Several studies have presented technological ensembles of active knee systems for transfemoral prosthesis. Other studies have examined the amputees' gait performance while wearing a specific active prosthesis. This paper combined both insights, that is, a technical examination of the components used, with an evaluation of how these improved the gait of respective users. This study aims to offer a quantitative understanding of the potential enhancement derived from strategic integration of core elements in developing an effective device. The study systematically discussed the current technology in active transfemoral prosthesis with respect to its functional walking performance amongst above-knee amputee users, to evaluate the system's efficacy in producing close-to-normal user performance. The performances of its actuator, sensory system, and control technique that are incorporated in each reported system were evaluated separately and numerical comparisons were conducted based on the percentage of amputees' gait deviation from normal gait profile points. The results identified particular components that contributed closest to normal gait parameters. However, the conclusion is limitedly extendable due to the small number of studies. Thus, more clinical validation of the active prosthetic knee technology is needed to better understand the extent of contribution of each component to the most functional development.
The development of the CAD/CAM (Computer-aided design and computer-aided manufacturing) system has globally changed the fabrication and delivery of prosthetics and orthotics. Furthermore, since the introduction of CAD/CAM in the 1980s, many successful CAD/CAM system are available in the market today. However, less than 20% of amputees have access to digital fabrication technology and large portion of the amputees are from the developing countries. This review designed to examine selected studies from 1980 to 2019 on CAD/CAM systems in the production of transtibial prosthetic sockets. A review was conducted based on articles gathered from Web of Science, Pubmed and Science Direct. From the findings, 92 articles found related to CAD/CAM-derived transtibial prosthetic socket (TPS). After a further screening of the articles, 20 studies were chosen and only one study was done in a developing country. The results showed an increase interest in CAD/CAM application in Transtibial prosthetic socket (TPS) production for both developed and developing countries, yet the technology has not fully utilised in the developing countries. Factors such as resources, accessibility, knowledge-gap and lack of experienced prosthetists remain the major causes of the lack of CAD/CAM system studies. Large-scale trials are required to employ digital fabrication in the developing regions, consequently advancing the production of high-quality CAD-CAM-derived TPS where most prosthetic and orthotics are needed.
The distribution of interface stresses between the residual limb and prosthetic socket of a transtibial amputee has been considered as a direct indicator of the socket quality fit and comfort. Therefore, researchers have been very interested in quantifying these interface stresses in order to evaluate the extent of any potential damage caused by the socket to the residual limb tissues. During the past 50 years a variety of measurement techniques have been employed in an effort to identify sites of excessive stresses which may lead to skin breakdown, compare stress distributions in various socket designs, and evaluate interface cushioning and suspension systems, among others. The outcomes of such measurement techniques have contributed to improving the design and fitting of transtibial sockets. This article aims to review the operating principles, advantages, and disadvantages of conventional and emerging techniques used for interface stress measurements inside transtibial sockets. It also reviews and discusses the evolution of different socket concepts and interface stress investigations conducted in the past five decades, providing valuable insights into the latest trends in socket designs and the crucial considerations for effective stress measurement tools that lead to a functional prosthetic socket.
Muscle fatigue is a decline in muscle maximum force during contraction and can influence the fall risk among people. This study is aimed at identifying the effect of fatigue on prospective fall risk in transfemoral amputees (TFA). Fourteen subjects were involved in this study with TFA (34.7 ± 8.1 yrs, n = 7) and normal subjects (31.1 ± 7.4 yrs, n = 7). Fatigue of lower limb muscles was induced with the fatigue protocol. Subjects were tested prefatigue and postfatigue using the standardized fall risk assessment. All results were calculated and compared between pre- and postfatigue to identify fatigue's effect on both groups of subjects. The results showed that the fall risk increased significantly during pre- and postfatigue for TFA (p = 0.018), while there were no significant differences in normal subjects (p = 0.149). Meanwhile, the fall risk between TFA and normal subjects for prefatigue (p = 0.082) and postfatigue (p = 0.084) also showed no significant differences. The percentage (%) of increased fall risk for TFA was 19.2% compared to normal subjects only 16.7%. However, 61.4% increased of % fall risk in TFA after fatigue by using the baseline of the normal subject as the normalized % of fall risk. The increasing fall risks for TFA after fatigue are three times higher than the potential fall risk in normal subjects. The result indicates that they need to perform more precautions while prolonging lower limb activities. These results showed the implications of fatigue that can increase the fall risk due to muscle fatigue from repetitive and prolonged activities. Therefore, rehabilitation programs can be done very safely and precisely so that therapists can pursue fitness without aggravating existing injuries.
This study aimed to compare the effect of satisfaction and perceived problems between Pelite, Dermo with shuttle lock, and Seal-In X5 liners on the transtibial amputees.
The suspension system and socket fitting of artificial limbs have major roles and vital effects on the comfort, mobility, and satisfaction of amputees. This paper introduces a new pneumatic suspension system that overcomes the drawbacks of current suspension systems in donning and doffing, change in volume during daily activities, and pressure distribution in the socket-stump interface. An air pneumatic suspension system (APSS) for total-contact sockets was designed and developed. Pistoning and pressure distribution in the socket-stump interface were tested for the new APSS. More than 95% of the area between each prosthetic socket and liner was measured using a Tekscan F-Scan pressure measurement which has developed matrix-based pressure sensing systems. The variance in pressure around the stump was 8.76 kPa. APSS exhibits less pressure concentration around the stump, improved pressure distribution, easy donning and doffing, adjustability to remain fitted to the socket during daily activities, and more adaptability to the changes in stump volume. The volume changes were adjusted by utility of air pressure sensor. The vertical displacement point and reliability of suspension were assessed using a photographic method. The optimum pressure in every level of loading weight was 55 kPa, and the maximum displacement was 6 mm when 90 N of weight was loaded.
This study aimed to evaluate the effects of prosthetic foot types on the postural stability among transtibial amputees when standing on different support surfaces.
The purpose of this study was to find the scientific evidence pertaining to various transfemoral suspension systems to provide selection criteria for clinicians. To this end, databases of PubMed, Web of Science, and ScienceDirect were explored. The following key words, as well as their combinations and synonyms, were used for the search: transfemoral prosthesis, prosthetic suspension, lower limb prosthesis, above-knee prosthesis, prosthetic liner, transfemoral, and prosthetic socket. The study design, research instrument, sampling method, outcome measures, and protocols of articles were reviewed. On the basis of the selection criteria, 16 articles (11 prospective studies and 5 surveys) were reviewed. The main causes of reluctance to prosthesis, aside from energy expenditure, were socket-related problems such as discomfort, perspiration, and skin problems. Osseointegration was a suspension option, yet it is rarely applied because of several drawbacks, such as extended rehabilitation process, risk for fracture, and infection along with excessive cost. In conclusion, no clinical evidence was found as a "standard" system of suspension and socket design for all transfemoral amputees. However, among various suspension systems for transfemoral amputees, the soft insert or double socket was favored by most users in terms of function and comfort.
Today a number of prosthetic suspension systems are available for transtibial amputees. Consideration of an appropriate suspension system can ensure that amputee's functional needs are satisfied. The higher the insight to suspension systems, the easier would be the selection for prosthetists. This review attempted to find scientific evidence pertaining to various transtibial suspension systems to provide selection criteria for clinicians.
Postural control has been widely evaluated for the normal population and different groups over the past 20 years. Numerous studies have investigated postural control in quiet standing posture among amputees. However, a comprehensive analysis is lacking on the possible contributing factors to balance. The present systematic review highlights the current findings on variables that contribute to balance instability for lower extremity amputees. The search strategy was performed on PubMed, Web of Science, Medline, Scopus, and CINAHL and then followed by additional manual searching via reference lists in the reviewed articles. The quality of the articles was evaluated using a methodological quality assessment tool. This review included and evaluated a total of 23 full-text articles. Despite the inconsistencies in the methodological design of the studies, all articles scored above the acceptable level in terms of quality. A majority of the studies revealed that lower extremity amputees have increased postural sway in the standing posture. Asymmetry in body weight, which is mainly distributed in the non-amputated leg, was described. Aside from the centre of pressure in postural control, sensory inputs may be a related topic for investigation in view of evidence on their contribution, particularly visual input. Other balance-related factors, such as stump length and patients' confidence level, were also neglected. Further research requires examination on the potential factors that affect postural control as the information of standing postural is still limited.
Lower-limb amputation is mainly a result of trauma, vascular disease, diabetes, or congenital disorders. Persons with amputation lose their ability to stand and walk on the basis of the level of amputation. Contribution of level of amputation, type of amputation, or cause of amputation to balance impairment has not been clearly defined. Furthermore, it is controversial how much the mentioned parameters influence standing stability. Therefore, the aim of this review article was to find the relationship between the abovementioned factors and balance impairment in the available literature. It was also aimed to find the possibility of improving standing stability by the use of different prosthesis components.
In recent years, computerized posturography has become an essential tool in quantitative assessment of postural steadiness in the clinical settings. The purpose of this study was to explore the ability of the Biodex(®) Stability System (BSS) to quantify postural steadiness in below-knee amputees. A convenience sample of 10 below-knee amputees participated in the study. The overall (OSI), anterior-posterior (APSI) and medial-lateral (MLSI) stability indexes as well as the percentage of time spent in left and right quadrants and four concentric zones were measured under altered sensory conditions while standing with solid ankle cushion heel (SACH), single-axis (SA) and energy storage and release (ESAR) feet. Significant difference was found between sensory conditions in SACH and ESAR feet for OSI (SACH, p = 0.002; ESAR, p = 0.005), APSI (SACH, p = 0.036; ESAR, p = 0.003) and MLSI (SACH, p = 0.008; ESAR, p = 0.05) stability indexes. The percentage of time spent in Zone A (0°-5°) was significantly greater than the other three concentric zones (p < 0.01). The loading time percentage on their intact limb (80%-94%) was significantly longer than the amputated limb (20%-6%) in all conditions for all three prosthetic feet. Below-knee amputees showed compromised postural steadiness when visual, proprioceptive or vestibular sensory input was altered. The findings highlight that the characteristics of postural stability in amputees can be clinically assessed by utilizing the outcomes produced by the BSS.
This study describes a newly developed prosthetic leg socket design for a below-knee amputation. Excessive heat and the resulted perspiration within a prosthetic socket were the most common causes for reporting a reduced quality of life for prosthetic users. The product namely AirCirc means air circulation and it has been designed by approach of medical device design process in providing the amputees to maintain the skin temperature inside the socket. This device has been designed to provide the amputees with comfort and ultimate breathable. In order to design the device, the small hole was made in prosthetic socket surface since it has a function as air circulation. Four types of proposed sockets namely P1, P2, P3 and P4 and one control socket were compared on a single patient to determine the best design of prosthetic socket. The result successfully reveals that by using holes can be maintain the temperature inside prosthetic socket. In addition to the eco-friendly material, the woven kenaf was used as material that provides good strength as compared to glass fibre and offer sustainable and biodegradable product yet provides unique and aesthetic surface as came from woven kenaf itself. The objective of this paper is to provide the airflow prosthetic socket design and optimize the use of natural fibre in prostheses field. Thus, with the use of the environmental friendly material, functionality device and heat removal capability make the device suitable for maintaining a comfortable and healthy environment for prosthesis. Implications of Rehabilitation Newly developed prosthetic leg socket design for a below-knee amputation Device has been designed to provide the amputees with comfort and ultimate breathable Woven kenaf was used as material that provides good strength as compared to glass fibre for sustainable and biodegradable product Results show that by using holes can be maintain the temperature inside prosthetic socket.
This paper presents a fiber Bragg grating (FBG)-instrumented prosthetic silicone liner that provides cushioning for the residual limb and can successfully measure interface pressures inside prosthetic sockets of lower-limb amputees in a simple and practical means of sensing. The liner is made of two silicone layers between which 12 FBG sensors were embedded at locations of clinical interest. The sensors were then calibrated using a custom calibration platform that mimics a real-life situation. Afterward, a custom gait simulating machine was built to test the liner performance during an amputee's simulated gait. To validate the findings, the results were compared to those obtained by the commonly used F-socket mats. As the statistical findings reveal, both pressure mapping methods measured the interface pressure in a consistent way, with no significant difference (P-values ≥0.05). This pressure mapping technique in the form of a prosthetic liner will allow prosthetics professionals to quickly and accurately create an overall picture of the interface pressure distribution inside sockets in research and clinical settings, thereby improving the socket fit and amputee's satisfaction.
Materials with low-strength and low-impedance properties, such as elastomers and polymeric foams are major contributors to prosthetic liner design. Polyethylene-Light (Pelite™) is a foam liner that is the most frequently used in prosthetics but it does not cater to all amputees' limb and skin conditions. The study aims to investigate the newly modified Foam Liner, a combination of two different types of foams (EVA + PU + EVA) as the newly modified Foam Liner in terms of compressive and tensile properties in comparison to Pelite™, polyurethane (PU) foam, and ethylene-vinyl acetate (EVA) foam. Universal testing machine (AGS-X, Shimadzu, Kyoto, Japan) has been used to measure the tensile and compressive stress. Pelite™ had the highest compressive stress at 566.63 kPa and tensile stress at 1145 kPa. Foam Liner fell between EVA and Pelite™ with 551.83 kPa at compression and 715.40 kPa at tension. PU foam had the lowest compressive stress at 2.80 kPa and tensile stress at 33.93 kPa. Foam Liner has intermediate compressive elasticity but has high tensile elasticity compared to EVA and Pelite™. Pelite™ remains the highest in compressive and tensile stiffness. Although it is good for amputees with bony prominence, constant pressure might result in skin breakdown or ulcer. Foam Liner would be the best for amputees with soft tissues on the residual limbs to accommodate movement.
Prosthetic alignment is an essential process to rehabilitate patients with amputations. This study presents, for the first time, an invented device to read and record prosthesis alignment data. The digital device consists of seven main parts: the trigger, internal shaft, shell, sensor adjustment button, digital display, sliding shell, and tip. The alignment data were read and recorded by the user or a computer to replicate prosthesis adjustment for future use or examine the sequence of changes in alignment and its effect on the posture of the patient. Alignment data were recorded at the anterior/posterior and medial/lateral positions for five patients. Results show the high level of confidence to record alignment data and replicate adjustments. Therefore, the device helps patients readjust their prosthesis by themselves, or prosthetists to perform adjustment for patients and analyze the effects of malalignment.
Transtibial amputees encounter stairs and steps during their daily activities. The excessive pressure between residual limb/socket may reduce the walking capability of transtibial prosthetic users during ascent and descent on stairs. The purposes of the research were to evaluate the interface pressure between Dermo (shuttle lock) and Seal-In X5 (prosthetic valve) interface systems during stair ascent and descent, and to determine their satisfaction effects on users.
Conventionally, patellar tendon-bearing (PTB) sockets, which need high dexterity of prosthetist, are widely used. Lack of chartered and experienced prosthetist has often led to painful experience of wearing prosthesis and this will in turn deter the patients to wear the prosthesis, which will further aggravate stump shrinkage. Thus, the hydrostatic socket which demands relatively lower level of fabricating skill is proposed to replace the PTB socket in order to produce the equivalent, if not better, quality of support to the amputee patients. Both sockets' pressure profiles are studied and compared using finite element analysis (FEA) software. Three-dimensional models of both sockets were developed using MIMICS software. The analysis results showed that hydrostatic socket did exhibit more uniform pressure profiles than that of PTB socket. PTB socket showed pressure concentration near the proximal brim of the socket and also at the distal fibula. It was also found that the pressure magnitude in hydrostatic socket is relatively lower than that of PTB socket.
The objectives of this study were to compare the effects of a newly designed magnetic suspension system with that of two existing suspension methods on pistoning inside the prosthetic socket and to compare satisfaction and perceived problems among transtibial amputees.