The SYMBIONIC® LEG: A synergy of intelligent knee and ankle functions Scott B. Elliott, C.P. (ABC) Össur Asia-Pacific Introduction Throughout history, individuals have attempted to better the function of prosthetic devices by replicating nature. Our human physiology is designed to function in a synchronized and coordinated manner so that gross and fine motor tasks are intuitive, complementary, safe and efficient. Replicating the myriad functions of individual joints has itself been a design challenge which has typically led to very specific and limited functional output in any one particular knee or ankle joint design. However, a few designers have approached the replication of knee and ankle functions from a synergistic perspective, designing functions to be complementary and thus allowing for a potentially greater functional output. Approaching the design of lower extremity prosthetic systems from a synergistic perspective has shown potential to be very beneficial for trans-femoral amputees, and the addition of microprocessor-controlled elements only further advances mobility functions, safety, symmetry and efficiency. Historical work on knee-ankle prosthetic systems During the early 1950’s, a few prosthetic devices started to emerge with coordinated knee ankle function. The first commercially available unit, the Stewart-Vickers Hydraulic Leg, which later became marketed as the Hydracadence (initially released by USMC and presently by Proteor of France) is a hydraulically controlled knee-shin and ankle system that allows for coordinated knee and ankle motion. It allows for dorsiflexion during swing for improved ground clearance, early plantarflexion during loading response for increased knee stability, and heel height adjustability1. A study by Sapin et al in 2008 examined functional gait analysis (3-D kinetic and kinematic) between individuals using the Hydracadence system vs. non-linked knee-ankle prosthetic systems vs. non-amputee volunteers. The following functional benefits were found with respect to the Hydracadence system over the non-linked knee-ankle prosthetic devices: Controlled plantar-flexion during loading response led to a greater knee extension moment in early stance thus contributing to increased knee stability. The Hydracadence swing phase characteristics in the sagittal plane were equal to that of the Mauch SNS. However, the greatest difference and potential advantage was the swing phase clearance between the prosthetic foot and floor. The minimum height of the sole of the foot during swing phase was found to be 1 36.9mm for the Hydracadence, 18.2mm for the other knee-ankle prosthetic systems, and 40mm for the normal control group. Even considering the greater swing phase clearance for the Hydracadence during level ground walking, no significant differences were found with respect to pelvic motion between the three test groups2. But what would occur if these same tests were completed on uneven surfaces or during ramp ascent? With double the ground clearance during swing phase, isn’t it possible that coordinated motion of the ankle is an excellent functional safeguard in preventing stumbles during swing and limiting compensatory motion on alternative walking surfaces? If so, then this is a design approach that inherently betters safety and walking ease for the trans-femoral amputee. Another lesser-known historical attempt at developing mechanical synergistic kneeankle systems was attempted by Hans Mauch at Mauch Inc. in Dayton, Ohio in the 1950’s. In 1956, Hans Mauch had developed a hydraulic ankle design that allowed transfemoral amputees to walk up and down ramps while maintaining good knee stability. Priority was given to the Mauch SNS control cylinder for further development between 1956 and 1963. In 1963, work resumed on a foot/ankle design which included an adjustable hydraulic dorsiflexion stop, hydraulic plantar-flexion, transverse rotation, inversion/eversion, and active dorsiflexion during swing. Production units were made by 1970 and a more refined prototype design was created by 1974 compatible with Engineering drawing of Mauch knee-ankle system. endoskeletal and exoskeletal knee/shin Mauch Inc. Dayton Ohio. systems with Mauch SNS control cylinder. A preliminary functional evaluation of the Mauch knee-ankle system was carried out by the V.A. in New York on 2 trans-femoral amputees with results showing that the system simulated anatomical motions during uneven ground walking, stair descent (step over step), ramp ascent and descent, and running. Unfortunately, the ankle unit had many issues with hydraulic leakage and never became proliferated within the Mauch product range3. Finally, the WLP-7R or ‘Waseda Leg’ was another interesting synergistic knee-ankle prototype design created by researchers at Meisei University (Fukushima, Japan) and Waseda University (Tokyo, Japan) in 1987. This design hydraulically connected the knee and ankle joint through the shin of the device which was the hydraulic 2 3 cylinder itself. The aluminium and carbon fibre reinforced plastic device reportedly weighed only 2.4 kg. Walking experiments at Kanagawa Sougou Rehabilitation Centre showed that the synergistic effect of balancing knee flexion and dorsiflexion of the ankle was beneficial for level ground walking, descending AND ascending stairs in a foot-over-foot manner4. The design was never brought to market but highlights the potential mobility advantages offered by coordinating knee and ankle motion. Clinical Evidence for the Symbionic Leg With the advancement of microprocessor, sensor and actuator technologies, more advanced knee and ankle systems have been developed that can increase the number of functional features and benefits available in one device compared to purely mechanical devices. The Rheo Knee (a microprocessor-controlled swing and stance knee system initially released by Össur in 2004) was developed using a rotary magnetorheologic actuator design that was chosen for its extremely low fluid drag characteristics. Hydraulic knee system designs traditionally use turbulent fluid flow characteristics through various orifices to manipulate resistance to swing and stance control and therefore inherently maintain some amount of fluid drag or resistance. In a rotary magnetorheologic actuator, a magnetic field manipulates iron particles suspended in a very small amount of fluid. The varying magnetic field strength changes the electromagnetic bonds between particles thus simulating a braking action in the joint. In a study by Johansson et al in 2005, the zero-pressure, lowdrag Rheo Knee was found to decrease metabolic cost by 5% compared to the Mauch SNS and by 3% compared to the C-Leg. More specifically, they found that there was less work required by the hip musculature to initiate knee flexion during terminal stance5. The effect of adding intelligent ‘user adaptive’ controls to the Rheo Knee (Össur’s ‘Dynamic Learning Matrix Algorithm’ – based on a concept by Herr 4 5 and Wildenfeld published in 2003) furthered functional advantages by allowing the knee to self-adjust knee flexion resistance during swing phase based on a programmed goal or ‘target’ thus limiting the need for continual adjustment of the system by the prosthetist6. The combination of these features allows users of the device to walk with great efficiency and ease while the knee self-optimizes its swing phase programming with changes in user activity and footwear. Use of force and angle sensors in the Rheo Knee combined with specific parameters for stance engagement and release enhance safety when compared to mechanical position deactivated systems like the Mauch SNS. This is especially important for users when engaging in ramp and stair descent activities. This was confirmed further by a recent study in Germany in 2011 by Greitemann et al which highlighted significant benefits for Rheo Knee users such as easy cadence adaptation, increased ease of walking on uneven ground, stairs, slopes, and a reduction in both the fear of falling and concentration when walking7. Initially released for trans-tibial amputees, Össur’s Proprio Foot has been found to have a number of mobility, safety and health related benefits for amputees. Through incorporation of a linear actuator, accelerometers, angle sensor, intelligent software and a carbon fibre foot module, the Proprio Foot allows for automatic dorsiflexion or plantarflexion changes based terrain and activity. Accelerometers and the angle sensor determine limb and joint position and identify motion. By recognizing motion patterns and limb position, the software is able to recognize level ground, slopes, stairs, and sitting. As a result, the system is able to adjust ankle position through the linear actuator to match needs. The unit is calibrated to the individual to dorsiflex 5° during midswing thus allowing for 15-20mm additional clearance. The additional clearance makes it easier to ascend ramps and to avoid tripping on uneven ground or when avoiding obstacles. The ankle adapts gradually to the angle of a slope during ascent and up to 25% of the degree of the slope during descent. During ascent, this allows the user to better transition body weight forward over the prosthetic foot which 6 7 reduces effort and allows for more normal distribution of socket pressures as found in a study by Wolf et al in 20098. During descent, plantar-flexion of the ankle assists with controlling descent speed as well as reducing knee flexion thrust and adverse socket pressures while descending. A study by Fradet et al in 2010 found that the increased dorsiflexion during ramp ascent enabled test subjects using the Proprio Foot to walk in a more physiologically correct manner, and patients reported feeling safer during ramp descent9. During stair ascent and descent, the ankle can be programmed to dorsiflex to 4° or 6°. For ascending purposes, this makes it easier once again to transfer weight forward and extend the knee to climb steps. For descent, this feature allows the user to place more of the foot on the step lending to a feeling of more stability vs. descending with just the heel on the edge of the step. A study by Alimusaj et al in 2009 found that the Proprio foot reduced compensatory movements during stair ascent and descent promoting increased knee flexion and knee moment during stance10. It’s important to note that the stair/ramp adaptation features are subjectively reported to be more valuable to those who are more impaired as in bilateral trans-tibial cases. It makes the difference between complete stair and ramp avoidance to being able to accomplish these mobility tasks with relative ease. The impact of this device on the energy cost of walking is alluded to in the study by Delussu et al in 2013. Despite the increased weight, they found that the energy cost of walking with the Proprio Foot was significantly lower than when using a conventional carbon fibre foot module11. The ankle unit also allows for plantarflexion to accommodate sitting positions and dorsiflexion of the ankle to assist in moving from sit to stand. Finally, the unit can be calibrated to self-align to the heel height of any shoe. This allows amputees to always have walking alignment optimized regardless of footwear or walking barefoot. Össur’s Symbionic Leg is a fusion of the Rheo Knee and Proprio Foot technologies into one system. The knee-ankle synergetic system is powered by one battery that is housed in the knee unit and shared by the knee and ankle system. All of the features mentioned with respect to the Rheo Knee and Proprio Foot remain available in the Symbionic Leg. One trial fitting of the Symbionic Leg has been completed in Australia in February of 2013 on a male transfemoral level osseointegration recipient and K3 level ambulator. The fitting was completed by APC Prosthetics (Sydney) in cooperation with Össur Asia-Pacific. Prior to receiving the osseointegration procedure, the user had been wearing a narrow ML socket design with atmospheric suction suspension, Rheo Knee and Re-Flex Rotate Foot since 2005. Follow up was conducted in May, 2013 in Sydney and by phone in September, 2013. Upon initial follow up in May of 2013, activity data collected from the original Rheo Knee unit’s onboard computer 8 9 10 11 compared to the data collected from the Symbionic Leg showed an overall increase in walking speed range and frequency with the new device: Walking Speed <2.6ft/s 2.6-3.6ft/s 3.6-5.6ft/s >5.6ft/s Rheo Knee + RF Rotate 16% 72% 12% 0% Symbionic Leg 13% 45% 33% 9% The table above outlines walking speed vs. percentage of the overall step count recorded from Rheo Knee and Symbionic Leg Bionic Workbench software programs at the time of first follow up visit. Percentages are calculated as % of all steps recorded on the Rheo Knee (452,080 steps) and Symbionic Leg (235,113 steps) devices respectively. Note the relative increase in % of steps taken for moderate to faster walking speeds, 3.6ft/s to >5.6 ft/s, using the Symbionic Leg. As of September 2013, he continues to use the Symbionic Leg with no functional issues or need for adjustment to the system since initial fitting in February. He chooses not to return to the pre-existing Rheo Knee and Re-Flex Rotate system. He subjectively reports the following advantages moving from the previous system to the Symbionic Leg: - - - To the subject’s recollection, not a single stumble has occurred using the Symbionic Leg. Further, the user cannot recall a single instance of catching the toe of the prosthesis on the ground while using the new device. With the previous system, he remembers several instances of toe catching and then stumbling and having to recover balance to prevent a fall. The Symbionic Leg has eliminated these adverse occurrences completely. Much less effort is required to ascend the ramps on the affected limb, and it is easier to step out with the sound limb. More stable descent of slopes with greater control and less thought required. Easy to change shoes to flats, barefoot and working shoes while maintaining alignment of the prosthesis. - Relaxed Mode (plantarflexion while sitting) is also appreciated for sitting in terms of cosmesis and in more confined spaces. A pilot study on 10 test subjects using the Symbionic Leg in Germany recently released in March of 2013 by Merbold et al reports that ‘the most pronounced improvements were seen in reducing the risk of falling, climbing slopes, reducing compensatory movements, longer walking distance and clearly improved comfort while walking.’12 Although it is early days in terms of available published peerreviewed clinical research to definitively support the synergistic combination of these devices, preliminary investigations like these appear very positive and highlight the great potential with respect to this design approach. Suggested indications for use The Symbionic Leg is presently recommended for K3 level transfemoral and knee disarticulation amputees of low to moderate impact levels. Foot sizes are available from 22-30cm and weight limit of 125kg. It is particularly recommended for those individuals who are presently experiencing difficulty with ramp ascent and descent as well as gait and stability compensation issues related to swing phase clearance. More Information The Symbionic Leg is expected to be released in Australia and New Zealand in 2014. Please contact Össur Asia-Pacific for more information: Össur Asia-Pacific 26 Ross Street North Parramatta, NSW 2151 Ph: (02) 8838 2800 www.ossur.com References 1. Wilson AB: Hydraulics and Above-Knee Prosthetics. Clinical Prosthetics and Orthotics 1983. Vol. 7, No. 4, 3-4. 2. Sapin E, Goujon H, de Almeida F, Fode P, Lavaste F: Functional gait analysis of trans-femoral amputees using two different single-axis prosthetic knees with hydraulic swing-phase control: Kinematic and kinetic comparison of two prosthetic knees. Prosthetics and Orthotics International 2008, 32 (2): 201-218. 3. Sowell TT: A preliminary clinical evaluation of the Mauch hydraulic foot-ankle system. Prosthetics and Orthotics International 1981, 5, 87-91. 12 4. Koganezawa K, Fujimoto H, Kato I: Multifunctional above-knee prosthesis for stairs walking. Prosthetics and Orthotics International 1987, 11, 139-145. 5. Johansson JL, Sherrill DM, Riley PO, Bonato P, Herr H: A clinical comparison of variable-damping and mechanically passive prosthetic knee devices. Am J Phys Med Rehabilitation 2005; 84: pp. 563-575. 6. Herr H, Wilkenfeld A: User-adaptive control of a magnetorheological prosthetic knee. Industrial Robot: An International Journal 2003; Vol 30, No 1: pp. 42-55. 7. Greitemann B, Niemeyer C, Lechler K, Ludviksdottir A. Verbesserung der Teilhabe durch mikroprozessorgesteuertes Kniegelenk – erste Erfahrungen einer Kohortenstudie. Medizinisch Orthopädische Technik 1-2011, pp. 90-101. 8. Wolf SI, Alimusaj M, Fradet L, Siegel J, Braatz F: Pressure characteristics at the stump/socket interface in transtibial amputees using an adaptive prosthetic foot. Clinical Biomechanics (Bristol, Avon) 2009, 24 (10): 860-5. 9. Fradet L, Alimusaj M, Braatz F, Wolf SI: Biomechanical analysis of ramp ambulation of transtibial amputees with an adaptive ankle foot system. Gait and Posture 2010, 32 (2): 191-8. 10. Alimusaj M, Fradet L, Braatz F, Gerner HJ, Wolf SI: Kinematics and kinetics with an adaptive ankle foot system during stair ambulation of transtibial amputees. Gait and Posture 2009, 30 (3): 356-63. 11. Delussu AS, Brunelli S, Paradisi F, Iosa M, Pellegrini R, Zenardi D, Traballesi M: Assessment of the effects of carbon fiber and bionic foot during overground and treadmill walking in transtibial amputees. Gait and Posture, May 2013. 12. Merbold D, Hahnel T, Brandenburg J, Muller Ch., Tschernig M. Verbesserte Sicherheit und Mobilitat durch ein mikroprozessorgesteuertes Beinprothesensystem – Erste Ergebnisse einer Multicenter-Pilotstudie (Improved Safety and Mobility with a Microprocessor-Controlled Leg Prosthesis System – Initial Results of a Multicentre Pilot Study). Orthopadie-Technik Magazine 3-2013, pp. 1-5. Acknowledgements Thanks to the staff at APC Prosthetics (Sydney) especially Stefan Laux for cooperating with Össur Asia-Pacific in conducting the Australian Symbionic Leg trial.
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