Prosthetic Users Research Articles

Listening to children with lower limb loss: Rationale, design, and protocol for delivery of a novel globally applicable research toolkit-Prosthetic user needs, quality of life, pain, and physical function.

Rehabilitation after childhood lower limb loss is complex and dependent on multiple stakeholders and environmental factors. While research with adults underscores the importance of involving prosthetic limb users and caregivers in discussions to drive innovation, children are often excluded or not effectively engaged. This protocol lays out the development and implementation protocol for an internationally applicable research toolkit which has been designed and evaluated around the essential presence of the child. Research domains span their unique prosthetic needs, quality of life, pain, and mobility. Cohorts of children in contrasting environments were identified (Cambodia, Gaza Strip, and the UK) to provide a comprehensive global understanding of the child with lower limb loss. A literature review revealed a lack of appropriate tools for identifying paediatric prosthetic user requirements leading to the development of novel interview guides for each key stakeholder: child, caregiver, and prosthetist. The child's guide centred around enjoyment and engagement using card games and activities. A panel of experts in paediatric limb loss and mental health rigorously reviewed the guides. Guides were integrated with existing validated measures for quality of life, pain, and mobility to form a comprehensive toolkit. The toolkit was successfully piloted with 5 children, their families, and 2 prosthetists. This protocol lays out the toolkit rationale and implementation plan (Jan 2023 to Dec 2025). This work offers the opportunity for this cohort to enjoyably engage with research that seeks to radically improve prospects for all children living with limb loss. The outlined best practices ensure ethical considerations when working with vulnerable cohorts. This study is approved to cover implementation at all geographical locations as well as the researcher institutions. Results will be disseminated through national and international conferences, as well as through manuscripts in leading peer-reviewed journals.

Self-reported prosthetic mobility of lower limb prosthetic users in Norway

Self-reported prosthetic mobility of lower limb prosthetic users in Norway

A dataset of optical camera and IMU sensor derived kinematics of thirty transtibial prosthesis wearers

Motion analysis has played a crucial role in providing gait analysis for prosthetic users. Understanding kinematics in motion analysis allows for the evaluation of the effects of prostheses and the development of a prosthetic component design that aids in walking within the community. However, there are currently limited open datasets available to study the locomotion of individuals using transtibial prostheses, and most research studies involve a limited number of participants. This dataset shows 30 transtibial prosthesis users walking comfortably on a 10-meter walkway inside a laboratory. We offer a set of joint ankles obtained from the inertial measurement unit (IMU) signals in CSV file format. We also provide the optical motion capture (OMC) system’s raw trajectory marker data in C3D file format and joint angle in CSV file format. This open dataset will provide resources for professionals interested in amputee gait for research in amputee gait detection and tracking algorithms. Moreover, the data will be the control data for comparison in developing advanced prosthetic components.

Psychosocial Correlates and Behavioral Response to a Carbon Fiber Orthosis and Intensive Rehabilitation Program

Introduction Carbon fiber custom dynamic orthoses (CDOs), a type of ankle-foot orthosis (AFO), have been shown to improve function and mobility. Psychosocial aspects of disability can influence outcomes in prosthetic and orthotic users, but their association with outcomes in CDO users is unknown. Objective The aim of this study was to examine the relationships between physical and psychosocial outcomes following an intensive rehabilitative program including a carbon fiber ankle-foot orthosis, and identify factors related to continued orthosis use. Study Design Retrospective cohort with long-term follow-up. Methods An online survey including questions about device behaviors, self-reported function, pain, global health, self-efficacy, pain interference, resilience, and kinesiophobia was completed by participants who received a custom carbon fiber ankle-foot orthosis and intensive training because of chronic neuromusculoskeletal lower-limb disability. Results The mean follow-up was 4.0 (±1.0) years. Sixty-three adult participants responded to the survey (21 women, 42 men; mean age, 41 ± 12 years). All psychosocial outcomes at follow-up were within “good” or “normal” limits (<1 SD from reference population mean) on average. Strong correlations were observed between self-reported physical function and psychosocial outcomes, and moderate correlations were observed among psychosocial outcomes, between baseline physical outcomes and psychosocial outcomes, and between long-term outcomes and psychosocial outcomes. Device continuation at long-term follow-up was 68%. Conclusions Four years after the intervention, respondents with chronic lower-limb disabilities reported scores that were comparable to normative values for kinesiophobia, health-related quality of life, self-efficacy for managing their condition, pain interference, and psychological resilience. Clinical Relevance Psychosocial variables can affect the outcomes with, and perception of, orthotic devices in individuals with lower-limb neuromusculoskeletal deficits. A goal-oriented care program with emphasis on technique training, postdelivery follow-up, and psychosocial status may help explain long-term outcomes with CDOs and continued device use.

Activities-specific balance confidence scale: a Rasch evaluation of the Arabic version in lower-limb prosthetic users

Purpose To evaluate the psychometric properties of the Arabic version of the Activities-Specific Balance Confidence Scale using the 5-option response categories for individuals with lower limb amputation (ABC-5/Ar). Materials and methods This was a methodological study on a convenience sample of individuals with unilateral lower-limb amputation attending outpatient rehabilitation centres in Saudi Arabia and Turkey (N = 155). Rasch analysis (WINSTEPS version 4.6.5) was used to examine the 5-categories rating scale structure, item fit, item difficulty hierarchy, person separation index, unidimensionality, local item dependency, and differential item functioning. Results The ABC-5/Ar 5-response option demonstrated an appropriate model fit. Most items fit the Rasch model, except for item #12 “walk in a crowded mall,” which showed an overfitting value of 0.63. The person separation indices 2.95 (Cronbach’s α = 0.96). Principal component analysis of residuals confirmed the unidimensionality of the scale; however, local dependency was detected between item #14 “Ride in escalator holding rail,” and item #15 “Ride in escalator not holding rail.” Conclusions The findings suggest that the ABC-5/Ar shows promise in assessing balance confidence in Arabic-speaking lower-limb prosthesis users. However, further studies with larger sample sizes and in diverse clinical contexts are needed to confirm its effectiveness in various clinical settings.

Development of the ECLIPSE model of meaningful outcome domains following lower limb amputation and prosthetic rehabilitation, through systematic review and best fit framework synthesis.

Little is known about which outcome domains characterise meaningful recovery following prosthetic rehabilitation and should be measured. Our previous qualitative work developed a conceptual model of outcome domains which are meaningful to patients. This qualitative synthesis aims to develop that model by exploring views and experiences of recovery captured in the limb loss literature, and use these to produce a second iteration of the model describing outcome domains of importance following prosthetic rehabilitation from the patient's perspective. Systematic searches were conducted using CINAHL, Psychinfo and Web of Science from 2011 to early 2023. Studies with a qualitative design focusing on views and experiences of lower limb prosthetic users were eligible for inclusion. Quality was assessed using the CASP tool. 'Best Fit' framework synthesis was used to synthesise the evidence and develop the conceptual model. 40 studies were included, describing the experiences of 539 participants. Data supported the pre-existing conceptual model and led to development of four of the five domains. The newly named ECLIPSE model describes meaningful outcome domains as 1) Being able to participate in important activities and roles, 2) Participating in the way I want to, 3) My prosthesis works for me, 4) If I am in pain, I can manage it, and 5) I am able to accept my new normal. Studies came from 15 countries showing good coverage of high-income settings. Few participants from low-and-middle-income countries were included, it is unclear if the ECLIPSE model describes outcome domains of importance in these settings. This synthesis provides a rigorous foundation for understanding outcome domains of importance following lower limb prosthetic rehabilitation from the patient's perspective. The ECLIPSE model is an accessible representation of recovery which could direct rehabilitation programmes, as well as inform the evaluation of prosthetic care through the selection of outcome measures.

The Dynamic Donning Technique of Prosthetic Liners

ABSTRACT Introduction Prosthetic liners are widely used for a variety of indications such as improving prosthetic socket fit and suspension. However, these are associated with complications affecting the skin, including skin rubs, breakdown, and ulceration. Methods and Discussion We outline the splinting effect of prosthetic liners as a possible contributing factor that results in increased shear during joint motion and propose a simple liner donning technique to minimize these shear forces by spreading liner/skin tension over the whole range of motion of the proximal joint. Clinical Relevance The proposed dynamic donning technique would minimize the risk of skin ulcerations and improve joint range of motion in prosthetic limb users.

A NEW TEMPORARY TRAINING PROSTHESIS FOR PEOPLE WITH TRANSTIBIAL AMPUTATION: A TECHNICAL NOTE

BACKGROUND: While waiting to receive a prosthesis, individuals with amputations could benefit from using a temporary training prosthesis to expedite the rehabilitation process and prepare them for subsequent walking with their prosthesis. OBJECTIVES: To design and build a temporary training prosthesis for people with a transtibial amputation. METHODOLOGY: Various temporary training prostheses were designed and simulated using SolidWorks software, followed by fabricating and testing multiple prototypes. Initial tests were conducted on five able bodied subjects without amputation to evaluate comfort, ensure the prototype functioned as intended, and to refine the design. The final prototype design had no weight-bearing on the residual limb end and required the person to wear a shrinker or silicone liner. FINDINGS: SolidWorks simulations showed that the device could tolerate up to 200 kg load. Subjective feedback indicated that body weight is primarily supported by the thigh section, while partially utilizing the patellar tendon and tibial flares. The thigh section can be shifted 5 cm up or down and 2.5 cm to the front or back from the knee joint center (to enhance knee stability or function). Additionally, the thigh angle can be adjusted to 0, 5, 10, or 15 degrees to accommodate hip flexion contracture. The shank section width is adjustable and can be shifted up or down based on the residual limb shape. All five able-bodied participants successfully walked with the non-amputee version of the temporary prosthesis prototype and the device withstood walking, sitting, and standing loads. CONCLUSION: An adjustable temporary training prosthesis was successfully designed, and pilot tested by five able-bodied individuals. Future testing will involve five experienced prosthetic users before conducting trials with individuals with a new transtibial amputation. Layman's Abstract A novel temporary training prosthesis was developed for individuals with new transtibial amputations while they await the healing of their residual limb and the receipt of a prosthesis. Utilizing SolidWorks computer-aided design software, various designs were explored, and rigorous testing was conducted to ensure durability and functionality. Adjustable features were incorporated to accommodate different body shapes and sizes. Initial testing on five people without amputations confirmed device effectiveness in supporting walking, sitting, and standing. Next, performance will be assessed on five experienced prosthetic users before proceeding to trials with individuals with a new transtibial amputation. This temporary prosthesis aims to expedite rehabilitation, enabling people to regain mobility and independence more efficiently. Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/43034/32865 How To Cite: Gholizadeh H, Baddour N, Dudek N, Lemaire E.D. A new temporary training prosthesis for people with transtibial amputation: A technical note. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 1, No.2. https://doi.org/10.33137/cpoj.v7i1.43034 Corresponding Author: Hossein Gholizadeh, PhD, CP (Canada)Department of Mechanical Engineering, University of Ottawa, Ottawa, Canada.E-Mails: hgholizadeh@uottawa.ca, gholizadeh87@yahoo.comORCID ID: https://orcid.org/0000-0001-5847-7985

Comprehensive rehabilitation model of children in need of upper limb prosthetics due to congenital diseases

Rehabilitation in the prosthetics process can significantly enhance patients’ functional abilities and their skill in managing prostheses. Nevertheless, most international rehabilitation recommendations for prosthetic users are aimed at adults. Prior to this research, Russian scientific studies had not proposed a comprehensive model that would integrate current scientific knowledge on the rehabilitation of children needing upper limb prosthetics due to congenital diseases.The aim of the study to develop an organizational-functional model of phased interdisciplinary medical rehabilitation for children requiring upper limb prosthetics due to congenital diseases.Materials and methods. Organizational-functional modeling based on the analysis of regulatory legal acts, scientific research, and guidelines for the medical rehabilitation of children with upper limb peculiarities.Results. The organizational-functional model of rehabilitation includes 3 stages: preparation for prosthetics, rehabilitation upon receiving the prosthetics, and family support during the use of the prosthetics. The main goals of each stage are developed, specialists responsible for solving specific tasks at each stage are identified, and organizations (divisions) responsible for the implementation of each stage are determined. Methodological materials for the parents of children from the target group have been created. Materials aim at optimizing interaction with families and their psychological support. A scheme for remote family support throughout the entire period of prosthetic use has been developed.Conclusion. The developed organizational-functional model of phased interdisciplinary medical rehabilitation for children needing upper limb prosthetics due to congenital diseases is designed to ensure adherence to the fundamental principles of rehabilitation – early start, phased approach, continuity, interdisciplinarity, individualized approach, as well as active family involvement in the rehabilitation process.

Multiplexing intensity and frequency sensations for artificial touch by modulating temporal features of electrical pulse trains.

In neural prostheses, intensity modulation of a single channel (i.e., through a single stimulating electrode) has been achieved by increasing the magnitude or width of each stimulation pulse, which risks eliciting pain or paraesthesia; and by changing the stimulation rate, which leads to concurrent changes in perceived frequency. In this study, we sought to render a perception of tactile intensity and frequency independently, by means of temporal pulse train patterns of fixed magnitude, delivered non-invasively. Our psychophysical study exploits a previously discovered frequency coding mechanism, where the perceived frequency of stimulus pulses grouped into periodic bursts depends on the duration of the inter-burst interval, rather than the mean pulse rate or periodicity. When electrical stimulus pulses were organised into bursts, perceived intensity was influenced by the number of pulses within a burst, while perceived frequency was determined by the time between the end of one burst envelope and the start of the next. The perceived amplitude was modulated by 1.6× while perceived frequency was varied independently by 2× within the tested range (20-40 Hz). Thus, the sensation of intensity might be controlled independently from frequency through a single stimulation channel without having to vary the injected electrical current. This can form the basis for improving strategies in delivering more complex and natural sensations for prosthetic hand users.

CSP2023: 4 - Quality Improvement Project: Improving Lower Limb prosthetic user’s Confidence in their home

CSP2023: 4 - Quality Improvement Project: Improving Lower Limb prosthetic user’s Confidence in their home

Embedded Machine Learning System for Muscle Patterns Detection in a Patient with Shoulder Disarticulation.

The integration of artificial intelligence (AI) models in the classification of electromyographic (EMG) signals represents a significant advancement in the design of control systems for prostheses. This study explores the development of a portable system that classifies the electrical activity of three shoulder muscles in real time for actuator control, marking a milestone in the autonomy of prosthetic devices. Utilizing low-power microcontrollers, the system ensures continuous EMG signal recording, enhancing user mobility. Focusing on a case study-a 42-year-old man with left shoulder disarticulation-EMG activity was recorded over two days using a specifically designed electronic board. Data processing was performed using the Edge Impulse platform, renowned for its effectiveness in implementing AI on edge devices. The first day was dedicated to a training session with 150 repetitions spread across 30 trials and three different movements. Based on these data, the second day tested the AI model's ability to classify EMG signals in new movement executions in real time. The results demonstrate the potential of portable AI-based systems for prosthetic control, offering accurate and swift EMG signal classification that enhances prosthetic user functionality and experience. This study not only underscores the feasibility of real-time EMG signal classification but also paves the way for future research on practical applications and improvements in the quality of life for prosthetic users.

An enhancement of the Genium™ microprocessor-controlled knee improves safety and different aspects of the perceived prosthetic experience for unilateral and bilateral users.

Bilateral microprocessor-controlled prosthetic knee (MPK) users have unique needs in traversing environmental barriers compared to unilateral users. An enhancement to the Genium™/Genium X3™ MPK which included an updated ruleset, hydraulics, and new bilateral parameter presets was made to improve safety while stumbling and the smoothness of gait for all users while also improving the experience of bilateral users. The purpose of the study was to evaluate the effectiveness of the enhancements in a sample with unilateral and bilateral amputation. A convenience sample of MPK users was recruited from two sites in the USA in two phases. Assessments included the L-Test of Functional Mobility, Activity-specific Balance Confidence Scale, Prosthetic Limb User Survey of Mobility, a study-specific questionnaire, and the Comparative Activities of Daily Living (ADL) Questionnaire. Statistical significance of extracted data was tested with the Wilcoxon Rank-Sum Test for independent data and Wilcoxon Signed-Rank for paired data with an a priori significance level of p < 0.05. Unilateral subjects were age-matched to the group of bilateral subjects for between-groups and within-groups analyses. Twenty-six subjects (n = 26) were enrolled. Stumble frequency reduced 85% from 16.0 ± 39.7 to 2.4 ± 2.3 (p = 0.008) between baseline and final assessment overall. The bilateral group reported 50% (p = 0.009) and 57% (p = 0.009) greater relative improvement in patient-reported ease and safety, respectively, of completing ADLs compared to the unilateral group. The unilateral group reported residual limb pain and low back pain reduced from 2.3 to 1.4 (p = 0.020) and 3.8 to 1.8 (p = 0.027), respectively, whereas the bilateral group did not. Substantial reductions in stumbles, residual limb pain, and back pain were shown overall. These reductions were driven by the unilateral group who also showed improvements in comfort, exertion, and concentration while walking. The enhancements to the knee likely reduced some gait asymmetry for unilateral users. Improvements in patient-reported ease and safety of completing ADLs were shown overall and were driven by the bilateral group. This study shows further improvement in patient experience is achievable through innovation in MPK technology even for patients who appear to be functioning well.

Application of ultrasound to monitor in vivo residual bone movement within transtibial prosthetic sockets

Transtibial prosthetic users do often struggle to achieve an optimal prosthetic fit, leading to residual limb pain and stump-socket instability. Prosthetists face challenges in objectively assessing the impact of prosthetic adjustments on residual limb loading. Understanding the mechanical behaviour of the pseudo-joint formed by the residual bone and prosthesis may facilitate prosthetic adjustments and achieving optimal fit. This study aimed to assess the feasibility of using B-mode ultrasound to monitor in vivo residual bone movement within a transtibial prosthetic socket during different stepping tasks. Five transtibial prosthesis users participated, and ultrasound images were captured using a Samsung HM70A system during five dynamic conditions. Bone movement relative to the socket was quantified by tracking the bone contour using Adobe After-Effect. During the study a methodological adjustment was made to improve data quality, and the first two participants were excluded from analysis. The remaining three participants exhibited consistent range of motion, with a signal to noise ratio ranging from 1.12 to 2.59. Medial–lateral and anterior–posterior absolute range of motion varied between 0.03 to 0.88 cm and 0.14 to 0.87 cm, respectively. This study demonstrated that it is feasible to use B-mode ultrasound to monitor in vivo residual bone movement inside an intact prosthetic socket during stepping tasks.

Using mobile eye tracking to measure cognitive load through gaze behavior during walking in lower limb prosthesis users: A preliminary assessment

BackgroundLower limb amputation does not affect only physical and psychological functioning but the use of a prosthetic device can also lead to increased cognitive demands. Measuring cognitive load objectively is challenging, and therefore, most studies use questionnaires that are easy to apply but can suffer from subjective bias. Motivated by this, the present study investigated whether a mobile eye tracker can be used to objectively measure cognitive load by monitoring gaze behavior during a set of motor tasks. MethodsFive prosthetic users and eight able-bodied controls participated in this study. Eye tracking data and kinematics were recorded during a set of motor tasks (level ground walking, walking on uneven terrain, obstacle avoidance, stairs up and ramp down, as well as ramp up and stairs down) while the participants were asked to focus their gaze on a visual target for as long as possible. Target fixation times and increase in pupil diameters were determined and correlated to subjective ratings of cognitive load. FindingsOverall, target fixation time and pupil diameter showed strong negative and positive correlations, respectively, to the subjective rating of cognitive load in the able-bodied controls (−0.75 and 0.80, respectively). However, the individual correlation strength, and in some cases, even the sign, was different across participants. A similar trend could be observed in prosthetic users. InterpretationThe results of this study showed that a mobile eye tracker may be used to estimate cognitive load in prosthesis users during locomotor tasks. This paves the way to establish a new approach to assessing cognitive load, which is objective and yet practical and simple to administer. Nevertheless, future studies should corroborate these results by comparing them to other objective measures as well as focus on translating the proposed approach outside of a laboratory.

Comparing the effectiveness of computer-aided design/computer-aided manufacturing (CAD/CAM) of insoles manufactured from foam box cast versus direct scans on patient-reported outcome measures: a protocol for a double-blinded, randomised controlled trial

IntroductionCustom insoles are a routine treatment for many foot pathologies, and the use of computer-aided design and computer-aided manufacturing (CAD/CAM) is well established within clinical practice in the UK. The...

The Development of a Virtual Reality-based Training System for Prosthetic Foot Users: Effects on Motion Sickness and Postural Stability

The Development of a Virtual Reality-based Training System for Prosthetic Foot Users: Effects on Motion Sickness and Postural Stability

Khmer translation and cultural adaptation of the Locomotor Capabilities Index-5.

Mobility is a major goal of prosthetic and orthotic rehabilitation, and use of outcome measures to evaluate mobility is necessary for good clinical practice. To support the use of outcome measures worldwide, work is needed to translate relevant instruments and adapt them for use in multiple cultures. The objective of this research was to use a standardized method to translate the Locomotor Capabilities Index-5 (LCI-5) into Khmer, the national language in Cambodia, and to evaluate its cultural integrity by assessing it with a group of prosthesis and orthosis users. Instrument translation and cultural validation. Two forward translations of the LCI-5 were produced and then reconciled into a single document. The Khmer version was back translated into English, and a group of experts reviewed the back translation. Two rounds of cognitive interviews were conducted with lower-limb prosthetic and orthotic users who provided feedback. During the reconciliation process, minor changes were made to 6 of the 14 items. Changes were most often made to better reflect the conceptual meaning of the original English version. Cognitive interviews resulted in the addition of a new response alternative. Use of a standardized method to translate the LCI-5 resulted in a linguistically and culturally valid Khmer version of the instrument. Following appropriate psychometric testing, this instrument will facilitate measurement of mobility in prosthetic and orthotic clinical practice in Cambodia as well as support national and multinational research.

A scoping review on upper extremity prostheses: Satisfaction, barriers, and their implications in resource-limited countries.

The rates of prosthetic abandonment are not extensively understood especially in resource-limited countries. A scoping review was conducted to examine the literature on the satisfaction with and barriers to using specifically upper limb prostheses. A systematic search of the literature identified 425 studies. After reviewing the articles using predetermined inclusion and exclusion criteria, 7 cross-sectional studies were included in the final review. Barriers to the use of upper limb prostheses include the characteristics of the prosthesis (type, comfort, weight, functionality, price, and availability) and individual patient factors (recent prosthetic user, level of amputation, congenital and accidental limb loss, pain, and duration between amputation and prosthetic fitting). Considering tailored prosthetic design and funding may result in improved prosthetic adherence.

An ex vivo animal model to study the effect of transverse mechanical loading on skeletal muscle

In many populations like wheelchair and prosthetic users, the soft tissue is subject to excessive or repetitive loading, making it prone to Deep Tissue Injury (DTI). To study the skeletal muscle response to physical stress, numerous in vitro and in vivo models exist. Yet, accuracy, variability, and ethical considerations pose significant trade-offs. Here, we present an ex vivo approach to address these limitations and offer additional quantitative information on cellular damage. In this study, skeletal muscle tissue from Sprague Dawley rats was isolated and transversely loaded. Histological analysis and fluorescence staining demonstrated that the setup was suitable to keep the tissue alive throughout the experimental procedure. Mechanically induced cell damage was readily distinguishable through morphological changes and uptake of a membrane impermeable dye. Our comparably simple experimental setup can be adapted to different loading conditions and tissues to assess the cell response to mechanical loading in future studies.