral crutch and simultaneous heel and crutch
support (Fig. 2). The height of the crutch selected is the one that elbow flexion from
208 to 308 produces [23,24]. The required speed was free cadence. The force applied
was selected by the patient in order to achieve heterogeneous load amounts,
provided that the correct technical gait gesture was respected.
The platforms were located half way along the route, parallel and spaced 40 cm
from each other. Thus, the subject walked in a straight line, stepping between the
plates and leaning the crutch on the platform on the same side. Signs were placed
along the center of the aisle, thus preventing subjects to focus their attention on the
platforms so as to make the crutch coincide on some of them (Fig. 3).
Data collection was carried out on 10 occasions with the right crutch and 10
more with the left one. The three valid central measurements of each crutch on each
platform were taken to do the statistical analysis. The software used was Moteview
Fig. 3. Gait aisle with force platforms.
2.0 for the GCH System 1.0 and Vicon Nexus for the AMTI platform, controlled by
Source: own.
two researchers who recorded and exported the applied loads when a crutch
coincided with a platform. Later, they recorded the time and the reference of that
support so as to correlate the data from both software in time.
2.6. Statistical analysis

The data obtained were organized and analyzed with SPSS 17.0 pack. The intra-
class correlation coefficient (R) was used to develop the concordance analysis, as the
variables are quantitative. The Landis and Koch classification [25] was used to
interpret them. R  0.70 was considered to be sufficient for good reproducibility of
the method [25]. 4R was obtained on comparing each of the two crutches with each
of the two platforms. A two-factor alpha model and mixed effects with absolute
agreement were used. Confidence intervals were 95%.
The analysis was complemented graphically with Bland and Altman representa-
tions [26], showing the limits of concordance. In addition, the mean difference and
confidence interval at 95% were calculated to demonstrate the magnitude of the
differences found.
We concluded the analysis with a linear regression analysis between the mean
values of the two measurements and the differences between measurements,
taking the latter as the dependent variable. We consider that significant levels
below 5% indicate a tendency for the difference between measurements to vary
over the range of measurement.

3. Results

We tackled the exploratory analysis (Table 1) of the data


obtained from the variables: GCH-right, GCH-left platform 1,
platform 2 and difference (platform 1 minus GCH-right, platform 1
minus GCH left, platform 2 minus GCH right and platform 2 minus
GCH left). The values of robust M-estimators: Huber-M Estimator,
Biweight–Tukey, Hampel M-Estimator and Andrews Wave, were
calculated for differences. The results obtained were within the
confidence interval for the average at 95%.
R has values above 0.99 in all cases in the concordance analysis,
with a significance level of p < 0.001, which shows a high level of
agreement between the measurements of both tools. The Bland
Fig. 2. Aided walking with simultaneous support of the heel and stick. and Altman graphs which illustrate the degree of concordance
Source: own. between these pairs of measurements are presented in Fig. 4.
G. Chamorro Moriana et al. / Gait & Posture 37 (2013) 564–569 567

Table 1
Descriptive analysis of the GCH, Platform and difference variables.

Variables Measuring Instrument that Mean 95% confidence interval SD Minimum Maximum
instrument exerts the vertical for mean
reaction force
Lower bound Upper bound

Vertical reaction force of the RIGHT_GCH PLAT. 1 11.51 10.31 12.72 5.76 2.9 26.97
platform on the crutch (GCH) (kg) RIGHT_GCH PLAT. 2 11.75 10.51 12.99 5.91 2.5 28.26
LEFT_GCH PLAT. 1 10.71 9.72 11.69 4.72 2.26 22.4
LEFT_GCH PLAT. 2 11.96 10.76 13.17 5.76 2.66 30.78

Vertical reaction force of the PLAT. 1 RIGHT_GCH 11.76 10.56 12.97 5.74 3.51 26.26
crutches on the platform PLAT. 1 LEFT_GCH 10.95 9.96 11.95 4.75 2.69 22.59
(PLATFORM) (kg) PLAT. 2 RIGHT_GCH 11.87 10.64 13.1 5.86 2.79 28.1
PLAT. 2 LEFT_GCH 12.1 10.88 13.31 5.79 2.77 31.16

Difference (kg) PLAT. 1 –RIGHT-GCH 0.25 0.14 0.36 0.51 0.92 1.02
PLAT. 1 – LEFT-GCH 0.25 0.13 0.36 0.54 1.00 1.01
PLAT. 2 –RIGHT-GCH 0.12 0.01 0.23 0.53 0.97 0.98
PLAT. 2 – LEFT-GCH 0.13 0.03 0.28 0.49 0.99 0.99

Finally, the analysis by linear regression between the mean [11,18], also designed and validated measurement systems for gait
values of both measurements and the differences between the analysis by comparing them with a validated force platform.
measurements showed that, in no case, did a significance level Our concordance study between measurement methods,
reach less than 5%. determined that there was broad agreement between the
observations made in said tools (R = 0.99, with a significance of
4. Discussion p < 0.001). However, even with satisfactory results, we were
forced to accept small alterations in the measurements of
4.1. The validity and reliability of GCH System 1.0 platforms which were due to slight interferences caused by the
absence of a filter in data recording as well as a precise failure in the
In agreement with Ruiz and Morillo [21], we compared both zero offset.
measurement techniques: GCH System 1.0 and AMTI force This study, according to Ruiz Morales and Morillo Zárate [21],
platform. Isakov [6], Hausdorff et al. [11] and Tveit and Karrholm allowed us to check the reliability of our system and qualify it so as

Fig. 4. Bland and Altman graph. Ordenate axis: difference between each pair of measurements (those made with GCH System 1.0 compared to those obtained with the force
platform). Abscissa axis: mean that corresponds to that pair of measurements. Dashed line: horizontal line that represents the mean value of differences. Superior and inferior
lines: concordance limits [mean difference  (1.96  SD)]. Absolute concordance was represented by a horizontal line on the value 0 in the ordenate-axis.
568 G. Chamorro Moriana et al. / Gait & Posture 37 (2013) 564–569

to replace the old one if appropriate, given its economic treatment is avoided in this way [5,7,8], which gives rise to a
advantages, transportability and ease of handling, its greater greater duration. Error reduction in loads [2,4,6] thanks to the LHC,
functionality, etc. Favorable aspects that authors such as Sanchez will lead to shorter duration and reduction in relapses and sequels,
et al., Ebert et al., Hausdorff et al. and Isakov [6,11,13,27] endorse. which will lead to a reduction in healthcare costs and working,
The adaptation of GCH System 1.0 is intended for the Canadian social and family inactivity [30].
crutch as it is the most widely used orthopedic medium by patients
with musculoskeletal disorders that require partial weight-bearing 5. Conclusions
gait [1,3]. On the other hand, we decided to do the aided gait in two
movements with the support of crutch and support of the foot of GCH System 1.0 constitutes a valid and reliable instrument for
the affected side simultaneously, since the reduction of the measuring the loads exerted on Canadian crutches used during
strength of vertical ground reaction is more effective [24]. In terms aided walking. The concordance study with the validated AMTI OR6 -
of quantity and objectivity of the applied loads, our Measurement 7-2000 force platform carried out in aided walking dynamics
System allows us to obtain data on the amount of mass applied on condition determined the effectiveness of the new System with
the crutches, graphically and numerically, such as the monitored computerized records, analysis and graphical display of data as well
force platforms designed by Isakov [6]. These real-time numerical as incorporating an acoustic and visual biofeedback mechanism.
results can be archived and exported to an excel file, thus allowing
comparative analysis between different patient’s records and Acknowledgements
actions, while objectively checking their evolution in relation to
the gait. According to authors such as Hershko et al. and Buckley We would like to thank the Junta de Andalucı́a and Spanish
et al. [8,28], we managed to reduce the degree of subjectivity of the Telephone Company Chair ‘‘Intelligence in the Network’’ for
evaluator. In addition, the biofeedback mechanism is able to funding for our study. Likewise, we are grateful for the cooperation
quantitatively graduate the requested load ranges with an of the Department of Physiotherapy, Department of Mechanics and
accuracy of up to 1 kg, an amount considered sufficient to achieve Electronics Technology Department at the University of Seville.
accurate and efficient training. According to previous studies
[6,12], and our experience with healthy subjects with excellent Conflict of interest
coordinative skills, experience with the use of crutches and
training of the exerted loads based on feedback, we found that they There is no conflict of interest between the authors.
were unable to control an exact load and maintain it for some time.
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