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New Device to Measure Cross-Sectional Areas and Segmental Volumes of Objects and Limbs

Taylor & Francis
Medical Devices: Evidence and Research
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Abstract and Figures

Purpose High accuracy volume measurements have important implications in different medical and non-medical situations. All methods used to date have challenges to achieve a usable clinical accuracy. Moreover, current methods have limitations to measure segmental volumes. We developed a new device that is able to measure a continuous profile of the cross-sectional areas along an object. Herewith the total volume of an object or any part of it are correspondingly determined. Methods The Peracutus Aqua Meth (PAM) generates continuous profiles of cross-sectional areas. Water is pumped in or out of a measuring unit at a nearly fixed flow rate and the speed of the water level (dh/dt) is measured continuously using a pressure sensor at the bottom. The change of the water level is a measure for the cross-sectional area of an object at any height. Signal processing is required to obtain valuable measurements. Three static objects and an arm of a test object were measured to demonstrate the accuracy and repeatability of the new device. Results Cross-sectional areas of a PVC pipe obtained with the PAM and with a caliper were compared. The differences between the two methods were less than 1.3%. Volume measurements of two mannequin arms show standard deviations of 0.37% and 0.34%, respectively, whereas the standard deviation of the volume measurement of a genuine arm was only 1.07%. These figures surpass reported clinical accuracy. Conclusion The new device demonstrates that determining the cross-section and its volumes of objects is possible in an accurate, reliable, and objective way. The results show that segmental volume measurements of human limbs are possible. Application in clinical and non-clinical situations seems meaningful.
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ORIGINAL RESEARCH
New Device to Measure Cross-Sectional Areas
and Segmental Volumes of Objects and Limbs
Frans Houwen
1
, Johannes Stemkens
2
, Don van Sonsbeek
3
, Robby van Sonsbeek
3
,
René van der Hulst
4
, Herman van Langen
5
1
Peracutus B.V., Kronenberg, the Netherlands;
2
Stemkens.Com B.V., Roggel, the Netherlands;
3
D-Sight B.V., Maastricht, the Netherlands;
4
Department of Plastic and Reconstructive Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands;
5
Department of Medical
Physics and Devices, VieCuri Medical Centre, Venlo, the Netherlands
Correspondence: Frans Houwen, Peracutus B.V., Peelstraat 4a, Kronenberg, 5976 NL, the Netherlands, Tel +31-650234240,
Email frans.houwen@peracutus.com
Purpose: High accuracy volume measurements have important implications in different medical and non-medical situations. All
methods used to date have challenges to achieve a usable clinical accuracy. Moreover, current methods have limitations to measure
segmental volumes. We developed a new device that is able to measure a continuous prole of the cross-sectional areas along an
object. Herewith the total volume of an object or any part of it are correspondingly determined.
Methods: The Peracutus Aqua Meth (PAM) generates continuous proles of cross-sectional areas. Water is pumped in or out of
a measuring unit at a nearly xed ow rate and the speed of the water level (dh/dt) is measured continuously using a pressure sensor at
the bottom. The change of the water level is a measure for the cross-sectional area of an object at any height. Signal processing is
required to obtain valuable measurements. Three static objects and an arm of a test object were measured to demonstrate the accuracy
and repeatability of the new device.
Results: Cross-sectional areas of a PVC pipe obtained with the PAM and with a caliper were compared. The differences between the
two methods were less than 1.3%. Volume measurements of two mannequin arms show standard deviations of 0.37% and 0.34%,
respectively, whereas the standard deviation of the volume measurement of a genuine arm was only 1.07%. These gures surpass
reported clinical accuracy.
Conclusion: The new device demonstrates that determining the cross-section and its volumes of objects is possible in an accurate,
reliable, and objective way. The results show that segmental volume measurements of human limbs are possible. Application in
clinical and non-clinical situations seems meaningful.
Keywords: volumetric, continuous prole, local volume, usable accuracy, objective
Introduction
High accuracy volume measurements have important implications in different situations. This holds for clinical
environments, sport sciences, and technical/industrial environments. Observing changes in (local) limb volume is often
difcult as increments and decrements are small and long treatment or exercising periods are needed for signicant
changes.
The measurement of limb volume with high precision is important for early detection of peripheral uid build-up
indicating, eg, starting edemas
1–3
or examination of increased or decreased muscle mass.
4–6
Further, during the treatment
of edemic patients by manual massage or recovering from an operation, it is extremely important to measure changes in
volumes in order to follow the impact of the treatment.
2,7,8
Because possible uid accumulation may move from one part
of the limb to another part, local changes in volume, ie, a precise segmental analysis, can help to monitor the treatment
appropriately. The same applies to the evolution of muscle recovery after limb fracture, a period of injury of a top athlete
or for the assessment of the effectivity and utility of the applied strength of a training program.
5,6,9–14
Also, accurate limb
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Medical Devices: Evidence and Research Dovepress
open access to scientific and medical research
Open Access Full Text Article
Received: 11 December 2022
Accepted: 23 March 2023
Published: 20 April 2023
volume and cross-sectional area measurement is important when taking measures for, eg, compression garments and
tools used in rehabilitation, and for the development of, eg, space suits.
15–17
Although volumetric measurement is important, there are challenges related to the different techniques used.
12,18–21
A measuring method should be reliable, valid, convenient, non-invasive, quick, accurate, operator independent, easy to
use, objective, and economically advantageous.
3,6,7,22–25
In this paper we describe a measuring device, the Peracutus Aqua Meth (PAM, Peracutus B.V.), for measuring
volumes of differently shaped objects. A detailed technical description of the PAM and of the measuring principle are
presented for this new volumetric device. The PAM utilizes water for the measurement, but it does not make use of water
displacement. Instead, a cross-sectional area is determined continuously along the length of a limb/object, resulting in
a prole of cross-sectional areas. The prole enables the determination of the volume of any chosen segment of the limb/
object.
The rst prototype of the device was evaluated by measuring arms of healthy volunteers.
26
Materials and Methods
Measurement Principle
An object is placed vertically in a cylinder and during lling or emptying of the cylinder, the height of the water column
in the cylinder is measured continuously using a pressure sensor on the bottom. Water is pumped at a nearly xed ow
rate and therefore the change of the water level is a measure for the cross-sectional area of the object at a certain height.
More specically, the cross-sectional area of an object at any height is assessed by determining the speed of the water
level (dh/dt) as function of the height (h). Thus, in the presence of an object, the following calculation for the cross-
sectional area (A) for each height applies
and, taking the calibration into account,
which results into
Signal Processing and Outcome
Measurement signals are processed by a state-of-the-art Analog/Digital Converter (ADC type AD7730BRZ, Elco Jacobs
B.V. Eindhoven, The Netherlands). The pressure is measured with a sample frequency of 200 Hz. Then, the signal is
ltered against noise (Butterworth lter) resulting in a net sample frequency of 20 Hz. The digital resolution of the
pressure signal is 7,064 points per mm water column. The ltered signal is sent to a Microsoft Excel le for additional
data processing. Due to mechanical vibrations which are not intercepted by the ADC-ltering, resonance effects occur
and a second lter, a moving average of 10 samples, is applied to render a smoother graph.
Each set of two subsequent results (measuring points) is processed and a prole of cross-sectional areas is derived. At
each height the thickness of the cylinder slice depends on the local cross-sectional area of the object. Furthermore, the
volume of a slice is approximated by the derivation A_Object * dh (slice). For A_Object, the averages of the slice start
and slice end values are applied. The total volume of a selected segment is calculated very accurately by integration
between any two chosen positions on the object, applying linear interpolation within the rst and last slices.
Peracutus Aqua Meth
The Peracutus Aqua Meth consists of a storage tank and a cylindrical measuring unit (200 mm x 1,000 mm) (Figure 1).
The storage tank is provided with two capacitive level switches and a temperature sensor, ensuring enough pre-warmed
water for three measurements. Water is pumped using a exible impeller pump (Combistar 2000 A, ZUWA-Zumpe
GmbH, Laufen, Germany) from the pre-warmed (30°C ± 1°C) storage tank via silicon and hydraulic tubing and two
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three-way valves into the measuring unit. The pump is 3-phase alternating current fed and is regulated by frequency in
terms of percentage of maximum turn frequency. The heater in the storage tank is a typical washing machine heater, 230
V and 1,950 W. All other components are electrically fed using weak current. The system is controlled by LabVIEW
(National Instruments). A safety transformer (Weseman 1 phase medical transformer) is used in order to prevent
electrical currents on the object.
First, the measuring unit is lled upwards till a capacitive level switch at the bottom of the measuring unit (switch 4),
and the pressure (height) is set to zero (calibration level). Then, data acquisition starts while pumping water in the
measuring unit with a nearly xed ow rate of 0.35 dm
3
per second till a predetermined height regulated by the upper
capacitive level switch (switch 3). The water is then almost immediately pumped out and the second data acquisition
starts. Both measurements take about 1 minute. The water leaves the system via three-way valve 1 to the drain. Emptying
the storage tank occurs via valve 2. Water is not reused.
During lling and emptying of the measuring unit, the height of the water column is measured using a pressure sensor
(Sendosensor SS115, Elco Jacobs B.V. Eindhoven, The Netherlands) at the bottom of the cylinder.
Detrimental inuence on the pressure signal is minimized by applying ow diffusing geometry: outgoing water is
conducted to the perimeter of the measuring unit, declining the ow velocity and leading the water away from the sensor.
In order to validate the measuring system, proles of cross-sectional areas of a piece of PVC pipe, the arms of two
mannequins, and the arm of a voluntary test object were determined. Data acquisition for the current study was only done
while emptying the cylinder.
System Characteristic
The speed of the water level (dh/dt) corresponds to the number of resolution points per measurement sample. The relation
between dh/dt and h, ie, the system characteristic, in the measuring unit without an object is not constant nor linear and is
depending on the outlet height of the water, container and piping geometry, temperature of the water, and pump
characteristics. Therefore, a calibration is needed to determine the characteristic curve for the measuring system.
Statistics
Descriptive statistics were applied to determine means and standard deviations of the measurements.
Level Switch 1
Minimum Water Level for
Heating and Measurement
Digital in
Level Switch 2
Digital in
Level Switch 3
Digital in
Level Switch 4
Calibration
Digital in
Pressure Senso
r
A
nalog in
Temperature Senso
r
A
nalog in
Waste Waste
Valve 1
Digital ou
t
Heater
Digital ou
t
Impeller
Pump
Digital out 2
x
Measuring Unit
Storage Tank
Valve 2
Digital ou
Figure 1 A schematic presentation of the Peracutus Aqua Meth.
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Availability of Data
The data that support the ndings of this study are available from the corresponding author, FH, upon reasonable request.
Results
Before measuring an object, the system curve (system characteristic) is determined without an object present, while
pumping water out of the measuring unit in about 1 minute. The system curve is not completely equal over the full range
of water levels. The system curve depends amongst others on the counter pressure in the pump, caused by the discharge
height of the water column and the resistance of the water in the tubing. The ratio between highest and lowest values was
less than 5% over the full range of water levels. Increased counter pressure results in a downward shift of an object
prole. Further, a downward shift of 0.5 cm
2
was measured per °C increase in temperature (not shown).
The system curve is appropriately described by a second degree polynomial dh = ah
2
+ bh + c (dh: resolution points;
h: cm). For the measurement of the piece of PVC pipe the system curve was determined from a series of ve
measurements. At 30°C the curve was described by dh = 0.0045 h
2
2.975 h 4,828.4. Converted to cross-sectional
area the signal carries a noise level of only approximately 0.5 cm
2
. This curve was also used to evaluate the
measurements on the arm of a voluntary test subject. As a result of adjustments in the measurement unit the system
curve was repeated before measurements of the mannequin arms. It was described by dh = 0.0176 h
2
4.6343 h
4,961.2, based on a series of six measurements. During the measurements the system characteristics are regarded as
invariable.
A static PVC pipe with a cross-sectional area (diameter) of approximately 75 mm upon which a PVC socket and a cap
were present was measured both with the PAM and with a caliper. Figure 2 shows the prole of cross-sectional areas of
the pipe. Although the measurement is based on vertical movement of the water the position on the cylinder is presented
on the horizontal axis; the corresponding cross-sectional areas are presented on the vertical axis. As the measurement, ie,
data acquisition, was carried out by pumping water out of the measuring unit (cylinder), the time lapse is from right to
left in the Figure. From the top of the pipe (right) to position 32 cm (A) cross-sectional areas of 44.2 cm
2
were measured,
with a noise level of approximately 0.5 cm
2
as was seen with the system curve.
The socket on the pipe with a ring at both edges is observed between positions 32 and 23 cm. Then, between position
23 and 5 cm again cross-sectional areas of 44.2 cm
2
were observed, interrupted by some dips and peaks (H) which were
caused by moving the pipe three times downwards and upwards. The response of the system was fast. As expected, the
Figure 2 Prole of cross-sectional areas of a PVC pipe with socket and cap. Remarkable features in the graph are indicated (see text and Table 1 and Table 2).
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dynamic intervention resulted in uctuations in the graph, though the integral over the specic length of the tube (prole)
did not change. Finally, the tube cover is seen in the graph between positions 5 and 1 cm.
Cross-sectional areas obtained with the PAM and calculated areas from diameter measurements with a caliper were
nearly equal (Table 1). As abrupt discontinuities were present on the object possible overshoot of signals, ie, the
minimum/maximum peak value of the signal, was assessed. At three out of ve positions the signal overshoot could
be calculated (Table 2). However, the additional cross-sectional areas of about 20 cm
2
(B) and 12 cm
2
(E), respectively,
of both small rings on the socket, were not wide enough to let the signal settle to its stable level and overshoot could not
be quantied.
The overall lter settings as applied enables an absolute measurement of cross-sectional areas with an accuracy of less
than 1 cm
2
.
The same lter settings were then applied to measure arms of two mannequins, 10 times each, statically xed in the
measuring unit. The proles of cross-sectional areas as a function of the height, ie, the position in the cylinder and thus
on the xed arm, are shown in Figure 3. The measurements were carried out by pumping water out of the measuring unit
(cylinder), and therefore the time lapse in fact is from right to left in the gure. However, the graphs are described
starting at the bottom of the cylinder (left), showing rst the nger, hand, and the rest of the arm.
The rst part of the graphs represent the no-object-zones, which in these examples are approximately between 0
(calibration level) and 8 cm and 0 and 13 cm in the cylinder, respectively. Between these positions, the noise was again
Table 1 Comparison of Cross-Sectional Areas Measured with the
PAM and with a Caliper
Range (cm) Cross-Sectional Area (cm
2
) Delta
PAM Caliper
a
(cm
2
) %
A 63–32 44.46 44.10 (0.17) 0.36 0.8
D 28–25 52.05 52.27 (0.11) 0.22 0.4
G 10–5 44.48 44.22 (0.24) 0.26 0.6
H
b b b b b
J 2.8–1.6 48.51 49.14 (0.20) 0.63 1.3
Notes:
a
Calculated from mean of three diameter measurements; segment A was
measured at three positions (a total of nine measurements). The corresponding
standard deviations are shown in parentheses.
b
Not applicable.
Table 2 Overshoot of Signals Due to Abrupt Discontinuities on the
Object
Position
(cm)
Cross-Sectional Area
(cm
2
)
Signal Overshoot
PAM Caliper
a
(cm
2
)
c
%
d
B 30.2 64.78 64.40
b b
C 28.7 50.53 52.27 1.74 14.3
E 22.8 64.13 64.28
b b
F 21.1 42.50 44.20 1.70 8.5
I 3.4 49.65 49.14 0.51 10.4
Notes:
a
Calculated from mean of three diameter measurements.
b
Not applicable.
c
Delta between the peak value minus the actual value.
d
Delta between the peak value
minus the actual value, relative to the step value.
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approximately 0.5 cm
2
. The arms were about 53 and 58 cm in the water column, and the maximum cross-sectional areas
of the upper arms were around 83 and 48 cm
2
, respectively.
The values in the no-object zones were slightly above the x-axis during the measurements; this must have derived
from differences in system characteristics between the measurements and determining the system curve.
Mannequin arm volumes were then calculated by integration between two chosen positions on the measuring unit
(Table 3). Percentage standard deviations for volume determinations were around only 0.35%.
Both mannequin arms measured do not have any abrupt discontinuities and the impact of signal overshoot is
considered negligable.
A nal set of measurements was performed on the left arm of a voluntary test subject. The proles of ten
consecutive measurements are presented in Figure 4. After each measurement the volunteer got up and put her
arm back in the measuring unit. The ten measurements took a total of about 40 minutes. Obviously, the arm was
not every time at exactly the same position (depth) in the measuring unit. All proles were therefore aligned by
setting the nger tips of all proles at 0. The arm volume was then calculated between positions 0 and 55 cm.
The mean arm volume based on the ten measurements was 2,319 cm
3
with a standard deviation of
24.90 cm
3
(1.07%).
Under the conditions used the method results in a nearly continuous measurement. The thickness of each measured
slice depends on the local cross-sectional area of the arm (see Materials and Method section). During the measurements,
the nearly constant ow of the descending water was 0.35 dm
3
/s. Having a tube internal diameter of 189.4 mm
Figure 3 Proles of cross-sectional areas of arms of two mannequins. Only the rst of 10 measured proles are presented.
Table 3 Calculated Mean Volumes Between Two Chosen Positions of
Arms 1 and 2
Part of the Arm
(Position in cm)
Mean Volume
(mL)
Range
(mL)*
Standard
Deviation
(mL) %
Arm 1 12.6–66.0 2393.1 32.09 8.90 0.37
Arm 2 8.0–66.0 1621.4 17.11 5.47 0.34
Note: *Difference between the largest and smallest values.
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(measuring unit) and a sample frequency of 20 Hz, slice thicknesses were between 0.7 mm at the ngertip to 1.1 mm at
a cross-sectional area of 83 cm
2
.
Discussion
Several different measuring principles are used to determine the volume of a limb or an object.
6
Water displacement with
overow is often regarded as the gold standard, mostly based on its repeatability.
1,27
With the PAM we introduce a new
volumetric method using water without displacement and overow, in which water movement determined with a pressure
sensor poses as a core element. The measuring principle is based on the local cross-sectional area in a container with an
object and the corresponding change in water surface level.
The system curve, which is measured in the absence of an object, is not linear nor constant. Different system curves
are obtained mainly due to moving and setting up the device, whereby the outlet height of the water is especially
important as it inuences the counter pressure in the pump. Further, the temperature of the water may be a changing
variable. The frequency needed for determining the system characteristic will in the end be depending on the robustness
of the measuring system (contamination, wear of components, etc.).
Measurements with the PAM appear to be very accurate and repeatable. Cross-sectional area proles are obtained and
volumes calculated. Three static objects, a PVC pipe, and two mannequin arms were measured as examples; percentage
standard deviations being around 0.35% for the arms. This is in accordance with or better than values found by others
using static objects for volume measurements.
6,25,28–30
Measuring the arm of a test person resulted in a standard deviation
of only 1.07% (Figure 4). This shows that also measuring limbs with the PAM can be done very accurately.
Current techniques to determine volumes locally are water displacement, girth, and caliper measurements, MRI
imaging, X-ray tomography, ultrasound, and three dimensional imaging.
21,31–34
The distance between girth measure-
ments on a limb determines the length of the segment that is used in the calculation of geometric volume. This segment
length has not been standardized,
18
and varies from 1 cm,
6
3 cm,
27,35–37
4 cm,
6,20,25,28,38–43
5 cm
44
to 10 cm and more
and in between.
14,18,44–49
The Perometer measures a change in volume every 2.54–4.7 mm.
8,21,28,42,50,51
In contrast, the
slice thickness using the PAM is 1.1 mm or less measuring an arm. This enables extreme local volume determination.
Standard methods, as well as techniques in development like three dimensional imaging, are becoming more and
more suitable for clinical applications. Results obtained with the PAM are currently equal or more accurate, though
compared to the different shape-capture methods. Moreover, there is no clinical learning curve involved for using the
PAM and costs are very low.
23,24,32–34
Figure 4 Ten proles of cross-sectional areas of the left arm of a voluntary test subject. The proles have been aligned by setting the nger tips of all proles at 0.
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Determining (local) volumes with the girth, caliper, the Perometer, and three dimensional imaging require geometric
formulas to evaluate raw data.
12,20,37,52–54
In contrast, no geometric volume formulas are used to process the data
obtained with the PAM; the measurement is shape-independent.
Abrupt discontinuities on an object cause small overshoots of the signal (Figure 2 and Table 2). These dips and peaks
in a prole can be completely prevented by reducing the ow rate. No or hardly any overshoot was observed while
measuring the mannequin arms and the arm of a test person (Figures 3 and 4), showing that the PAM is suitable for
accurate measurements of human limbs.
Results obtained with the PAM are digitally available, enabling an easy comparison with measurements done at
different times. Moreover, important anatomical positions like nger tips, wrist, elbow, and upper arm can be marked. In
current practice this is usually problematic and results obtained with different measuring methods, eg, girth, Bravometer,
and 3D-imaging, are not interchangeable and the absolute values remain unknown. The anatomic markers present in the
PAM proles can be used to align the proles of different measurements and to compare specic segments (intervals in
the proles) of the limb.
20
Obtaining exact proles with the PAM is sensitive to the extent to which the ngers are stretched during the
measurement, which may lead to wrong conclusions. This can largely be overcome by the introduction of a newly-
dened anatomic parameter (Houwen et al, Segmental limb proles of cross-sectional area determination of test subjects.
In preparation).
Evidence obtained so far shows the possibility of using the PAM in different applications like health care, sport
sciences and technical/industrial environments to measure local volumes.
Conclusion
The PAM measures the speed of the water level (dh/dt) at any height using a pressure sensor. The data are converted to
continuous proles of cross-sectional areas with a high accuracy and repeatability. No geometric formulas are needed to
process data and therefore accurate volumes are obtained of an object or any segment thereof.
Slices with a height of 1.1 mm or less are easily achieved, enabling a high resolution with respect to differences in
cross-sectional area. As no abrupt discontinuities are present on a human limb the PAM is suited to determine segmental
as well as total volumes of limbs.
The PAM achieves usable accuracy in clinical and non-clinical environments.
Acknowledgments
The authors thank José Coenen for acting as a voluntary test subject. Greg Czerwinski is highly acknowledged for his
valuable support in the early phase of this work.
Disclosure
FH is owner of Peracutus B.V. This company is developing a medical device to assess (local) volume changes in limbs
and other objects. DvS is closely related to Peracutus B.V whereas J.S. was co-owner of Peracutus B.V. This research
received no specic grant from any funding agency in the public, commercial or not-for-prot sectors. Dr Frans Houwen
has a patent EP3128910B1 issued to Peracutus Holding B.V., and a patent US10895453B2 issued to Peracutus Holding
B.V. The authors report no other conicts of interest in this work.
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Article
Full-text available
This study constitutes the first attempt to systematically quantify residual limb volume fluctuations in transfemoral amputees. The study was carried out on 24 amputees to investigate variations due to prosthesis doffing, physical activity, and testing time. A proper experimental set-up was designed, including a 3D optical scanner to improve precision and acceptability by amputees. The first test session aimed at measuring residual limb volume at 7 time-points, with 10 min intervals, after prosthesis doffing. This allowed for evaluating the time required for volume stabilization after prosthesis removal, for each amputee. In subsequent sessions, 16 residual limb scans in a day for each amputee were captured to evaluate volume fluctuations due to prosthesis removal and physical activity, in two times per day (morning and afternoon). These measurements were repeated in three different days, a week apart from each other, for a total of 48 scans for each amputee. Volume fluctuations over time after prosthesis doffing showed a two-term decay exponential trend (R ² = 0.97), with the highest variation in the initial 10 min and an average stabilization time of 30 min. A statistically significant increase in residual limb volume following both prosthesis removal and physical activity was verified. No differences were observed between measures collected in the morning and in the afternoon. Clinical Trials.gov ID: NCT04709367.
Article
Full-text available
Background: Measuring lymphedema with high accuracy is important for several reasons. The aim of this study was to assess the reliability and validity of three routinely used methods to estimate limb volumes. Methods and Results: Inverse water displacement, girth measurements, and Perometer measurements were executed. Although standard techniques were used, extra precautions were taken to maximize accuracy within and between observers. Water displacement, and girth and Perometer measurements resulted in standard deviations of 0.7%-0.8%, 0.5%, and 0.4%-1.0%, respectively. Conclusion: Measuring limb volumes using routine methods is not easy. Even under optimal conditions, the measurements are quite dependent on the observer. For practical situations, an easy, objective, and reliable method is lacking.
Article
Full-text available
Background: The swelling of the extremities seen in lymphedema can be measured with many different volumetric devices; however, many methods lack important characteristics including reproducibility and independence from the subjectivity and skill of the operator. The aim of this study was to validate the use of the Perometer® as a possible standard for volumetric measurement methods based on the inter-observer and intra-observer variability when using a standard method of Perometry®. Methods and Results: Volumetric measurements were performed on 10 healthy test subjects by 5 individuals (the observers) who had been instructed in the measurement techniques to be used. The inter-observer variability was assessed by having the five observers measure all the test subjects both in the morning and in the early afternoon. The intra-observer variability was examined by having each observer measure all the 10 test subjects 4 times in a row in the aforementioned time frames. A data set was created using the measurements, allowing for the assessment of other parameters including variation of volume between the right and left leg and daily variation in swelling. Statistical measurements were performed using the Statistical Package for the Social Sciences (SPSS), from which it was determined that there was no statistically significant inter-observer (p-value 0.997) and intra-observer variation (p-value 0.995) based on a significance level of >5%. Furthermore, it was observed that a statistically significant difference in volume occurred in the leg volume during the day. Conclusion: It was concluded that the use of the Perometer provides consistent measurements of volume independent of the observer and therefore appears to provide a candidate standard for volumetric measurements.
Article
Introduction Plaster casting and manual rectification represent the benchmark prosthetic socket design method. 3D technologies have increasing potential for prosthetic limb design and fabrication, especially for enhancing access to these services in low-resource settings. However, the community has a responsibility to verify the efficacy of these new digital technologies. The motivation for this study was to establish benchmarking data to assess digital shape capture technologies, specifically for clinically relevant residual limb shape and landmark capture for limb survey and socket design. The objective was therefore to assess the repeatability of plaster casting in vivo and to compare this with three clinically used 3D scanners. Materials and Methods A comparative reliability assessment of casting and 3D scanning was conducted in 11 participants with established transtibial amputation. For each participant, two positive molds were cast by a prosthetist and digitized using a white-light 3D surface scanner. Between casts, each participant's residual limb was scanned. The deviation among scan volumes, cross-sections, and shapes was calculated. Results A total of 95% of the clinically relevant socket shape surface area had a deviation between manual casts of less than 2.87 mm (SD, 0.44 mm), and the average deviation was 0.18 mm (SD, 1.72 mm). The repeatability coefficient of casting was 46.1 ml (3.47%) for volume and 9.6 mm (3.53%) for perimeters. For all clinically meaningful measures, greater reliability was observed for the Omega scanner and worse for the Sense and iSense scanners, although it was observed that the Sense scanner performance was comparable to casting (95th percentile shape consistency). Conclusions This study provides a platform to appraise new clinical shape capture technologies in the context of best practice in manual plaster casting and starts the conversation of which 3D scanning devices are most appropriate for different types of clinical use. The methods and benchmark results may support prosthetists in acquiring and applying their clinical experience, as part of their continuing professional development.
Article
Background and objective: The paper presents a novel procedure based on 3D scanning and 3D modelling to automatically assess linear and volumetric measurements of an arm and to be further applied to patients affected by post breast cancer lymphedema. The aim is the creation of a virtual platform easily usable by medical personnel to get more objective evaluations during the lymphedema treatment. Methods: The procedure is based on the 3D scanning of the arm using the Occipital Structure Sensor and an ad-hoc developed application, named Lym 3DLab. Lym 3DLab emulates the traditional measurement methods, which consist in taking manual circumference measurements or using the water displacement method. These measurements are also used to design the compression stockings, the typical orthopaedic device used for lymphedema treatment. A validation test has been performed to compare the measurements computed by Lym 3DLab with both water displacement and manual circumference measurements. Eight volunteers have been involved who are not affected by lymphedema. Furthermore, a specific usability test has been performed to evaluate the 3D scanning procedure by involving four physiotherapists. Results: The comparison between the volumes has highlighted how all the 3D acquired models have their volumes inside a range of acceptability. This range has been defined by considering the sensitivity error of the tape measure used to measure the water displacement. The comparison between the perimeters of cross sections computed with Lym 3DLab and the circumference measurements has shown results that are very accurate with an average difference of 2 mm. The measure errors have been considered negligible by the medical personnel who have evaluated the proposed procedure more accurate than the traditional ones. The test with physiotherapists has shown a high level of usability of the whole virtual environment, but the 3D scanning procedure requires an appropriate training of the personnel to make the 3D acquisition as fast and efficient as possible. Conclusions: The achieved results and the physiotherapists' feedback allow planning a future test with patients affected by lymphedema in collaboration with the hospital. A further test has been planned to use the computed measurements to design orthopaedic compression stockings.
Article
Background: There are challenges related to the accurate and efficient measurement of lymphedema in people with breast cancer. The LymphaTech 3D Imaging System (LymphaTech, Atlanta, GA, USA) is a mobile, noninvasive platform that provides limb geometry measurements. Objective: The objective of this study was to estimate the reliability and validity of the LymphaTech for measuring arm volume in the context of women seeking care in a specialty breast cancer rehabilitation clinic. Design: This was a cross-sectional reliability and convergent validity study. Methods: People who had stage I to IV breast cancer with lymphedema or were at risk for it were included. Arm volume was measured in 66 participants using the LymphaTech and perometer methods. Test-retest reliability for a single measure, limb volume difference, and agreement between methods was analyzed for 30 participants. A method-comparison analysis was also used to assess convergent validity between methods. Results: Both LymphaTech and perometer methods displayed intraclass correlation coefficients (ICCs) of ≥0.99. The standard errors of measurement for the LymphaTech and length-matched perometer measurements were nearly identical. Similar intraclass correlation coefficients (0.97) and standard errors of measurement (38.0-40.7 mL) were obtained for the between-limb volume difference for both methods. The convergent validity analyses demonstrated no systematic difference between methods. Limitations: The sample size was not based on a formal sample size calculation. LymphaTech measurements included interrater variance, and perometer measurements contained intrarater variance. Conclusions: The LymphaTech had excellent test-retest reliability, and convergent validity was supported. This technology is efficient and portable and has a potential role in prospective surveillance and management of lymphedema in clinical, research, and home settings.
Article
Introduction In trans-tibial prosthetics, shape-capture methods are employed to create a representation of the residuum. Shape-capture methods can be grouped into the categories of ‘hands-on’, ‘hands-off’ and computer-aided design. Objective This review examines the influences and trends of shape-capture methods on the outcomes of quality, comfort of user and clinical efficiency, in the population of trans-tibial prosthesis users. Method Databases and relevant journals were searched. Participants Trans-tibial prosthetics users/limb models. Intervention Shape-capture methods. Outcomes Quality, comfort of user and clinical efficiency. Results Overall, 22 papers were evaluated; 8 papers evaluated hands-on and hands-off methods, 2 evaluated computer-aided design and 12 evaluated measurement systems used with shape capture. No papers relating to clinical efficiency were found. Discussion and Conclusion Overall evidence was weak in suggesting that effects on outcomes were due to the sole influences of shape capture. However, studies suggest that hands-on methods are dependent on a prosthetist’s skill. Hands-off methods, although repeatable, might still require experience to attain a good fit. Computer-aided design studies were mostly done on theoretical models. Shape-capture measurements require more consistent ‘gold standards’. The relation between socket fit and comfort is still unclear. Overall, more research is required in each area. Clinical relevance A good fitting prosthetic socket is crucial for efficient and comfortable use of a prosthesis. To attain the best chances of a good fit, it is important that the characteristics of the residuum are captured as accurately as possible during the initial “shape capture” stage. This paper attempts to categorize and evaluate the existing shape capture methods on their influence and trends on various outcomes - Quality of shape capture, comfort of user and clinical efficiency.
Article
Objective: To investigate the reliability, time efficiency and clinical feasibility of five commonly used methods for assessing excessive arm volume in patients with breast cancer-related lymphoedema (BCRL). Design: Cross-sectional study. Setting: University Hospitals Leuven, Belgium. Subjects: 30 participants with unilateral BCRL. Methods: Excessive arm volume was determined by five different methods: traditional volumetry with overflow, volumetry without overflow, inverse volumetry, optoelectronic volumetry and calculated volume based on circumference measurements. To investigate intra- and inter-rater reliability, measurements were performed twice by the same assessor and once by a different assessor. Intraclass correlation coefficients (ICCs), standard errors of the measurement (SEMs) and systematic changes between the means were calculated. To determine time efficiency, the mean setup time, execution time and total time were examined for each method. Furthermore, 12 limitations regarding clinical feasibility were listed and scored for each method. Finally, an overall ranking score was determined between the methods. Results: Mean age was 65 (±8) years and mean body mass index was 28 (±4) kg/m2. Intra- and inter-rater reliability ranged between strong and very strong. Calculated arm volume based on circumferences (mean excessive arm volume: assessor A: 477 (±367) mL; assessor B: 470 (±367) mL; assessor A (second time): 493 (±362) mL) showed the highest intra- and inter-rater ICCs of .987 and .984, respectively. Optoelectronic volumetry was the fastest method, representing a mean total time of 1 minute and 43 (±26) seconds for performing a bilateral measurement. The least limitations were reported on the calculated volume based on the circumference method (3 out of 12 limitations). Conclusion: Calculated volume based on arm circumferences is the best measurement method for evaluating excessive arm volume over time in terms of reliability, low error rate, low cost, few limitations and the time spent.
Article
BACKGROUND: Lymphedema is a chronic, progressive disease consisting of tissue swelling resulting from excessive retention of lymphatic fluid. Measuring upper limb volume is crucial in patients to detect disease progression and to study the effects of treatment. The aim is to assess the validity and reliability of a newly developed system, Peracutus Aqua Meth, for measuring the upper limb volume compared with the gold standard water volumetry device. (In this study, the Bravometer was used). METHODS AND RESULTS: Healthy volunteers were recruited in October 2017. Three measurements were performed per device. The obtained data were recorded per measurement, device, and researcher. Primary outcome was to determine the validity and reliability of the Peracutus Aqua Meth. Secondary outcomes were intra- and interrater reliability, measurement time, self-reported participant satisfaction, and influence of body mass index (BMI). Thirty-nine healthy volunteers were included. Mean differences in the validity in the Peracutus Aqua Meth and Bravometer were 47.26 and 78.16 mL, respectively (p = 0.04), with a Pearson's r of 0.99. Intra- and interrater reliability of the Peracutus Aqua Meth were both 0.99, in the Bravometer 0.96 and 0.97, respectively (p < 0.01). The Peracutus Aqua Meth required more time to measure and obtained lower scores in the participant satisfaction questionnaire. BMI was statistically associated with the measurements (p < 0.01). CONCLUSIONS: The first prototype of the Peracutus Aqua Meth is proven to be an accurate and reliable device for measuring the volume of the arm. Further improvements are needed in case of usability, time management, and participant satisfaction. KEYWORDS: lymphedema; reliability; validity; water displacement volumetry
Article
Background: In the past, measurement of upper limb lymphedema was done by water displacement (WD), which is frequently cited as the gold standard. For various reasons, however, the use of WD is restricted in clinical settings. A more precise and easy-to-use method would be favorable. The high precision of three-dimensional (3D) imaging in comparison to WD has already been reported for healthy subjects. The aim of this study is to determine the validity and reliability of 3D imaging by comparing it to the WD method in women with unilateral upper limb lymphedema. Methods and results: Thirty-nine women with unilateral breast cancer-related lymphedema (BCRL) were included, of which 37 completed two volume measurement techniques (3D and WD) on the BCRL and contralateral healthy arm. Slightly larger volumes were measured by the WD method in healthy arms (+9.8 mL; p = 0.058) and also in BCRL arms (+18.5 mL; p < 0.001). All measurements were performed twice by the same researcher to evaluate reliability. There was no significant difference between the two measurements for healthy arms (p = 0.323) or BCRL arms (p = 0.807) in 3D imaging. Bland-Altman plots showed a high limit of agreement between the single measurements. 3D imaging had a high intrarater reliability (Intraclass Correlation Coefficient = 0.999). Conclusion: Results show that 3D imaging is an innovative method for measuring upper limb volume in BCRL patients. Even though image processing is time consuming, 3D imaging combines high reproducibility with high precision. By software automation, this technique could easily be integrated into clinical routine. It is for this reason that we would recommend implementing the Vectra 3D imaging technique for measurement of BCRL.