Qualitative Study of Prosthetic Suspension Systems on Transtibial Amputees' Satisfaction and Perceived Problems With Their Prosthetic Devices.

Abstract

Ali S, Abu Osman NA, Naqshbandi MM, Eshraghi A, Kamyab M, Gholizadeh H. Qualitative study of prosthetic suspension systems on transtibial amputees' satisfaction and perceived problems with their prosthetic devices. OBJECTIVE: To investigate the effects of 3 dissimilar suspension systems on participants' satisfaction and perceived problems with their prostheses. DESIGN: Questionnaire survey. SETTING: A medical and engineering research center and a university biomedical engineering department. PARTICIPANTS: Persons with unilateral transtibial amputation (N=243), using prostheses with polyethylene foam liner, silicone liner with shuttle lock, and seal-in liner. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Descriptive analyses were performed on the demographic information, satisfaction, and prosthesis-related problems of the study participants. RESULTS: The results showed significant differences between the 3 groups regarding the degree of satisfaction and perceived problems with the prosthetic device. Analyses of the individual items revealed that the study participants were more satisfied with the seal-in liner and experienced fewer problems with this liner. The silicone liner with shuttle lock and seal-in liner users reported significant differences in maintenance time compared with the polyethylene foam liner. Users of the silicone liner with shuttle lock experienced more sweating, while those who used the seal-in liner had greater problems with donning and doffing the device. CONCLUSIONS: The results of the survey provide a good indication that prosthetic suspension is improved with the seal-in liner as compared with the polyethylene foam liner and silicone liner with shuttle lock. However, further prospective studies are needed to investigate which system provides the most comfort and the least problems for participants.

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ORIGINAL ARTICLE
Qualitative Study of Prosthetic Suspension Systems on
Transtibial Amputees’ Satisfaction and Perceived Problems
With Their Prosthetic Devices
Sadeeq Ali, MEngSc, Noor Azuan Abu Osman, PhD, Mohammad Muzamil Naqshbandi, PhD,
Arezoo Eshraghi, PhD, Mojtaba Kamyab, PhD, Hossein Gholizadeh, MEngSc
ABSTRACT. Ali S, Abu Osman NA, Naqshbandi MM,
Eshraghi A, Kamyab M, Gholizadeh H. Qualitative study of
prosthetic suspension systems on transtibial amputees’ satis-
faction and perceived problems with their prosthetic devices.
Arch Phys Med Rehabil 2012;93:1919-23.
Objective: To investigate the effects of 3 dissimilar suspen-
sion systems on participants’ satisfaction and perceived prob-
lems with their prostheses.
Design: Questionnaire survey.
Setting: A medical and engineering research center and a
university biomedical engineering department.
Participants: Persons with unilateral transtibial amputation
(N?243), using prostheses with polyethylene foam liner, sili-
cone liner with shuttle lock, and seal-in liner.
Interventions: Not applicable.
Main Outcome Measures: Descriptive analyses were per-
formed on the demographic information, satisfaction, and pros-
thesis-related problems of the study participants.
Results: The results showed significant differences between
the 3 groups regarding the degree of satisfaction and perceived
problems with the prosthetic device. Analyses of the individual
items revealed that the study participants were more satisfied
with the seal-in liner and experienced fewer problems with this
liner. The silicone liner with shuttle lock and seal-in liner users
reported significant differences in maintenance time compared
with the polyethylene foam liner. Users of the silicone liner
with shuttle lock experienced more sweating, while those who
used the seal-in liner had greater problems with donning and
doffing the device.
Conclusions: The results of the survey provide a good indi-
cation that prosthetic suspension is improved with the seal-in
liner as compared with the polyethylene foam liner and silicone
liner with shuttle lock. However, further prospective studies are
needed to investigate which system provides the most comfort
and the least problems for participants.
Key Words: Amputees; Prosthesis; Rehabilitation; Satis-
faction.
© 2012 by the American Congress of Rehabilitation
Medicine
T
mobility, and satisfaction.1,2Secure suspension decreases re-
sidual limb movement within the prosthetic socket by firmly
attaching the prosthesis to the residual limb.3Conversely,
inappropriate suspension can result in deterioration of the pros-
thetic socket fitting, and a poorly fit socket can cause pain and
skin ulcers. These problems may result in an unwillingness or
an inability of the amputee to use the prosthesis until the pain
is relieved and the ulcers are healed.4-6
There are several methods of suspending a transtibial pros-
thesis to the residual limb.7These include the following:
1. Belt and suprapatellar cuff, which is the most common
suspension method and usually the most effective for
most wearers8
2. Figure-of-8 belt, which is a variation of the suprapatellar
cuff suspension9
3. Sleeve suspension, which can develop negative pressure
between the socket and residual limb10,11
4. Supracondylar-suprapatellar suspension12
5. Supracondylar suspension, which is a variation of supra-
condylar-suprapatellar suspension and is usually used
for long residual limbs13
6. Thigh corset, which provides more mediolateral stability
for the users14
7. Silicone liner suspension, such as distal locking pin,
lanyard, and suction suspension15
Patellar tendon-bearing prostheses with polyethylene foam
liners have been in use since 1950. They are fitted within the
socket to provide the residual limb with a soft cushion.16
Polyurethane foam liners are still used in practice, but modern
liners are generally made from silicone and other elastomers
that offer better suspension and cushioning.17-19Silicone and
gel liners were introduced worldwide in the mid 1990s and
were designed to lessen shear forces and produce a better
interface bond.3A new type of silicone liner, called the seal-in
liner, uses a membrane lip, which is placed circumferentially
around the distal end of the liner.20
The efficiency of the suspension systems can be evaluated
both objectively and subjectively with the use of question-
naires. Researchers have developed numerous questionnaires
as a means of assessing consumers’ satisfaction with prosthet-
HE SUSPENSION SYSTEM and socket fitting in pros-
thetic devices significantly affect the amputee’s comfort,
From the Department of Biomedical Engineering, Faculty of Engineering (Ali, Abu
Osman, Eshraghi, Gholizadeh), and Department of Business Strategy and Policy,
Faculty of Business and Accountancy (Naqshbandi), University of Malaya, Kuala
Lumpur, Malaysia; and Orthotics and Prosthetics Department, Faculty of Rehabili-
tation Sciences, Tehran University of Medical Sciences, Tehran, Iran (Eshraghi,
Kamyab, Gholizadeh).
Supported by the Malaysia UM/MOHE HIR (grant no: D000014-16001).
No commercial party having a direct financial interest in the results of the research
supporting this article has or will confer a benefit on the authors or on any organi-
zation with which the authors are associated.
Correspondence to Sadeeq Ali, MEngSc, Dept of Biomedical Engineering, Faculty
of Engineering, University of Malaya, 50603 Kuala Lumpur Malaysia, e-mail:
Sadeeqcpo@um.edu.my. Reprints are not available from the author.
In-press corrected proof published online on Jul 7, 2012, at www.archives-pmr.org.
0003-9993/12/9311-00188$36.00/0
http://dx.doi.org/10.1016/j.apmr.2012.04.024
List of Abbreviations
JMERC Janbazan Medical and Engineering Research
Center
person with transtibial amputationPTA
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Arch Phys Med Rehabil Vol 93, November 2012

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ics and orthotics.21-24The Prosthetic Evaluation Questionnaire
has been used to investigate satisfaction and perceived prob-
lems among prosthetic users. Dillingham et al25carried out a
survey regarding the use of and satisfaction with prosthetic
devices in 146 participants, most of whom were not satisfied
with their prostheses because of pain and skin problems. A
study by Kark and Simmons26also demonstrated that their
study participants were unsatisfied with their prostheses. A
research study16showed that 77% of participants were more
satisfied with their pin and lock system compared with the
polyethylene foam liner. On the contrary, in a prospective
study,27almost all the participants (75%) preferred the poly-
ethylene foam liner. Van de Weg and Van der Windt3con-
ducted a study on the effect of 3 transtibial interfaces on
satisfaction and perceived problems. No significant differences
were reported.
To our knowledge, only 1 study28has been conducted on the
satisfaction with the seal-in suspension concept. However, the
study sample was small. Moreover, some of the existing find-
ings on the satisfaction with different suspension systems had
contradictory results. Therefore, the aim of this study was to
investigate the effects of 3 different suspension systems on
participants’ satisfaction and perceived problems with their
prostheses. The 3 systems included the polyethylene foam
liner, the silicone liner with shuttle lock, and the seal-in liner.
We hypothesized that participants would be more satisfied with
the seal-in liner compared with the other 2 systems.
METHODS
Study Participants
The research team carried out a questionnaire survey among
persons with transtibial amputation (PTAs) in Janbazan Med-
ical and Engineering Research Center (JMERC), Tehran, Iran.
We selected 303 men with unilateral transtibial (traumatic)
amputation from the JMERC database and distributed the ques-
tionnaire among them. Participants were required to have used
their prostheses for a minimum of 1 year. The satisfaction and
perceived problems with the following suspension systems
were compared: the polyethylene foam liner, the silicone liner
with shuttle lock, and the seal-in liner (the Iceross-Dermo-
Seal-In linera) (fig 1).
The study was approved by the JMERC and the University
Malaya Medical Centre ethics committees.
Questionnaire
To study the effect of the 3 different suspension systems on
participant’s satisfaction and to identify the perceived problems
with the use of the prosthesis, we adopted some elements of the
Prosthetic Evaluation Questionnaire. A Persian version of the
questionnaire was produced to be used for the participants at
JMERC. The survey was composed of demographic variables
(age, sex, education level, marital status, weight, height), cause
of amputation, amputation side, and time since last prosthesis.
In addition, we asked some questions related to the use and
maintenance of the prosthesis, and activity levels of the par-
ticipants. The activity level was defined based on the Medicare
Functional Classification Level.29Four activity levels were as
follows: household ambulator (K1), limited community ambu-
lator (K2), community ambulator (K3), and high level user
(K4). The questionnaire also included questions about the
participant’s satisfaction and asked for details of any prosthet-
ic-related problems that the participant experienced with each
liner. In the satisfaction section of the questionnaire, partici-
pants were asked about the prosthetic fit, their ability to walk
with the prosthesis, their ability to walk up and down stairs,
their ability to don and doff the prosthesis, their ability to walk
on diverse surfaces, the appearance of the prosthesis, the ap-
pearance of the suspension, their ability to sit with the pros-
thesis, and their overall satisfaction. Problems with the pros-
thesis consisted of sweating, skin irritation, wounds, ulcers,
blisters, pistoning within the socket, rotation within the socket,
unpleasant smell of the prosthesis or residual limb, unwanted
sounds, and pain in the residual limb. A scale from 0 to 100
was used to score overall satisfaction with the prosthesis, with
0 indicating that a participant was “unsatisfied” with the liner
and 100 indicating that a participant was “completely satis-
fied.” For the variables related to problems/complaints, each
item was also measured on a scale from 0 to 100, where 0
meant “extremely bothered” and 100 meant “not at all both-
ered.”21
Analysis Procedures
Descriptive analyses were used to analyze the demographic
information of the participants. To analyze participants’ satis-
faction and examine problems related to the liners, we used
multivariate analysis of variance to compute the means of the
items related to each type of liner and determine the signifi-
cance. All data analyses were done using SPSS 16.0.b
RESULTS
Participants’ Profiles
A total of 243 questionnaires (80.19%) were returned. The
mean age, weight, and height of the participants were
44.02?6.26 years, 85.09?15.54kg, and 176.14?6.69cm, re-
spectively. Forty-nine percent of the participants were univer-
sity graduates, 34.6% had a diploma, 12.8% had attended high
Fig 1. Three different suspension systems: polyethylene foam liner
(A), silicone liner with shuttle lock (B), and seal-in liner (C).
1920
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school, and 3.7% had an elementary school education. The
average number of years PTAs had been using a prosthesis was
22.01?5.95. The number of left-sided PTAs (60.9%) exceeded
the number of right-sided PTAs (39.1%). Most of the partici-
pants (63.4%) reported an activity level of K3, followed by
18.9% reporting a level of K4 and 17.7% a level of K2. On
average, PTAs had used their prosthesis for 11.67?3.25h/d.
The average age of the liner was 21.02?14.48 months. There
was a significant difference (P?.05) between the maintenance
time among the 3 suspension systems. The silicone liner with
shuttle lock had the longest maintenance time of 2.98?2.63
hours per year, followed by the seal-in liner with 2.53?1.52
hours per year and the polyethylene liner with .54?.45 hours
per year. Most of the PTAs used the polyethylene foam liner
(41.2%). Table 1 describes the characteristics of the partici-
pants.
Satisfaction and Use
Most of the PTAs used the prosthesis for more than
11.67h/d, and daily prosthetic use time was not significantly
different between the 3 suspension systems. The mean overall
satisfaction on a 0- to 100-point numerical rating scale was
63.14 for the polyethylene foam liner, 75.94 for the silicone
liner with shuttle lock, and 83.10 for the seal-in liner. As shown
in table 2, PTAs were more satisfied with the seal-in liner
suspension. The P values in the test of between-participants
effect showed that the suspension type had a significant corre-
lation with all satisfaction items (P?.05 for all items). This can
be further understood by looking at table 2, which shows the
ranking according to the satisfaction ratings.
Problems/Complaints
The multivariate tests in table 3 show that there was a
significant difference between the 9 complaint/problem items
(P?.05) among the 3 suspension systems. The P values in the
test of between-participants effect showed that the suspension
type has a significant correlation with all complaint/problem
items (P?.05). The only exception was the “sweat complaint,”
which had a P value of .074. Participants found donning and
doffing to be more difficult with the seal-in liner, while pis-
toning was recorded the highest for the polyethylene foam liner
(see table 3).
DISCUSSION
Prosthetic satisfaction is a multifactorial issue. These aspects
mainly include prosthetic alignment, prosthetic components,
prosthetist’s skill, residual limb condition, level of activity, and
socket fit.30We investigated different suspension systems as an
influencing factor on PTA use and satisfaction with the pros-
theses. The findings supported our hypothesis that participants
would be more satisfied with the seal-in liner compared with
other 2 systems.
With the exception of the “sweat complaint,” significant
differences were found between different suspension systems
with respect to perceived problems. Sweating was reported
Table 1: Characteristics of the Survey Respondents (N?243)
Characteristics Values
Age (y)
Sex: male
Weight (kg)
Height (cm)
Education
Elementary
High school
Diploma
Graduate
Years since first prosthesis
Cause of amputation
Trauma
Amputation side
Right
Left
Activity level
K2
K3
K4
Prosthetics use every day (h)
Maintenance per year (hours)
Age of liner (mo)
Type of liner
Silicone liner with shuttle lock
Silicone seal-in liner
Polyethylene foam liner
44.02?6.26
243 (100)
85.09?15.54
176.14?6.69
9 (3.7)
31 (12.8)
84 (34.6)
119 (49.0)
22.01?5.95
243 (100)
95 (39.1)
148 (60.9)
43 (17.7)
154 (63.4)
46 (18.9)
11.67?3.25
1.88?2.07
21.02?14.48
85 (35)
58 (23.9)
100 (41.2)
NOTE. Values are mean ? SD or n (%).
Table 2: Satisfaction and Use With 3 Studied
Suspension Systems
Satisfaction Type/Liner TypeMean*P Ranking†
Fitting satisfaction
Silicone liner with shuttle lock
Polyethylene foam liner
Seal-in liner
Donning and doffing satisfaction
Silicone liner with shuttle lock
Polyethylene foam liner
Seal-in liner
Sitting satisfaction
Silicone liner with shuttle lock
Polyethylene foam liner
Seal-in liner
Walking satisfaction
Silicone liner with shuttle lock
Polyethylene foam liner
Seal-in liner
Uneven walking satisfaction
Silicone liner with shuttle lock
Polyethylene foam liner
Seal-in liner
Stair satisfaction
Silicone liner with shuttle lock
Polyethylene foam liner
Seal-in liner
Suspension satisfaction
Silicone liner with shutle lock
Polyethylene foam liner
Seal-in liner
Cosmetic satisfaction
Silicone liner with shuttle lock
Polyethylene foam liner
Seal-in liner
Overall satisfaction with prosthesis
Silicone liner with shuttle lock
Polyethylene foam liner
Seal-in liner
.000
79.59
64.82
87.09
2
3
1
.000
71.44
79.68
57.24
2
1
3
.000
68.80
76.44
79.41
3
2
1
.000
72.80
65.21
84.66
2
3
1
.000
63.91
54.10
77.93
2
3
1
.000
68.75
60.83
80.60
2
3
1
.000
81.72
55.20
93.71
2
3
1
.000
69.05
73.27
83.10
3
2
1
.000
75.94
63.14
83.10
2
3
1
*Greater mean indicates more satisfaction and use.
†Satisfaction increases from the ranking 3 to 1.
1921
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more often by PTAs with the locking liner (55 score) than by
those with the polyethylene foam and seal-in liners. In addition,
we registered significant differences between different suspen-
sion liners with respect to participant use and satisfaction.
However, the overall satisfaction rating was higher with the
seal-in liner (83.10 score) when compared with the locking
liner (75.94%) and the polyethylene foam liner (63.14 score).
In this study, the participants preferred the silicone liner with
shuttle lock and seal-in liner over the polyethylene liner. These
results contradict the findings of Coleman et al16and Boonstra
et al,27whose studies showed the polyethylene foam liner to
be more favorable. The findings of both crossover studies were
considerably less positive toward locking liners; however, the
study by McCurdie et al2clearly demonstrated the preference
for locking liners. Van der Linde et al31indicated that profes-
sionals in the field of rehabilitation preferred a locking liner in
their research study. Vacuum suspension is said to improve
proprioception in prosthetic users,32and this may be one pos-
sible explanation of preference for the seal-in liner.
Hatfield and Morrison33revealed that their participants who
used locking liners felt more comfortable. Aström and Sten-
ström34stated that locking liners delivered improved socket
comfort when compared with polyethylene liners. The same
was true with our study, as the participants were more satisfied
with the locking liner and seal-in liner during activities that
involved walking, walking on uneven ground, and walking on
stairs.
Enhanced suspension and cosmesis of the prostheses had a
positive effect on prosthetic function and the participant’s
satisfaction.13Our study showed improved suspension with the
silicone liner with shuttle lock and seal-in liners when com-
pared with the polyethylene foam liner. Cluitmans et al35and
Baars and Greetzen36found improved suspension with the
locking liners.
The ease of donning and doffing has an important effect on
prosthetic use.37,38Our results showed that participants who
used the polyethylene and locking liners found donning and
doffing easier than those who used the seal-in liner. The data
revealed that the polyethylene liner was the most durable of the
3 suspension systems. This is compatible with the findings of
Van de Weg and Van der Windt3and Coleman et al.16
The only study on the effect of seal-in liners on participant
satisfaction revealed that the participants were more satisfied
with the seal-in liner than the locking liner.28However, this
study did not purely examine satisfaction and perceived prob-
lems. Similarly, we found that all the satisfaction parameters
were higher for the seal-in liners than they were for the locking
system and the polyethylene foam liner. Furthermore, statisti-
cal analyses revealed that the participants had fewer problems
with the seal-in liner than they did with the 2 other liners.
Nevertheless, donning and doffing the seal-in liner was diffi-
cult, which is also consistent with the findings of Gholizadeh
et al.28
Study Limitations
One limitation of this study was that we could not fabricate
3 individual prostheses with 3 different suspension systems for
each of the participants to give equal chance for the compari-
son. Furthermore, the trajectory of prosthetic suspension sys-
tems, including the timing and extent of prostheses used under
each, was not determined. Future research should determine the
factors affecting the prescription or selection of the suspension
type by the prosthetist and PTA.
CONCLUSIONS
In this study, the participants reported significant differences
in their experiences with different suspension systems. There is
clear evidence in this study that supports the view that the
seal-in liner has higher participant satisfaction. There is also
good reason to believe that the prosthetic suspension may be
improved with the seal-in liner. A further study with a larger
number of participants is needed to compare the seal-in liner
with other suspension systems.
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With Regard to Complaints/Problems
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Seal-in liner
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Silicone liner with shuttle lock
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Seal-in liner
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Seal-in liner
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1922
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Suppliers
a. Ossur Inc., Grjothals 5, 110 Reykjavik, Iceland.
b. SPSS Inc, 233 S Wacker Dr, 11th Fl, Chicago, IL 60606.
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SUSPENSION SATISFACTION AND PROBLEMS, Ali
Arch Phys Med Rehabil Vol 93, November 2012