74487 POI37510.1177/0309364612474487Prosthetics and Orthotics InternationalAzadinia et al.

INTERNATIONAL
SOCIETY FOR PROSTHETICS
AND ORTHOTICS

Original Research Report

Prosthetics and Orthotics International

The effects of two spinal orthoses 37(5) 404410

The International Society for
Prosthetics and Orthotics 2013
on balance in elderly people with Reprints and permissions:
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thoracic kyphosis DOI: 10.1177/0309364612474487
poi.sagepub.com

Fatemeh Azadinia1, Mojtaba Kamyab1, Hamid Behtash2,

Nader Maroufi3 and Bagher Larijani4

Abstract
Background: Hyperkyphosis increases the risk of falls for elderly people by reducing postural balance. Spinomed orthosis
and the posture-training support are two available options for improving postural balance but have never been compared.
Objectives: To compare the effect of the Spinomed orthosis and the posture-training support on balance in elderly people
with thoracic hyperkyphosis.
Study Design: This study is a clinical trial on an accessible sample of elderly people with thoracic kyphosis.
Method: Eighteen participants (16 women and 2 men), aged 6080 years, with thoracic kyphosis greater than
50, completed the study procedure. Subjects were randomly allocated to two groups, namely, Spinomed orthosis
and the posture-training support groups. Sensory organization test and limits of stability were assessed using the Eq-
uiTest system and the Balance Master system, respectively. Balance score, directional control, and reaction time were
measured to evaluate balance with and without orthosis in a random order.
Results: In the posture-training support group, significant changes were observed in the studied balance parameters: bal-
ance score (p < 0.001), directional control (p = 0.027), and reaction time (p = 0.047). There was a significant change in
balance score (p < 0.001) and directional control (p = 0.032) in the Spinomed group. However, there were no significant
differences in the effect of the two orthoses, the Spinomed orthosis and posture-training support, on balance factors.
Conclusion: Both Spinomed orthosis and posture-training support may improve balance in the elderly with thoracic
hyperkyphosis in a similar manner.

Clinical relevance
Despite the importance of falls suffered by elderly people, not much attention has been paid to balance improvement and fall
prevention while managing hyperkyphosis. This study evaluates the effect of the Spinomed orthosis and posture-training sup-
port on balance in hyperkyphotic elderly people. It provides some new insights into reducing the risk of falls for elderly people.

Keywords
Kyphosis, balance, orthosis

Date received: 25 July 2012; accepted: 17 December 2012

Background 1Department of Orthotics and Prosthetics, Faculty of Rehabilitation

Falling is one of the most important risks for elderly people
that may be associated with serious consequences.1 Studies
in the United States considered falling to be the sixth cause
of mortality in people older than 65 years.2 About 30% of
Sciences, Tehran University of Medical Sciences, Tehran, Iran
2Orthopedic Department, Rasoul Hospital, Tehran, Iran
3Department of Physical Therapy, Faculty of Rehabilitation Sciences,
Tehran University of Medical Sciences, Tehran, Iran
4Endocrine & Metabolism Research Center, Tehran University of

individuals aged over 65 years experience at least one fall Medical Sciences, Tehran, Iran
per year, and the condition requires medical care in 20% of
Corresponding author:
the cases.3,4
Mojtaba Kamyab, Department of Orthotics & Prosthetics, Faculty of
Postural stability, or balance, is the ability to maintain Rehabiliation Sciences, Tehran University of Medical Sciences, Tehran,
the center of mass (COM) within the limits of base of Iran.
support. The COM is equal to the center of total body mass Email: mojtaba.kamyab@gmail.com
Azadinia et al. 405
and is determined by finding the weighted average of the
COM of each body segment. Movement of COM outside
the limits of the base of support could result in postural
instability and loss of balance.5 Postural instability, which
increases with age,68 is one of the influencing factors of
falls.810 Changes in the spinal curve along with hyperky-
phosis are among the main factors leading to postural insta-
bility.8,11,12 Most often, natural kyphosis in the thoracic
spine increases with age.13 Excessive increase in this curva-
ture, also known as hyperkyphosis, is reported in 20%40%
of the elderly.14,15
Kyphotic posture may cause anterior displacement
of the COM and instigate the COM to be located out of
the limits of stability (LOS) in standing posture,8
thereby increasing the risk of falls by reducing postural
balance.8,12
Despite the importance of falls for elderly people, not
much attention has been paid to balance improvement and
fall prevention while treating hyperkyphosis. Using a spi-
nal orthosis is a modality in the treatment of hyperkyphosis
in the elderly. These orthoses help in improvement of bal-
ance and preventing falls1618 as well as correcting pos-
ture.16,1921 Pfeifer et al.16 showed that the use of the
Spinomed orthosis resulted in a decrease in COM sway and
subsequently improved balance in elderly women. Sinaki
and colleagues17,18 noted that using posture-training sup-
port (PTS) and getting involved in an exercise program can
improve balance and decrease the risk of falls. However, no
study has been carried out on the effect of PTS without an
program; therefore, the isolated role of this orthosis has
never been defined clearly. Although the Spinomed ortho-
sis and PTS are the two best known and the least invasive
orthotic management for correcting elderly peoples pos-
ture, with supporting studies to demonstrate their therapeu-
tic effects on strength of back muscles, posture correcting,
pain management, and improvement of balance,1618 there
have been no other studies to compare these two orthoses.
Therefore, this study aims to assess the effects of the
Spinomed orthosis and PTS without exercise program on
balance in the hyperkyphotic elderly population.
Materials and method
The subject population in this study taken as a sample com-
prised elderly persons between the ages of 60 and 80 years.
Subjects with thoracic hyperkyphosis were recruited from
nursing homes, orthopedic clinics, general practitioners,
and elderly support groups. A total sample size of 18 was
determined to be enough to provide an 80% power, after
carrying out a pilot study on 5 participants using each of the
two orthoses (total of 10 participants) and calculating the
standard deviation of the balance score, as the main out-
come measure. The balance score was considered in the
role of the main outcome measure as it is a common and
recommended criterion to evaluate the risk of falling,12,22,23
demonstrating an acceptable testretest reliability and pre-
dictive validity.24 Individuals with thoracic hyperkyphosis
(with Cobb angle greater than 50) on lateral spinal radio-
graphs capable of walking without assistive devices and of
standing independently for at least 2 min were included.
The exclusion criteria were as follows: alcohol or drug use
affecting balance or influencing central nervous system
(within 48 h before testing); history of neurogenic or myo-
pathic disorders impairing sensory or motor functions; sco-
liosis; any history of joint arthroplasty in lower limbs;
having visual and auditory disorders not correctable by
glasses or hearing aids; history of fracture or surgery of
spine or lower limbs within at least 1 year before the study;
history of participating in spinal balance exercises (within a
month before testing); and back or neck pain at the time of
examination reported to be higher than 3 on the Visual
Analogue Scale (VAS), because lower pain intensity on
VAS does not affect postural sway in patients.25 This study
was a single blinded clinical trial with a
convenience sample of 18 elderly persons with thoracic
hyperkyphosis. All the participants voluntarily signed an
informed consent form. The study procedure was approved
by the Ethics Committee of the institution in which the
study was conducted (Letter No. 221).
The immediate effect of wearing Spinomed orthosis and
the PTS on postural balance was evaluated in this study.
These two orthoses are the best known and least invasive
orthotic recommendation for dorsal kyphosis in elderly.26
The Spinomed orthosis consists of an abdominal pad;
posterior padded metal upright; and pelvic, waistline, and
shoulder straps. According to the manufacturers guideline,
the posterior padded metal upright extends cephally up to
the 15 cm under C7 and extends caudally down to the coc-
cygeal level.27 According to the patients spinal curvature,
the middle part of this metallic upright is shaped without
applying any heat; the pelvic, waistline, and shoulder straps
are also adjusted to fit the patients size. The orthosis
weighs approximately 450 g (Figure 1).
The PTS orthosis consists of a posterior bag, which is
1020 cm in length and 510 cm in width. The bag is placed
exactly under the inferior angle of the scapula.26,28 Three
110 g weights and a 440 g weight are placed in this bag.
The PTS in this study was provided by Trulife, and the
weights were adjusted according to the recommendations
in the guideline of Sinakis28 patent (Figure 2).
Both of the orthoses were fitted on the participants by
a certified orthotist who adjusted the straps with the
same tension in all participants. Balance assessment in
this study was performed by scores of sensory organiza-
tion test (SOT) and the LOS test. A SOT was performed
using the NeuroCom EquiTest system according to the
manufacturers protocol.29 The system consists of two
force plates, placed parallel to each other and connected
by a pin joint and delimited by a visual surround in three
directions (front, left, and right) as follows:
406 Prosthetics and Orthotics International 37(5)
Figure 1. The Spinomed orthosis consists of an abdominal
pad; posterior padded metal upright; and pelvic, waistline, and
shoulder straps. The posterior padded metal upright extends
cephally up to the 15 cm under C7 and extends caudally down
to the coccygeal level.
The two force plates are supported by four force transducers
established symmetrically on a supporting plate. A fifth
transducer is bracketed to the center plate directly beneath
the pin joint.29
The load cells in the force plates transmit force informa-
tion to the computer 100 times per second. The SOT evalu-
ates the subjects ability to effectively use visual, vestibular,
and somatosensory inputs to maintain balance. In this test,
the average three balance scores gathered from six test
configurations were used to calculate the total score, which
ranged between 0 and 100. Score 0 indicates highest
level of impairment and imbalance, whereas score 100
shows the individuals total independence.22,23,29
The LOS test was performed by the NeuroCom
Balance Master according to the manufacturers proto-
col.29 The system consisted of two parallel force plates.
Vertical forces applied by the subjects feet, the location
of COM, and its relative movement were measured and
reported by four force transducers placed under the plates
as follows:
The transducers are mounted along the front-to-back center
line of each plate (one 29.25 inches behind and the other
Figure 2. Posture-training support consists of a posterior bag
that is 1020 cm in length and 510 cm in width. The bag is
placed exactly under the inferior angle of the scapula.
29.25 inches in front of the pin joint.) The lateral distance
between left and right plate transducers and center is 8.25
inches.29
Visual feedback about COM was provided for subjects
through a monitor.29 The LOS test evaluates the subjects
ability of volitional control of COM. In this study, the
measured quantities in LOS test were reaction time and
directional control. The reaction time (microseconds) is the
time required for the patient to respond to a visual stimulus.
Directional control (%) is the accuracy of movement from
the central square to the target and reported in percentage;30
a score of 100 shows that the patients movement toward
the target had occurred in a straight line.
In this study, balance was evaluated by measuring the bal-
ance score, reaction time, and directional control. The previ-
ous studies have established the association between risks of
falls and balance score and LOS test scores;22,23,31 moreover,
validity and reliability of balance score, reaction time, and
directional control have been confirmed in earlier studies.24,32
Protocol
Subjects selected based on the studys inclusion and exclu-
sion criteria were provided with sufficient information
Azadinia et al. 407
regarding the research aim and procedure. A spine special-
ist evaluated the participants and measured the Cobb angle.
On a standing lateral radiographic image of the thoracic
spine, two lines are drawn, one along the upper surface of
the T4 (4th thoracic) vertebral end-plate and one along the
lower surface of the T12 vertebral end-plate. Two perpen-
diculars are drawn to these two lines, and the angle at their
cross-point is measured with a protractor. Subjects who had
Cobb angle >50 were included.
Recruited subjects were randomly allocated to use either
the Spinomed orthosis or PTS. The randomization proce-
dure was to pick the name of the orthosis from a bag includ-
ing the names of both orthoses. Before measuring the
baseline measurements, the height and weight of all sub-
jects were recorded. The participants were informed about
the test procedure and were given enough time to learn the
correct method of test performance. SOT and LOS balance
tests were performed with and without orthosis. The
sequence of tests in these configurations was random in
order to limit the effect of learning and fatigue: 1-h interval
was considered between trials with and without orthosis
and 10-min rest between SOT and LOS tests. All subjects
in the two groups were asked to wear the orthoses for 1.5 h
to get used to them. Pfeifer et al.s16 study noted that
Spinomed orthosis must be worn approximately 2 h/day,
and Sinaki et al.17 in their study recommend to wear the
PTS daily for 1.5 h in the morning and 1.5 h in the after-
noon, and therefore, in this study, 1.5 h was considered as a
suitable orthotic adaptation time. In performing the SOT
test, the subject was asked to stand on the force plate of
EquiTest system and put his or her feet on certain points on
the force plate and look straight forward through his or her
visual limit. This test was performed in six different sen-
sory configurations, each repeated three times. The force
plate was stable in stages 13. In stage 1, subjects eyes
were open; in stage 2, subjects eyes were closed; and in
stage 3, the visual surround in front of subject was moving.
The force plate was moving from stages 4 through 6, and
the visual condition was the same as the three first stages.
With regard to the speed of the tilt in the force plates, sway
gain setting of 1 was chosen. In sway gain setting of 1,
force plates follow the patients sway exactly, and norma-
tive data are only available for this sway gain.29 In order to
eliminate any learning effect, sequence of these stages was
entirely randomized. Each testing stage lasted for 20 s.29
In performing the LOS test, the subject was asked to
stand on the force plate of the Balance Master system,
hanging his or her arms at the sides in a comfortable posi-
tion, and putting his/her feet on certain points on the force
plate and positioning the pointer that appeared on the moni-
tor showing the position of the COM in the central square
on the monitor. In addition to the central square, there were
eight peripheral squares, which showed the subjects LOS
up to 100%. In each stage, one of these squares was deter-
mined by yellow color, and starting of movement was
indicated when a blue circle appeared in the target square.
The patient was asked to move pointer toward the target
square, rapidly and carefully, by shifting body weight and
using an ankle strategy without displacing his or her feet
placement on the force plate and keeping the pointer in that
position until the blue circle disappeared. Each testing stage
was selected randomly and lasted 8 s, after which the
pointer disappeared.29 Reaction time and directional con-
trol were the variables evaluated in each stage. NeuroCom
systems include a self-calibration feature, which calibrates
the system on start of the application. This will make it
unnecessary to calibrate the system manually unless in the
case of changing the position of the force plates, which is
performed with the NeuroCom system Init utility provided
with version 7 system software, according to the manufac-
turers recommendations.29
Data analysis
Data analysis was performed with the SPSS software
(version 16). The KolmogorovSmirnov test was used to
test the normality of distribution of variables. Normal dis-
tribution was observed for variables in both groups.
Independent sample t-test was used to evaluate the groups
congruency for height, age, weight, degree of kyphosis, and
balance parameters. Balance parameters within the groups
(i.e. with and without orthosis) were compared using a
paired t-test with and without orthosis. To compare the
changes in balance parameters between the two groups, an
independent sample t-test was used. A p-value <0.05 was
considered to be statistically significant.
Results
Eight participants were allocated to the PTS group and 10
participants were allocated to the Spinomed orthosis. The
inequality of the size of each group was related to the group
allocation method as describe earlier. In total, 16 women
and 2 men with the mean age of 66.72 4.77 years, height
of 156.33 6.43 cm, weight of 66.88 9.68 kg, and Cobb
angle of 70.61 9.87 participated. The statistical analysis
(independent sample t-test) revealed no significant differ-
ence in subjects age (p = 0.06), weight (p = 0.391), height
(p = 0.406), angle of kyphosis (p = 0.959), balance score
without orthosis (p = 0.443), directional control without
orthosis (p = 0.118), and reaction time without orthosis (p =
0.141) among two groups on baseline measurement. The
use of Spinomed orthosis had a significant impact on both
the balance score (p < 0.001) and directional control (p =
0.032) but not the reaction time (p = 0.29) (Table 1).
The use of PTS, however, had a considerable effect of
using this orthosis on all the three studied variables (bal-
ance score (p < 0.001), directional control (p = 0.027), and
reaction time (p = 0.047); Table 2). There were, however,
no significant differences between the effects of Spinomed
408 Prosthetics and Orthotics International 37(5)

Table 1.The mean ( SD) for balance parameters in Spinomed the orthosis and exercise, the interpretation of results of this
group (without and with orthosis). study should be considered with caution in this regard.
Variables Mean SD p-value The results revealed an increase in the balance score fol-
lowing the use of both of the studied orthoses. This finding
BS without orthosis (n = 10) 65.1 7.795 <0.000* indicates the positive effect of these devices in improving
BS with orthosis (n = 10) 76.9 6.657 postural stability and balance. This is in line with Pfeifer
DCL (%) without orthosis (n = 10) 78.6 7.137 0.032* et al.s16 study on 62 elderly women with osteoporosis and
DCL (%) with orthosis (n = 10) 82.4 5.66 hyperkyphosis, which also reported that the use of the
RT (ms) without orthosis (n = 10) 0.731 0.109 0.29 Spinomed orthosis without engaging in any exercise pro-
RT (ms) with orthosis (n = 10) 0.687 0.115
grams resulted in a decrease in COM sway and subse-
BS: balance score; DCL: directional control; RT: reaction time; SD: stan- quently improved balance. However, in studies by Sinaki et
dard deviation. al.17,18 on elderly women with osteoporosis and hyperky-
*Significant difference. phosis, the improvement of the balance score was referred
to the using of PTS and getting engaged in sport programs.
Table 2.The mean ( SD) for balance parameters in PTS group Putting together the studies of Sinaki et al., Pfeifer et al.,
(without and with orthosis). and this study reveals that the improvement of balance in
the Sinaki et al. studies might have been achieved as a
Variables Mean SD p-value
result of using the orthosis, and not because of the exercise
BS without orthosis (n = 8) 62.38 6.63 <0.0001* program, or at least the orthosis had an effect on improve-
BS with orthosis (n = 8) 72.75 5.49 ment of balance in the subjects studied. Proprioception
DCL (%) without orthosis (n = 8) 73 7.151 0.027* change is often considered as one of the main consequences
DCL (%) with orthosis (n = 8) 78.13 7.918 of orthosis use.26 These devices increase proprioception
RT (ms) without orthosis (n = 8) 0.796 0.117 0.04* through increasing skin inputs.3337 This is caused by
RT (ms) with orthosis (n = 8) 0.697 0.140
increasing the activity of not only the afferent receptors in
BS: balance score; DCL: directional control; RT: reaction time; SD: stan- the skin but also the mechanoreceptors through increased
dard deviation; PTS: posture-training support. pressure on muscles and the articular capsule. Newcomer et
*Significant difference. al.34 and McNair et al.33 showed that lumbosacral corsets
improve proprioception and lower repositioning errors by
causing more afferents in the case of body position.
Table 3.The mean ( SD) for comparing the changes of balance Increased awareness about spinal position also prevents
parameters between the two groups (Spinomed and PTS). erroneous postures and reduces stress on spine.33,34 The
Variables Group p-value correction of forward inclination and helping the COM to
be placed within base of support are among other mecha-
Spinomed PTS nisms identified for Spinomed orthosis and PTS.17,18,26
(n = 10) (n = 8) Hyperkyphotic posture displaces COM forward so that it
Change of BS 11.8 5.76 10.37 4.77 0.583 falls out of LOS and, consequently, cause imbalance.10,12
Change of DCL (%) 3.8 4.73 4.5 6.3 0.791 Thus, these orthoses are designed to counteract these
Change of RT (ms) 0.026 0.07 0.096 0.12 0.152 deforming forces; in the PTS, this mechanism works by
applying force under the scapula, whereas the Spinomed
BS: balance score; DCL: directional control; RT: reaction time; orthosis retracts the shoulders through shoulder straps.26
SD: standard deviation; PTS: posture-training support.
Therefore, these orthoses generate extension moments on
the spine, displace the COM backwards, and maintain it
orthosis and the PTS on total balance score (p = 0.583), within base of support, as a result, improving balance and
directional control (p = 0.791), and reaction time (p = 0.152) decreasing falling risk.1618
(Table 3). In the LOS test, use of the PTS and the Spinomed
orthoses is associated with an increase in the degree of
directional control, implying better balance capabilities
Discussion
and less falling risk. Palumbo et al.,30 in their study on
This study aimed to compare the effect of PTS and examining the effects of backpack on dynamic stability
Spinomed on balance in elderly people with thoracic in standing position in 50 healthy university students,
kyphosis. In order to determine the net effect of the orthoses, showed that carrying a backpack increases directional
no exercise was included in the protocol. Other researchers control in the frontal plane but lowers it in the sagittal
also considered the effect of orthosis without performing plane. These changes demonstrate no lateral bending when
any exercise.16 This may reveal the pure effect of orthosis. carrying bags on both sides; forward bending, however, is
However, as it is common to prescribe the combination of significant in these cases.38 Thus, postural compensations
Azadinia et al. 409
in the sagittal plane may be more considerable than in the
frontal plane. In order to compensate for the changes in
COM, caused secondary to the backpack weight, postural
changes such as forward bending occur so that these
changes may alter activation modes of anterior and poste-
rior muscles to maintain dynamic balance. These changes
in the activation mode of the muscles may explain the
reduction noted in anterior and posterior directional con-
trol. Liaw et al.39 showed that KnightTaylor orthosis is
associated with decreased directional control in individu-
als with osteoporosis and compressive vertebral fractures.
These results are contrary to the findings of this study due
to the different characteristics of applied orthoses between
two studies. Liaw et al. used KnightTaylor orthosis,
which is a rigid spinal orthosis and limits functional activ-
ity, so that its utilization for a long time can result in atro-
phy of abdominal and spinal muscles. However, it is
supposed that the Spinomed and PTS orthoses, activate
spinal muscles better and increase their isometric
strength.16,40 These orthoses, unlike conventional rigid
braces, cannot maintain spine in an upright posture but
encourage people to keep their spines upright using spinal
muscles.26
In this study, the use of Spinomed orthosis did not sig-
nificantly affect the reaction time. PTS, however, reduced
the reaction time. The visual reaction time is the time
interval between observing visual stimulus and the start of
the attempt to displace the COM toward the determined
target by the patient.29 Although these orthoses may not be
influential on the first part of the nervous pathway that
dispatches the information related to observing a visual
stimulus to the brain cortex, they would be effective on
the second part, that is, attempting to displace the COM
toward the determined target. Therefore, the orthosis
increases the muscle tone through increasing the activity
of the skin receptors and consequently, enhances aware-
ness of body position in space. This would improve the
persons safety and lower reaction time. In theory, it is
expected that both orthoses will reaction time. This expec-
tation is supported in the group with the PTS, but reaction
time did not change in the Spinomed orthosis group. This
may be as a result of the structure of this orthosis because
the pelvic straps that are located under the hip may resist
hip joint movement and, consequently, limit hip function,
thereby reducing the speed of reaction while the PTS
orthosis does not induce any limitation in the hip area.
Study limitations
A control group that uses a placebo orthosis could have
been employed to determine the net effect of the interven-
tions; however, due to the nature of orthotic intervention,
employing a control group and developing a real placebo
orthosis is not convenient. The other limitation of this study
was the duration of the intervention. Due to the time limit
of the study, it was not possible to assess the long-term
effects of the intervention; thus, the results should be con-
sidered with caution as immediate effects of the interven-
tion have been studied.
Conclusion
It could be concluded that the Spinomed orthosis and PTS
are both effective in improving balance in hyperkyphotic
elderly people. It should be stressed that, based on our
results, there is no significant difference in the efficacy of
these two orthoses in improving balance factors.
Conflict of interest
We certify that no party having a direct interest in the results of
the research supporting this article has conferred, or will confer,
a benefit on us or on any organization with which we are
associated.
Funding
This study was fully funded by Tehran University of Medical
Sciences (grant No 813). The protocol of this study was approved
by the Ethics Committee of the institution in which the tests were
conducted (Letter NO. 221).
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