Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs Stance Control vs Locked KAFO: A Randomized Controlled Trial

Deems-Dluhy, Susan; Hoppe-Ludwig, Shenan; Mummidisetty, Chaithanya K.; Semik, Patrick; Heinemann, Allen W.; Jayaraman, Arun

doi:10.1016/j.apmr.2020.08.013

Cited by 8 publications

(4 citation statements)

References 44 publications

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“…Because this was the first study to evaluate walking safety for SCKAFOs in terms of knee joint functioning, our results cannot be compared with those of previous studies. It is noticeable that no LFs occurred during provocative walking tests on the treadmill because falling in daily life with SCKAFOs has been reported in others studies 21 , 22 and in our own study. Possibly because the walk tests on the C-Mill treadmill were not provocative enough.…”

Section: Discussionsupporting

confidence: 64%

Safety, walking ability, and satisfaction outcomes of the NEURO TRONIC stance-control knee-ankle-foot orthosis (SCKAFO): A comparative evaluation to the E-MAG active SCKAFO

Raijmakers,

Brehm,

Nollet

et al. 2023

Prosthetics &Amp; Orthotics International

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Background: Stance control knee-ankle-foot orthoses (SCKAFOs) ensure knee stability by locking during stance while allowing knee flexion during swing. Differences in function of the knee joints and building principles between devices may affect their effectiveness. Objective: To investigate the preliminary effectiveness of a NEURO TRONIC on safety outcomes, net energy cost (EC), and user experiences in individuals already using an E-MAG Active SCKAFO. Study design: Prospective uncontrolled intervention study. Methods: A convenience sample of 10 subjects with flaccid lower extremity muscle weakness, including the quadriceps, due to neuromuscular disorders already using an E-MAG Active SCKAFO were provided with a newly fabricated NEURO TRONIC SCKAFO. Outcomes included knee joint locking failures and unlocking failures (ULFs) (i.e., percentage of steps the knee joint failed to lock/unlock) when walking under challenging conditions on an instrumented treadmill while wearing a safety harness; net EC (J/kg per meter) assessed with a 6-min walk test at comfortable speed; 3D gait kinematics and kinetics; and patient-reported outcomes. Results: No differences between devices were found for knee joint locking failures (both devices 0%) and ULFs (9.9% for the NEURO TRONIC vs. 13.9% for the E-MAG Active SCKAFO). The mean (standard deviation) net EC with the NEURO TRONIC SCKAFO was 8.2% (from 3.68 [0.81] to 3.38 [0.75] J/kg per meter, p = 0.123) lower, although not significantly, compared with that with the E-MAG Active SCKAFO. Significant improvements with the NEURO TRONIC SCKAFO were found for ankle power (p = 0.003), perceived walking effort (p = 0.014), and reported falls (p = 0.034). Conclusion: Both the NEURO TRONIC SCKAFO and the E-MAG Active SCKAFO were safe in terms of knee joint locking, while ULFs were frequent with both devices. The net EC with the NEURO TRONIC SCKAFO decreased, although not significantly, by 8.2%, likely due to insufficient power. Perceived walking effort was in favor of the NEURO TRONIC SCKAFO.

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Section: Discussionsupporting

confidence: 64%

Safety, walking ability, and satisfaction outcomes of the NEURO TRONIC stance-control knee-ankle-foot orthosis (SCKAFO): A comparative evaluation to the E-MAG active SCKAFO

Raijmakers,

Brehm,

Nollet

et al. 2023

Prosthetics &Amp; Orthotics International

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“…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.…”

Section: Introductionmentioning

confidence: 99%

“…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.…”

Section: Introductionmentioning

confidence: 99%

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,

Eilers,

Seidinger

et al. 2024

Can. Prosthet. Orthot. J.

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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. Layman's Abstract People with an unstable knee due to nerve and muscle problems who wear orthotic devices frequently deal with issues including pain, falls, difficulty moving around, and being unable to participate in activities. We wanted to see how much these burdens affect people who used a traditional knee-ankle-foot orthosis and compare it to a newer type of brace with advanced technology. People who had been using a new microprocessor controlled device (product: C-Brace) for at least 6 months were invited to answer questions online about how they are doing with the new brace. They rated items like how they feel and their experiences with different braces. Twenty-one people who had been using the C-Brace for an average of about 2 years participated. Fourteen had used a traditional brace before. Most of them remembered falling more often with the previous brace than with the microprocessor controlled device. With the previous brace, not many could walk downstairs easily or at all, but with the C-Brace, most could. Many also said they felt less pain with the C-Brace. People with knee problems due to nerve and muscle issues have a hard time moving around and can experience falls when they use regular braces. But using newer, microprocessor controlled braces can help them move better, fall less, and feel less pain, which makes their lives better. It is important to note that results from previous use of knee-ankle-foot orthoses (KAFOs) may have been affected by memory bias. Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/42799/32845 How To Cite: 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 Corresponding Author: Prof. Dr. med. Bernd Brüggenjürgen, MPHHead 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 821E-Mail: brueggenjuergen.bernd@mh-hannover.de; bernd.brueggenjuergen@diakovere.deORCID ID: https://orcid.org/0000-0002-8866-0809

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“…The microprocessor control enables dampening of knee flexion during weight-bearing and speed-adapted control of knee flexion and extension during the swing phase. 7 This feature enhances patients’ confidence in knee joint function, increased walking speed and energy efficiency, and improved safety for walking on uneven terrain, stairs, and ramps. 8 Limited published data could only be obtained for one other microprocessor-controlled orthosis type, a microprocessor-controlled-stance-controlled orthosis (MP-SCO).…”

Section: Introductionmentioning

confidence: 99%

EXPERTS’ PERCEIVED PATIENT BURDEN AND OUTCOMES OF KNEE-ANKLE-FOOT-ORTHOSES (KAFOs) VS. MICROPROCESSOR-STANCE-AND-SWING-PHASE-CONTROLLED-KNEE-ANKLE-FOOT ORTHOSES (MP-SSCOs)

Brüggenjürgen¹,

Braatz

Greitemann

et al. 2022

Can. Prosthet. Orthot. J.

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BACKGROUND: Patients with neuromuscular knee-instability assisted with orthotic devices experience problems including pain, falls, mobility issues and limited engagement in daily activities. OBJECTIVES: The aim of this study was to analyse current real-life burden, needs and orthotic device outcomes in patients in need for advanced orthotic knee-ankle-foot-orthoses (KAFOs). METHODOLOGY: An observer-based semi-structured telephone interview with orthotic care experts in Germany was applied. Interviews were transcribed and content-analysed. Quantitative questions were analysed descriptively. FINDINGS: Clinical experts from eight centres which delivered an average of 49.9 KAFOs per year and 13.3 microprocessor-stance-and-swing-phase-controlled-knee-ankle-foot orthoses (MP-SSCOs) since product availability participated. Reported underlying conditions comprised incomplete paraplegia (18%), peripheral nerve lesions (20%), poliomyelitis (41%), post-traumatic lesions (8%) and other disorders (13%). The leading observed patient burdens were “restriction of mobility” (n=6), followed by “emotional strain” (n=5) and “impaired gait pattern” (n=4). Corresponding results for potential patient benefits were seen in “improved quality-of-life” (n=8) as well as “improved gait pattern” (n=8) followed by “high reliability of the orthosis” (n=7). In total, experts reported falls occurring in 71.5% of patients at a combined annual frequency of 7.0 fall events per year when using KAFOs or stance control orthoses (SCOs). In contrast, falls were observed in only 7.2 % of MP-SSCO users. CONCLUSION: Advanced orthotic technology might contribute to better quality of life of patients, improved gait pattern and perceived reliability of orthosis. In terms of safety a substantial decrease in frequency of falls was observed when comparing KAFO and MP-SSCO users. Layman's Abstract Patients who are not able to control the muscles of their legs may need to wear a brace to improve their ability to walk. However, some users are reporting problems including pain, falls, mobility issues and limited engagement in daily activities. The aim of this study was to analyse current real-life burden, needs and experiences of patients who need to wear a brace for their knee, ankle and foot (KAFO). Therefor, experts were interviewed via telephone with a structured set of questions. Eight experts provided observations for patients who suffered from several diseases affecting leg muscle control. The leading patient burdens were identified as “restriction of mobility”, followed by “emotional strain” and “impaired way of walking”. Potential patient benefits were seen in “improved quality-of-life” as well as “improved way of walking” followed by a “high trust in the brace”. Experts reported a higher number of falls per year when using KAFO without the active control of a microprocessor. On a long-term basis, experts observed consequences of KAFO use as disorders of the back, reduced amount of muscles as well as swelling in areas not covered by the brace, scrub marks and degenerative impact on joints. Braces with active control of a microprocessor might result in better quality of life of patients, improved normal way of walking and perceived trust in the brace. Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/37795/29114 How To Cite: Brüggenjürgen B., Braatz F., Greitemann B., Drewitz H., Ruetz A., Schäfer M., et al. Experts’ perceived patient burden and outcomes of knee-ankle-foot-orthoses (KAFOs) vs. microprocessor-stance-and-swing-phase-controlled-knee-ankle-foot orthoses (MP-SSCOs). Canadian Prosthetics & Orthotics Journal. 2022; Volume 5, Issue 1, No.7.https://doi.org/10.33137/cpoj.v5i1.37795 Corresponding Author: Prof. Dr. med. Bernd Brüggenjürgen,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. E-Mail:brueggenjuergen.bernd@mh-hannover.de ORCID ID:https://orcid.org/0000-0002-8866-0809

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Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs Stance Control vs Locked KAFO: A Randomized Controlled Trial

Cited by 8 publications

References 44 publications

Safety, walking ability, and satisfaction outcomes of the NEURO TRONIC stance-control knee-ankle-foot orthosis (SCKAFO): A comparative evaluation to the E-MAG active SCKAFO

Safety, walking ability, and satisfaction outcomes of the NEURO TRONIC stance-control knee-ankle-foot orthosis (SCKAFO): A comparative evaluation to the E-MAG active SCKAFO

Patients’ Burden Using Microprocessor-Stance-and-Swing-Control Knee-Ankle-Foot Orthoses and Outcomes Compared to Those With Prior Traditional Knee-Ankle-Foot-Orthosis

EXPERTS’ PERCEIVED PATIENT BURDEN AND OUTCOMES OF KNEE-ANKLE-FOOT-ORTHOSES (KAFOs) VS. MICROPROCESSOR-STANCE-AND-SWING-PHASE-CONTROLLED-KNEE-ANKLE-FOOT ORTHOSES (MP-SSCOs)

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