Advancing Exoskeleton Development: Validation of a Robotic Surrogate to Measure Tibial Strain.

Bone stress injuries are prevalent among athletes and military recruits and can significantly compromise training schedules. The development of an ankle-foot orthosis to reduce tibial load and enable a faster return to activity will require new device testing methodologies capable of capturing the contribution of muscular force on tibial strain. Thus, an actuated robotic surrogate leg was developed to explore how tibial strain changes with different ankle-foot orthosis conditions. The purpose of this work was to assess the reliability, scalability, and behavior of the surrogate. A dual actuation system consisting of a Bowden cable and a vertical load applied to the femur via a material testing system, replicated the action-reaction of the Achilles-soleus complex. Maximum and minimum principal strain, maximum shear strain, and axial strain were measured by instrumented strain gauges at five locations on the tibia. Strains were highly repeatable across tests but did not consistently match in vivo data when scaled. However, the stiffness of the ankle-foot orthosis strut did not systematically affect tibial load, which is consistent with in vivo findings. Future work will involve improving the scalability of the results to match in vivo data and using the surrogate to inform exoskeletal designs for bone stress injuries.

Experimental Demonstration of the Lower Leg Trajectory Error Framework Using Physiological Data as Inputs.

While many studies have attempted to characterize the mechanical behavior of passive prosthetic feet to understand their influence on amputee gait, the relationship between mechanical design and biomechanical performance has not yet been fully articulated from a fundamental physics perspective. A novel framework, called lower leg trajectory error (LLTE) framework, presents a means of quantitatively optimizing the constitutive model of prosthetic feet to match a reference kinematic and kinetic dataset. This framework can be used to predict the required stiffness and geometry of a prosthesis to yield a desired biomechanical response. A passive prototype foot with adjustable ankle stiffness was tested by a unilateral transtibial amputee to evaluate this framework. The foot condition with LLTE-optimal ankle stiffness enabled the user to replicate the physiological target dataset within 16% root-mean-square (RMS) error. Specifically, the measured kinematic variables matched the target kinematics within 4% RMS error. Testing a range of ankle stiffness conditions from 1.5 to 24.4 N·m/deg with the same user indicated that conditions with lower LLTE values deviated the least from the target kinematic data. Across all conditions, the framework predicted the horizontal/vertical position, and angular orientation of the lower leg during midstance within 1.0 cm, 0.3 cm, and 1.5 deg, respectively. This initial testing suggests that prosthetic feet designed with low LLTE values could offer benefits to users. The LLTE framework is agnostic to specific foot designs and kinematic/kinetic user targets, and could be used to design and customize prosthetic feet.

Quantification of rectifications for the Northwestern University Flexible Sub-Ischial Vacuum Socket.

BACKGROUND: The fit and function of a prosthetic socket depend on the prosthetist's ability to design the socket's shape to distribute load comfortably over the residual limb. We recently developed a sub-ischial socket for persons with transfemoral amputation: the Northwestern University Flexible Sub-Ischial Vacuum Socket. OBJECTIVE: This study aimed to quantify the rectifications required to fit the Northwestern University Flexible Sub-Ischial Vacuum Socket to teach the technique to prosthetists as well as provide a computer-aided design-computer-aided manufacturing option. STUDY DESIGN: Development project. METHODS: A program was used to align scans of unrectified and rectified negative molds and calculate shape change as a result of rectification. Averaged rectifications were used to create a socket template, which was shared with a central fabrication facility engaged in provision of Northwestern University Flexible Sub-Ischial Vacuum Sockets to early clinical adopters. Feedback regarding quality of fitting was obtained. RESULTS: Rectification maps created from 30 cast pairs of successfully fit Northwestern University Flexible Sub-Ischial Vacuum Sockets confirmed that material was primarily removed from the positive mold in the proximal-lateral and posterior regions. The template was used to fabricate check sockets for 15 persons with transfemoral amputation. Feedback suggested that the template provided a reasonable initial fit with only minor adjustments. CONCLUSION: Rectification maps and template were used to facilitate teaching and central fabrication of the Northwestern University Flexible Sub-Ischial Vacuum Socket. Minor issues with quality of initial fit achieved with the template may be due to inability to adjust the template to patient characteristics (e.g. tissue type, limb shape) and/or the degree to which it represented a fully mature version of the technique. Clinical relevance Rectification maps help communicate an important step in the fabrication of the Northwestern University Flexible Sub-Ischial Vacuum Socket facilitating dissemination of the technique, while the average template provides an alternative fabrication option via computer-aided design-computer-aided manufacturing and central fabrication.

Using a three-dimensional model of the Ankle-Foot Orthosis/leg to explore the effects of combinations of axis misalignments.

BACKGROUND AND AIM: Misaligning the mechanical axes of Ankle-Foot Orthoses with the ankle axis may lead to tissue damage, reduced gait efficiency, and mechanical wear on the orthosis. Previous models developed to describe the consequences of joint misalignments have only been applied to the sagittal plane. In this study, a previously developed three-dimensional model of the Ankle-Foot Orthosis/leg system was used to determine the effects of misalignments in the frontal and transverse planes and how they interact with misalignments in the sagittal plane. TECHNIQUE: The motion of two corresponding points on the leg and Ankle-Foot Orthosis was calculated for different binary combinations of translational and rotational misalignments of the mechanical axis, and the resulting displacements between those points recorded. DISCUSSION: Misaligning the mechanical joint axis of the Ankle-Foot Orthosis in the transverse plane led to much greater displacements than other misalignments. Results from the model suggest the importance of prioritizing transverse plane alignment by appropriately accounting for tibial rotation. CLINICAL RELEVANCE: Misalignments in the transverse plane had a dominating effect on relative motion between the Ankle-Foot Orthosis and leg emphasizing the importance of including the third dimension in the model and prioritizing accuracy of alignment in the transverse plane.

A three-dimensional model to assess the effect of ankle joint axis misalignments in ankle-foot orthoses.

BACKGROUND: Misalignment of an articulated ankle-foot orthosis joint axis with the anatomic joint axis may lead to discomfort, alterations in gait, and tissue damage. Theoretical, two-dimensional models describe the consequences of misalignments, but cannot capture the three-dimensional behavior of ankle-foot orthosis use. OBJECTIVES: The purpose of this project was to develop a model to describe the effects of ankle-foot orthosis ankle joint misalignment in three dimensions. STUDY DESIGN: Computational simulation. METHODS: Three-dimensional scans of a leg and ankle-foot orthosis were incorporated into a link segment model where the ankle-foot orthosis joint axis could be misaligned with the anatomic ankle joint axis. The leg/ankle-foot orthosis interface was modeled as a network of nodes connected by springs to estimate interface pressure. Motion between the leg and ankle-foot orthosis was calculated as the ankle joint moved through a gait cycle. RESULTS: While the three-dimensional model corroborated predictions of the previously published two-dimensional model that misalignments in the anterior -posterior direction would result in greater relative motion compared to misalignments in the proximal -distal direction, it provided greater insight showing that misalignments have asymmetrical effects. CONCLUSIONS: The three-dimensional model has been incorporated into a freely available computer program to assist others in understanding the consequences of joint misalignments. CLINICAL RELEVANCE: Models and simulations can be used to gain insight into functioning of systems of interest. We have developed a three-dimensional model to assess the effect of ankle joint axis misalignments in ankle-foot orthoses. The model has been incorporated into a freely available computer program to assist understanding of trainees and others interested in orthotics.

Interrater reliability of mechanical tests for functional classification of transtibial prosthesis components distal to the socket.

Substantial evidence suggests that the design and associated mechanical function of lower-limb prostheses affects user health and mobility, supporting common standards of clinical practice for appropriate matching of prosthesis design and user needs. This matching process is dependent on accurate and reliable methods for the functional classification of prosthetic components. The American Orthotic & Prosthetic Association developed a set of tests for L-code characterization of prosthesis mechanical properties to facilitate functional classification of passive below-knee prosthetic components. The mechanical tests require use of test-specific fixtures to be installed in a materials testing machine by a test administrator. Therefore, the purpose of this study was to assess the interrater reliability of test outcomes between two administrators using the same testing facility. Ten prosthetic components (8 feet and 2 pylons) that spanned the range of commercial designs were subjected to all appropriate tests. Tests with scalar outcomes demonstrated high interrater reliability (intraclass correlation coefficient(2,1) >/= 0.935), and there was no discrepancy in observation-based outcomes between administrators, suggesting that between-administrator variability may not present a significant source of error. These results support the integration of these mechanical tests for prosthesis classification, which will help enhance objectivity and optimization of the prosthesis-patient matching process for maximizing rehabilitation outcomes.

Modeling effects of sagittal-plane hip joint stiffness on reciprocating gait orthosis-assisted gait.

Upright ambulation is believed to improve quality of life for persons with lower-limb paralysis (LLP). However, ambulatory orthoses for persons with LLP, like reciprocating gait orthoses (RGOs), result in a slow, exhausting gait. Increasing the hip joint stiffness of these devices may improve the efficiency of RGO-assisted gait. The small, diverse population of RGO users makes subject recruitment challenging for clinical investigations. Therefore, we developed a lower-limb paralysis simulator (LLPS) that enabled nondisabled persons to exhibit characteristics of RGO-assisted gait, thereby serving as surrogate models for research. For this study, tests were conducted to determine the effects of increased hip joint stiffness on gait of nondisabled persons walking with the LLPS. A motion capture system, force plates, and spirometer were used to measure the hip flexion, crutch ground reaction forces (GRFs), and oxygen consumption of subjects as they walked with four different hip joint stiffness settings. Increasing the hip joint stiffness decreased hip flexion during ambulation but did not appear to affect the crutch GRFs. Walking speed was observed to initially increase with increases in hip joint stiffness, and then decrease. These findings suggest that increasing hip joint stiffness may increase walking speed for RGO users.

Walking mechanics of persons who use reciprocating gait orthoses.

Although ambulation with a reciprocating gait orthosis (RGO) may provide physical benefits to people with lower-limb paralysis, the high metabolic energy cost associated with ambulation limits orthosis use. The purpose of this case series was to investigate the dynamics of ambulation with RGOs to identify and better understand the potential causes of the high energy cost. Data were acquired from five regular users of RGOs. Kinematics and kinetics were measured, and the moments and powers acting at the hips and shoulders calculated. All RGO users walked with a flexed trunk and bore a large proportion of body weight through the arms during single support. Moments at the shoulder encouraged trunk extension, while moments at the hip encouraged trunk flexion. An extension moment acted on the hip at the beginning of swing, which was antagonistic to the goal of swing and contradicted the intent of the reciprocal link: to advance the swing leg. These results suggest that characteristics of RGO ambulation are consistent across users. The relationship between posture, forces acting on the walking aids, and the action of the RGO reciprocal link should be further explored because these factors likely contribute to the high metabolic cost of ambulation with an RGO.