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VOLUME 6, ISSUE 1 

 2023 

 

RESEARCH ARTICLE 

Miyata Y, Sasaki K, Guerra G, Dacharux W, Chaiwan P. Evaluating feasibility and durability of the AERO prosthetic liner in transtibial prosthetic users. Canadian 

Prosthetics & Orthotics Journal. 2023; Volume 6, Issue 1, No.5. https://doi.org/10.33137/cpoj.v6i1.41865 

https://jps.library.utoronto.ca/index.php/cpoj/index
mailto:cpoj@online-publication.com
https://publicationethics.org/about/our-organisation
https://publicationethics.org/members/canadian-prosthetics-orthotics-journal
https://doi.org/10.33137/cpoj.v6i1.41865


 

1 

Miyata Y, Sasaki K, Guerra G, Dacharux W, Chaiwan P. Evaluating feasibility and durability of the AERO prosthetic liner in transtibial prosthetic users. Canadian 
Prosthetics & Orthotics Journal. 2023; Volume 6, Issue 1, No.5. https://doi.org/10.33137/cpoj.v6i1.41865 

 

 

RESEARCH ARTICLE 

 

EVALUATING FEASIBILITY AND DURABILITY OF THE AERO PROSTHETIC LINER IN 

TRANSTIBIAL PROSTHETIC USERS 

Miyata Y1, Sasaki K1*, Guerra G2, Dacharux W3, Chaiwan P1 

1 Sirindhorn School of Prosthetics and Orthotics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. 
2 Department of Exercise and Sport Science, St. Mary’s University, San Antonio, TX, USA. 
3 Department of Anatomy, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. 

 

 

 

 

  

 

 

 

 

 

 

 

 

 

 

INTRODUCTION   

Transtibial amputations are prevalent worldwide, 

particularly in low and middle-income countries, due to 

various factors such as diabetes, trauma, and congenital 

conditions. Prosthetic treatment is vital for improving the 

satisfaction of people with amputation, and enhancing their 

quality of life (QoL).1,2 However, people with amputation in 

resource limited environments (RLE) face a range of 

challenges, encompassing issues of accessibility, 

constraints related to available resources, and the quality of  

 

 

prosthetic devices.3 Rehabilitation success in people with 

lower limb amputation depends on factors like pre-

amputation mobility, time between amputation and 

prosthetic fitting, and material selection.4 The elements 

taken into consideration for prosthetic intervention include 

the affordability, fabrication time, safety, and durability of the 

material. Thus, the selection of appropriate materials for the 

development of prosthetic devices plays a crucial role in 

enhancing the QoL for people with amputation.5  

The effectiveness of interface materials, particularly their 

impact on the residual limb, is an intriguing area of study. 

Roll-on gel liners, for instance, have shown higher 

satisfaction levels compared to polyethylene foam (Pe-

Lite).6 The ethylene-vinyl acetate (EVA) material exhibits 

similarities to Pe-Lite because both are closed-cell 

polymers. EVA is widely used in a multitude of product 

applications and is acknowledged for its cost-effectiveness. 

 
OPEN  ACCESS 

ABSTRACT 

BACKGROUND: The choice of prosthetic socket interface material significantly affects user comfort and 

satisfaction. The Affordable Ethylene-Vinyl Acetate Roll-On (AERO) liner was created with the aim of 

improving functionality and streamlining the wearing process for users. 

OBJECTIVE: The purpose of this study was to comprehensively assess user satisfaction, comfort, and 

durability of the AERO liner and compare it with the common soft Pe-Lite liner.  

METHODOLOGY: Fourteen individuals with transtibial amputation participated in this three-month 

randomized crossover trial study. The Prosthesis Evaluation Questionnaire (PEQ), Expanded Socket Comfort 

Score (ESCS), and liner thickness measurements were used to comprehensively compare the AERO and 

Pe-Lite liner. 

FINDINGS: The AERO liner demonstrated notable improvements in prosthetic comfort and functionality over 

Pe-Lite liner. After three months use, there was a significant reduction in reported frustration with the AERO 

liner (p=0.023, r=0.604) in the PEQ subscale. Specific aspects, such as walking with the prosthesis (p=0.030, 

r=0.601) and odor perception (p=0.024, d=0.579), favored the use of the AERO liner. The expanded socket 

comfort score (ESCS) revealed significant superiority for the AERO liner “at best” (p=0.04) and “on average” 

(p=0.02) after one and three months, respectively. Liner thickness analysis showed significant reductions at 

the mid-patellar tendon location for the AERO liner at one (0.57±0.48) and three months (0.90±0.69, p=0.01) 

and in the posterior region after three months (0.63±0.64, p=0.05).  

CONCLUSION: Our study highlights the potential advantages of the AERO liner in enhancing comfort and 

satisfaction. Yet, durability and thinning of the liner when compared to Pe-Lite may be a concern which may 

eventually affect socket fit. These findings contribute to ongoing efforts to optimize prosthetic interventions 

and improve the quality of life of individuals with lower limb prosthesis in resource-limited environments. 

ARTICLE INFO 

Received: October 15, 2023 

Accepted: December 19, 2023     

Published: December 26, 2023 

CITATION 

Miyata Y, Sasaki K, Guerra G, 

Dacharux W, Chaiwan P. 

Evaluating feasibility and 

durability of the AERO 

prosthetic liner in transtibial 

prosthetic users. Canadian 

Prosthetics & Orthotics Journal. 

2023; Volume 6, Issue 1, No.5. 

https://doi.org/10.33137/cpoj.v6i

1.41865 

KEYWORDS 

Limb Loss, Amputation, 

Prosthesis, Rehabilitation, 

Prosthetic, Prosthetic liner, 

Satisfaction, Comfort, Quality of 

Life, Questionnaire, Socket 

Comfort 

 

* CORRESPONDING AUTHOR: 

Kazuhiko Sasaki,   
Sirindhorn School of Prosthetics and Orthotics, Faculty of Medicine Siriraj 
Hospital, Mahidol University, Bangkok, Thailand. 

Email: kazuhiko.sas@mahidol.edu 

ORCID ID: https://orcid.org/0000-0002-1778-6308 

Journal Homepage: https://jps.library.utoronto.ca/index.php/cpoj/index 

Volume 6, Issue 1, Article No.5. 2023 

 

 

https://doi.org/10.33137/cpoj.v6i1.41865
https://doi.org/10.33137/cpoj.v6i1.41865
https://doi.org/10.33137/cpoj.v6i1.41865
https://orcid.org/0000-0002-1778-6308
https://jps.library.utoronto.ca/index.php/cpoj/index


 

2 

Miyata Y, Sasaki K, Guerra G, Dacharux W, Chaiwan P. Evaluating feasibility and durability of the AERO prosthetic liner in transtibial prosthetic users. Canadian 
Prosthetics & Orthotics Journal. 2023; Volume 6, Issue 1, No.5. https://doi.org/10.33137/cpoj.v6i1.41865 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X EVALUATING FEASIBILITY AND DURABILITY OF THE AERO PROSTHETIC LINER  
Miyata et al., 2023 

A cost-effective alternative, referred to as the Affordable 

Ethylene-Vinyl Acetate Roll-On (AERO) liner, has been 

created with the aim of improving functionality and 

streamlining the process of wearing for users.7 This 

prosthetic liner makes use of materials obtained from local 

sources and features a production method that is simple 

and easy to follow. Consequently, it provides an 

economically viable and environmentally friendly alternative 

for prosthetic liners in locations with limited resources. 

Preliminary pilot data suggested possible improvements in 

prosthesis comfort, stability, and pressure distribution in 

individuals with transtibial amputations. Nevertheless, it is 

imperative to recognize the constraints arising from a limited 

sample size and the selection of participants with optimal 

residual limb configurations.8 Therefore, assessing the 

liner's long-term impact and considering the user 

experience are crucial factors in revealing the strengths and 

weaknesses of the AERO liner.9 It was hypothesized that 

for individuals using the AERO liner prosthesis, comfort 

across a three-month use period would be maintained. 

Thus, our study purpose was to explore utility of the AERO 

liner in prosthesis users during a three-month period. 

METHODOLOGY 

Participants 

This study was approved by the Siriraj Faculty of Medicine 

Institutional Review Board (Si 419/2022). This study 

involved the participation of thirteen people with unilateral 

transtibial amputation and one with bilateral transtibial 

amputations. Prior to their involvement, all participants 

provided informed consent. 

Experimental protocol 

This study utilized a crossover design in which participants 

were randomly assigned to Pe-Lite or AERO liner groups 

(Figure 1). A certified prosthetist created and fit all the 

prostheses, which were patella tendon bearing (PTB) 

socket with Pe-Lite liner, in our clinic. And AERO liners were 

fit with either a prefabricated or custom-made liner. In total 

there were fourteen participants. Liners were either 

prefabricated in small, medium, and large sizes. Or custom 

made for a unique limb shape. Ten unilateral participants 

used prefabricated liners, three unilateral participants used 

custom liners, and finally one bilateral participant used a 

prefabricated liner on one limb and custom liner on the other 

limb. Pe-Lite liners were also fabricated specifically for all 

participants. Both liners were fabricated from a 5 mm thick 

material. No adjustments were necessary for user of PTB 

sockets with cuff strap. However, minor adjustments, such 

as the addition of a pad were made for PTB sockets with 

supracondylar suspension designs to ensure suspension. 

The prosthetist also instructed the participants on how to 

perform the roll-on donning method to ensure consistent 

and unbiased donning. The AERO liner was provided with 

two liners per each participant, one designated for primary 

use and the other as a spare liner. Participants were 

instructed to change to using the spare liner only if 

necessary for limb comfort and function. This approach 

ensured that participants had access to a backup liner in 

case of wear and tear or other unforeseen circumstances 

during the study. 

The Thai PEQ10 was used to evaluate patient satisfaction 

across different domains. The PEQ, originally developed in 

English, is composed of 82 questions, which are further 

divided into 9 subscales. These subscales are Ambulation 

(AM), Appearance (AP), Frustration (FR), Perceived 

Response (PR), Residual Limb Health (RL), Social Burden 

(SB), Sounds (SO), Utility (UT), and Well Being (WB). In this 

study, we used four subscales: AM, FR, RL, and UT, which 

are related to interface material evaluation. Additionally, we 

assessed nine individual items to gain insight into the effect 

of the liner on the patients. Participants completed the PEQ 

after one month and three months of using their prosthetic 

device. 

The participant’s comfort was assessed using the expanded 

socket comfort score (ESCS). Traditionally employed 

straightforward questionnaires may assess prosthetic 

comfort, however, obtaining feedback from users regarding 

their experiences with best, worst, and average comfort 

levels is one approach. This approach offers a more 

comprehensive evaluation of socket comfort than solely 

considering current comfort ratings.11 

We assessed pressure-sensitive and pressure-tolerant 

areas, including the mid-patellar tendon (MPT), tibial 

tubercle, distal end of the tibia, head of the fibula, medial 

flare, and posterior region. The liner thickness was 

measured using a depth gauge caliper, which measured the 

liner material, as shown in Figure 2. A caliper depth bar 

precision of 0.05 mm was utilized to evaluate liner thickness 

at intervals of 1 month and 3 months for each liner. These 

three outcome measures, PEQ, ESCS, and liner thickness 

evaluation, were administered for Pe-Lite and AERO liner 

prostheses. 

Data analysis 

Statistical analysis was conducted using R statistical 

software version 4.2.0 (R Project for Statistical Computing). 

To analyze the performance on the PEQ and ESCS 

between Pe-Lite and AERO liner at one month and three 

months, a Wilcoxon signed Rank Test (p < 0.05) was used. 

The designation “NR” for non-responses, which signified the 

absence of pain associated with the device, was evaluated 

using the Mann-Whitney U Test. The PEQ effect size was 

calculated using r, with interpretation based on established 

criteria: d > 0.10 denoting a small effect, d > 0.30 indicating 

a medium effect, and d > 0.50 signifying a large effect, 

depending on the statistical significance of the findings. The 

liner thickness for both Pe-Lite and AERO liner was 

analyzed using a Student’s t-test for one and three-month. 

https://doi.org/10.33137/cpoj.v6i1.41865


 

3 

Miyata Y, Sasaki K, Guerra G, Dacharux W, Chaiwan P. Evaluating feasibility and durability of the AERO prosthetic liner in transtibial prosthetic users. Canadian 
Prosthetics & Orthotics Journal. 2023; Volume 6, Issue 1, No.5. https://doi.org/10.33137/cpoj.v6i1.41865 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X EVALUATING FEASIBILITY AND DURABILITY OF THE AERO PROSTHETIC LINER  
Miyata et al., 2023 

 

 

Figure 1: Flowchart of participant allocation during the study, n= number of participants.  

Note: The number of participants: thirteen with unilateral transtibial amputations and one with bilateral transtibial amputation. 

 

Assessed eligible participants 

(n= 4) 

 nformed consent 

Allocated to intervention A (n= ) Allocated to intervention   (n= ) 

Analyzed intervention A (n= ) Analyzed intervention   (n= ) 

Analyzed intervention  , allocated 

to intervention A (n= ) 
Analyzed intervention A, allocated 

to intervention   (n= ) 

Analyzed intervention A (n= ) 
Analyzed intervention   (n= ) 

Analyzed intervention   (n= ) 
Analyzed intervention A (n= ) 

Randomization 

  month analysis 

  months analysis, 

Allocation crossover 

  month analysis 

  months analysis 

Allocation 

Concluded study 

 

Figure 2: The six areas used for evaluating liner thickness: (A) mid patellar tendon, (B) tibial tubercle, (C) distal end of tibia, (D) head of 

fibula, (E) medial flare, and (F) posterior. Liner thickness was check using the following procedure; (1) prepare caliper depth gauge and 

metal bar to sandwich the liner, (2) penetrate liner and check for contact with metal bar, (3) check the thickness of the caliper gauge. 

https://doi.org/10.33137/cpoj.v6i1.41865


 

4 

Miyata Y, Sasaki K, Guerra G, Dacharux W, Chaiwan P. Evaluating feasibility and durability of the AERO prosthetic liner in transtibial prosthetic users. Canadian 
Prosthetics & Orthotics Journal. 2023; Volume 6, Issue 1, No.5. https://doi.org/10.33137/cpoj.v6i1.41865 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X EVALUATING FEASIBILITY AND DURABILITY OF THE AERO PROSTHETIC LINER  
Miyata et al., 2023 

RESULTS 

This study involved fourteen participants, thirteen with 

unilateral transtibial amputations and one with bilateral 

transtibial amputation. The participants included twelve 

males with an average age of 52.1±10.4 years, and two 

females with an average age of 59.5±0.7 years. All 

participants used PTB prosthetic sockets, with eight using a 

cuff strap suspension system, including one person with 

bilateral transtibial amputation and six using an anatomical 

supracondylar suspension. Analysis of the PEQ revealed a 

significant reduction in reported frustration after three 

months with the AERO liner (p=0.023, r=0.604). 

Additionally, specific items related to walking with the 

prosthesis (p=0.030, r=0.601) and odor perception 

(p=0.024, d=0.579) indicated better results with the AERO 

liner compared to Pe-Lite after three months. While 

participants generally expressed a preference for the AERO 

liner, most preferences did not reach statistical significance 

compared to Pe-Lite (Figure 3). Three participants in the Pe-

Lite group indicated “NR” (no pain at the residual limb) at 

both one month and three-month assessments. In contrast, 

within the AERO liner group, four participants reported “NR” 

after one month, and this number increased to five 

participants after three months (Figure 3). The result of the 

ESCS for the AERO liner, showed significantly superior 

results when compared to Pe-Lite “at best, over the last   

days”, 8.0± .6 (p=0.04) after one month and “on average, 

over the last   days”, 8. ±0.9 (p=0.02) after three months 

(Figure 4). A significant reduction in liner thickness was 

observed at the MPT location for the AERO liner compared 

to Pe-Lite, both after one month 0.57±0.48 and three 

months 0.90±0.69 follow-up (p=0.01). Additionally, a 

significant difference was noted in the posterior region after 

three months 0.63±0.64 (p=0.05) (Figure 5).  

DISCUSSION 

We investigated the satisfaction, comfort, and changes in 

liner thickness of transtibial prosthetic users during three-

month use of AERO and Pe-Lite liner. The findings of this 

study shed light on several crucial aspects of transtibial 

prosthetic use and, in particular, the impact of the AERO 

liner on user experience. Our results demonstrated a 

significant reduction in reported frustration after three 

months of utilizing the AERO liner compared to Pe-Lite liner. 

Participants expressed a preference for the AERO liner, 

although this preference did not reach statistical 

significance when compared with Pe-Lite liner. These 

findings suggest that the AERO liner offers notable 

improvement in terms of user experience, particularly with 

regard to frustration reduction. Frustration reduction can 

play a crucial role in enhancing overall prosthetic 

satisfaction, as users are more likely to continue using 

devices that minimize daily challenges and discomfort.12,13 

Although the preference for the AERO liner did not reach 

statistical significance, it is possible that with a larger 

sample size, this trend might become more pronounced. 

Therefore, future research with a larger participant pool may 

provide further insights into the preference of the AERO 

liner over the Pe-Lite liner.  

Figure 3: Prosthesis evaluation questionnaire per subscale and 

individual items at one and three months for Pe-Lite and AERO 

liner. * Indicates significant differences (p<0.05). 

Pain is a significant concern for individuals using prosthetic 

devices as it can affect mobility, quality of life, and long-term 

compliance with prosthetic use.14-16 Three participants 

reported “NR” (no pain in the residual limb) when using Pe-

Lite after one and three months. In contrast, in the AERO 

liner group, four participants reported “NR” after one month, 

and this number increased to five participants after three 

months. Roll-on donning of the AERO liner may permit 

accommodation to the residual limb surface, and liner 

softness may reduce pain. Although differences were 

minimal, these findings suggest that the AERO liner might 

have contributed to a slightly reduced pain perception in 

users. 

 

Pe-Lite Better AERO Better 

Ambulation 

Frustration 

Residual limb health 

Utility 

Ambulation 

Frustration 

Residual limb health 

Utility 

Fit of prosthesis 

Donning/Doffing 

Walking with prosthesis 

Feeling with prosthesis 

Skin irritation 

Smell 

Wound 

Pain 

Sweat 

Fit of prosthesis 

Donning/Doffing 

Walking with prosthesis 

Feeling with prosthesis 

Skin irritation 

Smell 

Wound 

Pain 

Sweat 

Sub scale: 1 month p-value r 

Sub scale: 3 months 

Individual items: 1 month p-value r 

Individual items: 3 months 

https://doi.org/10.33137/cpoj.v6i1.41865


 

5 

Miyata Y, Sasaki K, Guerra G, Dacharux W, Chaiwan P. Evaluating feasibility and durability of the AERO prosthetic liner in transtibial prosthetic users. Canadian 
Prosthetics & Orthotics Journal. 2023; Volume 6, Issue 1, No.5. https://doi.org/10.33137/cpoj.v6i1.41865 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X EVALUATING FEASIBILITY AND DURABILITY OF THE AERO PROSTHETIC LINER  
Miyata et al., 2023 

 

  

Figure 4: Expanded socket comfort score results at one and three months for PE-lite and AERO liner. * Indicates significant differences 

(p<0.05). 

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Figure 5: Liner thickness differences over time between the one month and three-month intervals. These changes are analyzed across 

six regions: MPT; mid patellar tendon, fibula head, distal end of tibia, medial flare, tibial tuberosity and posterior. * Indicates significant 

differences (p<0.05), and **(p<0.01). 

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https://doi.org/10.33137/cpoj.v6i1.41865


 

6 

Miyata Y, Sasaki K, Guerra G, Dacharux W, Chaiwan P. Evaluating feasibility and durability of the AERO prosthetic liner in transtibial prosthetic users. Canadian 
Prosthetics & Orthotics Journal. 2023; Volume 6, Issue 1, No.5. https://doi.org/10.33137/cpoj.v6i1.41865 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X EVALUATING FEASIBILITY AND DURABILITY OF THE AERO PROSTHETIC LINER  
Miyata et al., 2023 

Prosthetists often express concern about liner durability 

when prescribing devices.5 Liner thickness is a critical factor 

for prosthetic comfort and fit. In our analysis, we observed 

significant differences in the liner thickness changes over 

time, particularly at the MPT location. The AERO liner 

demonstrated a greater reduction in liner thickness at both 

one month and three months compared to the Pe-Lite liner. 

Additionally, a significant reduction in liner thickness was 

noted in the proximal posterior region after three months. 

The softer AERO liner, which has more flexible material 

properties, may contribute to the observed reduction in liner 

thickness. Also, the observed outcome is attributed to the 

proximal pressure exerted on the AERO liner. Prolonged 

exposure to such pressures could potentially compromise 

the liner's durability, leading to discomfort within the 

prosthesis. Therefore, it is essential to consider the shape 

of the prosthetic socket to avoid localized pressure.  

One approach to minimize the impact of these symptoms is 

socket design. In this study, all participants used the PTB 

socket, which is a common choice for RLE. The PTB socket 

was designed to provide proximal compression within the 

socket for weight bearing. However, concerns have been 

raised in some studies about the potential impact of this 

socket design on residual limb.17,18 Given the roll-on 

application method of the AERO liner, it may be worth 

exploring the suitability of total surface bearing socket (TSB) 

to enhanced comfort and load distribution.19-21 Evenly 

distributing pressure across the liner is believed to reduce 

localized pressure points and maintain consistent liner 

thickness.22,23 

Limitations 

The limitations of this study must be acknowledged. The 

relatively small sample size may have influenced the 

statistical significance of certain findings such as user 

preferences. Since participants had the option to change to 

their AERO spare liner if necessary, this may have had an 

effect on satisfaction and odor. Future research, with larger 

and more diverse participant pools, may provide additional 

insights. Outcomes of interest in this study was comfort and 

satisfaction, which are pivotal factors that influence the 

acceptance and long-term use of prosthetic devices. 

Previous studies have recognized the effectiveness of gel 

liners but have also highlighted concerns related to 

discomfort resulting from sweating.6 While the AERO liner 

facilitates roll-on donning for a better fit with the residual 

limb, our investigation did not reveal any significant 

evidence supporting the notion that AERO liner usage is 

linked to increased perspiration. 

CONCLUSION 

In conclusion, this study highlights a potential comfort and 

satisfaction benefit of using the AERO liner. However, 

proximal liner thickness may reduce over time which might 

impact socket fit and comfort. While our results indicate 

promising trends, further research is needed to confirm 

these findings and explore the interplay between liner types, 

socket shapes, and user experiences comprehensively. 

These findings contribute to ongoing efforts to enhance the 

quality of life of individuals with lower limb amputations who 

reside in RLE by optimizing prosthetic interventions. 

ACKNOWLEDGEMENTS 

The authors would like to express their gratitude to the participants 

of this research and acknowledge the support from the Faculty of 

Medicine, Siriraj Hospital, Mahidol University. 

DECLARATION OF CONFLICTING INTERESTS 

The authors declare no conflicts of commercial or financial interest 

in this research. 

AUTHORS CONTRIBUTION 

• Yusuke Miyata: original drafting, writing, data collection, 

statistical analysis. 

 

• Kazuhiko Sasaki: conceptualization, writing, data collection, 

statistical analysis. 

 

• Gary Guerra: writing, statistical analysis, proofing. 

 

• Woratee Dacharux: writing, data collection, proofing. 

 

• Pilipda Chaiwan: writing, data collection, proofing. 

 

SOURCES OF SUPPORT 

This research received funding from the Faculty of Medicine, Siriraj 

Hospital, Mahidol University. 

ETHICAL APPROVAL 

This study was approved by the Siriraj Faculty of Medicine 

Institutional Review Board (Si 419/2022). 

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https://doi.org/10.33137/cpoj.v6i1.41865
https://spucon.spu.ac.th/filemanager/files/International%20Papers.pdf
https://spucon.spu.ac.th/filemanager/files/International%20Papers.pdf

