Categorization and recommendations for outcome measures for lower limb absence by an expert panel.

Background: Understanding the psychometric strengths and limitations of outcome measures for use with people with lower limb absence (LLA) is important for selecting measures suited to evaluating patient outcomes, answering clinical and research questions, and informing health care policy. The aim of this project was to review the current psychometric evidence on outcome measures in people with LLA to determine which measures should be included in a stakeholder consensus process.

Methods: An expert panel was assembled, and a 3-stage review process was used to categorize outcome measures identified in a systematic literature review into 3 distinct categories (recommended for measures with better than adequate psychometric properties; recommended with qualification; and unable to recommend).

Enabling Technology for Remote Prosthetic Alignment Tuning.

Introduction: This research has resulted in a system of sensors and software for effectively adjusting prosthetic alignment with digital numeric control. We called this suite of technologies the Prosthesis Smart Alignment Tool (ProSAT) system.

Materials And Methods: The ProSAT system has three components: a prosthesis-embedded sensor, an alignment tool, and an Internet-connected alignment expert system application that utilizes machine learning to analyze prosthetic alignment.

Comparison of a computerized algorithm and prosthetists' judgment in rating functional levels based on daily step activity in transtibial amputees.

The Medicare Functional Classification Levels: "K-Level" system is a standard scale for functional levels of amputees. But it is problematic to document objectively and reliably. The K-Levels are based on three characteristics: and of the amputees.

Functional level assessment of individuals with transtibial limb loss: Evaluation in the clinical setting versus objective community ambulatory activity.

The functional level (K level) of prosthetic users is used to choose appropriate prosthetic components, but ratings may highly subjective. A more objective and robust method to determine K level may be appealing. The aim of this study was to determine the relationship between K level determined in the clinic to K level based on real world ambulatory activity data collected by StepWatch.

Socket reaction moments in transtibial prostheses during walking at clinically perceived optimal alignment.

Background And Aim: The socket reaction moments are directly measured at the base of a socket and may be useful for fitting a prosthesis. Previous studies have focused on the effect of prosthetic alignment changes on them. The aim of this study was to explore their range at clinically perceived optimal alignment by investigating the individual differences.

Dynamic alignment of transtibial prostheses through visualization of socket reaction moments.

Background And Aim: Dynamic alignment of transtibial prostheses is generally performed based on visual interpretation of gait without the benefit of any kinetic analysis in the clinic. The aim of this technical note was to present and discuss the possibilities of assisting dynamic alignment of transtibial prostheses through visualization of socket reaction moments.

Technique: Smart Pyramid™ (currently Europa™) was used to measure the socket reaction moments under various alignment conditions from an amputee with transtibial prosthesis.

Individual responses to alignment perturbations in socket reaction moments while walking in transtibial prostheses.

Background: The alignment of transtibial prostheses has a systematic effect on the mean socket reaction moments in amputees. However, understanding their individual differences in response to alignment perturbations is also important for prosthetists to fully utilize the socket reaction moments for dynamic alignment in each unique patient. The aim of this study was to investigate individual responses to alignment perturbations in transtibial prostheses with solid-ankle-cushion-heel feet.

Effect of prosthetic alignment changes on socket reaction moment impulse during walking in transtibial amputees.

The alignment of a lower limb prosthesis affects the way load is transferred to the residual limb through the socket, and this load is critically important for the comfort and function of the prosthesis. Both magnitude and duration of the moment are important factors that may affect the residual limb health. Moment impulse is a well-accepted measurement that incorporates both factors via moment-time integrals.

Effect of alignment changes on socket reaction moments while walking in transtibial prostheses with energy storage and return feet.

Background: Energy storage and return feet are designed for active amputees. However, little is known about the socket reaction moments in transtibial prostheses with energy storage and return feet. The aim of this study was to investigate the effect of alignment changes on the socket reaction moments during gait while using the energy storage and return feet.

Effect of alignment changes on socket reaction moments during gait in transfemoral and knee-disarticulation prostheses: case series.

The alignment of a lower-limb prosthesis is critical to the successful prosthetic fitting and utilization by the wearer. Loads generated by the socket applied to the residual limb while walking are thought to be different in transfemoral and knee-disarticulation prostheses. The aim of this case series was to compare the socket reaction moments between transfemoral and knee-disarticulation prostheses and to investigate the effect of alignment changes on them.

Effect of alignment changes on sagittal and coronal socket reaction moment interactions in transtibial prostheses.

Alignment is important for comfortable and stable gait of lower-limb prosthesis users. The magnitude of socket reaction moments in the multiple planes acting simultaneously upon the residual limb may be related to perception of comfort in individuals using prostheses through socket interface pressures. The aim of this study was to investigate the effect of prosthetic alignment changes on sagittal and coronal socket reaction moment interactions (moment-moment curves) and to characterize the curves in 11 individuals with transtibial amputation using novel moment-moment interaction parameters measured by plotting sagittal socket reaction moments versus coronal ones under various alignment conditions.

Perception of socket alignment perturbations in amputees with transtibial prostheses.

A person with amputation's subjective perception is the only tool available to describe fit and comfort to a prosthetist. However, few studies have investigated the effect of alignment on this perception. The aim of this article is to determine whether people with amputation could perceive the alignment perturbations of their prostheses and effectively communicate them.

Influence of malalignment on socket reaction moments during gait in amputees with transtibial prostheses.

Alignment - the process and measured orientation of the prosthetic socket relative to the foot - is important for proper function of a transtibial prosthesis. Prosthetic alignment is performed by prosthetists using visual gait observation and amputees' feedback. The aim of this study was to investigate the effect of transtibial prosthesis malalignment on the moments measured at the base of the socket: the socket reaction moments.

Effect of transtibial prosthesis alignment changes on out-of-plane socket reaction moments during walking in amputees.

Alignment of lower limb prostheses is important for the gait of amputees. Observed deviations in a particular plane are corrected by altering the prosthetic alignment of the same plane. The assumption is that observed deviations are due to alignment errors within the same plane, but no research has confirmed this assumption.

Gait analysis of low-cost flexible-shank transtibial prostheses.

The latest lower-limb prosthetic designs have been incorporated with dynamic elastic response (DER) components to enhance prosthesis flexibility, which are suggested to be beneficial to gait. Although DER prosthetic. feet are preferred by most transtibial amputees and their benefits to gait are supported by some biomechanical studies, many are still utilizing the simple conventional solid ankle cushioned heel (SACH) designs because of the lower cost.

Finite-element analysis to determine effect of monolimb flexibility on structural strength and interaction between residual limb and prosthetic socket.

Monolimb refers to a kind of transtibial prostheses having the socket and shank molded into one piece of thermoplastic material. One of its characteristics is that the shank is made of a material that can deform during walking, which can simulate ankle joint motion to some extent. Changes in shank geometry can alter the stress distribution within the monolimb and at the residual limb-socket interface and, respectively, affect the deformability and structural integrity of the prosthesis and comfort perceived by amputees.

Quantification of prosthetic outcomes: elastomeric gel liner with locking pin suspension versus polyethylene foam liner with neoprene sleeve suspension.

For this randomized crossover trial, we compared two common transtibial socket suspension systems: the Alpha liner with distal locking pin and the Pe-Lite liner with neoprene suspension sleeve. Our original hypotheses asserted that increased ambulatory activity, wear time, comfort, and satisfaction would be found with the elastomeric suspension system. Thirteen subjects completed the study.

Ambulatory activity in men with diabetes: relationship between self-reported and real-world performance-based measures.

The measurement of physical activity, especially walking activity, is important for many outcome studies. In many investigations, the Physical Activity scale of the short-form-36 (SF-36) health assessment questionnaire is used in lieu of an actual physical measurement of walking. This study determined the relationship between the SF-36 questionnaire and the Step Activity Monitor (SAM), a real-world performance-based tool that counts the actual number of steps taken during daily activities.

Quantitative comparison of plantar foot shapes under different weight-bearing conditions.

Knowledge of the plantar foot shape alteration under weight bearing can offer implications for the design and construction of a comfortable and functional foot support. The purpose of this study was to quantify the change in three-dimensional foot shape under different weight-bearing conditions. The plantar foot shapes of 16 normal feet were collected by an impression casting method under three weight-bearing conditions: non-weight bearing, semi-weight bearing, and full-weight bearing.

Microprocessor-based ambulatory activity monitoring in stroke patients.

Purpose: Recovery of ambulatory function after stroke is routinely assessed using standardized subject- or observer-rated instruments that do not directly measure ambulatory activities in the home-community setting. Accuracy of conventional pedometers in stroke patients is not established, limiting their application in mobility outcomes monitoring. This study investigates the accuracy and reliability of a mechanical pedometer versus microprocessor-based step activity monitoring (SAM) in gait-impaired hemiparetic stroke patients.