Traditionally, the mechanical testing of ankle-foot orthoses (AFOs) has been performed with simple limb surrogates, typically with a single axis ankle joint and rigid foot and shank components. Since many current AFO designs allow 3D motion, a surrogate lower limb (SLL) that provides anatomically similar motion in all planes is needed to enable realistic load testing and cyclic testing in a controlled manner. The aim of this thesis was to design, fabricate and test a novel SLL that provides anatomically realistic 3D foot motion, based on a consensus of the passive lower limb range of motion (RoM) found in the literature. The SLL design was inspired by the Rizzoli model, sectioning the lower limb into five segments (shank, hindfoot, midfoot, forefoot, toes). Ball and socket joints were used for the shank-hindfoot, hindfoot-midfoot, and midfoot-forefoot. Forefoot-toes used a hinge-type joint. 3D printed flexible thermoplastic polyurethane (TPU) snap-fit connectors connected the 3D printed nylon foot blocks. A threaded ball stud connected the shank shaft and hindfoot. This shank shaft was surrounded by a 3D printed polylactic acid (PLA) shank cover. The foot was cast in silicone rubber to emulate soft tissue, with a PLA custom mould based on a Össur prosthetic foot cover model. The SLL was successfully designed for easy fabrication using readily available techniques, materials, and components. Only the metal shaft required additional machining. 3D printed components used an affordable 3D printer (Artillery Sidewinder X1), and readily available nylon, PLA, and TPU. Using motion capture testing, SLL foot rotation angles were found to be within standard deviation of mean foot passive rotation angle ranges found in the literature, showing that most joints were within 5° of target maximum rotation angles. With load testing, the SLL was shown to survive static loads representing 1.5 times body weight for a 100 kg individuals and cyclic loads representing normal gait loading for 500,000 cycles.

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京都大学 / 新制・課程博士 / 博士(人間健康科学) / 甲第24095号 / 人健博第102号 / 新制||人健||7(附属図書館) / 京都大学大学院医学研究科人間健康科学系専攻 / (主査)教授 市橋 則明, 教授 稲富 宏之, 教授 松田 秀一 / 学位規則第4条第1項該当 / Doctor of Human Health Sciences / Kyoto University / DFAM

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This master thesis deals with the engineering design of a knee-ankle orthosis and subsequent implementation of a functional sample. The subject of the first part of the thesis is the design of internal shape of the shell on the basis of the patient's leg using CAD software. The second part deals with the design of the hydraulic knee. The knee joint with hydraulic controlled bending enables easier movement for patients who are not able to bring up stairs and uneven surfaces than existing joints. In the implementation was used SolidWorks 2012 and Geomagic Studio 12.

Limited knowledge of the neuromechanical response to use of an ankle foot orthosis-footwear combination (AFO-FC) has created a lack of consensus in understanding orthotic motion control as a therapeutic treatment. Lack of consensus may hinder the clinician’s ability to target the motion control needs of persons with movement impairment (e.g., peripheral nerve injury, stroke, etc.). Some evidence suggests a proportional relationship between joint motion and neuromuscular activity based on the notion that use of lower limb orthoses that constrain joint motion may invoke motor slacking and decreasing levels of muscle activity. Use of AFO-FCs likely alters the biomechanical and neuromuscular output as the central control system gradually forms new movement patterns. If there is proportional relationship between muscle activation and joint motion, then it could be examined by quantifying joint motion and subsequent neuromuscular output. Considering principles of neuromechanical adjustment, my general hypothesis examines whether orthotic control of lower limb motion alters neuromuscular output in proportion to the biomechanical output as a representation of the limb’s dynamics are updated by the neural control system. The rationale for this approach is that reference knowledge of the neuromechanical response is needed to inform clinicians about how a person responds to walking with motion controlling devices such as ankle foot orthoses combined with footwear. In the first line of research, I hypothesize that a newly developed AFO which maximizes leverage and stiffness will constrain the talocrural joint and alter joint kinematics and ground reaction force patterns. To answer the hypothesis, I sampled kinematics and kinetics of healthy subjects’ treadmill walking using an AFO-FC in a STOP condition and confirmed that the AFO substantially limited the range of talocrural plantarflexion and dorsiflexion motion to 3.7° and in a FREE condition maintained talocrural motion to 24.2° compared to 27.7° in a CONTROL (no AFO) condition. A follow up controlled static loading study sampled kinematics of matched healthy subjects limbs and cadaveric limbs in the AFO STOP and FREE conditions. Findings revealed healthy and cadaveric limbs in the AFO STOP condition substantially limited their limb segment motion similar to matched healthy subjects walking in the STOP condition and in the AFO FREE condition healthy and cadaveric limbs maintained similar limb segment motion to matched healthy subjects walking in the FREE condition. In a second line of research, I hypothesize that flexibility of a newly developed footwear system will allow normal walking kinetics due to the shape and flexibility of the footwear. To answer the hypothesis, I utilized a curved-flexible footwear system integrated with an AFO in a STOP condition and sampled kinematics and kinetics of healthy subjects during treadmill walking. Results revealed subjects elicited similar cadence, stance and swing duration and effective leg-ankle-foot roll over radius compared to walking in the curved-flexible footwear integrated with the AFO in a FREE condition and a CONTROL (no AFO) condition. To validate rollover dynamics of the curved-flexible footwear system, a follow up study of healthy subjects’ treadmill walking in newly developed flat-rigid footwear system integrated with the AFO in a STOP condition revealed interrupted leg-ankle-foot rollover compared to walking in curved-flexible footwear in STOP, FREE and CONTROL conditions. In a third line of research, I hypothesize that use of an AFO that limits talocrural motion in a STOP condition will proportionally reduce activation of Tibialis Anterior, Soleus, Medial and Lateral Gastrocnemii muscles compared to a FREE and CONTROL condition due to alterations in length dependent representation of the limb’s dynamics undergoing updates to the central control system that modify the pattern of motor output. To answer the question, the same subjects and AFO-footwear presented in the first two lines of research were used in a treadmill walking protocol in STOP, FREE, and CONTROL conditions. Findings revealed the same subjects and ipsilateral AFO-footwear system presented in Aim 1 exhibited an immediate yet moderate 30% decline in EMG activity of ipsilateral Soleus (SOL), Medial Gastrocnemius (MG) and Lateral Gastrocnemius (LG) muscles in the STOP condition compared to the CONTROL condition. The reduction in EMG activity in ipsilateral SOL, MG and LG muscles continued to gradually decline during 15 minutes of treadmill walking. On the contralateral leg, there was an immediate yet small increase of 1% to 14% in EMG activity in SOL, MG, LG muscles above baseline. After 10 minutes of walking, the EMG activity in contralateral SOL, MG and LG declined to a baseline level similar to the EMG activity in the contralateral CONTROL condition. These collective findings provide compelling evidence that the moderate 30% reduction in muscle activation exhibited by subjects as they experience substantial (85%) constraint of total talocrural motion in the AFO STOP condition is not proportionally equivalent. Further, the immediate decrease in muscle activation may be due to a reactive feedback mechanism whereas the continued decline may in part be explained by a feedforward mechanism. The clinical relevance of these findings suggests that short term use of orthotic constraint of talocrural motion in healthy subjects does not substantially reduce muscle activation. These preliminary findings could be used to inform the development of orthoses and footwear as therapeutic motion control treatments in the development of motor rehabilitation protocols.

Dans le secteur industriel, la nécessité de fournir des données cliniques lors de la mise sur le marché d’un nouveau dispositif médical s’est sensiblement accrue suite à de récentes évolutions juridiques. L’objectif de ce travail de thèse était de recueillir des données cliniques relatives à l’utilisation d’un nouveau modèle d’orthèse de type releveur de pied pour valider son intérêt vis-à-vis de produits standards. Pour formuler des hypothèses raisonnées et interpréter objectivement ces données, la connaissance des caractéristiques mécaniques des orthèses étudiées a constitué l’étape préalable nécessaire. Après s’être assuré de la faisabilité et de la pertinence du protocole expérimental sur des sujets sains, l’analyse des effets du port des dispositifs lors de tâches motrices élémentaires que sont la station debout et la marche chez des patients (avec atteinte uni ou bilatérale, d’origine périphérique, des muscles fléchisseurs dorsaux de cheville) a constitué le cœur de nos investigations. Celles-ci ont ainsi pu mettre en évidence que le port d’orthèse induit des effets communs et d’autres spécifiques à chaque modèle. Dès lors, de façon originale, nous nous sommes proposés d’identifier, par des moyens simples et rapides, les patients qui tirent davantage profit d’un des modèles d’orthèse. Outre le prérequis indispensable qui est l’acceptation de l’appareillage par le patient, nos résultats précisent que le dispositif orthopédique le plus adapté est celui qui compense le(s) déficit(s) en restaurant la fonction motrice, sans contraindre les capacités préservées / In the industrial field, the necessity of providing some clinical data during the launching of a new medical device has noticeably increased after some recent legal evolutions. The aim of this thesis was to collect some clinical data concerning the use of a new ankle-foot orthosis in order to confirm its relevance in comparison with standard products. To formulate some reasoned hypotheses and objectively interpret these data, the knowledge of the mechanical characteristics of the studied orthoses has constituted the preliminary necessary step. After checking the feasibility and the relevance of the experimental protocol on healthy subjects, the analysis of the effects of the ankle-foot orthoses during some elementary motor tasks, which are the stance and gait, in patients (suffering from a uni or bilateral affection, of a peripheral origin, ankle dorsal flexor muscles) has been the core of our research. As a consequence, it results from this that the ankle-foot orthosesinfer some common effects and some other, specific to each model. From that moment on, in an original way, we were bound to identify, with some simple and fast ways the patients taking the larger advantage from one of the orthosis models. In addition to the necessary prerequisite which is the acceptance of the equipment by the patient, our results specify that the most adapted orthopaedic device compensates for the deficiency(ies) by restoring the motor function, without restraining the preserved abilities

The work presented in this paper aims at developing a hydraulic actuation system for an ankle exoskeleton that is able to deliver a peak power of 250 W, with a maximum torque of 90 N.m and maximum speed of 320 deg/s. After justifying the choice of a servo hydraulic actuator (SHA) over an electro hydrostatic actuator (EHA) for the targeted application, some test results of a first functional prototype are presented. The closed-loop unloaded displacement frequency response of the prototype shows a bandwidth ranging from 5 Hz to 8 Hz for displacement amplitudes between +/-5mm and +/- 20mm, thus demonstrating adequate dynamic performance for normal walking speed. Then, a detailed design is proposed as a combination of commercially available components (in particular a miniature servo valve and a membrane accumulator) and a custom aluminium manifold that incorporates the hydraulic cylinder. The actuator design achieves a total weight of 1.0 kg worn at the ankle.

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