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VOLUME 8, ISSUE 1 

 2025 
 

REVIEW ARTICLE 

Edwards R, Murray L, Buis A. The role of human thermoregulation in thermal discomfort in lower-limb prosthetics: A scoping review. 

Canadian Prosthetics & Orthotics Journal. 2025; Volume 8, Issue 1, No.3. Https://doi.org/10.33137/cpoj.v8i1.43073 

 

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1 

Edwards R, Murray L, Buis A. The role of human thermoregulation in thermal discomfort in lower-limb prosthetics: A scoping review. Canadian Prosthetics & 
Orthotics Journal. 2025; Volume 8, Issue 1, No.3. Https://doi.org/10.33137/cpoj.v8i1.43073 

 

 

REVIEW ARTICLE 

 

THE ROLE OF HUMAN THERMOREGULATION IN THERMAL DISCOMFORT IN LOWER-LIMB 

PROSTHETICS: A SCOPING REVIEW 

Edwards R*, Murray L, Buis A  

Department of Biomedical Engineering, Faculty of Engineering, University of Strathclyde, Glasgow, Scotland. 
 
  
 

 

 

 

  

 

 

 

 

 

 

 

 

 

 

 

 

INTRODUCTION   

 

Acquired amputation can result from a number of 

pathologies such as diabetes, vascular disease, cancer and 

trauma. Globally, in 2017, 58 million people were living with 

an  amputation  due  to traumatic causes.1  At a regional 

level, between 1990 and 2019, South Asia saw the highest 

prevalence during this period with 100 million traumatic 

amputations.  

 

 

 

 

 

Traumatic amputation accounts for 45% of all amputations. 

Individuals in this group typically have no additional 

comorbidities or pathologies and are likely to return to a 

level of activity similar to their pre-amputation status.2 

However, these prosthetic users who are wearing the 

prosthesis for longer periods, and actively engaged in 

employment and hobbies, often report complications related 

to thermal discomfort, regardless of geographical location.3 

The scientific literature regarding thermal discomfort and 

perspiration has been documented by multiple authors. It is 

for instance reported, that persons who wear a prosthesis 

are more susceptible to increased heat and perspiration, 

 
OPEN  ACCESS 

ABSTRACT 

BACKGROUND: Thermal discomfort is one of the most prevalent issues experienced by lower-limb 

prosthetic users where, on average, 54% of users report thermal-related issues. This arises from wearing a 

prosthetic socket, which may disrupt the thermoregulatory system due to the low thermal conductivity of 

materials used in prosthetic sockets and liners. Despite the reported prevalence, there is little understanding 

of the impact of wearing a prosthesis on the body’s thermoregulatory system and how users perceive thermal 

discomfort. 

OBJECTIVE(S): This review aimed to evaluate the current understanding of how human thermoregulation 

correlates with subjective measures of thermal discomfort among lower-limb prosthetic users. It sought to 

gain a deeper understanding of how thermoregulatory parameters compare and relate to the subjective 

experience of thermal discomfort in this population. 

METHODOLOGY: The study design followed a scoping review structure to identify gaps in knowledge on the 

topic. A literature search was conducted across five online databases: Medline (ProQuest), EMBASE, 

Cochrane, CINAHL and PsycINFO. The searches covered literature from the earliest available date in each 

database up until February 2024. A search strategy was created to identify the relevant literature. An 

inclusion/exclusion criterion was then applied to identify studies that only measured either physiological or 

psychological aspects of thermoregulation and compared these aspects to thermal discomfort/comfort 

feedback. The QualSyst critical appraisal tool was used to gain quality score for each included article. 

FINDINGS: 8 articles were identified for inclusion in this review, confirming a dearth in research into how 

wearing a prosthesis affects thermoregulation at the body/device interface (BDI) and the perception of 

thermal discomfort. Furthermore, it raised question to the relevance of using residual limb skin temperature 

measurements to assess thermal discomfort in lower-limb prosthetics. Perspiration at the BDI emerged as a 

potentially significant contributor to thermal discomfort, a consensus reflected in the literature. 

CONCLUSION: Despite significant technological advancements, thermal discomfort remains a persistent 

issue. Therefore, further research is warranted to further understand how wearing a prosthesis affects the 

thermoregulatory system, enabling the development of innovative components which can mitigate thermal 

discomfort and in turn improve the quality of life of lower-limb prosthetic users. 

 

 

 

ARTICLE INFO 

Received: April 12, 2024 

Accepted: March 17, 2025 

Published:  March    28,   2025 
 

CITATION 

Edwards R, Murray L, Buis A. 

The role of human 

thermoregulation in thermal 

discomfort in lower-limb 

prosthetics: A scoping review. 

Canadian Prosthetics & 

Orthotics Journal. 2025; 

Volume 8, Issue 1, No.3. 

Https://doi.org/10.33137/cpoj.

v8i1.43073 

KEYWORDS 

Literature Review; Scoping 

Review; Thermal Discomfort; 

Lower Limb Amputation; 

Prosthesis; Skin; Prosthetic; 

Amputation; Body/Device 

Interface; Thermoregulation; 

Temperature; Perspiration.  

 

* CORRESPONDING AUTHOR: 

Professor Arjan Buis, PhD 

Department of Biomedical Engineering, Faculty of Engineering, University 
of Strathclyde, Glasgow, Scotland. 

E-Mail: arjan.buis@strath.ac.uk 

ORCID ID: https://orcid.org/0000-0003-3947-293X 

 

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

Volume 8, Issue 1, Article No.3. 2025 

 

 

https://doi.org/10.33137/cpoj.v8i1.43073
https://doi.org/10.33137/cpoj.v8i1.43073
https://doi.org/10.33137/cpoj.v8i1.43073
mailto:arjan.buis@strath.ac.uk
https://orcid.org/0000-0003-3947-293X
https://jps.library.utoronto.ca/index.php/cpoj/index


 

2 

Edwards R, Murray L, Buis A. The role of human thermoregulation in thermal discomfort in lower-limb prosthetics: A scoping review. Canadian Prosthetics & 
Orthotics Journal. 2025; Volume 8, Issue 1, No.3. Https://doi.org/10.33137/cpoj.v8i1.43073 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X THERMOREGULATION AND THERMAL DISCOMFORT IN LOWER-LIMB PROSTHETICS: A SCOPING REVIEW 

Edwards et al., 2025 

evident in the fact that, on average, 54% of prosthetic users 

report thermal-related issues.3 Klute et al. described that 

susceptibility arises from wearing a prosthetic socket, which 

may disrupt the thermoregulatory system due to the low 

thermal conductivity of the materials used in manufacturing 

prosthetic sockets and liners.4 Despite the reported 

prevalence of the issue, there is little understanding of the 

impact of wearing a prosthesis on the body's 

thermoregulatory system and how users perceive thermal 

discomfort. Current research into thermal discomfort has 

been focused more on lower-limb prosthetics with one study 

reporting that people with a transfemoral amputation rated 

thermal discomfort to be higher compared to people with a 

transtibial amputation.5 

Overall prosthetic socket comfort is essential for prosthetic 

use and, clinicians and prosthetic companies strive to 

deliver the best fitting and most comfortable sockets 

possible. This is to ensure user satisfaction, a reduction in 

prosthetic abandonment and increasing quality of life.6 

Ensuring a good socket fit requires appropriate force 

transmission coupled with a reliable suspension method 

provided by a bespoke, socket. This, however, encloses the 

residuum which can hinder heat exchange, leading to 

elevated skin temperature and perspiration at the 

body/device interface (BDI). In addition, patella tendon-

bearing sockets are frequently being replaced by total 

surface-bearing sockets, which often require an elastomeric 

liner which, although functionally advantageous, could 

increase the incidence of prosthetic-related thermal stress.7 

The skin is vital for thermoregulation, enabling heat 

exchange between the body and the external environment, 

known as sensible heat transfer. This process involves heat 

loss through subcutaneous blood vessels via vasodilation, 

evaporative heat loss via sweating and the flattening of hairs 

to remove the insulating layer of air over the skin.8 Donning 

a prosthesis impairs heat transfer between the residual limb 

and the environment for all three of these mechanisms by 

creating an impermeable barrier at the BDI. This creates the 

potential for an unnaturally warm and moist environment, 

leading to skin pathologies and functional issues with the 

prosthesis. Users may experience skin irritation or blistering 

which combined with the unfavorable environment can lead 

to infections.9  

Pistoning, known as relative motion between the residual 

limb and the socket, can also occur due to micro-film 

lubrication as a result of sweat build-up, affecting socket 

suspension. Henao et al. discovered an increase in the 

coefficient of friction at the BDI in the presence of sweat 

which, when coupled with pistoning, could rapidly increase 

the onset of blistering.10 

The human thermoregulatory process tightly regulates body 

core temperature around 37°C against thermal 

disturbances to maintain homeostasis and can be divided 

into two categories: autonomic and behavioral. The 

autonomic thermoregulatory process is involuntary and can 

alter heat production and dissipation through shivering or 

non-shivering thermogenesis, or as aforementioned, 

through vasodilation of subcutaneous blood vessels and 

evaporative heat loss.11 Behavioral thermoregulation is a 

voluntary process whereby a conscious decision is made to 

adapt to a change in the thermal environment. For example, 

seeking shade in a hot climate or adding clothing when too 

cold.12 Human perception of thermal discomfort may play an 

important role in activating behavioral thermoregulation. 

Discomfort arises when thermal stimuli result in a deviation 

of core temperature from the norm.13 

Hensen et al. has defined thermal comfort as “that condition 

of mind which expresses satisfaction with the thermal 

environment”.14 It was also defined by The American 

Society of Heating, Refrigerating and Air-Conditioning 

Engineers (AHSREA) as “the condition of mind in which 

satisfaction is expressed with the thermal environment”.15 

These definitions allude to the fact that thermal comfort is a 

state of mind, rather than a state condition, indicating its 

subjectivity with it being influenced by personal differences 

in mood, culture and other individual, organizational and 

social factors.16  While thermal discomfort plays a role in 

autonomic thermoregulation, it primarily drives behavioral 

thermoregulation due to its significant influence on skin 

temperature. Skin surface temperature has a relatively 

greater contribution to subjective thermal discomfort than 

the autonomic response. Due to this, thermal comfort 

initiates behavioral thermoregulation before autonomic 

thermoregulation. This is due to autonomic 

thermoregulation being a more metabolically demanding 

response that maintains body temperature.17 When wearing 

a prosthesis, the heat exchange processes through 

autonomic thermoregulation could be compromised. In 

addition, the behavioral thermoregulatory act is for the user 

to remove their prosthesis. This should not have to occur, 

but if necessary, this may not always be possible during 

day-to-day activities, compromising this thermoregulatory 

process.  

With the knowledge that thermal discomfort may play a key 

role in both autonomic and behavioral thermoregulation, 

and that numerous prosthetics users report thermal 

discomfort, this scoping review has studied the available 

literature that compares thermoregulation to thermal 

discomfort in lower-limb prosthetics. It also assessed the 

breadth and depth of understanding of the impact that 

wearing a prosthesis has on the fundamental physiological 

processes involved in thermoregulation at the BDI. 

METHODOLOGY 

Search Strategy 

A scoping review was undertaken to assess the current 

knowledge relating to the involvement of human 

thermoregulation in thermal discomfort for lower-limb 

prosthetic users. This review aimed to assess the different 

https://doi.org/10.33137/cpoj.v8i1.43073


 

3 

Edwards R, Murray L, Buis A. The role of human thermoregulation in thermal discomfort in lower-limb prosthetics: A scoping review. Canadian Prosthetics & 
Orthotics Journal. 2025; Volume 8, Issue 1, No.3. Https://doi.org/10.33137/cpoj.v8i1.43073 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X THERMOREGULATION AND THERMAL DISCOMFORT IN LOWER-LIMB PROSTHETICS: A SCOPING REVIEW 

Edwards et al., 2025 

thermoregulatory factors, either physiological or 

psychological, to gain a deeper understanding of how 

human temperature regulation may be influencing thermal 

discomfort or vice versa. The methodology for this literature 

review was chosen to identify research gaps to guide future 

experimental research into the perception of thermal 

discomfort in lower-limb prosthetics. 

A literature search was conducted between 15/01/24 and 

02/02/24. The search was completed across 5 online 

databases; Medline (ProQuest), EMBASE, Cochrane, 

CINAHL and PsycINFO and the results were transferred to 

EndNote. Keywords were combined with Boolean operators 

to create a search strategy. The strategy utilized is 

highlighted in Table 1. 

Table 1: Search strategy used across all five databases. 

 

Search Selection 

The searches spanned the period from the earliest date of 

each database until February 2024. All chosen articles from 

each database were then transferred into the EndNote 

(Version 20.3.0.17787) reference management software, 

and all duplicates were removed. Search results from each 

database were screened by title and abstract. The relevant 

articles which matched the inclusion and exclusion criteria, 

as presented in Table 2, were then chosen. Articles were 

included if the abstracts discussed or measured 

thermoregulation and/or thermoregulatory processes in 

either physiological or psychological terms and made a 

comparison to thermal discomfort in lower-limb prosthetics. 

Articles inclusion was assessed by two researchers. Four 

articles were identified by one reviewer and not the other 

and were discussed as a group.18-21 Upon discussion, these 

articles were not included in the review. Although they 

measured thermoregulatory parameters and addressed 

thermal discomfort as an issue, they did not discuss or 

record subjective measurements for comparison with the 

thermoregulatory parameters. 

Data extraction  

Data from the remaining articles were extracted and 

documented in a data extraction table (Table 3), providing 

an overview of the current literature and highlighting 

emerging themes. The information gathered was as follows: 

author, year of publication, location of the study, sample 

size, study design, participant demographic, testing 

interventions temperature/perspiration outcomes and the 

QualSyst quality threshold score.22 The findings are 

summarized in the attached data extraction table. 

Table 2: Inclusion and exclusion criteria. 

Inclusion criteria Exclusion criteria 

• Studies published in English. 

• Only peer-reviewed. 

• Studies that measured 
thermoregulation and/or 
thermoregulatory processes 
and made a comparison to 
thermal discomfort feedback. 

• Studies that included lower-limb 
prosthetics users.  

• Literature review studies. 

• Studies that did not measure 
physiological or psychological 
aspects of thermoregulation 
and make a comparison to 
thermal dis/comfort feedback. 

• Studies conducted on animals 
or prototypes. 

 

Quality assessment 

Following the application of the inclusion and exclusion 

criteria to the titles and abstracts, all chosen full-text articles 

were critically appraised using the QualSyst tool. Proposed 

by the Alberta Heritage Foundation, this tool allows for a 

quantitative and reproducible method of identifying literature 

quality by providing an output number.22 The assessment of 

quantitative studies consists of 14 questions. A score of 0 to 

2 can be awarded for each question. A summary score is 

calculated for each paper indicating its quality. The 

QualSyst tool suggests a cut-off score of 0.75 for a paper to 

be included in a review article. The summary score 

calculation process can be seen in APPENDIX.  

The quality of the paper is then further defined in a literature 

review with a scoring system defined by Lee et al. as; strong 

(summary score of >0.80), good (summary score of 0.71-

0.79), adequate (summary score of 0.5-0.7) and limited 

(summary score of <0.5).23 The QualSyst score for each 

study can be seen in the data extraction table (Table 3). Due 

to the low number of included articles, the exclusion of 

papers lower than the cut-off score was not appropriate, 

therefore, quality assessment was conducted as an 

outcome measure to promote discussion, rather than an 

exclusion criterion.   

RESULTS 

The search yielded 2612 articles after the removal of 

duplications. After the inclusion and exclusion criteria were 

applied to the title and abstract of the remaining articles, 8 

were taken forward for quality assessment and review. This 

selection process can be seen in the PRISMA flow chart 

shown in Figure 1. Four studies achieved an adequate 

score, two achieved a good score and two achieved a 

strong score. The results discussed in the section are 

presented in more detail in Table 3.  

 

 Search terms 

1 Thermoregulation OR “Thermal response” OR Temperature 

2 Prosthe* OR “Artificial Limb” (MeSH) 

3 “Residual Limb” OR Stump 

4 Amputee (MeSH) OR Amputa* 

5 1 AND 2  

6 1 AND 3 

7 1 AND 4 

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4 

Edwards R, Murray L, Buis A. The role of human thermoregulation in thermal discomfort in lower-limb prosthetics: A scoping review. Canadian Prosthetics & 
Orthotics Journal. 2025; Volume 8, Issue 1, No.3. Https://doi.org/10.33137/cpoj.v8i1.43073 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X THERMOREGULATION AND THERMAL DISCOMFORT IN LOWER-LIMB PROSTHETICS: A SCOPING REVIEW 

Edwards et al., 2025 

 

Figure 1: PRISMA flow diagram. 

Countries reported 

Five studies reported data from the USA; three from 

Seattle,24-26 one from Ohio,27 and one from Indianapolis.28 

Two studies reported data from the UK; one from London,29 

and one from Oxford.5 One study reported data from 

Hiroshima, Japan.30 

Study method 

All eight studies used a quantitative approach. Specifically, 

four studies used a randomized control trial 

methodology.25,27,28,30 One study used a comparative study 

methodology,5 whilst another used a repeated measure 

pilot study methodology.29 One study used a structured 

observation study design,26 and another utilized an 

observational experimental methodology.24  

Study sample sizes 

A total of 96 participants were included across the eight 

studies, 62 participants with a transtibial amputation from 

seven studies,5,24-27,29,30 25 participants with a transfemoral 

amputation from four studies,5,28-30 2 participants with a bi-

lateral amputation from two studies,27,29 and 7 participants 

without an amputation from one study.30 One study tested 5 

participants with a transfemoral amputation and 2 

participants with a transtibial amputation alongside 7 

participants without an amputation as a control group for 

comparison.30 Another study involved a participant with a 

bilateral amputation to conduct a blind test of two 

interventions simultaneously, allowing for immediate 

comparison of results.27 

Thematic analysis 

Within the broad scope of reviewing thermoregulation and 

thermal discomfort in lower-limb prosthetics, four themes 

emerged. Theme 1 – The effect of activity on residual limb 

skin temperature, and making a comparison to thermal 

discomfort as a related issue, Theme 2 Comparing the 

effect of a prosthetic cooling intervention to a regular non-

cooling prosthetic design on thermoregulatory and 

subjective measures, Theme 3 – Comparing 

thermoregulatory and subjective responses between 

participants with a lower-limb amputation and control 

participants in a hot environment, Theme 4 – Measuring 

residual limb skin temperature to verify out-of-lab thermal 

comfort studies. 

Theme 1: Klute et al. investigated the impact of increasing 

activity on residual limb skin temperature in lower-limb 

amputees, commenting on thermal discomfort decreasing 

quality of life as a result of the increased temperature. The 

author highlighted the need for developing a cooling 

intervention to improve thermal comfort and promote 

prosthetic adherence by reducing local perspiration.24 Segal 

et al. reported an increase in mean residual limb skin 

temperature and core temperature during exercise testing 

in a cold environment. Perceived thermal discomfort levels 

were elevated on the residual limb compared to the 

contralateral limb post-exercise.26 Diment et al. reported 

both residual and contralateral limbs cooling during exercise 

and no significant difference in skin temperature between 

the limbs. Thermal discomfort was greater on the 

amputated side compared to the contralateral side.5 

Theme 2: Three studies25,27,28 tested a prosthetic cooling 

intervention against a regular non-cooling prosthesis and 

reported the differences in residual limb skin temperature 

and perspiration levels. Two studies compared the 

thermoregulatory measures against subjective responses 

including thermal comfort, thermal sensation and prosthetic 

satisfaction.25,28 Klute et al. compared a dynamic air 

exchange (DAE) prosthetic socket to a total surface-bearing 

suction socket (Suction). No significant difference in 

residual limb skin temperature was reported between the 

groups however a significant reduction in perspiration was 

observed in the DAE results. Subjective measures revealed 

better residual limb health and a reduction in heat and 

Records identified 
from databases: 
(n=3905) 
  
Medline (n=866) 

Embase (n=2516) 

Cochrane (n=253) 

Cinahl (n=225) 

PsycINFO (n=45) 

Records removed 
before screening: 
Duplicate records 
removed (n =1293) 

 Id
e

n
ti

fi
c
a

ti
o

n
 

Records screened 
(n = 2612) 

Records excluded 
(n = 2560) 

Reports sought for 
retrieval (n = 52) 

Reports not retrieved 
(n = 0) 

Reports assessed 
for eligibility (n = 52) 

Studies included in 
review (n = 8) 
 

S
c
re

e
n

in
g

 
 

In
c
lu

d
e

d
 

Identification of studies via databases and registers 

Reports removed for 

ineligibility (n = 44) 

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5 

Edwards R, Murray L, Buis A. The role of human thermoregulation in thermal discomfort in lower-limb prosthetics: A scoping review. Canadian Prosthetics & 
Orthotics Journal. 2025; Volume 8, Issue 1, No.3. Https://doi.org/10.33137/cpoj.v8i1.43073 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X THERMOREGULATION AND THERMAL DISCOMFORT IN LOWER-LIMB PROSTHETICS: A SCOPING REVIEW 

Edwards et al., 2025 

sweating when wearing the DAE prosthesis, however, it 

was found to be more frustrating than the Suction 

prosthesis.25 Gnyawali et al. compared a vented liner-

socket system (VS, Ossur) with a Seal-in liner and non-

vented socket (nVS, Ossur). During activity, relative socket 

humidity was reduced in the (VS, Ossur) compared to the 

(nVS, Ossur). However, no significant difference in in-

socket temperature between the two systems was reported. 

There was also no significant difference between subjective 

measure reports on suspension, comfort or stability 

between the two systems.28 Wernke et al. compared a 

SmartTemp Phase Change Material liner against a placebo 

liner and reported a reduction in residual limb skin 

temperature and local perspiration within the SmartTemp 

group.27  

Theme 3: Hasegawa et al. compared both 

thermoregulatory and subjective responses between 

participants with lower-limb amputation and a control group 

of participants without an amputation, under the same 

exercise conditions in a hot environment. Core temperature 

increased throughout exercise testing however no 

difference was observed between the groups. Skin 

temperature also increased throughout both groups but 

tended to be higher in the group of participants with a lower 

limb amputation. Local sweat rate increased for both groups 

however a difference between the amputated and 

contralateral limb was observed in the group of participants 

with a lower-limb amputation, with a higher local sweat rate 

being observed on the contralateral side. Thermal sensation 

was lower in the group of participants with a lower limb 

amputation. Thermal comfort decreased for both groups 

during exercise however it remained higher within the group 

of participants with a lower limb amputation.30  

Theme 4: Williams et al. compared residual limb skin 

temperature measurements during an exercise test in a 

controlled environment to measurements obtained during 

out-of-lab testing of participants engaging in daily activities. 

Results revealed that on average, residual limb skin 

temperatures were higher in out-of-lab testing.29 

DISCUSSION 

To the best of the author’s knowledge, this scoping review 

represents the first evaluation of literature regarding 

thermoregulatory measures – such as skin temperature, 

core temperature or sweating - for addressing thermal 

discomfort in lower-limb prosthetics. Notably, a previous 

literature review has been undertaken which explored the 

prevalence of heat and perspiration discomfort within 

prosthetics.3 The main findings of this review include 

inconsistent findings on the role of skin temperature in 

thermal discomfort, raising questions about its significance 

as a measurable parameter. In addition, thermal discomfort 

was often linked to sweat accumulation rather than skin 

temperature changes. Sweat accumulation in the socket 

may be a major discomfort due to the involvement of wet 

skin discomfort and mechanoreceptor activation. People 

with lower-limb amputation may compensate for heat 

dissipation with increased sweating and blood flow in other 

body areas. 

Review Scope and Objectives 

The findings of this review address the utilization of 

thermoregulatory measures in testing to investigate 

thermal-related issues in lower limb prosthetics, to 

potentially identify novel directions for experimental design 

in future research.  

Despite the importance of addressing thermal discomfort in 

lower-limb prosthetics and its consequent effect on user 

satisfaction and quality of life, limited evidence is available 

at present on how to address the issue. This may be due to 

a lack of understanding of the effects a prosthesis has on 

the thermoregulatory processes, how prosthetic liners or 

sockets interact with the skin and how thermal discomfort is 

perceived by people with an amputation. 

Skin Temperature Measurements 

When addressing the issue of thermal discomfort in lower-

limb prosthetics, researchers have measured skin 

temperature changes at the residual limb as many people 

with an amputation report elevated skin temperatures and a 

consequent increase in perspiration to be a cause of 

discomfort.3,31-35  All the studies included in this review 

measured the change in residual limb skin temperature in 

response to activity. This may be indicative of residual limb 

skin temperature being the most widely accepted 

measurement when carrying out experimental research into 

lower-limb prosthetic thermal discomfort. Four studies 

reported a significant increase in residual limb skin 

temperature during activity.24,26,29,30 Both Klute et al. and 

Wernke et al. reported an overall increase in residual limb 

skin temperature during activity, however, no significant 

difference between the DAE Socket and SmartTemp Liner 

designs was observed compared to the conventional socket 

and liner.25,27 Gynawali et al. reported no significant change 

in residual skin temperature post-exercise.28 Diment et al. 

reported a slight decrease in residual limb skin temperature 

on average post-exercise.5 The conflict in the results may 

allude to whether or not residual limb skin temperature may 

be the prime factor in thermal discomfort. 

Perspiration Measurements 

As a reported consequence of an increased thermal 

environment at the BDI, lower-limb prosthetic users also 

commonly report increased perspiration within the socket 

leading to sweat build-up. This has directed research 

towards improving socket and liner designs to reduce 
perspiration levels.  

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6 

Edwards R, Murray L, Buis A. The role of human thermoregulation in thermal discomfort in lower-limb prosthetics: A scoping review. Canadian Prosthetics & 
Orthotics Journal. 2025; Volume 8, Issue 1, No.3. Https://doi.org/10.33137/cpoj.v8i1.43073 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X THERMOREGULATION AND THERMAL DISCOMFORT IN LOWER-LIMB PROSTHETICS: A SCOPING REVIEW 

Edwards et al., 2025 

 

Table 3: Data extraction table. 

Author; year; 

location; 

sample size  

Study design 

Participant 

demographic: 

amputation; age 

Measurement 

tools utilised 
Temperature/perspiration outcomes 

QualSyst 

Quality 

Threshold 

Score 

Diment et al. 

2019; Oxford; 

305 

 

Comparative 

study. 

TF 11, TT 19; 

23-65yr 

Clinical infrared 

thermometer.                                    

6-point heat and 

sweat discomfort 

scale. 

 
Primary: i). Skin temperature change. 
Findings: ANOVA test showed that on average, the skin on 
both legs cooled during exercise (0.085°C/min, p = 0.002). 
There was no significant difference in skin temperature 
between the amputated and contralateral limbs. A significant 
difference in skin temperature was observed between the front 
and back of the leg with the back being significantly warmer 
post-exercise. 
 
Secondary: i). Variation in temperature response between 
amputated and contralateral limb. 
Findings: Temperature changes were small, with a large 
standard deviation of approximately 0.5°C on each limb. The 
average deviation between the 3 measurements taken at each 
location was 0.021°C. 
 

0.86 

Gnyawali et al. 

2023;  

Indianapolis; 

928 

Randomised 

controlled trial. 

TF 46.5yr ± 

14.03 

Vented liner-
socket system 
(VS, Ossur).  
Non-vented socket 
(nVS, Ossur).  
Data logger 
system with 
humidity and 
temperature 
sensors. 
10-point perceived 
sweat scale.  
CLASS Survey               

 
Primary: i). Skin humidity change. 
Findings: No meaningful changes were observed for both 
sound and a residual limb during baseline testing. Humidity 
significantly increased during activity compared to the baseline 
on the residual limb compared to the sound side. The relative 
residual limb humidity was significantly lower during activity 
with the use of the VS compared to the nVS. 
ii). In-socket/skin temperature change. 
Findings: No significant increase between the (nVS vs VS). 
There was also no significant difference in skin temperature 
between the residual and sound limbs. 
 
Secondary: i). Perceived sweat score 
Findings: Significantly lower in the VS group compared to the 
nVS group. 
 

0.83 

Klute et al. 

2016; Seattle; 

525 

Randomised 

control trial. 

TT; 18-70yr 
 

DAE socket. 
TSB suction 
socket. 
Two thermistor 
sensors. 
Gravimetry. 
Prosthesis 
evaluation 
questionnaire. 
Custom, self-
reporting 
questionnaire. 

Primary: i). Residual limb skin temperature change. 
Findings: No difference between the two prostheses was 
observed during the rest-walk-rest protocol. 
ii). Accumulated/expelled perspiration. 
Findings: The DAE prosthesis accumulated 1.09 ± 0.90g and 
expelled 0.67 ± 0.38g of perspiration. The Suction prosthesis 
accumulated 0.97 ± 0.75g of perspiration. 
 
Secondary: i). Residual limb skin temperature increased ~3°C 
for both prostheses during the 30-minute treadmill walk. 

0.79 

Hasegawa et 

al. 2020;  

Hiroshima; 

1430 

Randomised 

controlled trial. 

TF 5, TT 2, C 7; 

LLA (36.4yr ± 

4.4); C (31.7yr ± 

7.8) 

A rectal thermistor. 
Thermistor 

sensors. 

Body surface area 

DuBois formula. 

Sweat capsule and 

a local sweat 

meter. 

Laser Doppler 

blood flow meter. 

 
Primary: i). Rectal temperature change. 
 Findings: Increased throughout the test however no difference 
was observed between the groups. 
ii). Skin temperature change. 
Findings: Increased throughout the test in both groups 
however intended to be higher in the LLA group. 
iii). LSR change. 
Findings: Increased throughout the test for both groups at the 
thigh. A difference between the left and right leg was not 
observed in the C group. In the LLA group, LSR was 
significantly greater on the non-amputated side compared to 
the amputated side. The total sweat rate was also significantly 
higher in the LLA group. 
 

0.73 

Wernke et al. 

2015; Ohio, 

1627 

Double-blind 

randomised, 

crossover 

design. 

TT (1 BL); 32-

78yr 

SmartTemp liner 

and placebo liner.  

4 thermocouples.                                         

Gravimetry. 

 
Primary: i). Skin temperature change. 
Findings: The mean increase after activity was 0.2°C higher for 
the placebo liner compared to the SmartTemp liner. 
ii). Accumulated perspiration. 
 Findings: Significantly reduced when wearing the SmartTemp 
liner for 12 participants post-activity 
 
Secondary: i). Inclusion of a bilateral amputee for testing both 
treatments in the same activity. 
 Skin temperature increased during activity on both limbs, 
however, skin temperatures associated with the SmartTemp 
liner were lower compared to the placebo liner. 

0.68 

 

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7 

Edwards R, Murray L, Buis A. The role of human thermoregulation in thermal discomfort in lower-limb prosthetics: A scoping review. Canadian Prosthetics & 
Orthotics Journal. 2025; Volume 8, Issue 1, No.3. Https://doi.org/10.33137/cpoj.v8i1.43073 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X THERMOREGULATION AND THERMAL DISCOMFORT IN LOWER-LIMB PROSTHETICS: A SCOPING REVIEW 

Edwards et al., 2025 

Four of the eight included studies measured perspiration 

within the socket during testing. Klute et al., Wernke et al. 

and Gnyawali et al. all reported an increase in sweat or 

humidity at the BDI during exercise.25,27,28 Wernke et al. also 

disclosed that 4 of the 16 subjects did not sweat in either of 

the tested liners during exercise.27 Hasegawa et al. reported 

an increase in local sweat rate at the thigh, with the 

prosthesis removed for the group of participants with an 

amputation.30  

Prosthetic Interventions for Thermal-Related Issues 

Prosthetic technologies have been engineered to mitigate 

heat and perspiration, serving as a targeted intervention. 

Such interventions include sockets which incorporate 

cooling mechanisms such as heat pumps or cooling 

channels and liners composed of phase change materials 

which can store and release heat, as presented in Table 

3.2,27,36 Klute et al., Wernke et al. and Gnyawali et al. 

conducted studies assessing the efficacy of an intervention 

device in contrast to conventional prosthetic components. 

Their research aimed to elucidate the effects of these 

interventions on thermoregulatory parameters during 

exercise.25,27,28 Klute et al. and Gynawali et al. both 

compared a conventional socket to an intervention socket, 

designed to expel accumulated perspiration and discussed 

changes in residual limb skin temperature, sweating and 

subjective measures. Wernke et al. compared a placebo 

liner to a SmartTemp liner composed of phase change 

material.27 As previously discussed, all three studies 

reported a significant reduction in perspiration levels during 

activity. However, no significant change in skin temperature 

was recorded. Participants also rated perceived limb 

perspiration to be lower when using the intervention sockets 

compared to the standard sockets.25,28 The outcomes from 

these studies suggest that prosthetic interventions targeting 

heat and perspiration reduction were significantly more 

Table 3 (continued): Data extraction table. 

Author; year; 

location; 

sample size  

Study design 

Participant 

demographic: 

amputation; age 

Measurement 

tools utilised 
Temperature/perspiration outcomes 

QualSyst 

Quality 

Threshold 

Score 

Segal et al. 

2016; Seattle; 

826 

 

Structured 

observational 

study 

TT; 31-64yr 

Four thermistor 

sensors.                                     

11-point Likert 

psychometric 

scale.      

Ingestible 

temperature 

sensor.                        

Polar heart rate 

monitor. 

 
Primary: i). Residual limb skin temperature change. 
Findings: Mean temperature increased from 30.6 °C ± 2.6°C at 
Rest1 to 34.5°C ± 1.7°C at the end of Exercise2. Temperature 
increased by 2.7°C at the end of Exercise1 compared to the 
end of Rest1, followed by an insignificant decrease of -0.3°C 
after Rest 2. After Exercise2, a further increase of 1.5°C 
occurred compared to Rest2 followed by insignificant cooling 
of -0.4°C at the end of Rest3. 
ii). Perceived thermal discomfort. 
Compared with Rest1, PTC across all regions increased for 
Exercise1 and Exercise2. Across bouts, residual limb PTC was 
higher than the intact limb. 
 
Secondary: i). Core temperature change. 
Findings: Increased by 0.9°C on average during Exercise1 and 
remained elevated throughout the remainder of the testing 
session. 
 

0.68 

Klute et al. 

2014; Seattle; 

924 

Observational 

study. 
TT; 28-73yr 

16 thermistor 
sensors. 

 
Primary: i) Skin temperature change. 
Findings: Initial 30-minute rest: Avg temp 31°C ± 1.5°C. Post-
30-minute treadmill walk: Avg temp 34.1°C ± 1.3°C. Final 60-
minute seated rest: Avg temp 33.2°C ± 1.2°C.       
                                                                                                                                                                                                               

0.64 

Williams et al. 

2018;  

London; 529 

Repeated 

measure pilot 

study. 

UL TF 3, UL TT 

1, BL 1  

(R TF, L TT); 

19-42yr 

12 thermistor 
sensors.                                   
Arduino 
microcontroller 
connected to a 
real-time clock and 
an SD card. 

 
Primary: i). Residual limb skin temperature change. 
Findings: Phase One - increase after donning the prosthesis. 
Exercise one: 4 participants showed an increase. 1 participant 
displayed no notable change. Final rest phase:  all participants 
showed a further increase. 
 
 Phase Two: all participants showed a higher temperature 
relative to Phase One. However, it was noted that this was 
unsurprising due to the difference in ambient temperature 
between the two tests. A maximum change in was observed in 
participant 5 with an increase of 5.1°C. 
 

0.50 

Abbreviations: TT: Transtibial amputee, TF: Transfemoral amputee, BL: Bilateral, UL: Unilateral, LLA: Lower-limb amputee, C: Control (person without an amputation), 

PTC: Perceived thermal comfort, LSR: Local sweat rate, CLASS: Comprehensive Lower Limb Amputee Survey, DAE: Dynamic air exchange, TSB: Total surface-

bearing. 

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8 

Edwards R, Murray L, Buis A. The role of human thermoregulation in thermal discomfort in lower-limb prosthetics: A scoping review. Canadian Prosthetics & 
Orthotics Journal. 2025; Volume 8, Issue 1, No.3. Https://doi.org/10.33137/cpoj.v8i1.43073 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X THERMOREGULATION AND THERMAL DISCOMFORT IN LOWER-LIMB PROSTHETICS: A SCOPING REVIEW 

Edwards et al., 2025 

proficient in lowering perspiration levels compared to their 

impact on residual limb temperature. 

Impact of Amputation on Heat Dissipation 

The process of amputation, by nature, reduces the surface 

area of the human body. Body surface area is reduced by 

approximately 21% for a transfemoral amputation and 9% 

for a transtibial amputation.35 This may impair a person with 

an amputation's ability to dissipate heat as there is less area 

for convection, radiation, evaporation and conduction to 

occur.3 Hasegawa et al. measured local sweat rate, skin 

blood flow at the thigh, and total sweat rate in both 

participants with an amputation and control participants 

without an amputation. In the control group, both skin blood 

flow and local sweat rate increased symmetrically across 

both limbs during exercise. In the group of participants with 

an amputation, skin blood flow measurements were 

significantly higher in the contralateral limb compared to the 

residual limb during exercise. Similarly, local sweat rate was 

significantly higher on the contralateral limb compared to 

the residual limb. Despite these differences, the total 

amount of local sweat rate across both limbs did not differ 

between the two groups. However, the total sweat rate was 

significantly higher in the group of participants with an 

amputation. Hasegawa et al. suggested that despite the 

lower body surface area for heat dissipation in people with 

an amputation, the overall heat dissipation was similar 

between the two groups. This was likely due to 

compensatory sweating on the torso and contralateral limb. 

They also inferred that increased blood flow on the 

contralateral side might indicate compensatory vasodilation 

on the limb with an amputation.30 This was supported by 

Diment et al. who found that the contralateral limb was 

typically warmer than the residual limb, even with the 

prosthesis donned when measuring skin temperature 

during exercise.5 The consistency in these findings 

indicates a compensatory role of heat dissipation following 

amputation.30 

Subjective Measures for Thermal Discomfort 

Both socket and thermal comfort and discomfort are 

inherently subjective, difficult to distinguish and vary from 

individual to individual, posing challenges to reproducibility 

and reliability as a measurable parameter.37 However, 

within the domain of prosthetics, it holds significant 

importance for researchers as it aids the identification of 

specific scenarios or environmental conditions associated 

with increased thermal discomfort. Thermal comfort and 

discomfort are commonly assessed through subjective 

measure questionnaires, whereby users report on comfort, 

heat levels, perspiration, suspension and functionality of 

their prosthesis. Five of the included studies recorded 

subjective measures.5,25,26,28,30 Segal et al., Diment et al. 

and Hasegawa et al. all measured thermal comfort or 

discomfort as a direct outcome.5,26,30 All three studies 

agreed that thermal discomfort increased at the residual 

limb with exercise. When comparing thermal discomfort 

between the residual and contralateral limb, both Segal et 

al. and Diment et al. reported heightened thermal discomfort 

at the residual limb compared to the contralateral limb.5,26 

Parallel to this, when comparing a group of participants with 

an amputation to a control group without an amputation, 

Hasegawa et al. reported an increase in thermal discomfort 

during exercise across all limbs in both groups. 

Interestingly, thermal discomfort was significantly lower on 

average in the group of participants with an amputation than 

in the control group. This may, however, be a result of 

testing being conducted with the prosthesis removed, 

suggesting people with an amputation may be more tolerant 

to thermal discomfort as the issue is experienced much 

more often compared to a person without an amputation.30  

Correlation Between Thermoregulatory Parameters and 

Subjective Measures 

To gain a better understanding as to what may be causing 

thermal discomfort for people with a lower limb amputation, 

it is important to draw links between the subjective 

responses and thermoregulatory measurements gathered 

during testing. Klute et al. discussed a general increase in 

residual limb skin temperature for both intervention and 

conventional sockets tested, although, no significant 

difference was seen between the two during exercise. The 

intervention socket significantly reduced the amount of 

accumulated sweat compared to the conventional socket. 

Subjects reported that the intervention socket reduced heat 

and sweat. They also “strongly agreed” with the statement 

that the intervention socket kept their residual limb at a more 

comfortable temperature whereas they “slightly disagreed” 

when wearing the standard socket.25 Segal et al. reported a 

significant increase in skin temperature during exercise, 

coinciding with an increase in thermal discomfort. Thermal 

discomfort tended to be higher at the residual limb 

compared to the contralateral limb.26 Hasegawa et al. 

reported an increase in skin temperature post-exercise in 

both groups of participants with an amputation and control 

groups along with an increase in local sweat rate and 

thermal discomfort.30 Gnyawali et al. reported no significant 

increase in residual limb skin temperature for both 

intervention and conventional sockets throughout testing. A 

significant increase in residual limb humidity measurements 

was observed during exercise. The perceived sweat score 

was reported significantly lower for subjects wearing the 

intervention compared to the conventional socket, however, 

The Comprehensive Lower Limb Amputee Survey 

(CLASS), used when assessing prosthetic fit, showed no 

significant difference between the groups for suspension, 

comfort or stability.28 Diment et al reported a decrease in 

residual limb skin temperature during exercise, however, 

thermal discomfort was still experienced, more so on the 

amputated side.5  

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9 

Edwards R, Murray L, Buis A. The role of human thermoregulation in thermal discomfort in lower-limb prosthetics: A scoping review. Canadian Prosthetics & 
Orthotics Journal. 2025; Volume 8, Issue 1, No.3. Https://doi.org/10.33137/cpoj.v8i1.43073 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X THERMOREGULATION AND THERMAL DISCOMFORT IN LOWER-LIMB PROSTHETICS: A SCOPING REVIEW 

Edwards et al., 2025 

An intriguing link between thermoregulatory parameters and 

subjective measures was made. Both Klute et al. and 

Gnyawali et al. reported a decrease in thermal discomfort 

when subjects were wearing a socket designed to reduce 

heat and perspiration, however, participants could not be 

blinded to the intervention sockets. Both interventions also 

reduced the amount of accumulated sweat within the 

socket. However, Klute et al. reported no significant 

difference in the increase of residual limb temperature 

between the two sockets. Gynawali et al. also reported the 

lack of a significant increase in skin temperature for both 

sockets.25,28  

Considering the reduction in thermal discomfort, coinciding 

with a reduction in accumulated sweat, without any 

significant changes in residual limb skin temperature, 

suggests that skin temperature may not be the primary 

instigator for lower-limb thermal discomfort. Furthermore, 

Diment et al. concluded that skin temperature does not 

explain the thermal discomfort experienced by the 

prosthetic users in their study.5 However, it is noteworthy 

that both Hasegawa et al. and Segal et al. reported an 

elevation in thermal discomfort alongside an increase in 

residual limb skin temperature.26,30   

Behavioral Thermoregulation 

Shlader et al. explored behavioral thermoregulation as the 

most favored and effective form of temperature regulation. 

They demonstrated that eliciting this behavior does not 

require a temperature change; rather, thermal sensation 

and discomfort alone suffice as triggers.38 Discussing the 

findings of Diment et al., even in the absence of a rise in 

residual limb skin temperature, the presence of thermal 

discomfort alone during exercise may prompt the person 

with an amputation to remove their prosthesis as a 

behavioral thermoregulatory response.5 

Future Research Directions 

These findings pose the question of how thermal discomfort 

is perceived by a person with an amputation when wearing 

a prosthesis. An avenue for future research may be to 

explore the effects of prolonged skin wetness due to sweat 

accumulation at the BDI. Detecting skin wetness has been 

shown to impact thermal comfort, and therefore 

thermoregulatory behavior which makes it a crucial 

mechanism for thermal adaptation.39 Humans detect skin 

wetness through multisensory integration between thermal 

and mechanosensory inputs.40 Under normal 

thermoregulatory circumstances, temperature sensation 

and thermal discomfort are linked to skin surface 

temperature in cold environments. In warm environments, 

on the other hand, thermal discomfort is more related to 

sweating than skin temperature, as skin temperature is 

maintained at a favorable level due to evaporative cooling 

due to sweating. It is suggested that one factor for this 

thermal discomfort is the level of wetness over the skin 

surface.41  

Limitations 

A limitation of this study was the inclusion of low-quality 

articles due to the low number of included literature. As 

aforementioned, only two articles achieved a strong 

QualSyst score of >0.80, two articles achieved a good 

QualSyst score of 0.71-0.79 and four articles achieved an 

adequate QualSyst score of 0.5-0.7. Referring to the 

QualSyst scores in the extraction table, five of the included 

articles scored below the suggested QualSyst cut-off score 

of 0.75, and if the score was used as an exclusion criterion 

instead of an outcome measure as per this review, these 

articles would have been removed. 

CONCLUSION 

This scoping review evaluated the current literature 

concerning thermoregulatory measures associated with 

thermal discomfort in lower-limb prosthetics. Whilst 

literature has explored the prevalence of heat and 

perspiration discomfort within prosthetics, this review 

investigated the utilization of thermoregulatory measures for 

addressing thermal-related issues.  

Although numerous studies have tested thermal discomfort 

in lower-limb prosthetics, there may be a lack of 

understanding of how donning a prosthesis affects 

thermoregulation from a physiological point of view. 

Measuring the change in residual limb skin temperature has 

been the focal point for discussing thermal discomfort in 

lower limb prosthetics, with several studies reporting 

elevated skin temperatures during exercise. However, 

conflicting results reporting a reduction or no change in skin 

temperature pose questions about the significance of the 

parameter as the prime factor in lower-limb prosthetic 

thermal discomfort.  

Another significant aspect contributing to prosthetic thermal 

discomfort is perspiration at the BDI leading to the 

accumulation of unevaporated sweat. Prosthetic 

interventions designed to reduce heat and perspiration at 

the BDI show promise for reducing perspiration and sweat 

accumulation, consequently improving thermal comfort, 

emphasizing the importance of technological 

advancements in this area.  However, little evidence 

emerged regarding the efficacy of these interventions for 

reducing residual limb skin temperature, with a lack of 

correlation between skin temperature measurements and 

thermal discomfort at the BDI.  

Whilst progress has been made to combat and further 

understand lower limb prosthetic thermal discomfort, both 

through design and research, a knowledge gap remains. In 

particular, regarding the perception of thermal discomfort 

and the involvement of not only skin temperature but also 

https://doi.org/10.33137/cpoj.v8i1.43073


 

10 

Edwards R, Murray L, Buis A. The role of human thermoregulation in thermal discomfort in lower-limb prosthetics: A scoping review. Canadian Prosthetics & 
Orthotics Journal. 2025; Volume 8, Issue 1, No.3. Https://doi.org/10.33137/cpoj.v8i1.43073 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X THERMOREGULATION AND THERMAL DISCOMFORT IN LOWER-LIMB PROSTHETICS: A SCOPING REVIEW 

Edwards et al., 2025 

the effects of prolonged skin wetness due to unevaporated 

sweat. This may be a pivotal parameter for further managing 

thermal discomfort, increasing usage and improving the 

quality of life for lower-limb prosthetic users. 

ACKNOWLEDGEMENTS 

The author would like to thank the ESRPC Centre for Doctoral 

Training in Prosthetics & Orthotics for its support. 

DECLARATION OF CONFLICTING INTERESTS 

The author has no conflicts of interest to declare. 

AUTHORS’ CONTRIBUTION 

Rowan Edwards conceived the idea, conducted the research, and 

drafted the manuscript, while Arjan Buis and Laura Murray 

provided supervision. All authors actively participated in the 

discussion of results and contributed to the manuscript's revision. 

All authors have read and approved the final version of the 

manuscript. 

 

SOURCES OF SUPPORT 

EPSRC Centre for Doctoral Training in Prosthetic & Orthotics – 

Grant number: EP/S02249X/1. 

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https://era.library.ualberta.ca/items/48b9b989-c221-4df6-9e35-af782082280e


 

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Edwards R, Murray L, Buis A. The role of human thermoregulation in thermal discomfort in lower-limb prosthetics: A scoping review. Canadian Prosthetics & 
Orthotics Journal. 2025; Volume 8, Issue 1, No.3. Https://doi.org/10.33137/cpoj.v8i1.43073 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X THERMOREGULATION AND THERMAL DISCOMFORT IN LOWER-LIMB PROSTHETICS: A SCOPING REVIEW 

Edwards et al., 2025 

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APPENDIX  

Alberta Foundation QualSyst tool. 

Criteria 
YES 

(2) 

PARTIAL 

(1) 
NO (0) N/A 

1 
Question / objective sufficiently 
described? 

    

2 
Study design evident and 
appropriate? 

    

3 
Method of subject/comparison group 
selection or source of information/input 
variables described and appropriate? 

    

4 
Method of subject/comparison group 
selection or source of information/input 
variables described and appropriate? 

    

5 
If interventional and random allocation 
was possible, was it described? 

    

6 
If interventional and blinding of 
investigators was possible, was it 
reported? 

    

7 
If interventional and blinding of subjects 
was possible, was it reported? 

    

8 

Outcome and (if applicable) exposure 
measure(s) well defined and robust to 

measurement/misclassification bias? 
Means of assessment reported? 

    

9 Sample size appropriate?     

10 
Analytic methods described/justified 
and appropriate? 

    

11 
Some estimate of variance is reported 
for the main results? 

    

12 Controlled for confounding?     

13 Results reported in sufficient detail?     

14 Conclusions supported by the results?     

 

The grey highlights indicate that the ‘N/A’ box cannot be checked for that 

criteria question. A summary score is calculated for each paper by summing 

the total score obtained across relevant items and dividing by the total 

possible score (i.e.: 28 – (number of “n/a” x2)).22 

https://doi.org/10.33137/cpoj.v8i1.43073

