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VOLUME 7, ISSUE 1 

 2024 
 

RESEARCH ARTICLE 

 

Brüggenjürgen B, Eilers L, Seidinger S, Kannenberg A, Stukenborg-Colsman C. Patients’ burden using microprocessor-stance-and-swing-control knee-ankle-

foot orthoses and outcomes compared to those with prior traditional knee-ankle-foot-orthosis. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 

1, No.1. https://doi.org/10.33137/cpoj.v7i1.42799 

 

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.v7i1.42799


 

1 

Brüggenjürgen B, Eilers L, Seidinger S, Kannenberg A, Stukenborg-Colsman C. Patients’ burden using microprocessor-stance-and-swing-control knee-ankle-foot 
orthoses and outcomes compared to those with prior traditional knee-ankle-foot-orthosis. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 1, No.1. 
https://doi.org/10.33137/cpoj.v7i1.42799 

 

 

RESEARCH ARTICLE 

 

PATIENTS’ BURDEN USING MICROPROCESSOR-STANCE-AND-SWING-CONTROL 

KNEE-ANKLE-FOOT ORTHOSES AND OUTCOMES COMPARED TO THOSE WITH PRIOR 

TRADITIONAL KNEE-ANKLE-FOOT-ORTHOSIS 

Brüggenjürgen B1*, Eilers L1, Seidinger S2, Kannenberg A3, Stukenborg-Colsman C4  

1  Institute for Health Services Research and Technical Orthopedics, Orthopedic Department - Medical School Hannover (MHH) at DIAKOVERE Annastift Hospital, 

Hannover, Germany.  
2  Otto Bock Healthcare Products GmbH, Vienna, Austria.  
3  Otto Bock Healthcare LP, Austin, Texas, USA. 
4  Foot Department, Orthopedic Department - Medical School Hannover (MHH) at DIAKOVERE Annastift Hospital, Hannover, Germany. 

 
  
 

 

 

 

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
OPEN  ACCESS 

ABSTRACT 

BACKGROUND: Patients with neuromuscular knee instability who are fitted with orthotic devices 

experience issues such as pain, falls, mobility limitations, and restricted participation. 

OBJECTIVES: To analyze the burden of disease in patients using a microprocessor-stance-and-swing-

control orthosis (MP-SSCO) and, if they had a previous orthosis, to compare their outcomes to those 

with previous use of a traditional knee-ankle-foot-orthosis (KAFO) under real-world conditions. 

METHODOLOGY: A structured cross-sectional survey was conducted in six orthotic and prosthetic 

clinics in Germany. Individuals who had been using an MP-SSCO (C-Brace) for at least six months, 

answered an internet-based survey to rate their current and recall previous device outcomes and 

experience. The questionnaire was self-developed based on established questionnaire design principles 

and pretested. Patients' well-being dimensions were analyzed with Likert scales. Experiences with 

current and previous orthotic devices were compared. Falls were analyzed both with and without outliers. 

FINDINGS: 21 individuals who had used a MP-SSCO for an average duration of two years participated. 

Fourteen patients had prior experience with a traditional KAFO orthosis. Among them, 78.6% recalled 

experiencing falls, with a combined annual frequency of 67.9 (SD=167.0, Median=12.0) events. After 

excluding the two outliers (624 and 182 falls), a mean of 12.1 falls per patient per year was reported 

(range: 0 to 54, SD=15.9, Median=8.5). With the MP-SSCO, only 42.7% reported falls with an annual 

frequency of 5.3 (SD=17.0, Median=0.0) falls (p<0.01). After excluding outliers for MP-SSCO users, the 

average number of falls was 0.5 per year (range 0 to 3, SD=0.9, Median=0.0). This value was significantly 

lower compared to the previous orthosis (p<0.01). With their previous KAFO, 57.1% of the participants 

reported being able to walk downstairs, 14.3% to descend stairs with reciprocal gait, and 42.9% to vary 

their walking speeds. In contrast, 90.5% of MP-SSCO users reported being capable of descending stairs, 

81.0% reported to descend stairs with reciprocal gait (p<0.01), and 76.2% claimed they had the ability 

to walk with varying speeds (p=0.03). Additionally, 71.4% of the respondents experienced an 

improvement in their engagement in activities with the MP-SSCO. 50.0% reported pain with the previous 

orthosis, compared to 38.1% with the MP-SSCO. Pain intensity was higher for the previous orthosis use 

(3.8) compared to MP-SSCO use (2.8) on a 1-5 scale (p=0.06). 93.3% of the participants regarded the 

MP-SSCO as superior, noting an enhanced quality of life (QoL) compared to the previous orthosis. 

CONCLUSION: Advanced orthotic technology may positively impact outcomes such as fall frequency, 

activities of daily living, fear of falling and pain. However, in this study, results from the previous orthosis 

use might have been influenced by recall bias.  

ARTICLE INFO 

Received: February 28, 2024 

Accepted: May 8, 2024 

Published: May 30, 2024 
 

CITATION 

Brüggenjürgen B, Eilers L, 

Seidinger S, Kannenberg A, 

Stukenborg-Colsman C. Patients’ 

burden using microprocessor-

stance-and-swing-control knee-

ankle-foot orthoses and outcomes 

compared to those with prior 

traditional knee-ankle-foot-orthosis. 

Canadian Prosthetics & Orthotics 

Journal. 2024; Volume 7, Issue 1, 

No.1. 

https://doi.org/10.33137/cpoj.v7i1.4

2799 

KEYWORDS 

Knee-Ankle-Foot-Orthosis, 

Microprocessor-Stance-and-Swing-

Control Orthosis, Quality of Life, 

Activities of Daily Living, Pain, Falls, 

Orthosis, Disability, Orthotic 

 

* CORRESPONDING AUTHOR: 

Prof. Dr. med. Bernd Brüggenjürgen, MPH 

Head Institute Health Services Research and Technical Orthopedics, Orthopedic Department - Medical School Hannover (MHH) at DIAKOVERE Annastift Hospital  

Anna-von-Borries-Str. 1-7, 30625 Hannover, Germany 

Tel.: +49 (511) 5354 821 

E-Mail: brueggenjuergen.bernd@mh-hannover.de; bernd.brueggenjuergen@diakovere.de 

ORCID ID: https://orcid.org/0000-0002-8866-0809 

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

Volume 7, Issue 1, Article No.1. 2024 

 

 

https://doi.org/10.33137/cpoj.v7i1.42799
https://doi.org/10.33137/cpoj.v7i1.42799
https://doi.org/10.33137/cpoj.v7i1.42799
mailto:brueggenjuergen.bernd@mh-hannover.de
https://jps.library.utoronto.ca/index.php/cpoj/index


 

2 

Brüggenjürgen B, Eilers L, Seidinger S, Kannenberg A, Stukenborg-Colsman C. Patients’ burden using microprocessor-stance-and-swing-control knee-ankle-foot 
orthoses and outcomes compared to those with prior traditional knee-ankle-foot-orthosis. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 1, No.1. 
https://doi.org/10.33137/cpoj.v7i1.42799 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X MICROPROCESSOR VS. TRADITIONAL KNEE-ANKLE-FOOT ORTHOSES: PATIENT BURDEN & OUTCOMES 

Brüggenjürgen et.al, 2024 

INTRODUCTION   

Individuals affected by neuromuscular diseases or central 

nervous system disorders may experience joint instability 

which restricts their ability to participate in activities of daily 

living (ADLs). This limitation significantly impacts their 

engagement in social and professional aspects of life 

resulting in considerable patient burden. Furthermore, 

neuromuscular knee instability caused by these conditions 

can lead to safety concerns for the patients. However, this 

increased fall risk, could potentially be mitigated by the 

provision of more advanced and effective orthotic 

devices.1,2 

For these patients, orthotic devices designed to stabilize 

joints, such as ankle-foot orthoses (AFOs) or knee-ankle-

foot orthoses (KAFOs), can prove advantageous. AFOs 

may be sufficient if the knee instability is caused by paresis 

of the calf muscles. However, if the knee instability is 

caused by weakness of the quadriceps muscle, AFOs are 

no longer sufficient. In such cases, knee-ankle-foot 

orthoses (KAFOs) are frequently utilized to address knee 

instability associated with neuromuscular diseases and 

central nervous system disorders.3  

KAFOs are equipped with knee joints that either lock for 

both stance and swing phase and are only released 

manually by the patient when sitting down (locked KAFO) or 

lock for stance but are free for swing (free-swing KAFOs). 

Locked KAFOs require substantial compensations to 

achieve sufficient toe clearance during the swing, such as 

circumduction, hip hiking, and vaulting.2,3 Free-swing 

KAFOs are further distinguished in posterior-offset KAFOs 

and stance control orthoses (SCO) that allow the patient to 

freely swing during the swing phase. These types of 

orthoses allow for a more natural movement pattern and 

enable to walk more smoothly on level ground while also 

providing the needed stability due to locking during the 

stance phase. Nevertheless, ensuring safe control with 

these orthoses demands a certain level of remaining motor 

function in the affected limb. As a result, only a limited 

proportion of patients can be provided with these systems 

for reasons of safety.4   

In the view of experts, the increased risk of falling with both 

locked and free-swing KAFOs and SCOs contributes to the 

diminished capacity to walk, which is further impaired by 

reduced coordination and balance resulting from physical 

deconditioning.5 In addition to the safety concerns 

associated with traditional orthoses, there are also mobility 

limitations and restrictions in ADLs as well as pain 

associated with orthosis use that need to be addressed.1,6  

Since 2012, a microprocessor stance and swing control 

orthosis (MP-SSCO) has been available that controls the 

resistances against knee flexion and extension by hydraulic 

dampening during weight-bearing, thus enabling knee 

stance flexion and reciprocal slope and stair descent. It also 

provides stumble recovery and speed adaptation during the 

swing phase (Ottobock, Duderstadt, Germany).7 Compared 

to a locked KAFO, an MP-SSCO may facilitate the 

execution of numerous ADLs by making them easier, more 

natural, and safer than traditional leg orthosis 

technologies.6,8  

MP-SSCOs may allow for walking with increased balance, 

speed, greater energy efficiency and increased safety.7 

Objective studies in clinical and lab-based biomechanical 

settings comparing MP-SSCO to conventional KAFOs have 

already been performed. User reports emphasized that 

walking on uneven surfaces, stairs, and ramps was 

perceived as less challenging, resulting in increased 

walking autonomy. Independence and mobility are 

important factors for the daily routine of individuals with 

lower limb motor impairments and have a decisive influence 

on their participation and quality of life (QoL).9 

The burden of disease among leg orthosis users has so far 

received little attention. Very few studies have focused on 

demonstrating effectiveness in real-life settings.1 Therefore, 

not only mobility and functionality but also safety and patient 

burden of disease may be helpful for capturing the 

indication-specific benefits of a therapy. 

According to interviewed experts, patients with muscular 

knee instability following neuromuscular or central nervous 

system injuries or conditions who use KAFOs or SCOs 

experience limited and restricted mobility, impaired gait 

patterns, and emotional strain.5 Advanced orthotic 

technology, such as the MP-SSCO, might contribute to 

better QoL of patients, improved gait patterns with 

subsequent reduction of long-term consequences, and 

improved perceived dependability and stability of the 

orthosis while walking.5 Nonetheless, there is currently only 

a limited amount of published data, particularly concerning 

patient-reported outcomes in an unsupervised home 

environment. By gathering insights in the patients' 

perspectives on the MP-SSCO and previous orthoses used, 

it might be possible to identify unexpected or yet-unknown 

benefits of the MP-SSCO. 

Therefore, the aim of this study was to investigate whether 

the MP-SSCO provides benefits recognized by patients in 

real life. A further rationale was to identify whether there 

were differences to the previous orthoses in patients' 

reported mobility and safety, satisfaction with the orthotic 

treatment, and pain. In addition to this assessment, the 

burden of disease was studied including social 

environment, aspects of participation in work and ADLs 

including health-promoting activities, and quality of life. 

METHODOLOGY 

A structured cross-sectional survey was conducted in six 

orthotic and prosthetic clinics in Germany. Included in the 

https://doi.org/10.33137/cpoj.v7i1.42799


 

3 

Brüggenjürgen B, Eilers L, Seidinger S, Kannenberg A, Stukenborg-Colsman C. Patients’ burden using microprocessor-stance-and-swing-control knee-ankle-foot 
orthoses and outcomes compared to those with prior traditional knee-ankle-foot-orthosis. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 1, No.1. 
https://doi.org/10.33137/cpoj.v7i1.42799 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X MICROPROCESSOR VS. TRADITIONAL KNEE-ANKLE-FOOT ORTHOSES: PATIENT BURDEN & OUTCOMES 

Brüggenjürgen et.al, 2024 

study were individuals who met the following criteria:  

they had been using a C-Brace for more than six months 

and previously used a traditional locked or free-swing KAFO 

or SCO, or no orthosis prior to C-Brace fitting. Additionally, 

the participants had to be older than 18 years of age and 

provided informed consent. The survey was conducted in 

the period from December 2020 to November 2021 (seven 

months during COVID-19 pandemic). 

The online tool LymeSurvey was used to send out a link to 

the German-language questionnaire and collect the 

responses of participants. Technical reliability was internally 

tested. Pretest runs of the survey were carried out by 

different members of our departments. The survey 

comprised various topics, including demographics 

mobility/functionality, participation, safety, satisfaction, 

pain, and quality of life. Questions and response categories 

were adapted, wherever possible, from existing pain, 

mobility, and falls questionnaires. The questionnaire 

employed different types of questions, primarily using Likert 

scales with 1-5 point rating scales and one time a 1-10 scale 

for more detailed investigation of general safety perception. 

Additionally, binary questions and open-response questions 

were used.  

The language of the questionnaire was German. All 

designers, testers, and participants were native German 

speakers. Therefore, no translation of the questionnaire 

was necessary. The responses for the MP-SSCO were 

concurrent, whereas the responses for the previous 

orthoses or the state before MP-SSCO fitting had to be 

recalled from memory. Patients provided informed consent 

and received a link via email, allowing them to answer the 

questions at their own pace in a predefined order from the 

comfort of their homes. The usability of the MP-SSCO was 

assessed using a summary score that covered various 

categories and inquired about the patients’ satisfaction with 

the orthosis in different situations.  

The statistical analysis was conducted using IBM SPSS 

Statistics Version 29.0.0.0. The Wilcoxon one-sided exact 

test was used for primary comparisons between traditional 

KAFOs/SCOs and MP-SSCO. Comparisons to traditional 

KAFOs were performed only in those MP-SSCO users who 

had experience with such KAFOs (n=14). The Mann-

Whitney test was used for sub-analyses. In the case of an 

extreme range of values, an outlier test was performed 

using a box plot. Identified outliers were then checked for 

plausibility. In the case of legitimate outliers, two analyses 

were performed, one with and one without the outliers, to 

ensure maximum transparency. Due to the exploratory 

nature of the study, no sample size calculation was 

performed.  

Publication Ethics 

The observatory investigation is conducted in accordance 

with the European Medical Device Regulations (Art. 82 

MDR), the respective implementation the German Medical 

Device Law (Section 47 (Paragraph 3) MPDG) and 

complies with all applicable data protection legislation.10 

RESULTS 

Out of 22 patients participating in the online survey, which 

took approximately 60 minutes to complete, 21 participants 

met the inclusion criteria and were included in the analysis. 

One participant was excluded due a protocol violation as his 

previous orthosis had been a first-generation MP-SSCO 

rather than a traditional KAFO. Participants in the study had 

utilized the MP-SSCO for a minimum of 11 months (mean 

1.9, maximum 2.9 years). Fourteen respondents had prior 

experience with another KAFO, which they had used for an 

average of 12.5 years before transitioning to the MP-SSCO. 

The respondents reported diverse underlying conditions, as 

indicated in Table 1. 

Among the 21 survey participants, 10 individuals had 

additional comorbidities. Out of the 18 respondents aged 

below 65 years, 14 reported being employed. Moreover, 13 

participants were actively involved in more than six ADLs 

per week, such as shopping, cleaning, gardening, or 

exercising. Additionally, out of the 13 patients who had to 

climb stairs to reach their homes, 10 did not have access to 

an elevator. 

Most respondents had used their previous orthoses for 

more than eight hours per day. 57.1% of the respondents 

mentioned walking less than 1 km daily, 35.7% walked 1-3 

km, and 7.1% reported walking 3-5 km a day with it. 

Similarly, the MP-SSCO was used for at least 8 hours per 

day on average. The daily walking distance with the MP-

SSCO was reported as less than 1 km by 38.1% of the 

respondents, 28.6% walked 1-3 km, and 33.3% covered a 

distance of 3-5 km.  

Safety 

The general perception of safety of the prior KAFO (n=14) 

scored 6.4 on a scale ranging from 1 (completely safe) to 

10 (completely unsafe) (Table 2). 21.4% of the respondents 

recalled feeling very safe while standing with the previous 

orthosis. However, when using the MP-SSCO, the 

respondents' general perception of safety was rated with an 

average of 3.8, indicating an improved perception of safety 

compared to the previous orthosis (p=0.03). Specifically, 

76.2% of the respondents felt very safe while standing with 

the MP-SSCO. 

With the previous orthosis, the average fear of falling, rated 

on a scale from 1 (very low) to 5 (very high), was 3.4. 

However, after switching to the MP-SSCO, the average fear 

of falling significantly decreased to 1.5 (p<0.001). 

 

https://doi.org/10.33137/cpoj.v7i1.42799


 

4 

Brüggenjürgen B, Eilers L, Seidinger S, Kannenberg A, Stukenborg-Colsman C. Patients’ burden using microprocessor-stance-and-swing-control knee-ankle-foot 
orthoses and outcomes compared to those with prior traditional knee-ankle-foot-orthosis. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 1, No.1. 
https://doi.org/10.33137/cpoj.v7i1.42799 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X MICROPROCESSOR VS. TRADITIONAL KNEE-ANKLE-FOOT ORTHOSES: PATIENT BURDEN & OUTCOMES 

Brüggenjürgen et.al, 2024 

Table 1: Participant Characteristics. 

 

Among the users of previous orthoses, nearly 78.6% 

recalled experiencing falls while using it. On average, these 

users recalled 67.9 falls per patient (range 0 to 624,  

Median=12, SD=167.0) over the course of a year. After 

excluding the two outliers (624 and 182 falls), a mean of 

12.1 falls per patient per year was reported (range: 0 to 54, 

Median=8.5, SD=15.9). After being fitted with an MP-SSCO, 

only 42.9% of the respondents stated that they had 

experienced falls in the last six months. The average 

number of falls with the MP-SSCO was 5.3 per year (range 

0 to 78, SD=17.0, Median= 0.0), which was significantly 

lower compared to the previous orthosis (p<0.001). In 

patients currently employing MP-SSCO, three outliers of 78 

and two occurrences of 12 falls per year were identified. Of 

note, one user reported experiencing such outliers both with 

the preceding orthosis and the current MP-SSCO. After 

excluding outliers for current MP-SSCO users, the average 

number of falls was 0.5 per year (range 0 to 3, SD=0.9, 

Median=0.0). This value was significantly lower compared 

to the previous orthosis (p<0.01). 76.2% of all participants 

named safety the most critical aspect when assessing the 

orthosis. 

Mobility & Functionality  

Among the respondents who had used traditional KAFOs 

before, 85.7% mentioned that they had also used additional 

assistive devices alongside their previous orthoses (Table 

2). The majority of participants relied on walking sticks or 

forearm crutches, while 35.7% had used wheelchairs 

(manual or electric) or scooters, and these devices had 

been used more than 5 times a week by most. Out of the 

MP-SSCO users, only 42.9% required other aids such as 

walking sticks and forearm supports. Furthermore, 35.0% of 

the respondents had a wheelchair that the majority of them 

used 5 to 10 times a week. 

The individuals were asked about their ability to perform 

various ADLs in their lives including walking at different 

speeds. In three of the four situations described, there was 

a significant improvement, while the improvement in one 

situation just failed to attain significance since using the MP-

SSCO (Figure 1). The most significant improvement was 

observed in reciprocal stair descent, with the percentage of 

participants able to descend a stair with reciprocal gait 

increasing from 14.3% with the previous orthosis to 81.0% 

with the MP-SSCO (p<0.01). 

Regarding their gait pattern, 92.9% of the participants 

recalled poor or very poor symmetry with the previous 

KAFO. However, when using the MP-SSCO, this 

percentage significantly reduced to only 9.5% (p<0.001). 

Asked about how they assessed their ability to descend 

stairs, 75.0% of the patients rated it as bad or very bad with 

their previous orthosis. However, with the MP-SSCO, 

94.7% reported being able to descend stairs well or very 

well (p=0.01).  

The average usability rating for the previous orthosis was 

3.9 (SD=0.6), which indicates poor usability on a scale 

ranging from 1 (very good) to 5 (very poor). In contrast, the 

average usability rating for the MP-SSCO was 2.1 (SD=0.7), 

indicating good usability (p<0.001). Participants being able 

to pursue physically demanding activities are presented in 

Figure 2. 

  N % 

Age (years) 

All, Mean (SD)=48.1 (14.0); 

Min=27; Max=71 
  

Male, Mean (SD)= 53.6 (12.0)   

Female, Mean (SD)= 42.1 (14.0)   

Gender  
Female  10 47.6 

Male 11 52.4 

BMI  

All, Mean (SD)=25.4 (4.0); 

Min=19.0; Max=33.6 
  

Normal weight (BMI 18.5 – 24.9) 11 52.4 

Overweight (25.0 – 29.9) 7 33.3 

Obese (≥ 30) 3 14.3 

Underlying 

condition 

Poliomyelitis 8 38.1 

Incomplete paraplegia 4 19.1 

Neuromuscular diseases 2 9.5 

Traumatic brain injury (TBI)  1 4.8 

Other 6 28.6 

Comorbidities 

(multiple 

responses 

possible, 

percentages for 

those reporting 

comorbidities) 

None 11 52.4 

Diabetes 1 10.0 

Impaired vision 1 10.0 

Neuropathy 1 10.0 

Total hip replacement 1 10.0 

Hypertension 4 40.0 

Coronary heart disease 1 10.0 

Other 7 70.0 

Affected leg 

Right 6 28.6 

Left 14 66.7 

Both 1 4.8 

Previous 

Orthosis before 

MP-SSCO 

Free swing Knee-Ankle-Foot-

Orthosis (KAFO/SCO) 
10 47.6 

Locked Knee-Ankle-Foot-Orthosis 

(KAFO) 
4 19.0 

No previous orthosis 7 33.3 

Living alone  
Yes 8 38.1 

No 13 61.9 

Independent 

household 

management 

Yes 9 42.9 

No 1 4.8 

Partial 11 52.4 

Residential 

environment 

Flat 10 47.6 

Hilly 8 38.1 

Mountainous 3 14.3 

Residential 

floor 

0 – ground level 8 38.1 

1st 7 33.3 

2nd  2 9.5 

3rd  1 4.8 

Missing for non-ground level 3 14.3 

Orthosis since 

(years) 

All, Mean (SD)=12.5 (15.7); 

Min=1.7; Max=54.5 
  

https://doi.org/10.33137/cpoj.v7i1.42799


 

5 

Brüggenjürgen B, Eilers L, Seidinger S, Kannenberg A, Stukenborg-Colsman C. Patients’ burden using microprocessor-stance-and-swing-control knee-ankle-foot 
orthoses and outcomes compared to those with prior traditional knee-ankle-foot-orthosis. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 1, No.1. 
https://doi.org/10.33137/cpoj.v7i1.42799 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X MICROPROCESSOR VS. TRADITIONAL KNEE-ANKLE-FOOT ORTHOSES: PATIENT BURDEN & OUTCOMES 

Brüggenjürgen et.al, 2024 

Pain 

Out of all prior KAFO respondents, 50.0% had experienced 

discomfort or pain with their previous orthosis, primarily in 

the form of low-back pain (Table 2). On an overall average 

pain intensity scale from 1 to 5, with 1 representing very mild 

pain and 5 indicating very severe pain, the average pain 

intensity was 3.8. 

Table 2: Comparison of previous orthosis and C-Brace regarding safety, functionality, and pain. 

 

Mean - previous 

KAFO (n=14) 

Mean –  

C-Brace in 

previous KAFO 

users (n=14) 

P-Value 

Mean –  

C-Brace in previous 

KAFO and non-user 

(n=21) 

Safety 

General perception of safety1  6.4 3.8 0.03 4.1 

Safety while standing2 2.8 1.6 0.20 1.4 

Fear of falling3 3.4 1.5 <0.001 1.8 

Falls occurred? 4  0.8 0.4 0.35 0.4 

Number of falls per year 67.9 1.1 <0.001 5.3 

Number of falls per year, outliers excluded 12.1 (n=12) 0.3 (n=13) <0.01 0.5 (n=18) 

Mobility & 

Functionality 

Assistive devices used4  0.9 0.6 0.15 0.4 

Usability5 3.9 2.0 <0.001 2.1 

Symmetry of gait5 4.5 2.1 <0.001 2.2 

Ability to descend stairs5 4.0 1. 7 0.01 1.7 

Ability to descend stairs4  0.6 0.9 0.06 0.9 

Reciprocal stair descend4  0.1 0.8 <0.01 0.8 

Ability to walk an incline4  0.5 1.0 0.01 0.9 

Walking at varying walking speeds4  0.4 0.8 0.03 0.8 

Pain 

Pain4  0.5 0.3 0.08 0.4 

Pain intensity6 3.8 2.1 0.06 2.8 

Pain influence7 3.7 1.3 0.02 1. 7 
 

1scale ranging from 1 (completely safe) to 10 (completely unsafe) 
2scale ranging from 1 (very safe) to 5 (not safe) 
3scale ranging from 1 (very low) to 5 (very high) 
4 no=0 / yes=1 
5 scale ranging from 1 (very good) to 5 (very poor) 
6scale ranging from 1 (very mild pain) to 5 (very severe pain 
7scale ranging from 1 (no impact) to 5 (severe impact) 

 

 

 

 

 

Figure 1: Usability of previous KAFO vs. MP-SSCO separately reported for those with previous experience and all (percentage of 

participants indicating their capability to perform (yes=1, no=0))   

76%

95%

81%

91%

79%

100%

79%

86%

43%

50%

14%

57%

0% 20% 40% 60% 80% 100%

Walking at various speeds (p=0.03)

Ability to walk on an incline (p<0.01)

Reciprocal stair descent (p<0.01)

Ability to descend stairs (p=0.06)

Usability of Previous KAFO vs. MP-SSCO 

Previous KAFO (n=14) MP-SSCO (previous KAFO, n=14) MP-SSCO (all, n=21)

https://doi.org/10.33137/cpoj.v7i1.42799


 

6 

Brüggenjürgen B, Eilers L, Seidinger S, Kannenberg A, Stukenborg-Colsman C. Patients’ burden using microprocessor-stance-and-swing-control knee-ankle-foot 
orthoses and outcomes compared to those with prior traditional knee-ankle-foot-orthosis. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 1, No.1. 
https://doi.org/10.33137/cpoj.v7i1.42799 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X MICROPROCESSOR VS. TRADITIONAL KNEE-ANKLE-FOOT ORTHOSES: PATIENT BURDEN & OUTCOMES 

Brüggenjürgen et.al, 2024 

With use and after getting accustomed to the new MP-

SSCO, 38.1% of the participants reported pain (p=0.06). 

The overall average pain intensity for this group was 2.8. 

The impact of pain on the respondents' daily lives was 

evaluated using a Likert scale with 1 indicating no impact 

and 5 indicating severe impact. The average impact of the 

previous orthosis was 3.7 (quite severe) while that of the 

MP-SSCO was 1.7 (p=0.02). Those participants engaging 

in sports reported experiencing significantly more pain 

(p=0.03). 

Satisfaction with the MP-SSCO & Quality of Life  

80.0% of the respondents reported that the C-Brace 

treatment was considerably superior to their previous 

orthosis. The satisfaction levels were high, with 71.4% 

stating they were very satisfied, and an additional 23.8% 

expressed to be satisfied with the C-Brace. Only 4.7% were 

not satisfied. 

As shown in Figure 3, 15 out of 16 participants who 

responded on quality of life (QoL) believed that using the C-

Brace positively impacted their quality of life. Some patients 

mentioned specific improvements, such as one individual 

being able to go skiing and another to start dance lessons. 

Additionally, many patients appreciated the ability to interact 

with others at an eye-to-eye level, which had a significant 

impact on their emotional well-being. When ranking the 

benefits, the respondents considered safety, effectiveness, 

and weight as the most crucial factors in their evaluation. 

 

Figure 3: Individuals reporting improvements in quality of life since 

using the MP-SSCO (n=16). 

DISCUSSION 

Individuals who had been using an MP-SSCO (C-Brace) for 

a minimum of six months were invited to participate in an 

online survey. Twenty-one individuals were included in the 

analysis. The aim was to gain insights into the real-world 

impact of conventional locked and free-swing KAFOs or 

SCOs from the patients' perspective and to understand the 

differences experienced after using the MP-SSCO. The 

survey covered various aspects related to safety, mobility, 

functionality, participation, and pain. The age of the 

participants varied from 27 to 71 years, and females 

73%

20%

0%

7%

0%

0%

10%

20%

30%

40%

50%

60%

70%

80%

significantly
better

better the same worse significantly
worse

Improvement of Quality of Life since using the 
C-Brace

 

Figure 2: Comparison of physically demanding activities regularly undertaken of participants to the general population: Shopping11; 

Cleaning12; Gardening13; Childcare14 Caring15; Sport16; Leisure16; Walk17. 

76%

86%

48%

48%

14%

57%

57%

95%

26%

88%

45%

58%

20%

13%

71%

89%

0% 20% 40% 60% 80% 100%

Taking a walk

Excursions and leisure activities

Sport

Caring for those in need of care

Childcare

Gardening

Cleaning

Shopping

Participants reporting regularly undertaken activities 

General Population MP-SSCO (n=21)

https://doi.org/10.33137/cpoj.v7i1.42799


 

7 

Brüggenjürgen B, Eilers L, Seidinger S, Kannenberg A, Stukenborg-Colsman C. Patients’ burden using microprocessor-stance-and-swing-control knee-ankle-foot 
orthoses and outcomes compared to those with prior traditional knee-ankle-foot-orthosis. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 1, No.1. 
https://doi.org/10.33137/cpoj.v7i1.42799 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X MICROPROCESSOR VS. TRADITIONAL KNEE-ANKLE-FOOT ORTHOSES: PATIENT BURDEN & OUTCOMES 

Brüggenjürgen et.al, 2024 

accounted for 47.6% of the sample, representing relevant 

user groups for the MP-SSCO in terms of both age and 

gender.  

A major factor that restricts people’s mobility is the inability 

to negotiate stairs with reciprocal gait. There are still many 

places that are not accessible to persons with mobility 

limitations and/or restrictions, and the ability to negotiate 

stairs is essential for participation.18 When rating the ability 

to descend stairs, 12.5% of the patients using KAFOs 

recalled it to be good. With the MP-SSCO, 94.7% said they 

could descend stairs well or very well improving their 

activities of daily living. Furthermore, more than one third of 

MP-SSCO users achieved walking distances of the general 

population - a healthy person in Germany walks 

approximately 4 km a day.19  

55% of people with disabilities never engage in sports, while 

only 33% of people without disabilities do not.16 Users of the 

MP-SSCO demonstrated increased levels of sports 

activities, with 48% of individuals reporting regular 

participation in sports. Additionally, when it comes to 

shopping, excursions, and leisure activities,11 the MP-

SSCO users achieved levels similar as those of the general 

population as shown in Figure 2. However, our study sample 

may not accurately reflect the broader population, and there 

is a lack of published activity data with sufficient detail to 

enable a more precise comparison within the studied 

populations. Consequently, our evaluation sought to 

determine if individuals equipped with the MP-SSCO 

experienced significant limitations in their daily activities.  

Given the considerable personal commitment and potential 

financial investment required for orthotic provision, it is 

presumed that the subset of individuals using the MP-SSCO 

represents an active and potentially affluent subgroup 

seeking to maximize their newfound opportunities. 

Consequently, the notably higher prevalence of gardening 

and walking activities could be attributed to two factors. 

Firstly, a higher proportion of MP-SSCO users may have 

access to private yards or gardens. Secondly, walking may 

be perceived as a privilege or preferred form of exercise 

compared to other physical activities such as jogging. 

The use of MP-SSCOs resulted in a reduction in the number 

of individuals who recalled pain, a decrease in average pain 

intensity, and a significant reduction in limitations in their 

ADLs. It is important to consider that the increased activity 

levels of patients since using the MP-SSCO may have 

influenced the observed differences. Interestingly, when 

comparing MP-SSCO users who exercise with those who 

do not, the ones who exercise tended to report more pain 

on average. Despite the presence of some pain while using 

the MP-SSCO, it is perceived as significantly reduced in 

intensity and less restrictive in ADLs. The majority of 

patients expressed satisfaction with the C-Brace, which was 

evident in its significantly improved usability score 

compared to the previous orthosis. 

The conditions leading to the use of an MP-SSCO in this 

patient survey were comparable to those mentioned in 

interviews with experts.5 According to the experts 

interviewed, the primary patient burdens leading to the use 

of a MP-SSCO were "limited mobility," followed by 

"emotional stress" and "altered gait pattern." The most 

significant factors affecting patients were identified as the 

dependability and stability while walking, restoring a natural 

gait, and the ability to perform ADLs.5  

Our patient survey revealed that safety and effectiveness 

were considered as the leading relevant aspects, and that 

aligns with the views expressed by the experts. However, 

the weight of the orthosis emerged as the third-most 

relevant aspect, which was not explicitly highlighted by the 

experts. 

A health-technology assessment (HTA) and systematic 

patient survey identified the reduction of pain, falls, and the 

improved ability to perform ADLs as the outcomes primarily 

desired by patients, while the most valued orthosis features 

were reported to be effectiveness, reliability, comfort, and 

durability, as presented in Table 3. However, the existing 

evidence on the effectiveness of orthoses is limited, 

especially when focusing on the most important outcomes 

from the perspective of the users.1  

Among the individuals in our patient survey, 76.2% 

regarded safety as the most critical aspect when assessing 

the orthosis. In contrast, the experts prioritized 

dependability and stability, and they did not consider safety 

to be as significant a factor when evaluating an orthosis.5  

With the MP-SSCO compared to traditional KAFOs, the 

average number of falls per year was reduced significantly 

by 92.2%. It is noteworthy that the presence of extreme 

outliers in the survey may have influenced these averages. 

As per the expert interviews, falls occurred in 71.5% of 

patients using KAFOs or SCOs with a combined annual 

frequency of 7.0 fall events. In contrast, the experts had 

observed falls in only 7.2% of MP-SSCO users and an 

annual frequency of 2.2 fall events per year. This suggests 

that the use of MP-SSCO resulted in a considerable 

reduction in fall incidents compared to traditional types of 

orthoses.5 However, the numbers also suggest that patient 

may not report all falls to their treating physicians. 

According to the experts, advanced orthotic devices may 

enhance physical and psychological health and well-being 

by enabling patients to pursue their daily routines.5 This was 

directly confirmed by patients’ results in our study regarding 

usability and improved quality of life. Improved gait patterns 

https://doi.org/10.33137/cpoj.v7i1.42799


 

8 

Brüggenjürgen B, Eilers L, Seidinger S, Kannenberg A, Stukenborg-Colsman C. Patients’ burden using microprocessor-stance-and-swing-control knee-ankle-foot 
orthoses and outcomes compared to those with prior traditional knee-ankle-foot-orthosis. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 1, No.1. 
https://doi.org/10.33137/cpoj.v7i1.42799 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X MICROPROCESSOR VS. TRADITIONAL KNEE-ANKLE-FOOT ORTHOSES: PATIENT BURDEN & OUTCOMES 

Brüggenjürgen et.al, 2024 

were not explicitly mentioned by patients but might result in 

subsequent reduction of long-term consequences, 

according to experts.5   

Experts’ and patients’ perspectives might differ. Horenkamp 

et al.20 investigated the impact of obtaining results from 

different perspectives. Experts’ estimate on resource use or 

patients’ burden was principally lower when compared to 

patients’ own reported outcomes. Hence, this is in line with 

the comparative results reported in our analysis.20 

Our results confirm the need for incorporating outcomes 

that are relevant to the patients into research of orthotic 

devices for knee instability related to neuromuscular and 

central nervous system conditions. 

Study limitations 

The retrospective nature of this study results in a possible 

recall bias. Recall bias refers to different results in 

interviews or self-reports of previous exposures or events. 

It is therefore primarily a problem in retrospective studies. 

This collection of past information, especially on the 

situation before the current MP-SSCO and when actively 

using it, carries the risk of recall bias as a form of information 

bias when collecting retrospective data. In general, patients 

tend to overestimate pain and underestimate mobility in the 

past.21 Additionally, there could be a technology bias since 

all patients were already using the MP-SSCO at the time of 

the survey, especially affecting previous KAFO results. This 

refers to preconceived positive notions of the used 

technology and hence biased opinions in favor of adopting 

the technology.22 Another consequence arises from the 

number of individuals who participated in this study, 

potentially leading to a bias due to a greater influence of 

extreme values. Finally, though outcome measures in this 

exploratory study were developed according to sound 

empirical practices and applied standard response items 

such as Likert-scales, a prior validation had not been 

conducted. 

CONCLUSION 

Individuals with knee instability caused by neuromuscular 

diseases or central nervous system disorders face 

limitations and restrictions in mobility, impaired gait 

patterns, and experience emotional strain when using 

conventional locked and free-swing KAFOs. The 

implementation of advanced orthotic technology has the 

potential to positively impact patient-specific parameters 

such as fall frequency, fear of falling, pain, activities of daily 

living, and reliance on other assistive devices. Notably, the 

use of MP-SSCO resulted in a significant reduction in the 

frequency of falls compared to conventional KAFOs. 

When assessing their orthoses, individuals emphasized 

safety, effectiveness, and weight as the most relevant 

attributes. In contrast, experts considered dependability and 

stability as the most crucial aspects. This highlights the 

importance of involving patients in the orthosis selection 

process and taking into account the aspects that users rate 

as most significant. Furthermore, individuals' quality of life 

was identified as a relevant dimension and an area that 

could see substantial improvements for KAFOs/SCOs 

users. 

Table 3: Comparison of leading aspects from different survey sources. 

 Patient survey Expert survey5 O´Connor analysis1 

Important aspects  

• Perception of safety and high 
stability while walking 

• Physiologic gait 

• Participation in daily life 

• Engagement in daily activity 

Patients desired outcomes 

• Safety 

• Independence 

• Quality of life 

• Meeting fellow people on eye 
level 

• Improved gait 

• Reliability 

• Stability while walking 

• Physiologic gait 

• Ability to perform daily routine 
(data on file) 

• Reduction in pain, falls or trips. 

• Improved balance and stability 

Most valued features 

• Effectiveness 

• Safety 

• Weight 

• Improved quality of life 

• Improved gait patterns 

• High dependability of the 
orthosis 

• Effectiveness 

• Reliability 

• Comfort and durability 

Frustration 
Uncomfortable (n=1) and not water 
proof (n=1) 

• Setting Correct indication 

• Intensive service support 

• Access to reimbursement 
decision maker 

Perceived deficiencies in service 
provision related to: 

• Appointment 

• Administrative systems and 

• Referral pathways 

Lead patient burden  
• Restriction of mobility, emotional 

strain, impaired gait pattern 
 

Other burden  
• Appearance and good look 

• Cosmetic issues 

• Appearance - Want to look as 
normal as possible. 

• Women are especially affected 
in dressing 

 

 

https://doi.org/10.33137/cpoj.v7i1.42799


 

9 

Brüggenjürgen B, Eilers L, Seidinger S, Kannenberg A, Stukenborg-Colsman C. Patients’ burden using microprocessor-stance-and-swing-control knee-ankle-foot 
orthoses and outcomes compared to those with prior traditional knee-ankle-foot-orthosis. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 1, No.1. 
https://doi.org/10.33137/cpoj.v7i1.42799 

CANADIAN PROSTHETICS & ORTHOTICS JOURNAL 

ISSN: 2561-987X MICROPROCESSOR VS. TRADITIONAL KNEE-ANKLE-FOOT ORTHOSES: PATIENT BURDEN & OUTCOMES 

Brüggenjürgen et.al, 2024 

ACKNOWLEDGEMENTS 

We wish to thank all patients that participated in the study. 

DECLARATION OF CONFLICTING INTERESTS 

Bernd Brüggenjürgen: Received lecture fees.  

Lena Eilers: Nothing to be declared. 

Susanne Seidinger: Full-time employee of Ottobock. 

Andreas Kannenberg: Full-time employee of Ottobock. 

Christina Stukenborg-Colsman: Nothing to be declared. 

 

AUTHORS CONTRIBUTION 

Bernd Brüggenjürgen:  

Conception and design, analysis and drafting of the paper, 

interpretation of the data; revising it critically for intellectual content 

and final approval of the version to be published.  

Lena Eilers: 

Analysis and drafting of the paper, interpretation of the data; 

revising it critically for intellectual content.  

Susanne Seidinger:  

Conception and design, interpretation of the data; revising it 

critically for intellectual content and final approval of the version to 

be published.  

Andreas Kannenberg:  

Interpretation of the data; revising it critically for intellectual content 

and final approval of the version to be published.  

Christina Stukenborg-Colsman:  

Interpretation of the data; revising the manuscript critically for 

intellectual content and final approval of the version to be published. 

 

SOURCES OF SUPPORT 

This work was supported by an unrestricted grant of OttoBock 

Healthcare Products GmbH, Wien. 

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Brüggenjürgen B, Eilers L, Seidinger S, Kannenberg A, Stukenborg-Colsman C. Patients’ burden using microprocessor-stance-and-swing-control knee-ankle-foot 
orthoses and outcomes compared to those with prior traditional knee-ankle-foot-orthosis. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 1, No.1. 
https://doi.org/10.33137/cpoj.v7i1.42799 

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https://www.prognos.com/de/projekt/teilhabebericht-ueber-die-lebenslagen-von-menschen-mit-beeintraechtigungen
https://de.statista.com/statistik/daten/studie/171913/umfrage/haeufigkeit-spazieren-gehen-in-der-freizeit/#:~:text=Umfrage%20in%20Deutschland%20zur%20H%C3%A4ufigkeit%20des%20Spazierengehens%20in%20der%20Freizeit%20bis%202021&text=Im%20Jahr%202021%20gab%20es,die%20mehrmals%20w%C3%B6chentlich%20spazieren%20gingen
https://de.statista.com/statistik/daten/studie/171913/umfrage/haeufigkeit-spazieren-gehen-in-der-freizeit/#:~:text=Umfrage%20in%20Deutschland%20zur%20H%C3%A4ufigkeit%20des%20Spazierengehens%20in%20der%20Freizeit%20bis%202021&text=Im%20Jahr%202021%20gab%20es,die%20mehrmals%20w%C3%B6chentlich%20spazieren%20gingen
https://doi.org/10.21256/zhaw-26080
http://dx.doi.org/10.17169/refubium-12119

